THANK YOU ALL FOR COMING. IT IS MY PLEASURE TO START THE DAY AND ORIENT THE DAY. THE FIRST TWO SESSIONS ARE GOING TO BE A DISCUSSION ABOUT THE TEMPLATE DOCUMENTS THAT WE HAVE CREATED TO FACILITATE AN FY 16 RFA. SO WE HAVE A CLEAR GOAL, WE WANT GENERAL FEEDBACK ON SPECIFIC TERMS IN THOSE DOCUMENTS THAT I WILL FACILITATE. BUT LATER IN THE DAY WE WILL TALK ABOUT ISSUES THAT WOULD BE NECESSARY FOR BRAIN TO ADDRESS IN FUTURE YEARS, ET CETERA WITH THE IDEA TO THE TAP YOUR BRAIN AS A PLANNING EFFORT. THERE'S TALKING TO MANY OF YOU YESTERDAY. EVERYBODY IS EXCITEDDED BECAUSE THERE'S A LOT OF PEOPLE IN THE ROOM TOGETHER FOR THE FIRST TIME AND THEY SEE A LOT OF POSSIBILITY TO ADDRESS OPPORTUNITIES AND BARRIERS TOGETHER. BUT IN THE MORNING WE HAVE TO FOCUS ON WHAT IS NECESSARY FOR A BRAIN RFA IN FY 16 AND WE HAVE PLANNING SESSIONS AND THE HOPE QUITE FRANKLY IS FOR ALL OF YOU TO IDENTIFY FOR US OPPORTUNITIES BARRIERS PEOPLE WHO NEED TO BE IN THE ROOM TO TALK SPECIFIC SUBJECTS, WITH THE IDEA OF FOLLOW ON WORKSHOPS FULLY DEDICATED TO THOSE SUBJECTS AS WELL. YOU WILL HELP OUR PLANNING EFFORT. MORNING, FOCUS GOAL LATER IN THE AFTERNOON EVERYTHING YOU THINK WE CAN DO THROUGH THIS CONSTRUCT TO HELP IN THE FUTURE. A LOT OF THE IDEAS BEHIND THIS PUBLIC PRIVATE PARTNERSHIP, WE PILOTED THROUGH THE N CATS DRUG REPURPOSING PROGRAM. WE HAVE BEEN TRYING TO FOLLOW THAT MODEL AS MUCH AS POSSIBLE BECAUSE THIS WAS A VERY SUCCESSFUL PROGRAM THAT HAS BEEN DONE THROUGH N CATS, THE NATIONAL CENTER FOR ACCELERATING ADVANCING TRANSLATION -- THERE WE GO. IT IS THE MY PLEASURE TO INTRODUCE DR. DAN TAGLE FROM N CATS WHO WILL DESCRIBE THE N CATS PROCESS AND SEGUE HOW WE HAVE TO MODIFY FOR DEVICES A LITTLE BIT BUT WE HAVE A SUCCESSFUL HISTORICAL PRECEDENT THAT WASN'T EASY HERE TO GET SEVERAL PHARMA COMPANIES CLINICAL PIs, UNIVERSITY TRANSFER OFFICES TO AGREE TO TEMPLATE DOCUMENTS ANT A PROCESS TO FACILITATE THESE COLLABORATIONS. DAN TAKE IT AWAY. >> THANK YOU. AND FANTASTIC JOB FOR YOU AND NED IN ORGANIZING THIS MEETING. THANKS FOR THE ORGANIZING COMMITTEE FOR THE INVITATION. SOL QUICK ORIENTATION WITH THE MORNING FIRST 20 MINUTES, BACK TO GAVE A BRIEF INTRODUCTION ABOUT N CATS AND THEN I WILL SEGUE INTO ENABLING PUBLIC PRIVATE PARTNERSHIPS THROUGH THE PROGRAM, THAT KIP MENTIONED. IN TERMS OF DRUG DEVELOPMENT THERE'S BEEN MENTIONED YESTERDAY IN TERMS OF THE VALUE LIFE DEATH, SO THERE'S -- THINGS ARE (INAUDIBLE) AFTER YOU GO THROUGH THE VALUE LIFE DEATH SO THIS IS FOR SMALL MOLECULES, FOR DRUG DEVELOPMENT THIS IS WHAT THE LANDSCAPE LOOKS LIKE, 10 TO 15 YEARS TO BRING A SINGLE DRUG MARKET APPROVAL FROM 1.2 TO $5 BILLION FOR SMALL MOLECULES SO CERTAINLY A DAUNTING TASK. AND CAUSEDDED SIGNIFICANT CONCERN. IN TERMS OF WHAT YOU'RE LOOKING HERE AT THE PLOT OF DRUGS NEW DRUGS APPROVED STARTING FROM 1950, 1950 THROUGH TO 2010. SO IT'S NOT REALLY A TREND YOU WANT TO SEE. IT'S SIGNIFICANTLY GOING DOWN. QUOTED (INAUDIBLE) LAW WHICH IS THE FLIP AFTER MOORE'S LAW WHICH IS FOR YOU IN THE BIOCOMPUTATIONAL FIELD, THE CAPACITY TO COMPUTATIONAL DOUBLE EXPONENTIALLY EVERY FEW YEARS OR SO. SO IT DOES NOT ESCAPE THE ATTENTION OF CONGRESS SO BACK IN 2011, AS PART OF THE APPROPRIATIONS ACT, THE NATIONAL CENTER FOR ADVANCING TRANSLATION A SCIENCES WAS CREATED AND GOT STOOD UP IN DECEMBER OF 2012. ESSENTIALLY THE MISSION OF N CATS IS TO CATALYZE THE GENERATION OF INNOVATIVE METHODS AND TECHNOLOGIES THAT WILL ENHANCE DEVELOPMENT AND TESTING IMPLEMENTATION DIAGNOSTICS AND THERAPEUTICS ACROSS A WIDE RANGE OF HUMAN DISEASES AND CONDITIONS. SO IT'S ALL ABOUT PROCESS, IN TERMS OF DEVELOPING TECHNOLOGIES METHODOLOGIES IN TRANSLATIONAL SCIENCE. BECAUSE THIS IS A LARGE FIELD AND N CATS IS ONE OF 27 CENTERS INSTITUTES AND OFFICE WITNESS THE NIH WE NEED TO PARTNER. N CATS IS ALL ABOUT PARTNERSHIPS AND SO WE PARTNERED NOT ONLY WITHIN VARIOUS ORGANIZATIONS WITHIN THE NIH, BUT ALSO CATALYZE COLLABORATIONS OUTSIDE OF THE NIH IN TRANSACADEMIA, ESPECIALLY THE PATIENT ADVOCACY GROUPS, NON-PROFIT ORGANIZATION, OTHER GOVERNMENT AGENCIES, PHARMA, AND BIOTECH. N CATS STUDIES SCIENTIFIC AND ORGANIZATIONAL PROBLEMS HERE IS A LIST, NOT AN EXHAUSTIVE LIST, SOME OF THE AREAS THAT WE'RE WORKING ON. SOME OF THEM ARE SCIENTIFIC, SOME ARE ORGANIZATIONAL ISSUES. TOXICOLOGY EFFICACY STUDIES ORGANIZATIONAL IN HARMONIZED IRB AND ONE THING WE'RE ALSO WORKING ON, FACILITATING PUBLIC PRIVATE PARTNERSHIPS. SO HERE IS THE NEW REALITY THAT WE'RE WORKING ON. SO WE'RE NOT WORKING RIGHT NOW WITH THE BIG PHARMA PIPELINE MODEL WHICH IS THE MODEL IN PLACE, WE'RE NOT LOOKING AT THE ECONOMIC COMPETITION EARLY STAGE INNOVATIONS AND THEN BASIC AND APPLIED RESEARCH. SO THE NEW REALITY WE WORK ON IS THAT WE HAVE THE DISTRIBUTED PARTNERSHIP MODEL, PRECOMPETITIVE COLLABORATION, PATIENT CENTERED GOALS AND PATENTING ONLY DEVELOPED PRODUCTS AND OF COURSE TEAM BASED RESEARCH WHICH IS CENTRAL TO BRAIN AND TO OTHER EFFORTS THAT N CATS IS INVOLVED IN. SO WE HAVE DONE AWAY WITH OFFICE OF TECHNOLOGY TRANSFER AND REPLACED WITH OFFICE OF STRATEGIC ALLIANCES. AND PRIMARILY FOCUSED ON EXPLORING COLLABORATIVE APPROACHES. FACILITATES AND OPERATES ENTIRELY ACROSS THE ENTIRE TRANSLATIONAL SPECTRUM FROM T 1 TO T 4 AND PART OF THIS IS ALSO MANAGING A VERY I WOULD SAY VERY INNOVATIVE SMALL BUSINESS PROGRAM THAT USES NOT ONLY SMALL BUSINESS OMNIBUS FACILITATIONS BUT SBIR CONTRACTS AND THE HEAD OF THAT OFFICE IS LILY PORILLA IN CASE YOU WANT TO FIND OUT MORE ABOUT IT SO ONE OF THE THINGS THAT LILY'S OFFICE HAS DONE IN FACILITATING PUBLIC PRIVATE PARTNERSHIPS IS USE OF TEMPLATE AGREEMENTS, WHICH IS THE SUBJECT OF CONVERSATION FOR THE NEXT HOUR OR SO. CERTAINLY GIVEN YOU COPY OF THE TEMPLATE AGREEMENT THAT WAS -- THAT N CATS WORKED WITH WITH PHARMA COMPANIES SO THIS IS I THINK THE ONES THAT ARE IN YOUR HANDS ARE THE MEMORANDUM OF UNDERSTANDING, CONFIDENTIAL DISCLOSURE AGREEMENTS, TECH TRANSFER AGREEMENT, COLLABORATIVE RESEARCH AGREEMENT AND WE ALSO HAVE CERTAIN OTHER THINGS LIKE CLINICAL TRIALS AGREEMENT AND THE CREDAs. THIS TEMPLATE AGREEMENT HAVE BEEN VETTED WITH OFFICE OF GENERAL COUNCIL NIH GONE THROUGH SIGNIFICANT VETTING AS WELL WITH VARIOUS UNIVERSITIES, BIOTECH AND PHARMA INDUSTRY. SO ONE EXAMPLE OF THE PUBLIC PRIVATE PARTNERSHIP WITH THE USE OF TEMPLATE AGREEMENT IS IN DISCOVERING OF NEW THERAPEUTIC USE FOR EXISTING MOLECULES. SO THIS IS ESSENTIALLY LOOKING AT REPURPOSING DRUGS. WHAT HAPPENS HERE IS THAT YOU CAN SEE THERE ARE ESSENTIALLY IN THIS VIN DIAGRAM NIH THROUGH NCATS, FAR MANY AND RESEARCHERS AND PHARMA CONTRIBUTES TO THE LANDSCAPE IN TERMS OF DEVELOPING THE DRUG DEVELOPERS AND UNDER THIS AGREEMENT THEY PROVIDE AGENTS INCLUDING PLACEBO PK PD DATA, AND SAFETY PROFILING INFORMATION. NCATS WILL FACILITATE THIS KIND OF INTERACTION WITHIN PHARMA AND THE NIH AND ACQUIRE THE AGENT INFORMATION PUBLISH TO OUR WEBSITE, DEVELOP TEMPLATE AGREEMENTS, AND ESSENTIALLY DO A CROWD SOURCING TYPE SOLICITATION FOR USE OF SMALL MOLECULE AND PROVIDE THE FUNDING. THE CLINICAL RESEARCHERS ON THE OTHER HAND WILL PROVIDE NEW THERAPEUTIC USE IDEAS ACCESS TO PATIENT POPULATIONS, AND CONDUCT A CLINICAL TRIALS AND IN THE CASE OF DRUGS WILL FILE THE IND, INVESTIGATIONAL NEW DRUGS. UNDER THE NEW THERAPEUTIC USE PROGRAM, ENABLES INVESTIGATORS TO PROPOSE THERAPEUTIC NEW THERAPEUTIC APPLICATIONS FOR EXISTING MOLECULES AND THIS INCLUDES ADULT AS WELL AS PEDIATRIC INDICATIONS, I PUT DOWN THE CONTACT INFORMATION, THE NAME OF THE PROGRAM OFFICER CHRISTINE COLVIS WHO THESE PROGRAM AND I MENTION NIH OR NCATS PROVIDE A TEMPLATE PARTNERSHIP, THE C AREDA, THE CRA, AS WELL AS MOU. PEER REVIEW FUNDING AND OVERSIGHT. THE PHARMA PARTNERS INCLUDE ASTRA ZENECA, JANSEN, PFIZER AND SANOFI. CERTAINLY LARGE PHARMA COMPANIES. THE TEMPLATE AGREEMENTS HAVE BEEN USED THE MOU DONE SMOOTHLY NEGOTIATIONS WITH GSK FOR PROGRAM I'M HEADING AND SIGNED THE MOU IN TWO MONTHS WORKING ON ANOTHER AGREEMENT WITH PFIZER. IT'S VERY -- AT LEAST CERTAINLY AMENABLE TO THE USE FOR PHARMA. IN THIS CASE ACADEMIC RESEARCHERS PROVIDE UNDERSTANDING OF DISEASE BIOLOGY, PROVIDES NEW CONCEPTS TO TEST AND RUNS A CLINICAL TRIAL AND OF COURSE ACCESS TO THE PATIENTS. IN TERMS OF WHAT WE PUT OUT AS SELECTION FOR AGENTS THE PHARMA, AGENTS NEED A MECHANISM OF ACTION IT WILL AGENT MUST BE SELECTIVE. PK DATA IS SUITABLE TO EXPLORE THE MECHANISM IN A NEW INDICATION. PHASE 1 CLINICAL TRIAL IS COMPLETED, SAFETY PROFILE ACCOMPLISHED PRE-CLINICAL AND CLINICAL AGENT AND PLACEBO WILL BE PROVIDED IN KIND BY THE PHARMA PARTNER FOR THE CLINICAL STUDIES AND AVAILABILITY OF ADDITIONAL SAFETY AND DATA INFORMATION FOR REGULATORY DOCUMENTS SHOULD BE MADE AVAILABLE TOWARDS AN IND. SO HERE IS AN EXAMPLE, SOME EXAMPLES OF SMALL MOLECULES ARE MADE AVAILABLE BY THE COMPANY SO SHOWS ON THE TOP ON THE LEFT HAND COLUMN ESSENTIALLY THE IDENTIFYING NUMBERS FOR THE AGENT COLUMN FOR MECHANISM OF ACTION, ORIGINALLY INDICATED USE FOR SMALL MOLECULE AS WELL AS ROUTE OF ADMINISTRATION SO THIS IS THE TABLE THAT N CATS PROVIDE TO THE SCIENTIFIC COMMUNITY IN TERMS OF THE INITIAL ENTRY POINT. IN TO THE NTU PROGRAM, NEW THERAPEUTIC USE PROGRAM. IF YOU CLICK ON THE AGENT NUMBER, IT WILL EXPAND TO MORE INFORMATION, THAT'S BEEN SUPPLIED BY THE COMPANIES IN THIS CASE AN AGENT SUPPLIED BY ASTRA ZENECA WILL BE -- WILL GIVE YOU MORE OVERVIEW OF THE ACTION, SELECTIVITY, SAFETY TOLERABILITY DATA, ADDITIONAL INFORMATION SUCH AS ADVERSE EVENTS EXPERIENCED. USING THIS DRUG, AND CERTAINLY SOME OF THE CLINICAL TRIALS ONGOING FOR THIS PARTICULAR AGENT. SO THAT WHAT DOES THE NTU PROGRAM LOOK LIKE? THIS IS SORT OF THE GENERAL FLOW THAT KIP AND NED IN USE WITH THE BRAIN INITIATIVE. IT'S A PUBLIC PRIVATE PARTNERSHIP ESTABLISHED THROUGH AN MOU WITH PHARMA THAT ALLOWS THE PHARMA TO PROVIDE INFORMATION ABOUT THE KIND OF DRUGS AND ASSOCIATING INFORMATION. WE THEN PUT THAT OUT ON THE WEBSITE, PUBLISH FUNDING OPPORTUNITY ANNOUNCEMENT ALONG WITH INFORMATION ON INFORMATION MADE AVAILABLE. ON THE RIGHT HAND SIDE THE GENERAL TIME LINE KIND OF LIKE THE USUAL NIH NINE MONTH CYCLE. WE PROVIDE A WEBINAR TO THE APPLICANTS AND THEN PRE-APPLICATION NON-BINDING BUT ESSENTIALLY CLINICAL INVESTIGATORS LOOK AT THE INFORMATION ON THE WEBSITE AND THINK ABOUT POTENTIAL NEW INDICATION NEW USE FOR THAT COMPOUND, SUBMIT XO TO SUBJECT TO PEER REVIEW THROUGH CSR. NIH LOOKS AT THAT TIME TOP APPLICATION AND SHARE IT WITH PHARMA AND TOGETHER WITH PHARMA WE DECIDE ON APPLICATIONS INVITE TED FOR A FULL PROPOSAL THEN CLINICAL ACADEMIC INVESTIGATORS WILL THEN INITIATE A CDA, A CONFIDENTIAL DISCLOSURE AGREEMENT, RESEARCH AGREEMENT THAT ALLOWS PHARMA PARTNERS TO PROVIDE ADDITIONAL INFORMATION SO A FULL PROPOSAL CAN BE SUBMITTED. IN THIS PARTICULAR CASE THIS IS A PHASE APPLICATION, COOPERATIVE AGREEMENT, UH-2, 3, THE SAME MECHANISM KIP AND NED PLAN TO USE FOR BRAIN, THE UH-2 IS TWO YEARS OF PRE-CLINICAL OR EARLY CLINICAL STUDY AN UH-3 IS A CLINICAL TRIAL STUDY. SO THE FULL APPLICATIONS ARE REVIEWED, GOES THROUGH SECOND LEVEL REVIEW BY COUNCIL, AWARDS ARE MADE, THEN PROJECT ESSENTIALLY RUNS FOR TWO TO FOUR YEARS. AN EXAMPLE OF THIS IS ASTRA ZENECA DRUG REPURPOSED FOR ALZHEIMERS DISEASE, SO IN THIS CASE AZD 5030 ORIGINALLY DEVELOPED FOR CANCER. IN FACT ON GOING PHASE 2B CLINICAL TRIALS FOR RENAL PROSTATE AND BREAST CANCER, WHAT THIS AGENT IS, ENZYME INHIBITOR FOR FIN KINASE, WHEN THE DRUG WAS AVAILABLE BY PHARMA AS SOON AS POSTED ON THE WEB WITHIN A FEW WEEKS, THERE WAS A PUBLICATION THAT CAME OUT IN NATURE NEUROSCIENCE BY STEVE STREETMATTER FROM YALE INDICATING THAT ALZHEIMERS AMYLOID BETA OLIGOMERS IS BOUND MORE PROTEIN, THAT LEADS TO IMPAIRMENT OF THE NEURONS. SO THIRDLY, CERTAINLY A SCIENTIFIC MATTER TO -- AUGUST 2020 WITHIN A MONTH THAT WE MADE THE INFORMATION AVAILABLE TO THE PUBLIC. THEN THROUGH USUAL PEER REVIEW, PARTNERSHIP WITH ASTRA ZENECA, NIH OR NCATS AWARDED A PRE-CLINICAL AND PHASE 1B TRIAL, FOR UH-2 AWARD. IN THIS CASE IT WAS THE PRE-CLINICAL THE FDA WANTED WAS PROOF OF CONCEPT THAT IT WORKS IN ALZHEIMER'S MOUSE MODEL AND IN FACT IT DID, THAT WAS ACTUALLY PUBLISHED JUST EARLY THIS YEAR. SHOWING KINASE RESCUES THE MEMORY AND ALZHEIMERS MOUSE MODEL. SO THE UH-2 UH-3 AWARD WAS JUST ACTUALLY GIVEN TO THIS GROUP, PRE-CLINICAL, PHASE 1B AND ONGOING PHASE 1 TRIAL AND ACTIVELY RECRUITING PATIENTS. AT THIS POINT. JUST TO MENTION THERE IS A PARALLEL PROGRAM CALLED SPARK STIMULATING PERIPHERAL ACTIVITY TO CONDITIONS THAT IS PARALLEL TO THE BRAIN INITIATIVE. LOOKING AT NEUROMODULATION IN THE BRAIN BUT PERIPHERAL NERVOUS SYSTEM, THIS IS SOMETHING THAT A NEW PROGRAM THAT IS FUNDED BY THE NIH COMMON FUND, STARTS THIS YEAR AND WILL RUN TO 2021, FOCUSED ON THREE MAJOR AREAS LOOKING AT THE BIOLOGY DEVELOPING FUNCTIONAL PERIPHERAL NERVOUS SYSTEM DEVELOPING NEXT GENERATION TOOLS AN CERTAINLY OF INTEREST OF THIS GROUP WILL BE SMALL MARKET INDICATIONS WHICH INVOLVES PARTNERSHIP WITH INDUSTRY AND FDA PROOF OF CONCEPT STUDIES. AND KIP HAS BEEN HEAVILY INVOLVED IN PLANNING OF THIS NEW PROGRAM. THIS IS THE CONTACT INFORMATION AND SMALL MARKET INDICATIONS WOULD BE SOMETHING THAT I THINK WILL BE LOOKING FORWARD TO TEMPLATE AGREET COMING OUT OF DISCUSSIONS THROUGH BRAIN AND YOU CAN PROBABLY SEE THOSE TEMPLATE AGREEMENTS AGAIN LATER ON. WHEN WE FULLY LAUNCH SPARK. THIS WILL BE USED -- I THINK I HAVE ALREADY HAD INITIAL DISCUSSIONS WITH SOME OF THE DEVICE MANUFACTURERRING HERE SO THOSE ARE ESSENTIALLY THE SAME AGREEMENTS WE WILL BE UTILIZING AND WE WILL BE MOVING FORWARD WITH THOSE AGREEMENTS WITH SOME SLIGHT MODIFICATIONS. THEN THE LAST SLIDE MORE ABOUT NCATS, SOME SOCIAL MEDIA SITES THAT WE HAVE HAPPY TO TAKE QUESTIONS IF THERE ARE ANY OR JUST MOVE ON TO YOUR DISCUSSION. >> GENERIC DRUGS, HAVE YOU HAD ANY SUCCESS WITH THE OLDER DRUGS THAT ARE REPURPOSED? BECAUSE INDUSTRY IS LESS INTERESTED USUALLY IN DEALING WITH THE UNPATENTED VERSIONS. WE DON'T HAVE THAT RIGHT NOW IT'S ON THE LIST BECAUSE CERTAINLY NOT ON THE LIST OF DRUGS THAT WE'RE PARTNERING WITH INDUSTRY AT THIS POINT SO WE HAVE NOT HAD OCCASION A GENERIC DRUG WOULD BE SOMETHING THAT WOULD COME TO OUR ATTENTION FOR REPURPOSING. BUT COULD BE -- >> THAT'S A PROBLEM, RIGHT? BECAUSE THERE ARE MANY DIFFERENT -- I CERTAINLY KNOW IN MY OWN INSTITUTION THERE'S SEVERAL OLD DRUGS BEING INVESTIGATED THAT YOU CAN'T ACTUALLY GET PARTNERS FOR. >> YEAH. IF IT'S -- IT'S SOMETHING WE HAVE LOOKED AT IN TERMS OF RARE DISEASES, PIPPED SECURITIZATION FOR RARE DISEASES SO THOSE ARE THINGS BEING FUNDED THROUGH ANOTHER PROGRAM AT NCATS. THERAPEUTICS. (OFF MIC) >> SO THE PART OF THE CRA COLLABORATIVE RESEARCH AGREEMENT, THE COMPANY HAS THE RIGHT OF FIRST REFUSAL. (OFF MIC) >> CORRECT. >> THANKS VERY MUCH. >> ALL RIGHT. SO THIS I THINK IS GOING TO BE A LOT OF FUN. I HAVE BEEN LOOKING FORWARD TO THIS FOR SEVERAL MONTHS. BUT WE NEED TO ORIENT THIS SESSION. SO THIS IS IN SUPPORT OF A SHORT TERM GOAL FOR THE WORKSHOP. WHAT WE WANTED TO DO IS GENERATE TEMPLATE AGREEMENTS TO SUPPORT AN FY 16 BRAIN RFA WITH SET ASIDE WHERE CLINICAL INVESTIGATORS COULD LEVERAGE COMPANY DEVICES WITH EXISTING SAFETY DATA AND UTILITY DATA TO CONDUCT NEW EXPLORATORY CLINICAL RESEARCH STUDIES. THE HOPE REALLY IS THAT THE EXPLORATORY DATA IS NECESSARY TO CREATE A FULL BUSINESS CASE, IN EXPLORATORY STUDIES ARE SUCCESSFUL IN INITIAL RESULTS THAT THEY WILL BE COMPELLING ENOUGH TO HAVE COMPANY PARTNERS POTENTIALLY INVEST IN THE LARGER SCALE CLINICAL TRIALS THAT WOULD BE NECESSARY TO BRING THESE TO FULL COMMERCIAL MARKET. SO I HAVE THIS CAVEAT ON THE BOTTOM. PLEASE FOR THE SESSION FOCUS ON WHAT IS CRITICALLY NECESSARY, WHAT ARE DEAL BREAKERS FOR FY 16 VERSUS LATER SESSIONS TODAY WE WILL TALK ABOUT OPPORTUNITIES THAT COULD AND SHOULD BE ADDRESSED THROUGH PUBLIC PRIVATE PARTNERSHIPS BUT WE WANT THE TO IDENTIFY WHAT ARE KEY DEAL BREAKERS FOR PUBLIC PRIVATE PARTNERSHIPS FOR FY 16. SO DAN GAVE A FANTASTIC OVERVIEW, WE HAD A PROCESS TO FOLLOW HERE. WE HAVE BEEN WORKING FROM ORIGINAL NCATS TEMPLATES REFINED THROUGH SEVERAL ITERATIONS WITH LEGAL, PHARMA, ET CETERA, THAT ADDRESSED THE STICKING POINTS IN CONVERSATIONS ALREADY. WE WILL DISCUSS THOSE KEY POINTS SO YOU WERE GIVEN TEMPLATES ON SUNDAY, MANY HAVE NOT READ THEM, DON'T WORRY. WE'LL TALK KEY STICKING POINTS IN INITIAL CONVERSATIONS. NED MYSELF AND SEVERAL OTHERS SPENT THE LAST SEVERAL MONTHS IT RATING WITH DEVICE COMPANIES NOT TAKING THE NCATS DOCUMENTS BUT EXAMPLE DOCUMENTS THAT THEY HAVE USED TO CREATE COLLABORATIONS TO SEED A BRAIN FOA ALREADY RELEASED, IT WAS RELEASED IN FEBRUARY AND HAD A RECEIPT DATE IN APRIL THE TO DO EXPLORATORY CLINICAL RESEARCH STUDIES SO THEY HAD EXISTING CDAs AND CRAs AND WE LOOKED AT WHAT THE TERMS WERE FOR THOSE THAT WERE COME TO AFTER MONTHS OF NEGOTIATION. WE USED THAT TO MERGE WITH THE NCATS DOCUMENTS TO CREATE THIS PROCESS. AS PART OF THIS PROCESS WE HAD INITIAL PHONE CALLS WITH INSTITUTIONAL TECH TRANSFER AND CONTRACT OFFICES TO TALK ABOUT AT LEAST SOME OF THE KEY POINTS AND GET THEIR FEELINGS ON WHETHER THE STARTING POINTS FOR THESE TEMPLATES. THESE ARE INTENDED TO BE STARTING POINT FOR NEGOTIATION, THE HOPE IS THESE ARE GOOD STARTING POINTS THAT WILL BE ACCEPTED AS IS IN MANY CASES, FACILITATE THE SUPPRESS NCI IN OTHERS BUT YOU CAN MAKE CHANGES OR AT LEAST TRY TO GET THE COMPANIES TO AGREE TO CHANGE TO THE TEMPLATE, IF YOU SO CHOOSE, AND IF THE END COMPANIES MAY OR MAY NOT AGREE TO THAT. THAT'S PART OF THE -- I WON'T CALL RISK BUT PART -- YOU WANT TO CHANGE THESE TERMS? YOU'RE GOING TO HAVE TO HAVE BOTH SIDES AGREE TO IT. THAT MAY THEY CAN A LONG TIME. WE HAVE ALSO HAD CLINICAL RAYTORS WHO HAVE UTILIZED PARTNERSHIPS WITH COMPANIES BEFORE GIVE FEEDBACK ON TERMS WE GOT TO AS STARTLING POINTS. WE BROUGHT UP THE FDA IN THIS PROCESS INFORMING THEM AS WELL TO GET THEIR PERSPECTIVE. WE HAD THESE GO THROUGH NIH GENERAL COUNCIL AND THE NINDS AND NIH TECH TRANSFER OFFICE AS WELL TO GET THEIR FEEDBACK ON THESE TERMS. DAN TALKED ABOUT THIS BUT THERE ARE THREE TEMPLATE DOCUMENTS. ONE IS A MEMORANDUM OF UNDERSTANDING. THE MEMORANDUM OF UNDERSTANDING IS NOT A LEGALLY FINDING DOCUMENT. IT IS AN AGREEMENT BETWEEN NIH AND COMPANIES THAT OUTLINES THE PROCESS FOR THESE PUBLIC PRIVATE PARTNERSHIPS. IT DESCRIBES THE PROCESS FOR COLLABORATIONS, BUT ALSO INCLUDES EXHIBIT C AND D WHICH ARE SPECIFIC TO EACH COMPANY. THAT OUTLINES, I SHOULD MENTION AT THIS POINT ALL THESE ARE TENTATIVE, COMPANIES HAVE LOOKED A T THESE, CONSIDERING DOING AND CONSIDERING AGREEING TO BUT NOTHING IS FINAL. BUT DESCRIBE IT IS SORT OF DEVICE CAPABILITIES THEY FEEL THEY CAN ENABLE OR WILLING AND ABLE TO DO EXPLORATORY CLINICAL RESEARCH STUDIES THAT WOULDN'T REQUIRE SIGNIFICANT ADDITIONAL PRE-CLINICAL DATA TO ENABLE. THAT'S AN IMPORTANT POINT. WE HAVE THROUGH FY 15 FOA ALREADY OUT HAD A UH-2 MECHANISM TO SUPPORT NON-CLINICAL TESTING TO DO DEVICES ENTIRELY NEW CONCEPT DEVICES KNOWN SAFETY AND PRE-CLINICAL AND POTENTIALLY CLINICAL UTILITY DATA FOR NEUROSCIENCE TO DO EXPLORATORY CLINICAL RESEARCH SAW STUDIES. THE NEXT IS A CONFIDENTIAL GUESS DISCLOSURE AGREEMENT, A STANDARD AGREEMENT BETWEEN THE COMPANIES TAN RESEARCH INSTITUTE, TO FACILITATE THE TRANSFER OF MORE SPECIFIC TECHNICAL SPECIFICATIONS, ET CETERA, ABOUT THE COMPANY DEVICES. THE MOU WILL ONLY TALK DEVICE CAPABILITIES IN GENERAL TERMS SO RESEARCHERS CAN LOOK AT IT LOOK ACROSS MANY COMPANIES AND GET AN IDEA WHAT THEY CAN PROVIDE BUT UNDER CDA WILL TALK TO COMPANIES ABOUT MORE SPECIFIC TECHNICAL DETAILS YOU NEED TO KNOW TO ENABLE NIH APPLICATION. THERE IS NO RIGHT NOW CDA BETWEEN THE NIH AND THE COMPANIES. THIS WAS AFTER DISCUSSION WITH THE COMPANIES. THE REASON BEING NIH STAFF IN TERMS OF MAIN TAGGING CONFIDENTIALITY IS COVERED UNDER THE FEDERAL TRADE ACT AND THE REVIEW PROCESS AND FEDERAL TRAIT TRADE SEQUENCE, THERE'S CONFIDENTIALITY AGREEMENTS PART OF REVIEWS AS WELL. WE'RE WILLING TO DISCUSS THIS THE IF ANY COMPANY FELT THERE WAS A NEED TO DISCLOSE INFORMATION AND POINT THEY FELT TO MINI STAFF THAT NEEDED CONFIDENTIAL DISCLOSURE AGREEMENT WILLING TO DO THAT BUT PRELIMINARY CONVERSATIONS NOT USED NECESSARY STRAIGHT COMPANIES RESEARCH INSTITUTION TESTIMONY THIRD DOCUMENT IS THE COLLABORATIVE RESEARCH AGREEMENT, THE COMPANIES AND RESEARCH INSTITUTION AND IT COVERS RULE AND RESPONSIBILITIES THAT WILL GOVERN COLLABORATION INCLUDING POINTS ON HANDLING OF THE DATA, HANDLING INTELLECTUAL PROPERTIES AS WELL AS OUTLINES SO EVERYBODY KNOWS UP FRONT OUTSIDE THE STANDARD COMPANY AGREEMENT NIH AWARD REQUIREMENTS. IN TERMS OF THINGS TO REPORT AND PROCESS AND EVERYONE IS AGREEING, THEY HAVE TO COMPLY WITH THE TERMS IN THE NIH AWARD AND PROCESS OF THIS RESEARCH AGREET. THESE AGREEMENTS ONLY GO INTO EFFECT IF THERE'S NIH AWARD, GO INTO EFFECT WHEN THE NIH AWARD IS AWARDED THAT'S AN IMPORTANT POINT AS WELL. YOU SUBMIT APPLICATION DON'T GET AWARD, COLLABORATIVE RESEARCH AGREEMENTS HAVE NO WEIGHT WHATSOEVER. SO I WISH I HAD SEEN DAN'S FLOWCHART. I HAD MY OWN BUT IT IS VERY SIMILAR AND THIS IS THE PROCESS WE ENVISION. RIGHT NOW WE'RE GOING TO CREATE MOUs, PUBLICIZE AND MAKE IT SO ALL CLINICAL PIs INTERESTED CAN SEE THE GENERAL CAPABILITIES THESE COMPANIES ARE WILLING TO ENABLE. THEY'RE GOING TO LOOK AT THIS AND USE IT TO SEED A SHORT APPLICATION, AN XO-2. THE IDEA IS UTILIZING DEVICE CAPABILITIES TO THE NIH AND WE WILL DO A QUICK REVIEW. N CATS WAS ABLE TO GET THIS TO SIX WEEKS AND THEY JUST REQUIRED A FOUR PAGE PROPOSAL. WE DON'T KNOW WHAT EXACT DEFINITION OF XO-2 WILL BE FOR THE NIH YET BUT THAT'S THE MODEL WE HOPE TO FOLLOW SO NOT TOO ONEROUS FOR THE CLINICAL PIs AND YOU GET A QUICK HIGHLY MERITORIOUS GOOD SHOT FUNDING VERSUS NO SHOT ONE OF THE DIFFICULTIES THEM DOING THIS SORT OF THING IS THEY DON'T NECESSARILY HAVE THE BANDWIDTH TO TALK TO HUNDREDS OF CLINICAL INVESTIGATORS AND THEY WANTED THIS FILTER TO SAY DOES THIS HAVE A GOOD SHOT AT REWARD FOR DOESN'T, THAT MAKES COMPLETE SENSE. SO AFTER REVIEW, HIGHLY MERITORIOUS PRE-APPLICATIONS WILL BE PAIRED WITH THE COMPANY AND UNDER A CDA THE COMPANY WILL PROVIDE MORE TECHNICAL DETAILS THAT ARE NECESSARY TO WRITE A FULL NIH APPLICATION TO A BRAIN RFA WITH SET ASIDE TO SUPPORT EXPLORATORY CLINICAL RESEARCH PROJECTS. THEY WILL SIGN A CRA CONTINGENT ON THE AWARD AND WORK TOGETHER TO SUBMIT A FULL APPLICATION TO A BRAIN UH-3 RFA I SEE JAMIE GOING -- SO THIS IS AN IMPORTANT PART. THE WAY THESE ARE WRITTEN, THE IDE OR IF IT HAPPENS TO BE AN I AREB NON-SIGNIFICANT RISK STUDY, APPROVAL IS EXPECTED IN UO-1 OF THE AWARD. YOU'RE NOT EXPECTED TO HAVE APPROVAL BEFORE GET AGO WARD A, B, VERY IMPORTANT POINT T RESEARCH INSTITUTION WILL SPONSOR THE IDEs, ET CETERA, AND CLINICAL INVESTIGATOR. THE COMPANIES ARE AWARE THEY WILL HAVE TO SUPPLY SOME REGULATORY SUPPORT AND TECHNICAL SUPPORT AND REALLY EXPERIENCE IN TERMS OF HELPING THE INVESTIGATOR CREATE AN IDE BUT A SONSOR WILL BE RESEARCH INVESTIGATOR AND RESEARCH INSTITUTION WHICH MEANS A LOT OF RESPONSIBILITY WILL BE ON THE RESEARCH INVESTIGATOR AND RESEARCH INSTITUTION. BECAUSE THEY'RE EXECUTING THE STUDY, THAT MAKES A LOT OF SENSE. SO WE WANT TO TALK ABOUT THE BENEFITS TO THIS AND WHAT WE'RE ENVISIONING BUT DEFINITELY CURIOUS TO HEAR YOUR THOUGHTS ON THIS AS WELL. THE BENEFIT TO RESEARCH INSTITUTION AN RESEARCHER, FIRST THESE ARE DEVICES IN MANY CASES TEN YEARS AWAY FROM MARKET APPROVAL. THEY HAVE SHOWN SAFETY AND UTILITY FOR NEUROSCIENCE AND WE WANT ACCESS TO DO EXPLORATORY CLINICAL RESEARCH. TWO, MANY OF THESE MARKET APPROVED DEVICES HAVE SCIENTIFIC RESEARCH PLATFORMS TALKED ABOUT SO ELOQUENTLY THAT CAN BE UNLOCKED TO PROVIDE EXPANDED CAPABILITIES FOR CLINICAL RESEARCHERS TO DO CLINICAL RESEARCH. YOU GET TO LEVERAGE THE PREVIOUSLY DEMONSTRATED SAFETY AND DEVICE CAPABILITY FROM THESE COMPANIES TO CREATE NEW IDEs OR AT LEAST DO NEW IRB NON-SIGNIFICANT RISK STUDIES. THE HOPE ALSO IS ALL THE COMPANIES SEEM RIGHT NOW TENTATIVELY ARE AGREEING TO SIMILAR WORDING FOR THE CRA CDA AND MOU AND WE'LL SEE HOW THAT BEARS OUT, THESE WILL BE EASIER AND TRANSPARENT FOR PEOPLE TO REVIEW. LOOK AT THE CAPABILITIES, THEY CAN PROVIDE AND ALSO LOOK AT THE STARTING POINTS ACROSS THE CA,As AND SEE WHAT TURN -- TERMS IN TERMS OF IP DATA HANDLING, LIABILITY, AND WE'LL TALK ABOUT THOSE IN DETAIL IN A SECOND. NIH FUNDING FOR EXPLORATORY RESEARCH THAT'S A BIG BENEFIT. THE BENEFIT TO THE COMPANIES IS REALLY IMPORTANT TO ARTICULATE. I DON'T MEAN TO SAY THIS IS GOING TO BE ALL THE BENEFIT, ET CETERA, AND CURIOUS COMPANY FEEDBACK ON IT BUT ONE BIG THING IS NIH FUNDING TO ADDRESS UNKNOWNS IN BUSINESS CASE, NEW THERAPIES BIOMARKERS, BIOLOGICAL UNDERSTANDING TO OPTIMIZING EXISTING THERAPIES. THIS IS QUITE HARD AND I COME FROM INDUSTRY TO GET FUNDING BECAUSE IT'S AN UNKNOWN IN THE BUSINESS CASE WHEN YOU TRY SOMETHING NEW AND YOU GO TO HUMAN BEING FIRST TIME YOU LEARN A LOT. AND IT'S REALLY HARD TO JUSTIFY TO YOUR BUSINESS DEPARTMENT AND YOUR LEGAL DEPARTMENT AT THAT POINT THAT WE WILL MAKE MONEY OFF THIS IDEA BECAUSE FRANKLY WE DON'T KNOW. AND I WOULD LIKE TO POINT OUT ALSO I WORKED VERY CHOSELY WITH ALL THE COMPANIES THROUGHOUT THIS PROCESS, AND REALLY ALMOST ALL CASES THIS IS REALLY BEING FORWARDED BY RESEARCH DEPARTMENTS, ET CETERA, AND A LOT OF WAYS WHERE THEIR SCIENTISTS WHO WANT TO HELP PEOPLE AND THEY WANT TO DO THE SCIENCE TO ADDRESS SCIENTIFIC UNKNOWNS. AND THEY'RE EXCITED TO DO THIS BECAUSE THEIR SCIENTISTS JUST LIKE YOU. AND THEY'RE VERY APPROACHABLE AND THEY'RE ACTUALLY CHAMPIONING THIS, GETTING PUSH BACK FROM THEIR LEGAL AND FROM THEIR BUSINESS DEPARTMENTS ON HOW TO ARTICULATE THIS VALUE. MOST WON THAT BATTLE BUT I WANT TO POINT OUT, A LOT OF TIMES I TALK TO PIs, COMPANIES AS BIG BLACK BOXES, THEY THINK THEY ONLY CARE ABOUT FUNDING. I CAN SAY PEOPLE YOU WORK WITH THIS IN THESE ROOMS ARE VERY GOOD SCIENTISTS FROM THESE COMPANIES. WHO REALLY JUST CARE ABOUT THE PATIENTS IN DOING THE SCIENCE AT THIS POINT. THAT'S AN IMPORTANT -- IMPORTANT TO REMEMBER. COMPANIES GET TEMPLATES GENERATED TO NIH PUBLIC PROCESS. THE HOPE IS START OF THAT PROCESS BUT THE HOPE IS THAT ALL COMPANIES AGREE TO TEMPLATES OR CLOSE TO THEM AS SMALL MODIFICATIONS THEY HAVE SIMILAR WORDING VETTED IN THE PROCESS FOR CLINICAL PIs HAVE SEEN REPRESENTATIVES FROM TECH TRANSFER OFFICES AND CONTRACT OFFICES HAVE SEEN THEM, THESE WILL EXPEDITE THE PROCESS GREATLY, IT CAN TAKE THREE TO SIX MONTHS TO COME TO THESE TERMS WITH TECH TRANSFER OFFICES AND COMPANIES THE HOPE IS THAT THIS MAKES IT EASIER FOR A LOT OF YOU, NOT GOING TO SOLVE ALL PROBLEMS. THEY GET ACCESS TO MORE IDEAS BROADLY. SEVERAL COMPANIES AT DIFFERENT POINTS SAY WE REALIZE ALL THE BEST IDEAS ARE NOT GOING TO COME FROM OUR COMPANY. THERE ARE BRILLIANT MINDS IN THIS ROOM. QUITE FRANKLY THERE WILL BE SIGNIFICANT IP SACKS TO THEM FOR BEING EXPOSED TO THESE IDEAS. WE WILL DISCUSS THAT IN DETAIL. THEY ALSO, THIS IS ADVANTAGE THAT I DIDN'T KNOW STARTING OUT BUT FOR SEVERAL, NIH PEER REVIEW IS A BIG ADVANTAGE. AND CAN BE A BIG ADVANTAGE TO HAVE SOMEBODY EXTERNAL SCIENTIFIC EXPERTS LOOK AT THIS AND SAY THIS IS THE SCIENTIFICALLY RIGHT THING TO DO, IT CAN MAKE INSURANCE UNDERWRITING EASIER BUT ALSO BE -- IMPOSSIBLE TO HAVE EXPERTISE IN ALL THESE DISEASE PATHOLOGIES BIOLOGICAL MECHANISMS, ET CETERA AND SMALLER COMPANIES NIH MAKES IT EASIER TO GET FURTHER INVESTMENT AS WELL. IT WILL BE OUTSIDE EXTERNAL PEER REVIEW. BUT NOT BE IN PERSON STUDY SECTION THE WAY WE CONCEPTUALIZE IT, THAT'S CONSISTENT WITH THE XO-2 MODEL, THOSE WERE MAIL IN REVIEWS, IS THAT CORRECT? >> QUICKLY I GUESS THE MODEL WE WANT TO DO IS MAKE SURE THE PRE-PROPOSAL PROCESS GOT THE SIX WEEKS SO WE WANT TO ADOPT THE N CATS MODEL PERFECTLY BECAUSE THEY WERE ABLE TO GET THOSE TURNED AROUND IN SIX WEEKS. AND THAT'S AN IMPORTANT POINT HERE. BENEFITS TO THE FDA. WE WANTED AND WE HAVE BEEN WORKING WITH THE FDA VERY CLOSELY ABOUT THIS. AND THEY -- PARTNERING WITH US TO HELP THE PROCESS HERE. THE BENEFIT TO THE FDA FOR THIS IS THEY GET EARLY NOTICE OF POTENTIAL STUDIES, IT'S EASIER TO EXPEDITE IF MONOGRAPH. THE PROCESS IF THEY KNOW WHAT'S COMING DOWN THE PIPELINE AND START THINKING ABOUT IT AND THINK ABOUT WHAT SORT OF TESTING BUT ALSO OUTREACH IS IMPORTANT. NOT ONLY WEBINAR BUT THEY WAN TALK ABOUT THE CLINICAL PI IF WRITING IDE LEVERAGING EXISTING COMPANY DATA, WHAT IS THE BEST WAY TO DO IT, THAT'S AN IMPORTANT POINT, THAT'S WHAT WE'RE TRYING TO BRING IN. BUT ALSO THEY VIEW THIS AS AN OPPORTUNITY FOR CLINICAL INVESTIGATOR SMALL COMPANIES AN LARGE COMPANIES TO GIVE FEEDBACK TO THE FDA ABOUT HOW THEIR GUIDANCES OUTREACH, ET CETERA, ARE INTERPRETED. CLARIFICATION, ET CETERA, HOPEFUL BY PARTICIPATING IN THIS PROCESS THEY HAVE LOT OF EXPERIENCE WORKING WITH LARGE COMPANIES BUT IN TERMS OF CLINICAL PI DOING THIS THE FIRST TIME, ET CETERA, THERE IS IT'S DIFFICULT TO UNDERSTAND WHAT'S CONFUSING FOR THIS THE FIRST TIME, THE HOPE IS TO IDENTIFY THINGS THAT MAY NEED FURTHER CLARITY AND REFINE THEM, THIS IS PARTNERSHIP AND INNOVATION PEOPLE YOU HAVE IN THIS ROOM FROM THE FDA I WORKED WITH FOR FOUR YEARS THEY EMBRACED THEIR CONCEPT OF A PARTNERSHIP AND INNOVATION. THEY WANT TO SEE NEW DEVICES THAT GET TO MARKET TO HELP PEOPLE, THEY WANT TO MAKE SURE THEY'RE SAFE BUT CRITICALLY REALIZE THINGS THAT HELP PEOPLE GET TO PEOPLE QUICKER AND WANT TO WORK WITH YOU TO UNDERSTAND HOW WE CAN ENSURE SAFETY, BUT ALSO ADDRESS SPEED TO MARKET CONCERN THAT HAVE SUCH PROMISE. BENEFIT TO THE PUBLIC IS IMPORTANT TO ARTICULATE AS WELL. WE BELIEVE BY LEVERAGING EXISTING COMPANY DATA EACH CLINICAL PI TO DEVELOP A NEW DEVICE THAT COSTS TENS OF MILLIONS OF DOLLARS AND YEARS, ET CETERA, THEY GET ACCESS TO THESE -- THIS MILLIONS OF DOLLARS OF RESEARCH TO DO NEW CLINICAL EXPLORATORY RESEARCH. FDA MANUFACTURES ARE INVOLVED IN THE BEING. ONE THING WE STRUGGLE WITH AT THE NIH IS HOW TO COMPLIMENT PATHWAY THE GETS THINGS TO MARKET. BY PARTNERS MANUFACTURERS EARLY STAGE THINGS THAT ARE ARE PROMISING IN EXPLORATORY RESEARCH THE COMPANY IS THERE, THEY'RE AWARE, THEY'RE TALKING ABOUT WHAT THE DATA HAS TO LOOK LIKE BEFORE THEY BE WILLING TO INVEST. IN LARGE SCALE CLINICAL TRIALS AND HAPPENING BEFORE THE EXPLORATORY STUDY INSTEAD OF AFTER BECAUSE THERE'S A GAP TRYING TRY FIGURE OUT EXPLORATORY CLINICAL STUDIES DESIGNED SUCH THAT THEY ANSWER A SCIENTIFIC QUESTION BUT DON'T ADDRESS UNKNOWNS IN THE BUSINESS CASE WITHOUT ADDITIONAL WORK. SO ANOTHER IMPORTANT THING WE ARE NOT GOING TO COVER ALL PROBLEMS TODAY. WE HAVE AN HOUR PANEL SESSION, BUT WHAT WE WANT TO DO IS START GETTING FEEDBACK ON THE KEY STICKING POINTS, THE THAT NEEDS TO HAVE FOR RFA AND TEMPLATES IN FY 16. YOU'RE ALWAYS WELCOME TO GIVE FEEDBACK ON THE FIRST OF ALL THROUGH ME, I HOPE SEVERAL OF YOU WHO HAVEN'T READ DOCUMENTS WILL READ THEM IN DETAIL AND JUST HAVE CONVERSATIONS WITH ME AND TRY TO FIGURE OUR HOW WE CAN ADDRESS THIS AS A COMMUNITY. SECONDLY, OR SPECIFIC THINGS THAT COME UP THAT WE DON'T RESOLVE HERE TODAY, THE CHAMPIONS OF THAT PARTICULAR POINT, I'M GOING TO FOLLOW-UP WITH YOU PERSONALLY, WE WILL FOLLOW-UP WITH YOU AND FIGURE THE BEST WAY TO COME TO A CONSENSUS TO ADDRESS STICKING POINTS. THE END OF THIS MONTH THERE WILL BE A REQUEST FOR -- PUBLIC REQUEST FOR INFORMATION. THIS AUDIENCE WAS LIMITED TO GOAD GET RIGHT EXPERTISE IN THE ROOM BUT ABLE TO HAVE INFORMAL TO IT RATE STICKING POINTS AND GET MORE THOUGHTS, BUT WE NEED TO DO THIS WIDER AND MAKE SURE EVERYBODY WHO HAS AN INTEREST HAS A CHANCE FOR FEEDBACK, THAT'S THE RFI. THESE DOCUMENTS ARE NOT FINALIZED FOR THE RFA UNTIL AUGUST. WE BAKED IN A LOT OF TIME TO TRY TO RESOLVE STICKING POINTS AS BEST WE CAN, WE WON'T RESOLVE ALL TODAY BUT SEVERAL MONTHS PLANNED AFTER THIS, STICKING POINTS FOR AN FY 16 RFA. I WILL STOP THERE BEFORE PANEL SESSION. I ASKED SEVERAL REPRESENTATIVES TO BE COMMUNITIES TO BE PART OF THE PANEL BUT WHETHER IT'S PANE, CLINICAL PIs, INSTITUTIONAL TECH TRANSFER AND CONTRACT OFFICES REPRESENTATIVES, THIS IS A WIDER DISCUSSION. WE HOPE YOU WILL GIVE YOU INPUT. WE DISCUSS KEY POINTS IN THE PANEL DISCUSSION THAT I WILL INTRODUCE INTELLECTUAL PROPERTY, DATA SHARING CONFIDENTIALITY, LIABILITY THAT'S ALL WE'LL COVER IN AN HOUR, I DON'T THINK WE'LL IT RATE THROUGH TOPICS THAT'S AN EXTENT WE WANT TO. KEEP YOUR POINTS SHORT. FIRST I WILL STOP, I WILL OUTLINE THE PROCESS WE ENVISION. QUESTIONS ON THE PROCESS BEFORE KEY POINTS IN CRAs AND CDAs. >> SO BACK TO THE FLOWCHART A SECOND. YOU TALKED ABOUT THE THIS IDEA OF ADDRESSING UNKNOWNS IN THE BUSINESS CASE, SO THAT PRESUMABLY THEN THAT -- THIS OCCURS AFTER ONE SCHMITZ FO-2 INVESTIGATOR INITIATED. >> UNKNOWN BUSINESS CASE IS WHEN YOU SUBMIT THE FULL APPLICATION, TALK TO THE COMPANIES, THEY CAN GUIDE YOU IF THERE ARE THINGS IN A CLINICAL STUDY TO MAKE IT EASIER FOR THEM TO PRESENT THE BUSINESS CASE FOR SUCCESSFUL TO GO FURTHER WITH THIS, THEY CAN GIVE FEEDBACK ON THAT, MOST WOULD BE WILLING TO SAY THIS WOULDN'T BE HARD FOR YOU TO DO. BUT IN THE COMMERCIAL MARKET THIS IS INVESTMENT THROUGH US OR OTHER PEOPLE AS WELL. (OFF MIC) >> YOU KNOW MY NEXT COMMENT, RIGHT BOB? THANK YOU FOR VOLUNTEERING. THESE ARE NOT GOING TO BE REVIEWED THROUGH CSR. THESE ARE GOING TO BE REVIEWED IN HOUSE AND THE PEOPLE CAN W DEVICE EXPERTISE IS WORKING VERY CLOSELY WITH THE GREAT SCIENTIFIC REVIEW BRANCH THAT NINDS, THESE WILL LIKELY BE REVIEWED AT NINDS. BUT I ALSO MINED EVERYBODY I KNOW THAT WON'T COMPETE WITH YOU BUT HAS COMPANY EXPERIENCE, WHO HAS DONE THIS AND UNDERSTANDS ONE THING THAT'S DIFFICULT TO UNDERSTAND IS EXPLORATORY CLINICAL RESEARCH, THE FIRST TIME YOU MAKE THE JUMP, I SAID THIS TO SEVERAL IN THE ROOM, YOU DON'T KNOW WHAT THE MEANS AN VARIANCES ARE. YOU ARE NOT -- ETHICALLY IMPLANTABLE DEVRIES YOU DON'T IMPLANT A HUNDRED PEOPLE TO START. YOU HAVE TO GET DATA IN Ns OF FIVE OR TEN AND YOU LOOK FOR MEAN SIGNAL DIFFERENCES, LOOKING FOR THINGS THAT ARE MANY PROMISING ENOUGH THAT'S A CULTURE SHIFT AND THAT'S WHAT WE HAVE TO BAKE INTO THE FOA BAKE INTO REVIEW AND MAKE SURE EVERYBODY UNDERSTANDS AND ON BOARD WITH, UNDER THOSE CONSTRUCTS, W FUND THE STUDIES MOST USE OF PROCESS AND EVALUATE SAFETY FOR THERAPEUTIC USES. THESE HAVE ESTABLISHED SAFETY, PARTICULAR INDICATION, NEW INDICATION YOU CAN ALWAYS LEARN SOMETHING AND THAT HAS TO BE FIRST AN FOREMOST. >> SO MORE A COMMENT, I WAS LOOK AT THE N CATS UH-3, THEY GIVE YOU THREE YEARS. GIVEN WHAT WE TALKED ABOUT BY -- >> FIVE. >> THERE WE GO. THE UH-3 MECHANISM, UH-2, 3 MECHANISM FOR FY 15, THAT'S FIVE YEARS, THAT IS WHAT WE THINK FOR ALL OF THIS IS WHAT WE'RE THINKING. BECAUSE THOSE HAVE TO BE FINALIZED. THANK YOU FOR MENTIONING THAT, WE WILL MENTION THAT POINT. >> IN YOUR FLOWCHART YOU PUT THE NIH PROCESS IN THE FLOW BEFORE IDEAS AND RESEARCHERS ARE PAIRED WITH COMPANIES. THAT'S NOT THE WAY IT'S HAPPENED IN MY EXPERIENCE IN THE COCHLEAR IMPLANT FIELD, WE COME UP WITH IDEAS WE WORK WITH THE COMPANY DIRECTLY AND COME UP WITH A FULL-FLEDGED APPLICATION. IS THERE AND THE OPPORTUNITY IN THIS FLOWCHART TO JUMP IN THE MIDDLE IF YOU HAVE BEEN THERE? TWO THINGS, ONE COMPANIES ARE WORKING WITH THAT A LITTLE BIT THROUGH THE MOU THROUGH THE OUTREACH FORM, TRUE POSTER SESSIONS AND FOLLOW UP, THEY'RE OUTLINING THE GENERAL CAPABILITIES, I EXPECT SEVERAL WILL TALK TO THEM BEFORE YOU DO THE PRE-PROPOSAL. ALSO THE EXPECTATION IS SEVERAL PEOPLE THEY'RE WORKING WITH, WILL SUBMIT A PRE-PROPOSAL AS WELL THAT'S FIENT BUT WE WANT TO MAKE COMPANIES WILLING AND OPEN TO IDEAS FOR PEOPLE THAT THEY HAVEN'T WORKED WITH BEFORE BUT IN A PROCESS THAT'S MANAGEABLE FOR THEM WHERE THEY CAN LOOK AT THE GENERAL CAPABILITIES PROPOSE THE IDEA, THINGS THAT HAVE NO CHANCE OF NIH FUNDING, THEY DON'T HAVE DEAL WITH. THEN SEND TO COMPANIES TO MAKE A FULL APPLICATION UNDER A CDA AND THAT CRA. >> HOW DO YOU ENVISION THAT TO HAPPEN? IS NIH OR THE STUDY SECTION? >> THE PAIRING WILL HAVE -- THE INVESTIGATOR WILL CHOOSE BASED OFF GENERAL CAPABILITIES CAPABILITIES THEY THINK BEST FIT THE STUDIES THEY CAN DO. THIS IS AN INTERESTING POINT, IT MAYBE POSSIBLE A COUPLE OF COMPANIES, THAT'S YOUR POINT, I THINK WE'LL DEFINITELY ALLOW THAT AND THEY CAN TALK TO POTENTIALLY MULTIPLE COMPANIES BASED OFF SPECIFIC CAPABILITIES AND SEE WHAT WORKS BEST AS WELL. THAT'S OFF THE TOP OF MY HEAD, I HAVE TO TALK MORE INTERNALLY BUT MAKES SENSE. (OFF MIC) >> RESEARCH WORKSHOPS TO SEE WHAT COMPANIES WERE INTERESTED IN DOING THIS FOR FY 16. SEVERAL PEOPLE AND COMPANIES AND INSTITUTIONS HAVE EXPRESSED INTEREST IN DOING THIS ALREADY, THE GOAL WAS TO HAVE EXISTING DATA THAT COULD BE LEVERAGED WITHOUT ADDITIONAL PRE-CLINICAL DATA TO ENABLE EXPLORATORY RESEARCH STUDIES, SEVERAL PEOPLE AND SEVERAL COMPANIES HAVE SAID WAIT IT WILL YOU SEE WHAT WE HAVE AN IDE FOR IN A YEAR. IS THAT'S PROMESS FOR FUTURE WE HOPE TO ENABLE. THIS WAS DONE IN WE ARE TRYING TO GET MONEY OUT THE DOOR IN FY 16. SUGGESTIONS TO ADDITIONAL COMPANIES WHETHER ECT COMPANY OR ET CETERA. THE HOPE IS TO PROVIDE FEEDBACK, WHO DID WE MISS, WE DID A PUBLIC REQUEST FOR INFORMATION BUT FACE IT MOST COMPANIES AREN'T LOOKING AT NIH PUBLIC REQUEST FOR INFORMATION SO WE WANT THE TO MINE YOUR EXPERIENCE WHO WE SHOULD BE APPROACHING. THIS YEAR. YES. THAT'S THE SCOPE OF THE UH-3 BUDGET FOR THIS YEAR, FY 15 FOA THAT COMES IN WAS ACTUALLY WE PUT NO HARD LIMIT, WE SUGGESTED THAT WE WOULD RARELY SEE MORE THAN A MILLION DOLLARS IN DIRECT COSTS. A YEAR FOR IT. HOWEVER, BASED OFF OF FEEDBACK ON THE UH-2 UH OF-2, WHICH WAS -- UH-3, 1.5 MILLION, 1 MILLION FOR UH-2 PHASE NON-CLINICAL TESTING AND BASED OFF WORKING EVERYBODY WITH APPLICATIONS, WE SHOULD HAVE FLIPPED FOR REGULATORY APPROVAL AND 1 MILLION, INVESTIGATORS GET AS YOU ARE AWARE GET SOME DEFRAYMENT OF COSTS THROUGH VARIOUS REIMBURSEMENT CHANNELS AS WELL. PLUS SINCE YOU ARE LEVERAGING EXISTING DEVICES, OVERHEAD CREATING A NEW ONE IS NOT AS MUCH BECAUSE THEY HAVE VOLUME ON THESE ALREADY. SO THE EXPECTATION IN EXHIBIT C IS THINGS PAID FOR UNDER THE NIH AWARD AND THAT CAN INCLUDE ALL THE THINGS THAT THE COMPANY IS PROVIDING. INCLUDING DEVICE, REGULATORY SUPPORT, TECHNICAL SUPPORT, SOME OF THE COMPANIES WANTED THE OPTION TO SAY MAYBE WE WANT TO GIVE UP 75 FREE DEVICES AND THAT WAS GOING TO BE EXHIBIT D IN THAT DOCUMENT, IF THEY'RE WILLING TO PROVIDE SOMETHING NOT REQUIRE REIMBURSEMENT FROM THE NIH >> SEGUE TO THE QUESTION, MAYBE NOT THE RIGHT TIME TO GET INTO THE WEEDS BUT EXHIBIT C AND D ARE CONSISTENT. WILL THERE BE A MORE CONSISTENT FORMAT FOR THOSE? >> YES. SO THE POINT WAS TO WORK WITH THE COMPANIES TO TRY TO GET WHAT THEY THOUGHT WAS EXHIBIT C AND D AND IT RATE TWO MONTHS BEFORE. BUT A LOT OF -- THERE'S A COUPLE THAT HAVEN'T COME IN AND THE EXPECTATION WAS COMPANIES LOOK AT WHAT OTHER COMPANIES DID FOR THIS AND IT RATE LALE BIT AS WELL. THAT'S PROBABLY BENEFICIAL TO THE RESEARCH COMMUNITY AS WELL. MANY SAID THIS, THIS IS A COMPETITION. THAT'S GOOD FOR EVERYBODY HERE. (OFF MIC) >> TO ANSWER THAT QUESTION QUICKLY, THEY'LL TALK ABOUT THE GENERAL CAPABILITYS IN THE MOU BUT AFTER THE PRE-PROPOSAL PROCESS, UNDER A CDA THEY'RE WILLING TO DISCLOSE EVERYTHING YOU NEED TO KNOW TO WRITE YOUR APPLICATION. (OFF MIC) >> AND WHAT THAT IS WHY WE HAVE THE CDA -- THE PRE-PROPOSAL IS A SHORT APPLICATION. IF YOU'RE GOING IN SPECIFICS AT THAT POINT WITH COMPANY FOR SHORE PROPOSAL GOOD LUCK BEING JUDGE MERITORIOUS APPLICATION. AFTER THE PRE-PROPOSAL AT THAT STAGE FULL APPLICATION WRITTEN UNDER COMPANY WITH CDA WHERE YOU HAVE ACCESS TO ALL THE DETAILS YOU NEED THAT'S THE HOPE. WITH WE WILL SEE. (OFF MIC) >> WE ARE NOT EXPECTING MATCHING FUNDS, THE NIH WILLING TO FUND OR AT LEAST CONSIDER APPLICATION S THROUGH AFTER PEER REVIEW AND APPROPRIATE SCIENTIFIC MERIT TO FUND IT. IF THEY'RE IF THEY'RE WILLING TO DEFRAY, AN RFA WILL SET AASIDE. WE TYPICALLY GO STUDY SECTION SCORES THERE'S A LOT OF VIRTUAL TIES. WE'RE GOING TO TRY TO THINK PROGRAM MATICALLY HOW TO STRETCH OUR DOLLAR THE MOST. IN SOME CASES, THE STUDY COSTS LESS BECAUSE COMPANIES DEFRAY COSTS WE'LL CONSIDER THAT. SMALL COMPANIES CAN'T DO SAME THINGS LARGE COMPANY CAN. WHAT WE HOPE TO DO IS CONSIDER PROGRAM BALANCE AS WELL IS THE BEST THICK I WILL SAY THERE. (OFF MIC) >> IN ALL CASES BUDGETARY CONSIDERINGS FOR REALLY -- I'M LOOKING AT ALAN BECAUSE HE KNOWS MORE ABOUT REVIEW THAN I DO. BUT ALL BUDGETARY CONSIDERINGS ARE NOT SCORABLE. WE WILL CERTAINLY ASK YOUR SCIENTIFIC EXPERTISE ON THINGS MAKE SENSE AND IF THERE'S CONCERNS BUT THAT SHOULDN'T JUDGE IN TO YOUR EVALUATION SCIENTIFIC MERIT. ALAN, DID I SAY THAT OKAY? ALL RIGHT. ANY MORE PROCESS QUESTIONS BEFORE WE GET INTO THE FUN STUFF? ALL RIGHT. I WOULD LIKE TO INVITE THE PEOPLE ON THE PANEL UP. THE HOPE IS GOING TO REPRESENT TO A CERTAIN EXTENT YOUR COMMUNITY AND PERSPECTIVES BY PEOPLE QUICKLY. STARTING WITH CINDY. I DON'T KNOW HOW TO PRONOUNCE YOUR LAST NAME, JUST OCCURRED SHANE GUILLORY, MARTY MORRELL, JOE JOEL FINS AND KIMBERLY HANKE WHO IS REPRESENTING THE TECH TRANSFER CONTRACT OFFICE PERSPECTIVE BUT WE HAVE SEVERAL IN THE AUDIENCE AS WELL. WE HAVE SEVERAL FROM EACH OF THESE DOMAINS IN THE AUDIENCE. WE WANT ALL OF YOUR FEEDBACK. SO THE GOAL IS TO IT RATE THROUGH MAJOR STICKING POINTS, WE DON'T HAVE A LOT OF TIME, SO PLEASE TRY TO BE CONCISE AS MUCH AS POSSIBLE. WE WON'T SOLVE EVERYTHING TODAY WE WILL TAKE NOTE AND FOLLOW-UP WITH IT, WE WANT THE BEST COMMON CONSENSUS ON SOME OF THESE POINTS. SO I'M GOING TO START WITH THE HARDEST ONE. INTELLECTUAL PROPERTY. I WANT TO START WHAT WE ENVISION FOR STUDIES ENABLED BY THIS, REALLY THREE TYPES OF STUDIES I WANT TO LIST THEM. STUDIES CREATING NEW IP. WE'RE EXPECTING SEVERAL OF THESE, IT CAN BE A FOCUS ON BIOLOGICAL MECHANISMS FOR EXISTING THERAPIES THAT MAY HELP OPT MICE BUT THERE MAYBE UNLIKELY TO BE CREATED SIGNIFICANT INVESTIGATOR-DRIVEN IP, THAT'S PROBABLY GOING TO BE THAT'S EASY TO COME TO INTELLECTUAL PROPERTY TERMS ON. SECOND FOR DEVICES STUDIES THAT IDENTIFY NEW THERAPY TARGETS WILL HAVE POTENTIALLY SIGNIFICANT IP THAT MAYBE CREATED BY THE INVESTIGATOR. I WANT TO PUT THAT UP FRONT BUT WORTH POINTING OUT THE COMPANY DEVICE WILL BE CRITICALLY NECESSARY TO GET THAT IT. STUDIES THAT WILL INFORM FUTURE GENERATION DEVICES BIOMARKERS SOFTWARE, ET CETERA, THAT CAN ALL HAVE IP WITH IT BUT DIFFERENT THAN THE TARGET SPECIFIC IP, WANT TO PUT THOSE THREE OUT THERE AND THE SORTS OF THINGS THAT -- IP THAT MAYBE CREATED BY INVESTIGATORS DURING THIS PROCESS. SO KEY BACKGROUND THAT EVERYONE NEEDS TO KNOW. THESE AGREEMENTS WILL ONLY COVER NEW IP CREATED DIRECTLY RELATED TO THE NIH AWARD. ANYTHING OUTSIDE THE AWARD IS YOURS, ANYTHING TO THE TABLE IS YOURS. PERIOD, THAT'S THE STARTING POINT. SECOND, AGAIN WORTH REITERATION. THESE EXPLORATORY CLINICAL RESEARCH STUDIES WON'T HAPPEN WITHOUT COMPANIES AN DEVICES, EVERYONE IN THE ROOM HAS TO REAL ADVERTISE COMPANIES HAVE PUT DECADES OF WORK AND TENS OF MILLIONS OF DOLLARS TO THESE DEVICES AND NO MATTER HOW WE WORK THE LIABILITY COMPANY WILL TAKE SIGNIFICANT LIABILITY USED IN CLINIC IF SOMETHING GOES WRONG, THERE'S NO WAY AROUND THAT NO MATTER HOW WE WORD IN THE CONTRACTS. PEOPLE WHO HAVE BAD THINGS HAPPEN TO THEM DON'T LOOK AT CRA AND SAY I'M ONLY GOING TO SUE THE INSTITUTION. THEY WILL SUE EVERYBODY AND SUE THE BIGGEST POCKETS, EVERYBODY COMPANY REALIZES THAT'S A RISK THEY'RE TAKING. IP IS REALLY IMPORTANT TO REALIZE AS WELL. THERE HAVE BEEN SEVERAL PROMISING EXPLORATORY CLINICAL RESEARCH STUDIES WE TALKED SEVERAL TODAY THAT FAILED PIVOTAL TRIALS AND DIDN'T HAVE VALUE. THAT'S THE MARKETPLACE RIGHT NOW FOR IP FOR IMPLANTABLE DEVICES AND YOU NEED THE REALIZE THAT. THE IP CREATED IN EXPLORATORY RESEARCH STUDY, THIS IS THE 4 IN HAD ELOQUENTLY MENTIONED THIS, SOMETIMES A MISCONCEPTION. THE IP HAS LIMITED VALUE WITHOUT FULL BUSINESS CASE, RIGHT NOW A FULL BUSINESS CASE IS REQUIRING YOU TO GET FURTHER AND FURTHER BEFORE SIGNIFICANT COMMERCIAL VALUE. YOU HAVE TO REALIZE THAT. THE IP TERMS WERE DISCUSSED EXTENSIVELY WITH CLINICAL INVESTIGATORS WHO WORKED WITH THESE DEVICES BEFORE. DEVICE COMPANIES BEFORE TO DO SIMILAR THINGS TO GET THEIR FEEDBACK ON WHERE STARTING POINTS WERE. KEEP THAT IN MIND AS WELL, THEY ALL SAID IN MANY CASES IT TOOK US MONTHS OF NEGOTIATION WITH THAT COMPANY TO GET TO THE STARTING POINT IP TERMS SO A RELATIVE PERSPECTIVE. KEEP IP PROVISIONS IN THE COLLABORATIVE RESEARCH AGREEMENT, THIS IS THE COMPANY STARTING POINT FOR RESEARCHER IP OR JOINT IP. I MAY ASK YOU TO ASK FOR CLARIFICATION. ASK YOU THE ASK FOR CLARIFICATION IF I'M NOT CLEAR. THE COMPANY HAS THE RIGHT OF FIRST OFFER TO ANY IP YOU GENERATE. THE RIGHT TO GIVE AN OFFER TO EXCLUSIVE RIGHT THE TO THAT IP. YOU DON'T HAVE TO TAKE THAT OFFER, THE ONLY CAVEAT NOW, I'LL USE AN EXAMPLE, TWO RANDOM COMPANIES, MEDTRONICS ON THE OTHER SIDE OF THIS AND THEY OFFER $100 YOU CAN'T GO TAKE $50 FROM BOSTON SIDE BUT YOU CAN TAKE $150. IE, IF THEY GIVE AN OFFER YOU CAN'T TAKE A WORSE OFFER FROM ANOTHER COMPANY BUT YOU CAN TAKE A BETTER ONE. CLEAR ENOUGH? FROM THIS IS THE ONE THAT CONFUSES PEOPLE. COMPANY RETAINS NON-EXCLUSIVE RIGHT TO PRACTICE. THIS IS DIFFERENT THAN THE NCATS DOCUMENTS AND IT IS NON-EXCLUSIVE RIGHT TO COMMERCIAL PRACTICE. YOU IDENTIFY A TARGET, AND THEY DON'T BUY EXCLUSIVE IP THEY CAN GO BUILD A COMMERCIAL PRODUCT AND SELL IT AND DO CLINICAL TRIAL ET CETERA, THIS IS A MAJOR CONCESSION, WE WILL DISCUSS THIS IN DETALL. HOWEVER STUDIES DON'T HAPPEN AND YOU DON'T CREATE IP WITHOUT THESE DEVICES SO THINGS TO KEEP IN MIND. THE INSTITUTION STARTING POINT FOR COMPANY IP. FOR ANY IP THAT YOU CREATE THE COMPANY PURCHASE. THE RESEARCH INSTITUTION RETAINS THE NON-TRANSFERRIAL RIGHT TO PRACTICE FOR RESEARCH AND EDUCATIONAL PURPOSES. IT IS WORTH NOTING THAT THE RESEARCHER AND INSTITUTION WARRANTS THAT ALL EMPLOYEES CONTRACTORS OR COLLABORATORS ENGAGE IN THE PROJECT PLAN, THE NIH AWARD, ARE BOUND BY THIS AGREEMENT AS WELL, THAT'S IMPORTANT BECAUSE IF ONE COLLABORATOR GOES OFF AND GETS ACCESS TO THIS, AND CREATES IP COMPANIES UNDERSTANDABLY WANT SOME ASSURETY THAT THAT'S NOT AN AVENUE TO GET OUT OF CONTROL AND NOT FOLLOW ON THE AGREEMENT. SO THOSE ARE THE MAJOR IP POINTS. I WILL FIRST ASK CLARIFICATIONS NEEDED. (OFF MIC) >> THAT CAVEAT IS KIND OF CORRECT ST.ED JUDE COULDN'T SWEEP IN WITHOUT THEIR OWN $150 MILLION CATH CLINICAL TRIAL TO REDUCE TO IT PRACTICE, ET CETERA. THERE'S A REALLY IMPORTANT ENVIRONMENTAL THING ALSO YOUR IP HAS NO VALUE, YOU CAN DO THAT. LIMITED VALUE, THAT'S CORRECT. >> WILL THERE BE FIELD OF USE RESTRICTIONMENT? >> THOSE I THINK CAN BE NEGOTIATED BUT REALISTICALLY I'M NOT SURE I UNDERSTAND THE QUESTION, CAN YOU CLARIFY WHAT YOU MEAN? >> SO IF YOUR THE PROCESS OF DOING RESEARCH APPROACH OR TECHNOLOGY APPLIED TO OTHER AREAS OR NEUROMODULATION. IF THERE'S A COMPANY LIKE MOST HERE THAT ARE SEEKING TO APPLY TECHNOLOGY TO MANY PLACES INDUSTRY PERIPHERAL CENTRAL NERVOUS SYSTEM. >> DO THEY GET THEN EXCLUSIVE RIGHTS -- THERE IS NO FIELD OF USE RESTRICTION RIGHT NOW. IT IS AN INTERESTING POINT. I WOULD ACTUALLY SAY IT IS INTERESTING IN TERMS OF TOOLS AN BROAD IP AND WHAT INFORMATION YOU CREATE TO DESIGN NEW DEVICES THAT DON'T FALL UNDER THE SIGNIFICANT IP. KEEP IN MIND, THIS IS AN EXAMPLE I WANTED TO USE, WORSE FUNDING TO DO VASCULARLY IMPLANTED LEADS IN THE BRAIN. THAT'S COVERED BY IP FOR BOSTON TEN YEARS AGO. A LOT OF STUFF YOU THINK HAS IP DOESN'T HAVE IP BECAUSE COMPANIES ARE REALLY GOOD ABOUT COVERING EXPANDED USE BASES. BUT PRACTICALLY IF THAT'S A CONCERN, THESE ARE STARTING POINTS FOR NEGOTIATION AND COULD BE INCORPORATED AFTER THE TEMPLATE DOCUMENTS. >> IT IS ROYALTY FREE. THAT IS WHAT IT IS, GOOD POINT, GREAT CLARIFICATION. YES. >> COULD YOU CLARIFY, BACK UP THE SLIDE, I'M CONFUSED BY THE EXCLUSIVE RIGHT AND THE RETAINING NON-EXCLUSIVE RIGHT TO PRACTICE. SO IF TRYING TO FIGURE OUT WHERE THIS QUESTION -- IF WE'RE IN AGREEMENT WITH NEUROPACE AND NEUROPACE GETS THE FIRST OFFER AND THEN YOU TAKE SOMEONE ELSE'S BETTER OFFER, NEUROPACE STILL HAS THE NON-EXCLUSIVE RIGHT TO PACK IN THIS >> YES. >> -- PRACTICE? >> YES. >> WHAT IS THE EXCLUSIVE RIGHT THE OTHER COMPANY BOUGHT? >> THE OTHER COMPANY WOULD BE PURCHASING THE EXCLUSIVE RIGHT WITH ONE EXCEPTION. >> ALMOST (INAUDIBLE) >> ALMOST EXCLUSIVE LIKE. >> FLAT OUT REDUCES THE VALUE OF YOUR IP, NO DOUBT ABOUT IT. NOT GOING TO ARGUE, THERE HAS TO BE SIGNIFICANT CONCESSIONS TO MAKE THIS HAPPEN, THESE ARE STARTING POINTS FOR NEGOTIATION. (OFF MIC) >> THE NON-EXCLUSIVE RIGHT TO PRACTICE WAS NON-EXCLUSIVE RIGHT TO PRACTICE FOR INTERNAL RESEARCH PURPOSES ONLY, NOT COMMERCIAL PRACTICE. BIG DIFFERENCE. HOWEVER, AGAIN, IT'S A VERY DIFFERENT BEAST IN TERMS OF DEVICES. AND HAVING DISCUSSIONS WITH ALL THE COMPANIES AND HAVE ARING DISCUSSIONS WITH CLINICAL PIs WHO WORKED WITH THEM THESE ARE TERMS YOU GET TO AFTER MONTHS OF NEGOTIATIONS AND THE COMPANIES WERE ALL WILLING TO ACCEPT AS STARTING POINTS. TENTATIVELY, I WILL ADD TENTATIVELY AGAIN. BOTTOM LINE, IF YOU'RE DOING IMPLANTABLE DEVICE THAT CAN GO WRONG YOU, A, ALMOST IMPOSSIBLE FOR CLINIC TO DO THIS THEMSELVES, AND GET ACCESS TO THIS SECONDLY, THE COMPANY IS JUST GOING TO I HAVE BEEN CUR LIABILITY NO MATTER HOW YOU SET UP THAT AGREEMENT. AT LEAST RIGHT NOW, THEY'RE WILLING TO TAKE THAT IF THESE IP TERMS ARE AGREED TO AS A STARTING POINT BUT I GUARANTEE YOU PROBABLY MOST ARE WILLING TO AT LEAST HEAR OTHER POSSIBILITIES. (OFF MIC) (OFF MIC) >> VERY MUCH SO, TENS OF MILLIONS OF DOLLARS, YEARS OF REGULATORY APPROVAL, WHAT NUMBERS SHOULD I USE? HUNDREDS OF MILLIONS OF DOLLARS, THAT'S WHAT YOU GET ACCESS TO. >> JUST CLARIFICATION. THIS IMPLIES A SINGLE COMPANY AND YOU HAVE BEEN DESCRIBING AS IF THERE WOULD BE A SINGLE COMPANY AGREEMENT, BUT SUPPOSE FROM THE STUDY THERE'S CENTRAL DATA REPOSITORY AND POST DOC ANALYSIS OF DATA GENERATED BY DEVICES FROM MULTIPLE COMPANIES, THEN TRANSDIAGNOSTIC FASHION YIELDS SOME NEW INDICATIONS THAT WAS NOT PREVIOUSLY ENVISIONED, HOW WOULD YOU ADDRESS THAT IF YOU HAVE A RESULT THAT'S COMING FROM DATA COMING FROM DEVICES FROM MULTIPLE COMPANIES? THIS MAY SORT OF LEAD TO THE NEXT PANEL WHICH IS A DISCUSSION ABOUT OPEN DATA SHARING AND JUST TAKE THIS SEGWAY TO MENTION THIS IS A VALUE TO ALL OF US TO CONSIDER THE IMPORTANCE OF OPEN SOURCE DATA SHARING ACROSS THESE STUDIES. ONE PERSON'S NOISE COULD BE ANOTHER PERSON'S SIGNAL. >> COUPLE OF THINGS. ONE, ONCE DATA GOES PUBLIC, THE IP BECOMES DIFFERENT HOW YOU DO THAT, ET CETERA AND REALISTICALLY I DON'T HAVE A GOOD QUICK ANSWER FOR YOU RIGHT NOW ON THAT. I'M CURIOUS IF ANY OF THE OTHER PANELISTS OR ANYBODY IN THE AUDIENCE HAS A VIEWPOINT ON THAT. THEN GO FROM THERE. >> BY THE WAY WE'RE ON VIDEOCAST. (OFF MIC) >> AND I ANIMAL NO IP BASED ON THE DATA. (OFF MIC) >> I'M GOING TO SAY FOR THIS PARTICULAR POINT IN THE INTEREST OF TIME, THIS IS A POINT THAT THERE'S FOLLOW-UP, WE'LL TALK TO YOU, WE'LL TALK TO THE COMPANIES AND TRY TO COME TO A REASONABLE AGREEMENT OR TEMPLATE TO THEN SEE THE RFI FOR BROADER FEEDBACK AS WELL BUT WE HAVE ROUGHLY FIVE MORE MINUTES TO TALK ABOUT IP BEFORE WE GET THE OTHER STUFF, IF THERE'S TIME AT THE END WE'LL COME BACK BUT THIS IS THE START OF THE PROCESS. ANY CONCERNS WE'LL KEEP TRACK OF THIS, FOLLOW-UP WITH YOU, AND WE WILL IT RATE. >> BACK TO THE FLOW SHEET. INSTEAD OF HAVING A COMPETITIVE SITUATION AFTER DIFFERENT COMPANIES INITIALLY SUPPORTED EARLY WORK AND THEN THERE'S A HIGHER OFFER THAT YOU HAVE POTENTIAL OF HAVING DYNAMIC THAT COULD LEAD TO COMPETITIVE DYNAMIC FAILURE, MAYBE POSSIBLE TO TO SUGGEST A TEMPLATE, ALL THE IP IS RETROSPECTIVE, SO A LOT HYPOTHETICAL, 10,000 TO ONE, YOU DON'T WANT TO GET BOGGED DOWN EARLY ON BUT MAYBE IF YOU CAN REACH A CONSENSUS TEMPLATE FASHION SAYING EACH STEP IS WORTH A CERTAIN PERCENTAGE OF THE ULTIMATE VALUE OF THE PRODUCT AS RELATES THE TO ROYALTY AND THE LIKE SO A COMPANY THAT DOES MAKE AN IMPORTANT CONTRIBUTION IN THE PRE-APPLICATION PHASE GETS SOME SMALL PERCENTAGE OF THE IP VALUE BUT NOT THE ENTIRETY OF THE VALUE. SO YOU CAN HAVE A DISTRIBUTED MODEL, AN ECONOMIC PARALLEL. >> SO THAT'S A VERY INTERESTING IDEA. THERE'S SOME PROMISE THERE, SOME THINGS THAT WOULD HAVE TO GET DOWN TO TALKING TO ALL THE COMPANIES, SEEING IF THIS MAKE SENSE FROM THEIR PERSPECTIVE, THEY ARE THE GATE KEEPERS HERE. THERE'S NO DOUBT ABOUT IT. YOU CAN'T DO THESE STUDIES WITHOUT IT. I WOULD BE CURIOUS OFF THE TOP O THEIR HEADS TO ASK MARTY AND/OR SHANE TO RESPOND TO THAT. >> AND YOU CAN SAY I GOT TO THINK ABOUT IT. >> I HAVE TO THINK ABOUT IT. I THINK THAT COMING FROM MOST OF MY CAREER ACADEMIA AND COMING TO BUSINESS I LEARNED THAT SURPRISED ME OR THINGS WE MAY LEARN, FIRST YOU MAY HAVE A GRADE GREAT IDEA BUT YOU HAVE TO FIGURE OUT WHETHER THERE'S FREEDOM TO OPERATE. AND IT IS DIFFICULT TO GO THROUGH AND SEE WHAT PRIOR ART EXISTS YOUR TECH TRANSFER OFFICE MAYBE ABLE TO DO THAT BUT I SUSPECT NOT AS WELL AS THE -- THE ATTORNEYS THAT WORK WITH COMPANIES AND IF YOU HAVE AN IDEA, THAT IDEA IS -- IF YOU HAVE AN IDEA AND WANT TO WORK WITH US, MEDTRONIC ALREADY HAS THE INTELLECTUAL PROPERTY THERE. WHICH COULD BE THE CASE, WITH WE MAY SAY WELL, WE CAN DO A WONDERFUL STUDY WITH YOU BUT WHEN WE FINISH THE STUDY WE CAN'T DO ANYTHING HERE. SO THERE MAYBE ADDITIONAL COMPLICATION IN THAT THERE WOULD HAVE TO BE SOME NEGOTIATIONS WITH THE COMPANY OR ENTITY THAT OWNS THE PRIOR ART IN ORDER TO MAKE ANY BUSINESS CASE FOR THIS. EVERY SITUATION IS SOMEWHAT DIFFERENT. BUT NOT NECESSARILY STRAIGHT FORWARD WE HAVE A LOT OF GREAT IDEAS AND SUPREME COURT RULED MADE CHANGES WHAT'S PATENTABLE NOW, SO A COUPLE OF WEEKS AGO SO YOU MAY NEED TO BE INFORMED BY YOUR TECH TRANSFER OFFICE OR BY THE COMPANY ABOUT WHAT IS PATENTABLE AND WHAT IS ALREADY COVERED. FROM INDIVIDUALS. >> I WANTED TO STRESS, THESE AGREEMENTS ARE ALREADY HAPPENING BETWEEN INDIVIDUAL CLINICAL INVESTIGATORS. AND THE COMPANIES ARE READY TO CRO ONES, THE HOPE IS TO MAKE THAT MORE TRANSPARENT FOR YOU, WE'RE NOT GOING TO BE ABLE TO -- WE OBVIOUSLY HOPE THE STARTING POINT IS A BETTER DEAL FOR YOU TO START THAN IF YOU'RE GOING TO THEM INDIVIDUALLY. WE'RE NOT GOING TO GET TO YOUR DREAM WORLD. WE NEED TO GET TO WHAT NEEDS TO HAVE BEFORE THIS GOES FORWARD VERSUS STARTING POINT. WE'RE GOING TO START WITH THIS. (OFF MIC) IN FACT A LOT OF THEM WE'RE HOPING SPECIFICALLY TO TAKE ADVANTAGE OF DEVICES THAT ARE ARE APPROVED FOR EXPLORATORY CLINICAL RESEARCH FOR ONE THING, THEY HAVE TO GET A NEW IDE, TO USE. AND THERE'S GOING TO BE SIGNIFICANT RISK TO THE COMPANY NCI IN USING THAT FOR THAT PURPOSE. (OFF MIC) >> REALISTICALLY THE WAY THIS WORKS IS THE THIS IS COVERING IP THAT'S CREATED DURING THE TERM OF THE AWARD. IF YOU ALREADY HAVE IP ON THIS NEW INDICATION NEW IDEA, ET CETERA, THEN YOU CAN BRING THAT TO THE TABLE OR FILE IT, ET CETERA, AND IT WON'T FALL UNDER THIS AWARD. THAT'S AN IMPORTANT DISTINCTION BECAUSE IF YOU HAVE -- IT'S ONLY IF YOU HAVE A NEW IDEA DURING THE TERM OF THE AWARD THAT COMES FROM THIS DATA. SO YOU'RE RIGHT. BOTH SIDES NEED TO BE RESPECTED BUT THAT'S AN IMPORTANT ONE. (OFF MIC) >> REALISTICALLY, IF YOU THINK YOU HAVE A NEW IP IDEA UP FRONT, FILE IT. YES. >> I THINK TIME FOR ONE MORE COMMENT. I WANT TO GET THE RESPONSE AS WELL BUT THEN MOVE TO THE NEXT TOPIC AND TRY TO GET THROUGH AS MUCH AS WE CAN BUT WE DO HAVE TO KEEP THE TRAIN ON SCHEDULE. >> WE HAVE ANOTHER TOPIC COMING UP. THAT IS APPROPRIATE. DATA IS THE NEXT TOPIC. >> IN RESPONSE TO YOUR FIRST QUESTION, VERY DIFFICULT THESE THINGS OUT OF THE GATE TO THE SPECIFIC DETAILS SPECIFIC CASE. SO THAT WOULD BE THE CASE. THIS MORNING -- I WANT TO MAKE A QUICK POINT, INTELLECTUAL PROPERTY IS AN OVERLOADED TERM SO AND I THINK BRIAN IS RIGHT IN THE CLASSICAL SENSE, PATENT TRADEMARKS COPY RIGHT AND SUCH, OBVIOUSLY INTELLECTUAL PROPERTY IS DIRECTLY OUT OF DATA BUT MORE GENERAL SENSE THOSE COULD BE USED TO SUPPORT REGULAR RATORY SUBMISSION, FURTHER SUPPORT IDE, SO SOME WOULD STILL CALL UNDER UMBRELLA OF -- KICK VALUE AND STRATEGIC VALUE WHEN LOOKING AT FOLLOW-ON APPLICATIONS IN THE CONTEXT OF THAT RESEARCH. >> YES. >> I MIGHT ADD, THIS IS CONFUSING BUT IT'S ALMOST ALWAYS SOLVABLE. AND IT'S DONE ALL THE TIME. YOU MAY COME WITH AN IDEA, MOST IS A NEW IDEA BUT NOT ALL. YOU CAN PATENT PART OF IT AND WE CAN DECIDE THE OTHER PART IS WORTH LICENSING. SO EACH SITUATION IS DIFFERENT, I DON'T THINK PEOPLE WILL GET ROBBED WHAT THEY'RE DUE. I DON'T. >> YOU SAID STARTER DO YOU MEAN DEAL STOPPER? >> DEAL STOPPER. >> NEXT TOPIC, HOPEFULLY THERE'S THIS IS AN IMPORTANT TOPIC AND I DON'T MEAN TO SHORTCHANGE IT BUT WE COULD SPEND TWO DAYS TALKING ABOUT THIS TOPIC. WE WANT THAT OFFLINE AS WELL TO GET YOUR FEEDBACK. PROJECT DATA. KEY PROJECT DATA PROVISIONS, THERE ARE OTHER PROVISIONS, I ENCOURAGE YOU TO READ THE TEMPLATE DOCUMENTS PROVIDE FEEDBACK BUT THINGS THAT CAME UP IN PRELIMINARY CONVERSATIONS WITH ALL REPRESENTATIVES FROM AS MANY PERSPECTIVES WE CAN GET. FIRST DEFINITION, PROJECT DATA INCLUDES RAW ANALYZED DATA SIGNALS, EG, ELECTROPHYSIOLOGICAL -- INTERPRETATIONS OF THE DATA NECESSARY FOR APPROPRIATE ANALYSIS. PROJECT DATA UNDER TERMS OF COLLABORATIVE RESEARCH AGREEMENT RIGHT NOW. THE INSTITUTION AND RESEARCHER MAY AT THEIR DISCRETION PUBLISH RESULTS UNDER THIS AGREEMENT WITH TWO CAVEATS. THERE'S THREE. BUT ONE THEY HAVE TO GIVE NOTIFICATION OF THE COMPANY WHILE THEY DO IT, TWO, THEY HAVE TO GIVE THE COMPANY, THE OPPORTUNITY TO IDENTIFY IF THERE'S CONFIDENTIAL DATA THAT SHOULDN'T GO OUT. IN THIS PUBLICATION ANY PUBLIC FORM, ET CETERA, THE COMPANY THE FLEECE SUBSTITUTE THEY CAN GIVE YOU REMOVE THE CONFIDENTIAL AGREEMENT BUT SUBSTITUTE THEY CAN GIVE YOU NOT CONFIDENTIAL THEY'LL TRY THE BEST TO GIVE YOU THAT AS WELL. SECOND, THE COMPANY SHALL NOT PUBLICLY DISCLOSE INFORMATION DERIVED FROM THE PROJECT DATA WITHOUT THE INSTITUTION APPROVAL A WOULD BE EXCEPT NEEDED FOR REGULATORY AND PAENT FINDINGS SO THEY WON'T -- PATENT FINDING. SO THEY'RE NOT GOING TO MAKE IT AVAILABLE AND MAKE IT SO YOU CAN'T PUBLISH. HOWEVER, THIS WILL BE A TOPIC FOR CONVERSATION. IF A PUBLICATION IS NOT RELEASED WITHIN ONE YEAR AFTER COMPLETION OF THE RESEARCH ACTIVITIES FOR TERMINATION OF AGREEMENT, NOT WHEN YOU GET THE DATA BUT COMPLETION OF RESEARCH AGREEMENT, THE COMPANY WILL HAVE THE RIGHT THE TO USE THE DATA AND REPORTS FOR ANY PURCHASES WITHOUT THE INSTITUTION APPROVAL. SO THE IDEA OF TERMS OF THIS AGREEMENT, AT THE END OF THE AGREEMENT IF YOU HAVEN'T PUBLISHED A YEAR AFTER THE AWARD OR WHETHER IT'S TERMINATED THE COMPANY DOESN'T HAVE TO ASK YOU WHETHER OR NOT IF THEY WANT TO FIND PUBLISH OR WHAT HAVE YOU, THEY HAVE TO GET PERMISSION. DOES EVERYBODY UNDERSTAND? I MUST BE GETTING CLEAR. CLARIFICATION NEEDED. THERE WE GO. >> YOU SAID YOU HAVE TO RESPECT STANDARDS OF AUTHORSHIP, RIGHT? >> SO THAT IS A SUBPOINT AS WELL. IN THE ACTUAL TEMPLATE DOCUMENT, I DIDN'T WANT TOO MUCH DETAIL AROUND HERE. Q. RIGHT. INTERESTING PUBLISH SOMETHING BUT DIDN'T INCLUDED THE AUTHORS. >> THEY CAN'T UNTIL AFTER TERMS OF THE AWARD. >> TECHNICALLY STILL FOLLOW THE RULES OF AUTHORSHIP, IF YOU CONTRIBUTE THEN YOU JUST BY THE WAY THE WORLD WORKS AUTHOR THEY TAKE THAT SERIOUSLY. >> THEY WORRY ABOUT LIABILITY >> I AGREE, THAT'S A REASON I FLAGGED IT, WHAT IS REASONABLE. TWO YEARS SUBMITTED. COMPANY REPRESENTATIVES. TWO YEARS SUBMITTED. HOW MUCH HEART BURN >> I GET YOUR POINT ABOUT SUBMISSION. HAPPENED TO ME. SO YEAH, PERSONALLY, I DON'T HAVE THE FINAL VOTE HERE. I THINK IF IT'S SUBMITTED THAT'S FINE. I MEAN, THE ISSUE IS THAT SOMETIMES THINGS GET DROPPED AND THEY LANGUISH AND VALUABLE STUFF SITS THERE ON SOMEBODY'S DESK FOR A LONG TIME. >> I'M SORRY TO CUT YOU OFF BUT COMPANIES IF THE TERM IS WE ARE TWO YEARS SUBMITTED, FIRST OF ALL THE SUBMITTED BOTHER YOU VERSUS PUBLISHED. GIVEN THAT IT TAKE AS YEAR TO GO THROUGH REVIEW. SO ANSWER THAT -- GRANTED IT'S AT TERMINATION OF AGREEMENT SO YEAR ONE YOU CREATE DATA AND IT'S FIVE YEAR TERM YOU GET UNTIL YOU'RE OF TO DO IT BUT IT'S A PROBLEM ATTEND. >> VOIR TO INTERRUPT. >> THERE WE GO. >> LIKE WE CAN DO WHATEVER WE WAN WITHOUT LETTING YOU KNOW. >> NOT WITHOUT LETTING YOU KNOW, YOU HAVE TO DO CONFIDENTIALITY SO THE EARLIER ONES, MAYBE I WASN'T CLEAR, YOU HAVE TO NOTIFY THE COMPANY BEFORE PUBLISHING, THERE'S AMOUNT OF TIMES THAT I WOULD LOVE TO DISCUSS IN DETAIL HERE, IT'S -- NOTIFICATION, THEY HAVE TO VIEW AND SAY SORRY THAT'S CONFIDENTIAL INFORMATION AND HAVE THAT REMOVED FROM THE PUBLICATION. SUPPOSED TO TRY TO REPLACE WITH SOMETHING AFTER TERMINATION OF AGREEMENT IF NOT RELEASED IN A YEAR THEY CAN DO WHATEVER THEY WANT WITHOUT APPROVAL, YOU CAN PUBLISH IT. YOU STILL HAVE TO TALK CONFIDENTIALITY AT THAT POINT. >> OF COURSE YOU DON'T WANT SOMEONE TO LANGUISH SOMETHING BUT SEEMS LIKE THERE SHOULD BE A PARTNERSHIP HERE AND THE SCIENCES ARE REPRESENTED. SO IT'S SEEMS LIKE YOU LET IT GO. IF IT'S LANGUISHING, SAY WE'RE CONCERNED ABOUT THIS BUT DO SOMETHING WITHOUT THE INSTITUTION APPROVAL, SEEMS -- I CAN'T IMAGINE THAT COMPANIES >> TRY TO PUBLISH YOUR STUFF (OFF MIC) >> WE PUSH FOR SIMILAR TYPE LANGUAGE IN COMPANY SPONSORED LANGUAGE WISH ON THAT DATA AND NOT ALLOW US TO PUBLISH SO WE ACTUALLY EXTEND THAT TERM TO MAKE OUR DATA PUBLIC. SO MAYBE THE TWO YEARS WE CAN'T AGREE TO GO TWO YEARS FOR COMPANY SPONSORED STUDIES WITHOUT GOING UP THE CHAIN OF COMMAND. MAYBE COMPROMISING 18 MONTHS. I KNOW WHAT THE COMPANIES ARE TRYING TO GET AT, IT'S A MATTER OF MAKING SURE THAT THOSE INVESTIGATORS KNOW THE TIME LINE THEY NEED TO MEET IN ORDER TO GET THAT PUBLICATION OUT AND THEY CAN MEET THAT DEADLINE. >> SO I THINK I CAN SAY FOR THIS POINT, TO MOVE ON IN CASE OTHER POINTS IN CONFIDENTIALITY IS IT'S NOTED WE WILL HAVE CONVERSATION IN TERMS OF SUBMISSION. WE WILL HAVE THE CONVERSATION IN TERMS OF WHETHER IT'S 18 MONTHS, WHAT'S THE MOST PALATABLE AND FOR EVERYBODY IN THIS ROOM THIS GETS DOWN TO HAVE TO HAVE VERSUS WANTS TO HAVE. SOMEBODY IN THIS ROOM WILL SAY WE DO 18 MONTHS, SOMEBODY WILL SAY NO CHANCE UNLESS THREE YEARS. WE'LL COME UP WITH THE MOST PEOPLE AND REALIZE THAT. BECAUSE RIGHT NOW THESE ARE HAPPENING AGAIN, WITHOUT ANY OF THIS. ALL OF THIS IS STARTING POINTS, PUT IN THE TEMPLATE AND THE HOPE IS THEY'RE CLOSE ENOUGH TO A STARTING POINT, ESPECIALLY FOR THE PEOPLE WHO WANT TO DO BIOLOGICAL RESEARCH, SOME RIGHTS TO THE IP BUT I WANT TO SEE EXCITING NEW THERAPIES GET TO PEOPLE WORKING WITH THE COMPANIES TO -- SOMETHING WORK OUT TO HAVE THAT PATH GREAT. THEY'LL ACCEPT AS IS, IF YOU ARE SOMEBODY WHO IS SIGNIFICANTLY INTERESTED IN CREATING YOUR OWN IP, THE EXPECTATION IS YOU WILL TALK TO THE COMPANIES, YOU WILL CHANGE ANYTHING YOU WANT IN THE COLLABORATIVE RESEARCH AGREEMENT BUT YOU HAVE TO GET THEM TO AGREE TO IT. >> I THINK YOU CLARIFIED THE MAIN POINT IS TO PUT IN PLACE PROVISIONS THAT ARE BASIS FOR NEGOTIATION, I DON'T THINK ANYBODY WILL BE HELD TO THAT SIMPLIFIED SO YOU WANT TO HAVE ANOTHER -- IF YOU WANT 48, AND EVERYBODY AGREES THAT'S OKAY, THE SPIRIT -- ALL OF US WANT THIS TO HAPPEN QUICKLY. SOMETIMES THEY'RE -- STUFF STAYS ON THE DESK FOR MONTHS AND NOTHING HAPPENS SO IF YOU DON'T HAVE CLEAR TIME LINES CONSEQUENCES THERE'S NO WAY TO ENFORCE THAT AND YOU DON'T NEED THAT. BUT AGAIN EVERYBODY THAT'S CONCERNED WE DON'T NEED MUCH TIME TALKING ABOUT WHAT IT IS IN THE TEMPLATE BECAUSE EVERYONE OF US HAS THE ABILITY TO CHANGE THAT IN OUR CASE WE SEE FOR WHATEVER REASON IT'S NOT APPLICABLE. >> I WANT TO STRESS PEEP KEEP IN MIND THE PEOPLE IN THE COMPANY SIDES WHO ARE DOING THIS, ARE VERY INTERESTED IN THE RESEARCH. IF THIS IS 18 MONTHS AND THAT'S WHAT THEY NEED TO GET BY THE DEPARTMENT, ET CETERA, THE HOPE IS EVERYBODY WILL GO WHAT DO YOU NEED. THREE MORE MONTHS? OKAY. WE'LL HAVE THAT CONVERSATION. THERE DOES HAVE TO BE BOUNDS IN CASE IT DOES COME DOWN TO LEGAL BUT THE HOPE IS THAT EVERYBODY EVERYBODY WANTS TO SEE THE SCIENCE GET OUT, >> YOU MENTION -- I'M ON BOTH SIDES, MY (INAUDIBLE) IS ON THE UNIVERSITY. I INVESTED THINGS TO GET IT OUT THERE. THE RISK IS ONCE YOU HAVE THE ITEMS OUT THERE, JUST ABOUT TO BE APPROVED YOU'RE STARTING TO FINALLY MAKE A PROPER WORKING BUSINESS CASE OUT OF THAT. JUST IMAGINE, WE DO THAT MOST OF THE TIME GIVE TO PEOPLE THAT TRY NEW THINGS SOMETHING IS WRONG IN THAT STUDY. IT'S FAR LESS ABOUT THE MONEY TO GET TO THIS POINT, THERE'S A FACTOR, SOMETHING WRONG IN YOUR STUDY, NOTHING TO DO WITH WHAT WE HAVE DONE WITH SOMEBODY ELSE'S STUDY. THE ENTIRE PRODUCT IS PUT ON, -- RISK IS FLAG IN AN OFF LABEL INDICATION OR EVEN IF IT IS NOT THIS CASE COULD BE SOMETHING FOR -- MEDTRONIC TO MILLION SOMEBODY BE ON HOLD? IN REVENUES IN THERE TO SAY WE WANT TO HELP EVERYBODY PLAY WITH THIS, WE WAN THIS TO MOVE, YES, WE NEED YOU BUT PLEASE ALSO HELP PROTECT OUR SIDE A LITTLE BIT BECAUSE YOU CAN DESTROY IN ONE SWEEP 70 OR 20,000 PEOPLE'S JOBS JUST BECAUSE YOU PLAYED WITH IT, IT'S AND SOMETHING WEPT SIDEWAYS. >> ALSO I WANT TO MAKE THE POINT SOMETIMES WE HAVE TO SUBMIT THIS DATA TO FDA FIRST. WE DON'T WANT FDA TO BECOME AWARE THERE'S AN ISSUE WITH THE PRODUCT. FROM PUBLICATION IN A JOURNAL. THAT -- TO RESPECT FDA'S REQUIREMENTS TO ENSURE THE SAFETY, THAT OFTEN HAS TO GO FIRST. >> I'M GOING TO GO SHANE, HELEN THEN WE HAVE TO MOVE TO THE NEXT TOPIC BUT I'M GOING SAY SOMETHING NOW OFF THE TOP OF MY HEAD, RAISE YOUR HAND IF YOU'RE WILLING TO PARTICIPATE IN AN NIH FACILITATED WEBINAR IN THE NEXT MONTH. YOU WON'T HAVE TO COME ANYWHERE SPEND MORE TIME IT RATING ON THIS TOPIC IF NECESSARY. THAT MAYBE A STRATEGY AS WELL. THOUGH WE DO SOME OFFLINE WE MAY NEED TO IT RATE THROUGH SOME POINTS. KEEP THAT IN MIND. >> I AGREE, THOSE ARE NUTS AND BOLTS TYPE OF THINGS ON A CASE-BY-CASE BASIS. STEPPING BACK, ONE BIGGER CONCERN THAT ANY COMPANY IS GOING TO HAVE IS -- WHEN YOU TURN DEVICE OVER TO A RESEARCH TEAM, BY THE ACT OF USING IT AND TRYING FOR DIFFERENT PURPOSE THEY'RE GOING TO LEARN, GOING PICK UP NEW THINGS COME UP WITH THINGS THAT YOU DON'T ABOUT ABOUT ANTICIPATE LOW LEVEL INDIRECT THINGS THAT ARE IMPORTANT. THE NIGHTMARE SCENARIO IS GIVE RESEARCHER A TOOL THEY CAN USE AN CREATE INTELLECTUAL PROPERTY USING OUR TOOL THAT THEN GETS OUT OF CONTROL AND GETS PICKED UP BY A COMPETITOR USED TO COMPETE AGAINST YOU. SO WHENEVER YOU'RE THINKING NEGOTIATIONS WITH THE COMPANY, IT'S THOSE KINDS OF THINGS IN THE BACK OF THEIR MIND, THOSE ARE THE THING ASSURANCES THEY'LL LOOK FOR, IT'S NOT THE MECHANICS OF PUBLISHING THINGS LIKE THAT, IT'S MORE IN THE REALM OF BIG PICTURE ITEMS OF -- COLLABORATIVE AGREEMENT WE CREATE IP TOGETHER AND PROFIT FROM IT TOGETHER OR IS THIS JUST PUTTING LOOSE ENDS THAT CAN GET AWAY FROM US QUICKLY. >> HELEN HAD HER HAND UP A WHILE. JOE, YOU'LL HAVE TO BE QUICK BECAUSE WE NEED TO MOVE TO THE NEXT TOPIC. (OFF MIC) >> WE'RE HAVING A DATA DISCUSSION AS WELL AS PART OF THE SESSION LATER BUT THIS COULD BE A TOPIC BROUGHT UP AS PART OF THAT AS WELL. VERY IMPORTANT JOEL YOU HAD A COMMENT. >> QUICKLY ON THE ISSUE OF NOTIFYING THE COMPANY, ABOUT THE PUBLICATION, AND THE QUESTION IS, WHAT IS THE PROPRIETARY CONFIDENTIAL RESULT, ACADEMIC RESULT THAT WOULD BE PIVOTAL FOR PUBLICATION. VERSUS WHAT AN ACADEMIC SHOULD HAVE AND RETAIN FREEDOM OF PUBLICATION. >> RIGHT NOW IT'S CONFIDENTIAL INFORMATION, MY READ MAYBE MORE EXPLICIT IS THINGS THAT HAVE SIGNIFICANT IP VALUE, ET CETERA. YOU GOT NEGATIVE RESULTS THAT SHOWS SOME STUFF THEY CAN KEEP YOU FROM PUBLISHING. THAT IS MY PUBLICATION -- TIM AND LEE. I'M MAKING IT UP ON THE FLY. I'M SORRY. (OFF MIC) >> EXACTLY. RIGHT. >> I'M ENCOURAGED TO LOOK AT TEMPLATE DOCUMENTS, KEY POINTS BRIEFLY THERE, IS WORDING TO THAT EFFECT, WHETHER OR NOT IT'S SUFFICIENT WE LOVE TO HEAR YOUR PERSPECTIVE ON, THANKS FOR WAITING SO LONG. >> COMMENT MAYBE QUESTION FOR LATER. WHEN I LOOK AT THE FIRST PARAGRAPH, ANALYZE DATA SIGNALS, REPORTINGS FULLY ANNOTATED WELL ENOUGH FOR SOMEBODY NOT PREVIOUSLY INVOLVED IN STUDY TO ANALYZE THEM, JUMP TO THE END A YEAR LATER THAT GOES TO THE COMPANY. OF COURSE (INAUDIBLE) TO HAPPEN AND WHAT YOU CAN SPEAK TO BEST POTENTIAL HEALTH INFORMATION THAT'S CONSIDERED TO BE NEARLY INSEPARABLE WITH TREMENDOUS EFFORT FROM THE ELECTROPHYSIOLOGICAL (INAUDIBLE) IN THE FIRST PLACE. THEN NEEDING TO RECRUIT THE PARTICIPANTS IN THE FIRST PLACE, THE LITTLE TAG LINE AT THE END, BY THE WAY SOME PORTION OF YOUR DATA WILL BE IN COMPANY (INAUDIBLE) >> SO THERE IS LANGUAGE IN THERE TO ADDRESS THAT, ESPECIALLY IN TERMS OF WHAT IS FEASIBLE VIA HIPAA. THIS IS ONE OF THE REASONS USING THE NCATS DOCUMENTS AND EXISTING DOCUMENTS IS SO IMPORTANT SO WE DIDN'T MISS THING LIKE THAT. IT'S IN THERE. WHETHER OR NOT IT IS SUFFICIENT WE LOVE TO GET YOUR FEEDBACK ON. BUT IT IS IN THERE, IT IS ADDRESSED. SO I'M SORRY, WE'LL HAVE TO MOVE TO THE NEXT POINT AS WELL. WE'RE ALREADY RUNNING OVER WHICH IS NOT A SURPRISE HERE BUT WE ALSO WANT TO GET YOU HOME AT SOME POINT. CONFIDENTIALITY. SO RIGHT NOW. AN INSTITUTION IS RESPONSIBLE FOR ALL EMPLOYEES CONTRACTORS AND LAB RAY THETORS ENGAGED IN THE PROJECT PLAN. IF YOU HAVE CONFIDENTIAL INFORMATION THAT YOU GOT FROM THE COMPANY, AND SOMEBODY YOU WORK WITH DISCLOSES, YOU'RE RESPONSIBLE FOR IT AND YOU HAVE TO HAVE THAT CONTROL ON IT. AS WRITTEN, WORTH DISCUSSION, THERE ARE NO REVERSE POSITION -- PROVISIONS IN CRA CONFIDENTIALITY SECTION STATING CONFIDENTIALITY SECTION STATING THE COMPANIES RESPONSIBILITY FOR CONFIDENTIAL DATA RESEARCHER MIGHT CREATE. THOSE ARE OTHER SECTIONS. IT'S COVERED IN THE IP. COMPANY SHALL NOT PUBLICLY DISCLOSE PROJECT DATA WITHOUT APPROVAL. ONE YEAR DETERMINATION CAVEAT. RIGHT NOW AS WRITTEN ALL CONFIDENTIALITY OBLIGATIONS HE CAN PYRE FIVE YEARS FROM THE EXPIRATION OF THE AGREEMENT EXCEPT TRADE SECRETS. THOSE WILL BE COVERED BY THE TRADE SECRETS LEGISLATION. SO QUESTIONS. WE ARE HAPPY TO ADD IN THE COUNTER PROVISION DEEMED NECESSARY. THERE IS ALREADY LANGUAGE FOR IT IN THE EXISTING TASK DOCUMENT. (OFF MIC) Q. COMPLETELY AGREE. DOES THAT CREATE A PROBLEM? I DIDN'T THINK IT WOULD. WE WILL ADD IT. >> I WAS GOING TO MENTION I THINK THAT CONFIDENTIALITY -- CONFIDENTIAL DISCLOSURE AGREEMENT AS WELL WHEN -- HAS TO BE MUTUAL. >> THAT'S -- IF YOU LOOK AT THE TEMPLATE I NOTED POINTS FOR DISCUSSION, THAT WAS ONE IN THE CDA AS WELL. WE HAVE TEMPLATE LANGUAGE THAT LOOKS DIFFERENT BUT WE HAVE IT FOR N CATS AS WELL FOR COUNTER PROVISIONS, COMPANIES EXPECT TO SEE UPDATED LANGUAGE ON CONFIDENTIALITY SECTION THAT HAS TWO WAY PROVISIONS. >> THERE'S CERTAINLY NOTHING WRONG WITH INCLUDING OPTIONAL SECTIONS WITH TEMPLATES, SHORT GUIDELINES WHEN THOSE SHOULD BE CONSIDERED. >> L I WOULD LOVE SOME FEEDBACK ON THAT BECAUSE I THOUGHT ABOUT ADDING A LOT OF THINGS THAT COULD BE OPTIONAL. THE WORRY WAS EXPANDING TOO MUCH ON THINGS HARD TO GET AGREEMENTS O UPON AND THOUGHT THOSE COULD BE ADDED AS CASE-BY-CASE BASIS AND FOR PEOPLE WHO RELATIVELY NAIVE THEY SEE AN OPTION, IT HOLES THINGS UP IN A WEIRD WAY TO UNDERSTAND MAKE THINGS CLEAR. WHY THEY HAVE THIS, ET CETERA. THAT'S WHY YOU HAVE INSTITUTIONAL TECH TRANSFER OFFICES TO IDENTIFY THINGS MOST IMPORTANT IN YOUR CASE. >> IN GENERAL STRATEGICALLY IMPORTANT OR MAYBE EXPEDITIOUS TO STAY SILENT ON MANY THINGS AS POSSIBLE BUT INCLUDE GUIDANCE MAYBE YOU SHOULD CONSIDER THE TEMPLATE DOCUMENT ACTUALLY DOESN'T INCLUDE THINGSEN UNLESS THEY'RE TRULY NECESSARY. SO SOME THINGS MAYBE IT'S A GOOD IDEA. STAY STY LENT ON THAT AND THE TEMPLATE DOCUMENT AND WE CAN WRITE THOSE TO THE INDIVIDUAL AGREEMENTS WHEN NECESSARY. >> WE CAN ALSO OUTSIDE OF THE TEMPLATE AGREEMENT, COME WITH OPTIONAL PROVISIONS OUTSIDE OF BASE TEMPLATE, MAKE PUBLICLY AVAILABLE ITSELF AND SOME EXPLANATION TO WHAT THE THOUGHT PROCESS WAS AND HAVE ALL THESE GO UP ON WEB SITES AND WE CAN ACTUALLY PROBABLY COME UP WITH SOME CREATIVE WAYS TO ADDRESS THESE THINGS. >> ANOTHER WAY TO GET TO THE CONTRACT, EDUCATIONAL ESPECIALLY L SMALLER COMPANIES FAQ, THAT WOULD BE HELP. -- HELPFUL. >> GREAT IDEA. (OFF MIC) >> ONE THING WE HAVE DONE A LOT OF IS HAVING EQUIVALENTS OF TERM SHEET. WHAT ARE THE THINGS TO CONSIDER BEFORE ENTERING THE CONTRACT MEANING THESE ARE FANTASTIC, BUT AS SCIENTISTS ENGINEERS WE GET INTO THE DETAILS QUICKLY, MAYBE 18 VERSUS 17 MONTHS VERSUS 20 MONTHS HIGH LEVEL SET OF TERMS WE WILL TALK CONFIDENTIALITY, TALK IEP. THEN ESCALATION -- AN ESCALATION TYPE OF SUGGESTION WHERE IF THIS AREA OF CONCERN FOR YOU, HERE ARE THINGS THAT YOU CAN CONSIDER. SO IP IS IT GOING TO BE PUT EVERYTHING IN PUBLIC DOMAIN VERSUS THE OTHER EXTREME GOING TO OPENLY ALLOW LICENSURE, FRAME IT TO MAKE IT APPROACHABLE SO YOU DON'T JUMP THE TEMPLATE AND NEGOTIATE THE POINTS RIGHT AWAY. >> GREAT IDEA AND COKE CURS TO ME -- OCCURS FOR ME PEOPLE WHO HAVE SUCCESSFUL PRE-POLYS WHEN THEY GET TO THE STAGE OF HAMMERING OUT THE CRA WITH WE CAN HAVE A WEBINAR WITH PRE-PROPOSALS AS WELL, HAVE NIH TECH TRANSFER, ET CETERA, THEIR TECH TRANSFER OFFICES AND HAVE A GROUP DISCUSSION OF THOSE THINGS AS WELL ALONG WITH THE TEMPLATE DOCUMENTS THAT YOU DESCRIBE. FAQs, THINGS TO LOOK FOR, ET CETERA. THAT WILL HELP AS WELL. OTHER COMMENTS OR QUESTIONS BEFORE THE NEXT TOPIC. WE HAVE RUN OUT OF TIME FOR THIS SESSION BUT WE'LL MOVE TO THE NEXT TOPIC AND WE'RE GOING TO DO IT. ALL RIGHT. THAT WENT BETTER THAN I THOUGHT. MISCELLANEOUS. I LOOK FOR LIABILITY MISCELLANEOUS BECAUSE EVERYBODY -- A LOT OF PEOPLE ARE GOING LIABILITY, ET CETERA. SO THERE ARE PROVISIONS FOR LIABILITY, TYPICALLY INCLUDED SOMETHING SAYING THE MANUFACTURER CREATES NO WARRANTEES, ET CETERA FOR THIS REALISTICALLY THIS IS ONE THAT NEEDS TO BE FLESHED OUT MORE POTENTIALLY, RIGHT NOW, BECAUSE THE RESEARCH INSTITUTION AND RESEARCHER ARE ARE SPONSORING THIS, THEY'RE RESPONSIBLE FOR THE IDE, THEY BARE A LOT OF RESPONSIBILITY, HOWEVER, AGAIN AS SAID BEFORE, SOMETHING GOES WRONG FOR DEVICE FUNCTION THE MANUFACTURER PROBABLY SHOULD HAVE CAUGHT, THEY'RE GOING TO GET SUED AND THEY ALL REALIZE IT. THERE WILL BE A LONG -- IN THE ETHICS SECTION THERE WILL BE SOME DISCUSSION ABOUT FOLLOWING THESE PATIENTS OUT ABOVE AND BEYOND THE TERM. WE CAN HAVE THAT NOW OR COULD BE ADDED TO AT THIS TIMICS DISCUSSIONS, REALLY IMPORTANT POINT LATER. SO WE WILL FOLLOW THATUP IN THE ETHICS DISCUSSION. THE LONG TERM CARE OF THE PATIENT AFTER TERM OF AWARD. (OFF MIC) Q. CLARIFY THAT QUICK, NOT TO INTERRUPT, ARE YOU SAYING NO WAY TO DO IT OR NO WAY TO -- HARD TO GET FUNDED THROUGH AN NIH PROPOSAL FOR IT? (OFF MIC) >> THE INSURANCE TO BE COVERED IN CASE SOMETHING -- >> TALK ABOUT THIS IN HIS TALK, AND IN THE INTEREST OF TIME SINCE WE HAVE RUN OVER -- >> WHAT I ENCOURAGE NOW, I DON'T THINK WE HAVE TIME TO GET INTO BUT POINT THESE OUT -- THIS OUT REAL QUICK. RIGHT NOW, THE AGREEMENT CONFLICTS WITH -- OR THERE ARE CONFLICTS THEY HAVE TO FOLLOW A PROCESS TO RESOLVE CONFLICTS NOT ENUMERATED WITHIN THE CRA WHICH IS UNIFORM TRADE SECRETS ACT. N CATS HAS LANGUAGE WE CAN DRAW IN TERMS OF ARBITRATION ISSUES AS WELL. I ASSUME IT'S ADDED BUT I WANT TO GENERAL FEEL FOR IT. CURIOUS YOU ARE THOUGHTS ARTICULATING THE CONFLICT WITH LAW, SOMETHING ARBITRATED HAVING ENUMERATED THE AGREEMENT EXPLICITLY. >> CALL ATTENTION TO IT, MOST CASES WILL BE (OFF MIC) >> WE'LL PROBABLY NEED TO LOOK AT N CATS TO SEE WHAT THEY HAVE AS WELL, WE WERE TRYING TO COMPLEX IN THE N CATS DOCUMENT TO BE SPECIFIC DEVICES AND SIMPLIFY THE THINGS BASED OFF WHETHER OR NOT IT WAS NECESSARY, DRAW THAT LANGUAGE AND GET FEEDBACK AS WELL. OTHER COMMENTS ON THIS PARTICULAR POINT? (OFF MIC) >> TAGLE, THERE'S AN N CATS QUESTION IN TERMS OF LIABILITY PARALLELS IN THE DRUG DEVICES, CURIOUS TO YOUR COMMENT, BECAUSE I CANNOT CLAIM TO BE AN EXPERT IN DRUGS. (OFF MIC) THE MAJOR DIFFERENCE AS EVERYBODY KNOWS FOR IMPLANTABLE DEVICE NOT GIVING DRUG ONE TIME, NOT ET CETERA, IT'S IMPLANTED FOR LIFETIME OF PATIENT AND CAN CREATE PROBLEMS FOUR YEARS FROM NOW SO THOSE ARE DIFFERENT HOW TO HANDLE THOSE ENUMERATE IN THE AGREEMENT, WE HAVE TO FOLLOW-UP AND FIGURE OUT THE LANGUAGE MOST ARE COMFORTABLE WITH. >> THIS IS DIFFERENT. >> I WANT TO SAY WITH THE DRUG REPURPOSING TYPICALLY TALK ABOUT COMPOUNDS THE COMPANY HAS GIVEN UP ON. IN THAT REGARD THIS IS DEVICES THE COMPANIES STILL HAVE A LOT OF STAKE IN. SO IF THERE'S ADVERSE EVENT WITH THAT PARTICULAR COMPOUND THE COMPANY THOUGHT IT WOULD NEVER DEVELOP IN THE FIRST PLACE YOU CAN IMAGINE CONCERNS ABOUT LIABILITY >> DEVICES IN PANEL RIGHT NOW DOING THIS FOR SOMETHING ELSE BECAUSE YOU'RE DOING STUFF HELP YOU WITH AND CONTROL BEST THEY CAN PREDICT AND CREATED A VERSE EVENT, IF THAT ADVERSE EVENT IS MANAGEABLE, IT WILL IMPACT OTHER BUSINESS EVENTUALIALITIES. THIS IS THE FINAL QUESTION TABOR THE SESSION, WE'LL IT RATE THINGS WE MISSED NOT IN DETAIL BUT IT RATE AND DISCUSS. WHAT'S BLATANTLY MISSING. SOME IN TEMPLATE AGREEMENT WE'RE NOT DISCUSSING RIGHT NOW. (OFF MIC) >> WE HAVE TO DISCUSS THAT INTERNALLY, SEVERAL PEOPLE MENTIONED IT, BUT WE'LL DISCUSS THAT AND SEE WHAT REALLY IS FEASIBLE THROUGH THE MECHANISMS. COST IS GOING TO MATTER TOO. (OFF MIC) >> DO WE SAVE IT AT THE CRA? ANOTHER POSSIBILITY IS PEER REVIEWED AS WELL THROUGH NIH PEER REVIEW. IS THERE ANY HEART BURN ABOUT HAVING IMPLANT UP FRONT BUT ALSO HAVING THAT SEGMENT BE SOMETHING THAT IS EXTREMELY PEER REVIEWED AS WELL BECAUSE IT'S AN ETHICAL QUESTION, GOOD IDEA IN MY MIND TO GET OTHER PERSPECTIVES. IS THERE ANY HEART BURDEN OF PROOF ABOUT THAT BEING ADDED Q. IT TOTALLY DEPENDS ON WHO IS ON THAT PEER REVIEW. WHETHER THEY UNDERSTAND THAT WHEN THE DEVICE IS IMPLANTED THE COMPANY OWNS IT FOR THE LIFE OF THAT DEVICE. >> CRA IS WHAT I'M HEARING. >> YES. >> OKAY. (OFF MIC) REALISTICALLY SOME SMALL BUSINESSES, ET CETERA, OR EVEN LARGE BUSINESSES, EXPLORATORY RESEARCH STAGE THEY DON'T HAVE PRODUCTS TO MARKET OR MAYBE IN THE FUTURE MIGHT NOT BE AROUND IN THREE YEARS. IT'S POSSIBILITY. (OFF MIC) >> I'M GOING TO SAY RIGHT NOW THAT CAME TO ME ON THE FLY. DON'T WORRY ABOUT IT. SOUNDS LIKE CRA BETWEEN INVESTIGATOR AND COMPANY. >> NOT THE INVESTIGATOR IS -- INVESTIGATOR AND COMPANY HAS A PLAN. >> MESSAGE RECEIVED OTHER KEY POINTS THAT WE REALLY SHOULD BE DISCUSSING AND IT RATING THROUGH AND POTENTIAL FOLLOW ON YOU HAVE THE TEMPLATE DOCUMENTS ON -- WE WILL TRY TO MAKE THAT HAPPEN WE'LL TRY TO DO IT SEVERAL WEEKS AND LOOK AT IT IN DETAIL. OTHER POINTS I SHOULD BE PART OF THE CUSHION BASED ON WHAT YOU HAVE SEEN SO FAR. WHAT ARE WE MISSING? OH MY GOD. REALLY. >> INDEMNIFICATION AS WHOLE SILENT IN THE AGREEMENT ITSELF >> FROM THE UNIVERSITY STAND POINT BUT WITH WHAT PARTICULAR WE CAN FOLLOW-UP WITH THAT, WHAT PARTICULAR, THERE'S SOME LANGUAGE FOR INDEMNIFICATION BASED ON SPECIFIC THINGS REALISTICALLY IF YOU ARE RESPONSIBLE FOR THE CONDUCT OF THE STUDY, YOU ARE THE IRB SPONSOR, YOU WILL NOT HAVE COMPLETE INDEMNIFICATION IF YOU CONDUCT IT POORLY. THE COMPANY DOESN'T HAVE CONTROL OVER THAT. >> INDEMNIFICATION IS WHAT WE WOULD SEEK IF WE GOT BROUGHT IN ACCLAIM, MOST EXPENSE CLAIMS YOU CAN BE BROUGHT IN ON. INFRINGEMENT TYPICAL USE OF DATA WHICH CAN GET A LITTLE CONVOLUTED. BUT IF THEY'RE GOING TO HAVE THE ABILITY TO DO WHAT THEY WANT TO DO WITH THE DATA. >> REVERSE PROVISION AS WELL. THERE'S PROVISIONS THAT SAY THE INSTITUTION HAS TO HAVE ALL RIGHTS TO ANYTHING THAT IS PART OF THIS AND THEY HAVE COMPLETE CONTROL AND THERE'S NOT SOME THIRD PARTY WITH PARTIAL RIGHTS REALISTICALLY THERE SHOULD BE REVERSE PROVISION THE COMPANY WARRANTS THAT THEY HAVE. THAT MAKE SENSE. >> IF YOU LOOK FOR AREAS THAT WHERE YOU SPEND YOUR TIME MAXIMUM IMPACT CONSIDER IN REGARDS TO DATA RIGHTS ASPECTS. THAT'S WHERE MOST CONCERNS -- >> SO GUIDANCE WITHIN THE DOCUMENTS BUT ALSO GUIDANCE -- ARE YOU THINKING SPECIFIC CLARIFICATION LANGUAGE IN THE DOCUMENTS THAT'S NOT THERE VERSUS THINGS WE'RE TALKING ABOUT WHETHER WEBSITE FAQs OR BOTH. >> THINGS PUT INTO THE TEMPLATE AS PART OF THE CHATTER OF THAT, PART OF THE GUIDANCE OF OPTIONAL SECTIONS THAT YOU MAY INCLUDE, THE DATA RIGHTS JUST RECOGNIZE MAYBE EARLY, THAT'S WHERE A LOT OF THE CONCERNS, BACK AND FORTH MIGHT BE ACT SERRATE THE PROCESS. >> THANK YOU, IN THE INTEREST OF TIME I'M GOING SAY ONE MORE TIME ANY OF YOU VERY ACCESSIBLE IF YOU HAVE ANY CONCERNS, ANY IDEAS, ET CETERA, WE HAVE A FAIR BIT OF TIME TO IT RATE COME TALK TO ME AND WE WILL FIGURE A WAY TO VET THROUGH EVERYBODY SIGNIFICANT CONCERNS. THANK YOU VERY MUCH TO OUR PANELISTS. AND WE HAVE TO MOVE TO THE NEXT SESSION. ARE WE AT BREAK NOW? TAKE A BREAK. GET SOME COFFEE. I NEED SOME. >> CHIEF OF DIVISION OF MEDICAL ETHICS AT CORNELL MEDICAL COLLEGE, HE'S ALSO PROFESSOR OF MEDICINE. SO DR. FINS PUBLISHED EXTENSIVE LY IN THE AREA OF ETHIC S OF NEUROMODULATION ESPECIALLY INVASIVE DEVICES AND ETHICS OF SMALL -- OF RELATIVELY RARE DISORDERS. SO HE'S RECENTLY PUBLISHED A BOOK CALLED RIGHTS COME TO MIND. BRAIN INJURY ETHICS AND THE STRUGGLE FOR CONSCIOUSNESS WHICH IS TO BE PUBLISHED IN AUGUST 2015 BY CAMBRIDGE UNIVERSITY PRESS SO DR. FINS, THANKS FOR COMING. >> THANK YOU VERY MUCH, IT'S A PLEASURE TO BE HERE I HAVE TITLED MY TALK I REWROTE IT LAST NIGHT, LIKE TO WRITE AGAIN THIS MORNING A AFTER ALL THAT'S HAPPENED. ETHICS AND INNOVATION BECAUSE I TRULY THINK THAT WHAT YOU GUYS DO AND WHAT KIP AND NED AND EVERYBODY IS TRYING TO ACHIEVE IS EPIC. IT REMINDS ME OF THE GREATEST EPIC OF THEM ALL, DIVINE COMEDY. WE TALK ABOUT THE VALLEY OF DEATH, WE HEARD PEGTORY AND YOU RECALL THE -- PURGATORY AND ALL HOPE YE WHO ENTER HERE. I DON'T THINK IT'S THAT BAD AND I THINK WE'RE ON THE CUSP OF MAKING SOME REAL PROGRESS. I THINK THE KIND OF DISCUSSIONS THAT WE HAD THIS MORNING, I THINK THE REALLY HISTORIC CONVERSATIONS AND KIP AND NED AND FOLKS AT N CATS GET TREMENDOUS CREDIT FOR BRINGING ALL THE PEOPLE TOGETHER. AND I WANT TO EXTEND THE METAPHOR, SINCE I LOVE HISTORY BACK TO HISTORY TO REMIND US OF THE PROBLEMS WE FACE AND WHY WE'RE HERE. INVOKING THE METAPHOR, I WANT TO REMIND US OF VIRGIL WHO HELPED TO BRING DAUNTY THROUGH HELL AND PURGATORY WHICH POINT KIP PICKED THEM UP AND TOOK THEM TO HEAVEN. SO I WANT TO TALK ABOUT FOUNDATIONAL PROBLEMS ABOUT WHY THIS IS SO PERPLEXING AND DIFFICULT. I THINK THE FIRST THING, THAT WE NEED TO REMEMBER IS HOW DEFINITIONAL CLARITY. WHAT EXACTLY IS THIS WORK? IS IT RESEARCH OR THERAPY? THAT HAS ETHICAL IMPLICATIONS, VOCATIONS AND FAMILIES UNDERSTAND ABOUT THERAPEUTIC MISCONCEPTION AND THE LIKE BUT ALSO POLICY IMPLICATIONS WHICH IS WHAT I WANT TO FOCUS ON. AND A MORE MACRO LEVEL. THE PANEL WILL TALK MORE ABOUT THE EXPERIENCES OF PATIENTS IRB AND THE LIKE I BELIEVE IS WHAT WE'RE GOING TO TALK ABOUT BUT I WANT TO TALK THE MACROECONOMIC LEVEL. I ALSO WANT TO TALK ABOUT BECAUSE OF THAT CONFUSION BETWEEN RESEARCH AND THERAPY, HOW WE HAVE TRUNCATED SCIENCE, PREVENTED SCIENCE FROM HAPPENING BECAUSE WE REGULATE THIS FUNDAMENTALLY THAT THEY WERE THERAPIES NOT APPRECIATING THESE DEVICES HAVE PROBATIVE VALUE AND ARE TOOLS OF DISCOVERY. DBS TO A NEUROSCIENCE IN THIS SPACE IS CAR BOB TO A CHEMIST. AND WE HAVE TO MAKE SURE EVERYBODY HAS ACCESS TO CARBON. SO AFTER BUILDING ON THAT AND TALKING ABOUT HUMANITARIAN DEVICE EXEMPTION THE MINE SHIFT THE CANARY AND MINE SHAFT THERE WAS A SENTINEL EVENT TO REALIZE HOW PROBLEMATIC THINGS ARE, PRAGMATIC RESPONSE WHICH LOOK LIKE THE N CATS WORK BUT I WROTE ABOUT THIS FIVE OR SEVEN YEARS AGO. TALKING ABOUT SOME REFORM OF INTELLECTUAL PROPERTY CONFIGURATION AND IT TRANSFER AN IDEA THAT JOE AND GARY (INAUDIBLE) WE SUGGESTED A CLEARINGHOUSE FUNCTION. TO CREATE THIS PARTNERSHIP WE SEE NOW HAPPENING. I'M ALSO GOING TO TALK ABOUT INSURANCE ISSUE, INDEMNIFICATION ISSUE THAT THESE THING IS CATALYZED I WILL CONCLUDE GOOD SEGUE WITH AFFIRMATION WHAT THE ETHICAL PRINCIPLES ARE THAT ARE MORE GRANULAR TALK. LET ME START WITH THIS PAPER WE WROTE HELEN MAYBERG WITH A PAPER AND WITH COLLEAGUE AS WELL, WHAT WE DESCRIBED THE MISUSE OF FDA HUMANITARIAN DEVICE EXEMPTION FOR DBS AND OCD. THE BASIC ARGUMENT WAS THIS IS A NEW TARGET USING ESTABLISHED DEVICE AND GIVEN WE NEED TO REQUIRE INVESTIGATIONAL DEVICE EXEMPTION NOT COVERED UNDER HDE. THE REASON FOR THAT IS THAT IN HD COVERS SAFETY BUT NOT EFFICACY, AND WHEN YOU DO HD IN LIEU OF BIGGER IDE TRIALS YOU NEVER ESTABLISH A PROPERLY POWERED CLINICAL TRIAL YOU DON'T GET GENERALIZABLE RESULT ARES. YOU CAN'T AGGREGATE DATA, YOU CAN'T UNDERSTAND ADVERSE EVENTS IN A SYSTEMATIC WAY. AND SAFETY IS A STANDARD OF EQUIVALENCE BY DEDEVISE BUT NOT SITE. I THINK THERE'S A CARRY OVER FROM THE FACT THE FDA REGULATES DRUGS MOSTLY IN DEVICES LESS THAT THEY THINK ABOUT THE DRUG AND DON'T THINK ABOUT DEVICE IN CONTEXT, IT'S DIFFERENT THE TARGET NUCLEI YOU'RE STRUCTURING THIS I THINK ALSO RELATES TO RESEARCH AN THERAPY, IF YOU LOOK AT THE REGULATIONS FOR IDE YOU HAVE TO GO TO -- IRB FOR APPROVAL BUT DOESN'T CONSTITUTE RESEARCH SO THERE'S AMBIGUITY THERE. IF YOU FAIL TO DEMONSTRATE EFFICACY AS YOU CAN IN HDE YOU HAVE PROBLEMS WITH REIMBURSEMENT DOWN THE ROAD BECAUSE IT'S NOT ESTABLISHED AS A VETTED THERAPY. FUNDAMENTALLY THIS IS AN OPPORTUNITY FOR SCIENTIFIC DISCOVERY. SO WHY DID THIS HAPPEN? WHY WAS THIS A PROBLEM? I THINK IT WAS AN EFFORT TO AVOID THE IDE PROCESS BECAUSE THE RESOURCES IS HARD TO RECRUIT PATIENT AND GET FUNDING, OVERRELIANCE ON INDUSTRY, THIS IS THE PROTOTYPICAL ILLUSTRATION OF DEMONSTRATING PROOF OF PRINCIPLE THIS IS THE VALLEY OF DEATH. YOU GO TO HDE DO GET THROUGH THE DESERT. YOUR MULE PACK AS WE DISCUSSED YESTERDAY. HDE IS WORST OF BOTH WORLDS BAD SCIENCE WITH NO GENERALIZABLE RESULTS AND NO NEED TO DEMONSTRATE EFFICACY BUT ILLUSTRATES THE PROBLEM -- NOT BEING JUDGMENTAL. I THINK THIS WAS AN EARNEST EFFORT TO SUSTAIN WORK SO TO PROMISING AN ONLY WAY INVESTIGATORS COULD DO IT. THERE IS A GREAT ANALOGY TO THE HDE STORY AND 5, 10-K STORY I WANT TO BACK UP ON, THESE ARE HOW DEVICES ARE APPROVED UNDER SECTION 1976 MEDICAL DEVICES AMENDMENT AND THIS USES PREDICATE APPROVAL ON SUBSTANTIAL EQUIVALENCE TO DEMONSTRATE THESE ARE SAFE. IN THE HD CONTEXT THE DEVICE USED WAS WELL WARNED IN PARKINSON DISEASE, SAME DEVICE USE SPACE IS A PROBLEM AND THAT SHOULD REQUIRE A PMA PROCESS. IN 2011 THE IOM HAD A REPORT ON 5, 10-K PROCESS WHICH UNIFORMLY CRITIQUED BY IT'S VERY IMPORTANT TO LOOK AT WHAT THEY SAID BECAUSE IT'S RELEVANT TO OUR SPACE, THE 5, 10-K PROCESS ENSURING SAFETY OR EFFICACY, WRITTEN IN THE WAKE OF DEVICE FAILURES, CRITERIA THEY LAID OUT I THINK ARE THE CRITERIA WE SHOULD ENDORSE AS A COMMUNITY, FOR REGULATION OF DEEP BRAIN STIMULATION THERE. SHOULD BE SOUND SCIENCE, A PREDICTABLE STRAIGHT FORWARD PATHWAY THAT'S IMPORTANT FOR INVESTORS AN SHOULD IMPROVE THE PUBLIC HEALTH OR LIFETIME VIGILANCE OF DEVICES AND SHOULD IMPORT A RISK-BASED ANALYSIS INTEGRATED APPROACH. MOST IMPORTANTLY THEY TALK IMPACT OF 5, 10-K PROCESS AND RED KID APPROVAL ON INNOVATION AND CRYIATION OF NEW DEVICE, THE IT WAS EASIER TO IMPROVE OLD DEVICE AGAIN AND AGAIN THAN THE TO DO SOMETHING NEW. IN A CASE THAT INVOLVED 5, 10-K PROCESS, MEDTRONIC WHICH IS VERY IMPORTANT. BENEATH TEAR STATUTORY SCHEME OR LEGISLATIVE HISTORY SUGGEST 5, 10-K PROCESS WAS ANYTHING OTHER THAN MAINTAIN THE STATUS QUO. SCIENCE IS NOT STATUS QUO IT'S INNOVATION AND THAT'S WHAT WE NEED TO TRY TO PROMOTE AND CULTIVATE AS WE REFORM THE PROCESS. I THINK THAT THIS GOES BACK TO THE THIS MOW SAY SCHISM THAT WHAT WE'RE DOING IS RESEARCH AN THERAPY, FINANCE OR REGULATE DBS AS PUNITIVE THERAPY LIMITING THE INVESTIGATIONAL POTENTIAL I'M GOING TO NOW ADD TO THE GREAT WORK THAT KIP AND DAN HAVE DONE, MAKE MORE STRATEGIC RECOMMENDATIONS, THAT ARE TOTALLY CONTINUE INNOCENT WITH THE CONTRACTS WE HEARD ABOUT THIS MORNING. THE FIRST IS, WE NEED TO PREVENT THE PREMATURE MODIFICATION OF IDEAS. THAT ENGENDER CONFLICT OF INTEREST AND CREATE THE INTANGLEMENTS WE SAW THIS MORNING, AND THINK ABOUT A MODIFICATION OF THE BY DOLE ACT AND APPLICATION TO THIS -- RECALL THE BY DOLE ACT WAS A BIPARTISAN AS IT WERE WE DON'T REMEMBER ANY MORE, EFFORT BETWEEN FIRST BUY AND BOB DOLE 1982, THAT WOULD ALLOW FOR THE IP TRANSFER TO THE INSTITUTIONS THAT DID THE WORK, THEY RECEIVE FEDERAL FUNDING IN ORDER TO ACCELERATE IDEAS FROM GOING FROM BENCH TO BEDSIDE. AND SECONDLY, TO CREATE FACILITATED REGULATORY PATHWAY, THE MANY IDE WHICH N CATS EMBRACED, TALK ABOUT THE BIDOLE ISSUES, A PAPER I WROTE IN 2009 TO CATALYZE THE SPACE. THE IDEA HERE, SOME OF THIS IN THE ITERATION THAT KIP WAS TALKING ABOUT THAT AVOID PREMATURE IP TRANSFER UNTIL YOU GET TO PUNITIVE PHASE 2. AFTER PROOF OF PRINCIPLE IS ESTABLISHED THEN HOUSE A CLEARINGHOUSE PUBLIC PRIVATE PARTNERSHIP INVOLVING THE NIH, THE FDA, INDUSTRY AND ACADEMY, IN A WAY TO FACILITATE THE DISTRIBUTION OF DEVICES RIGHTS AND REFERENCES ACCESS TO THESE TOOLS AND DISCOVERY, THIS IS A LOT LIKE WHAT DAN WAS SAYING ABOUT DISTRIBUTED PARTNERSHIP MODEL, WHICH WAS ADDED THIS MORNING. THE BENEFIT TO ACADEMY IS MORE FUNDING FOR FOUNDATIONAL RESEARCH. I WOULD ENVISION INDUSTRY HELPING TO SUPPORT SOME WORK AND CLEARINGHOUSE, THE BENEFIT TO INVESTIGATORS WOULD BE GIVING ACCESS TO THE RIGHTS TO THE THE TOOLS DISCOVERY AND RIGHTS OF REFERENCE. ONE THING THAT WASN'T SAID YESTERDAY BUT WHICH DOES HAPPEN IS SOMETIMES INDUSTRY DOES NOT PROVIDE RIGHT OF REFERENCE TO COMPETITIVE SPACE, AND THAT INVESTIGATORS CAN'T GENERATE THEIR OWN IDs OR EVEN HDs, BY NOT GIVING INVESTIGATORS THE INTELLECTUAL PROPERTY RIGHT UNTIL THEY HAVE HAD THE DEMONSTRATION OF PROOF OF PRINCIPLE, YOU AVOID CONFLICT OF INTEREST. THERE'S POLICY WITH DOUBLE AMC ABOUT REBUTTABLE PRESUMPTION. YOU HAVE TO PROVE IF YOU HAVE CONFLICT OF INTEREST YOU'RE ENTITLED TO DO THE WORK. AND THE IDEA, IF YOU HAVE A CONFLICT OF INTEREST AND YOU'RE EARLY ON AND YOU GET TAKEN OUT, YOU'RE THE MOST QUALIFIED PERSON TO DO THE WORK. SO MAYBE WE SHOULD DEFER AND DELAY THAT IMPOSITION OF THE IP AND CONFLICT OF INTEREST UNTIL A BIT LATER AND HAVE A HAND OFF IN PHASE 2, OTHER INVESTIGATORS CONTINUE TO WORK WHO ARE LESS CONFLICTED, THIS WILL OPTIMALLY DECREASE CONFLICT OF INTEREST. I THINK IT'S IMPORTANT TO APPRECIATE THAT INDUSTRY ALSO WINS WITH THIS KIND OF APPROACH. REMEMBER THE SLIDE THERE WAS 10,000 THIS SLIDE AND ONE ON THE OTHER SLIDE, INDUSTRY CAN PICK THE WINNERS, THEY HAVE DEMONSTRATED PROOF OF PRINCIPLE. AND IN PHASE 2, THEY CAN AVOID INVESTMENT IN EARLY WORK WHICH MIGHT MOST LIKELY WILL FAIL. THERE IS ALSO ANCILLARY BENEFIT TO CLEARINGHOUSE OF THIS FOR ESTABLISHED REGISTRIES DATA COLLECTION AND STANDARDIZATION OF ETHICAL REVIEW, MULTIPLE VIEW AN SITES, THE BENEFIT FOR SOCIETY IS PUBLIC TRUST WHICH IS PRICELESS AND PEOPLE ARE SKEPTICAL AND CRITICAL. THE MINI IDEA IS A PAPER I WROTE WITH GARY TARPIN AND JOE (INDISCERNIBLE) IN NEW YORK ACADEMY OF SCIENCES, THE IDEA HERE IS A MANY DEMENTIA PROPOSAL, KIND OF LIKE WITH KIP AND DAN PRESENTED, A MINI IDE. YOU START WITH PREDICATE APPROVAL HD ESTABLISH DEVICE THAT IS APPROVED, OR THE 5, 10-K BUT THAT'S NECESSARY BUT NOT SUFFICIENT FOR DEVICES TO MOVE FORWARD. YOU HAVE A COP TIN GENT LIESHIP YOU STAGE IT AND IT REQUIRES ANIMAL STUDIES IN ADDITION TO PREED KIT APPROVAL AND LICENSURE BY ACHIEVING MILESTONES THROUGH PHASE 1, 2, 3 AND MOST PEAKING PHASE. THE BENEFIT OF THIS IS THAT YOU WOULD ALLOW A LOT OF DIFFERENT PEOPLE TO WORK TON SAME PROTOCOL, CONTRIBUTENA GEOGRAPHICALLY DISPERSED AND TEMPORALLY DISPERSED WAY AND OVER TIME ACCUMULATE ENOUGH DATA TO GET APPROVAL IN THE IDE FRAMEWORK AT THE SAME TIME DOING Ns OF ONE BUT THROUGH A SYSTEMATIC APPROACH. THERE COULD BE PAYMENT LIMITED TO PROTOCOL ENROLLMENT WHICH IS LIKELY PHASE 4 WINGSPAN MODEL AND CHECK AGGREGATE EFFICACY AN ADVERSE DATA EVENTS THIS STAGES THE WORK, AMORTIZES THE COST AN DECREASES THE BURDENS OF BARRIERS TO ENTRY WHICH ARE QUITE HIGH. ONCE YOU HAD THE REQUISITE DATA, STATISTICAL SIGNIFICANCE YOU GROW TO ESTABLISHED IDA APPROVAL. THE FINAL POINT TO GO THROUGH QUICKLY SO WE HAVE TIME FOR THE DISCUSSION WHICH IS MOST NECESSARY, ARE TWO VERY IMPORTANT POINTS, ASSURANCE AND OBLIGATION. I WROTE THIS PAPER ABOUT NON-ABANDONMENT AT THE NEURAL INTERFACE AND REALLY WORRY ABOUT PATIENTS WHO WERE IMPLANTED AND STUCK WITH THEIR DEVICES AND COMPANIES FAIL OR THERE'S A PROBLEM, WITH THEIR DEVICE OR THEY JUST NEED BATTERY REPLACEMENT FOR A DEVICE THAT SEEMS TO BE WORKING. I THINK THERE NEEDS TO BE LONGTITUDINAL INSURANCE COVERAGE FOR REMOVAL OF AND MAINTENANCE OF DEVICES POST TRIAL, IF IT'S NOT OTHERWISE COVERED BY THEIR INSURANCE PLANS, I THINK THIS SHOULD BE HELEN WAS ASKING STIPULATED IRB APPROVAL. AT THE OUTSET. IT SHOULD BE COST OF PART OF THE COST OF DOING BUSINESS. THERE SHOULD BE A GOVERNMENT ROLE FOR THIS INSURANCE INDIVIDUAL HOSPITALS MAY NOT BE ABLE TO BUY THIS INSURANCE. AND FOR THESE PATIENTS THE CLINICAL NEEDS OF THE THE INDIVIDUAL PATIENT AND THIS MIGHT BE SOMETHING PURGED THROUGH THE OHRP OR TRUST FUND THAT COULD RESIDE IN A GOVERNMENTAL DOMAIN. THE DETAILS FOR THE LAWYERS AND OTHERS THE TO WORK OUT. THE SECOND POINT IS INDUSTRY. SCOTT AND I WERE TALKING AT THE BREAK WHY WOULD A COMPANY TAKE ON THE VIABILITY OF ALLOWING ONE OF THEIR DEVICES TO BY USE FOR SOMETHING HYPOTHETICAL, SOME BENEFIT, IF IT GOES BAD THE MARKET SHARE IS DESTROYED FOR THAT, FOR A KEY PART OF THEIR PORTFOLIO. I THINK THAT WE HAVE TO SEE THIS AS A NATIONAL NEED, THERE SHOULD BE LEGISLATIVE RESPONSE LIKE THERE HAS BEEN FOR VACCINES WHICH WERE FELT INTERNATIONAL INTEREST AND THERE'S TWO THAT PERHAPS ARE USEFUL TO SEE PROVIDE GUIDANCE, NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986. AND MORE RECENT WAS IN THE CONTEXT OF DEVELOPING VACCINES IN THE CONTEXT OF BIOTERRORISM. THE SAFETY ACT OF 2002. AGAIN, THIS IS NOT FOR TODAY OR TOMORROW BUT WE HAVE TO HAVE A LONGITUDINAL APPRECIATION THAT INDUSTRY TAKES A RISK WHEN THEY SHARE THEIR DEVICES FOR THINGS THAT ARE MORE SPECULATIVE. THEY NEED TO BE PROTECTED IN THAT LIABILITY. THE REASON I PUT THESE TWO CONSTRUCTS TOGETHER ON THE SAME PAGE, IS ONE IS VERY PATIENT CENTERED, AND ONE IS INDUSTRY CENTERED. IF YOU COUPLE TOGETHER YOU MIGHT ENGENDER A BALANCE SUPPORT FOR THE TWO TIERS. SO THAT'S -- THOSE ARE SOME OF THE RECOMMENDATIONS. LET ME CONCLUDE WITH INVOKING MY FAVORITE PHILOSOPHER JOHN DULY, THE AMERICAN (INAUDIBLE) ALL COMMON SENSE SCIENTIFIC INQUIRY WROTE INVENTIONS OF AGENCIES CREATE NEW CONSEQUENCES, WHICH STIR MEN AND WOMEN TO FORM NEW PURPOSES. SO I WANT US ALL -- A NEW PURPOSE BUT ALSO REMIND US OLD ETHICS THAT I THINK ARE EMBEDDED IN MY TALK. MORE OPERATIONAL AND THEORETICAL. FIRST IS PROMOTION OF BENEFF SENSE, THE WORK EACH OF THESE TRIALS P P P P P THE ONE I WAS INVOLVED IN IS A 15 YEAR ADVENTURE, AN EPIC VOYAGE. THEY'RE HARD TO DO. PEOPLE IN OUR SOCIETY NEED THE BENEFIT FROM FRUITS OF NEUROSCIENCE, BRAIN INITIATIVE, THIS IS GREAT WORK, WE HAVE TO MAKE IT HAPPEN. WE HAVE TO PROMOTE THE GOOD. SAME TIME, JUSTICE, AND STEWARDSHIP OF SCARCE RESOURCES. WE ARE IN THE LONGEST SCIENTIFIC RECESSION SINCE THE SECOND WORLD WAR. WE HAVE TO MAKE SURE EVERY DOLLAR IS SPENT WELL AND WISELY. AND AT THE SAME TIME WE HAVE TO BE RESPONSIBLE. SO WE HAVE TO HAVE A RESPONSIVE APPROACH TO THE NEEDS OF THESE PATIENTS WHO HAVE THE MOST MALIGNANT DISEASES THERE ARE AND HAVE RESPONSIBLE REGULATORY FRAMEWORK. WE HAVE THIS SCIENTIFIC OPPORTUNITY TO DO THIS WORK. WE SHOULD NOT STUDIES UNDERPOWERED OR DON'T GENERALIZE AGGREGATE DATA AND WE HAVE TO MAKE SURE WE USE OUR RESOURCES TO SEE EVERY PATIENT WHO GETS DEEP BRAIN STIMULATOR CONTRIBUTES THE COLLECTIVE KNOWLEDGE THAT EVERYONE OF THESE PATIENTS AT THIS EARLY DAY EVEN PATIENTS WITH PARKINSON'S DISEASE CAN CONTRIBUTE. SO MOVING TOWARDS DISCOVERY. I THINK ALSO THIS LINKS UP TO THE PIVOTAL ROLE, I DON'T THINK WE SAID THIS ENOUGH, DBS WILL PLAY IN BRAIN MAPPING. YOU GUYS ARE AS MUCH SCIENCE AS CARTOGRAPHERS. THE MAPPING OF THE BRAIN IS BASED ON CIRCUITRY, AND BDS IS ONE OF THE KEY WAYS TO MAP THE BRAIN. NEXT POINT INTEGRITY WITHIN WORKABLE REGULATORY SCHEME. WE HAVE TO FIND A GOOD BALANCE BETWEEN THE NEEDS OF THE MARKET, THE IMPORTANCE OF CORPORATE COLLEAGUES VERSUS THE NEEDS OF ACADEMICS. AND WE HAVE TO AVOID THE THERAPEUTIC MISCONCEPTION AS PUBLIC POLICY WHERE DEVICE OR APPROACHES YET VETTED TO BE EFFICACIOUS ARE SEEN AS THERAPY. WE HAVE TO ALSO APPRECIATE THERE IS GOING TO BE COST SHARING THAT COMES WITH THIS JOINT ENDEAVOR. EARLIER YESTERDAY WE HEARD ABOUT THE 707 AND THE 727 ANALOGY. I WILL MAKE THE 787 ANALOGY, THAT PLANE WAS OUTSOURCED AROUND THE ENTIRE WORLD. EVERY PART CAME FROM DIFFERENT PLACES. WE HAVE TO COLLABORATE TOGETHER AND THERE'S GOING TO BE COST SHARING AND WE CAN'T DO THIS WITH INDUSTRY, OR ACTIVITY OR GOVERNMENT IN ISOLATION, WHAT KIP AND DAN HAVE DONE IS HISTORIC. WE SHOULDN'T BE THINKING COMPETITIVE BUT COLLABORATORS, THAWER COMES FROM LATIN TO CO-LABOR TOGETHER IN THE SERVICE OF THE GOOD. DON'T FORGET WHY YOU'RE HERE. IT'S AN INTERESTING SCIENTIFIC PROBLEM BUT REMEMBER THE MOTIVATIONS THAT BROUGHT YOU HERE. THAT'S TO THE LAST POINT THE ETHICAL PRINCIPLE OF NON-ABANDONMENT, WHATEVER WITH WE DO, WE CAN'T LEAVE PATIENTS AND FAMILIES OF -- TETHERED TO MACHINES OR DEPRIVED OF THE TECHNOLOGY, THAT HAS BEEN HELPFUL, AND I THINK WE HAVE LONGITUDINAL OBLIGATIONS FIDUCIARY OBLIGATIONS TO SUBJECTS AND WE HAVE TO SEE THE TAIL INLEARN COST OF THE ENDEAVOR. AND WE HAVE TO PRICE THAT INTO OUR WORK. SO I WILL STOP THERE AND THANK YOU VERY MUCH. [APPLAUSE] >> GREAT. THANKS A LOT, JOE. SO OUR PANEL HAS SOME REALLY INTERESTING FOLKS ON IT FROM THE NEUROETHICS STANDPOINT CHRISTINE GRADY IS CHIEF OF BIOITSELF ETHICS NIH INTRAMURAL, SCOTT KIM IS INTRAMURAL DEPARTMENT OF BIOETHICS AND HELEN MAYBERG YOU HAVE SEEN. SHE'S TRYING TO BE ETHICAL. RIGHT. SO I THINK THE PURPOSE OF THE PANEL IS TO SHIFT FOCUS A LITTLE BIT MORE TOWARDS THE PATIENT. AND THINK -- SO WE THOUGHT ABOUT THE PROBLEMS AND REGULATORY FIXES, BUT THOSE TAKE TIME AND THE RESEARCH IS ONGOING NOW. SO I THINK I INVITE THE PANEL TO THINK ABOUT, WHAT ARE THE MAJOR ETHICAL ISSUES THAT WE SHOULD BE RECOGNIZING, THE CURRENT SITUATION, WHAT SHOULD INVESTIGATORS, COMPANIES, NIH BE COGNIZANT OF IN TERMS OF MOVING FORWARD IN THIS KIND OF CHAOTIC ENVIRONMENT WITH ALL ITS LANDS MINES. CERTAINLY THE WORST CASE SCENARIO IS WHAT HAPPENED IN GENE THERAPY WHERE A EVENT DESTROYS THE FEEL FOR 20 YEARS. THAT'S ALWAYS IN THE BACK OF YOUR MIND, HOW TO AVOID THAT GOING FORWARD. ALSO WHAT DISCRETE ETHICAL RERESEARCH QUESTIONS COULD BE PURSUED AT THIS POINT IN TIME THAT WOULD HELP US MOVE ALONG. SO WHAT PRODUCT, THINGS THAT INFORM PATIENTS OR IRBs OR INFORM CONGRESS ABOUT WHAT THE BRAIN INITIATIVE IS DOING IN THE BIOETHICS STANDPOINT, WOULD BE VERY IMPORTANT TO HAVE AS WE MOVE FORWARD. SO WITH THAT I'M GOING TO ASK PAUL FORD TO START OUT BY JUST TELLING US FROM WHAT YOU HAVE HEARD TODAY, WHAT SHOULD THE PATIENT BE THINKING ABOUT AND HOW SHOULD WE FRAME THESE RESEARCH PRODUCT -- PROJECTS TO THE PATIENTS. >> PRETTY BROAD TOPIC. SO I'LL JUST HIT ON A COUPLE OF IMPORTANT THINGS TO CONSIDER. FOR MANY PROJECTS THESE PATIENT SUBJECTS ARE COLLABORATORS IN WAYS THEY AREN'T IN DRUG TRIALS. I WAS STRUCK BY THE VIDEO WE SAW OF THE WOMAN WITH THE PROSTHETIC ARM WHO IS CONTROLLING IT AND ONE OF YOUR COLLEAGUES WAS SAYING THAT HE HAD TO STRUGGLE WITH AN IRB TO ACKNOWLEDGE BY INITIALS EVEN THE PERSON WHO WANTED TO BE ACKNOWLEDGED FOR THEIR CONTRIBUTION. SO THESE ARE -- PATIENTS BECOME SUBJECTS BUT MANY STUDIES UP FRONT WE WANT TO THINK HOW THEY'RE COLLABORATORS OF HERE IS AN OPPORTUNITY NOT JUST TO RECOGNIZE THEIR COLLABORATION BUT PERHAPS LEARN SOME THINGS AND DOMAINS HOW WE OUGHT TO BE PURSUING THESE IN BETTER WAYS. AND IN SHORT, KIND OF DISCUSSIONS OR ENTERVIEWS BUILT TO THE RESEARCH FROM THE BEGINNING. SO I WAS STRUCK BY THE NDIC FDA COLLABORATION TO LOOK AT HOW MUCH RISK SUBJECTS PATIENTS ARE WILLING TO TAKE WITH THESE PROJECTS, THE IT WAS MENTIONED YESTERDAY. AND HAVING THAT CALCULUS UP FRONT IS HELPFUL IN TERMS OF KNOWING WHETHER THE ADJUDICATION OF INDICATION IS REALLY WORTHWHILE FOR PATIENT PERSPECTIVE. VERY QUICKLY TO NCATS THE NEW PARADIGM, ONE WAS RAISED ON STRAIN, WE SAW THIS MORNING OF PATIENT CENTERED OUTCOMES AND I WILL GO IN A BIT OF A BUZZ WORD, IT CAN BE A VERY IMPORTANT THING BOTH TO THE USE LATER BUT ALSO ENROLLMENT. THERE ARE DEVICE TRIALS AND SURGICAL TRIALS THAT HAVE FAILED BECAUSE OF LACK OF ENROLLMENT BECAUSE THE -- THEY COULDN'T GET PEOPLE TO BUY IN TO WHATEVER THE PROTOCOL IS SO IT'S IMPORTANT TO INCLUDE THE PATIENT PERSPECTIVES, EARLY ON RISK OPPORTUNITY TO GET RESEARCH HOW TO DO THINGS BETTER. AND I THINK THE LAST THING BEYOND A LONG TERM COMMITMENT IS NCATS ALSO IS ENCOURAGING PEDIATRIC ADOLESCENT INDICATIONS AND I HAVEN'T HEARD THAT AS A SEPARATE POPULATION YET. THE LAST TWO DAYS BUT CERTAINLY OFTEN AN ORPHAN GROUP AND MAY CARRY ITS OWN LIABILITIES AND CHALLENGES, ETHICAL CHALLENGES BUT WORTHY OF PURSUING. >> >> YOU HAVE CERTAINLY BEEN IN THIS ZONE A WHILE AND HAD LOTS OF EXPERIENCE, I HEARD YOU TALK ABOUT THE IMPORTANCE OF THE PATIENT AND THE CONTRACT BETWEEN THE PATIENT AND THE DOCTOR AND SO COULD YOU TALK MORE ABOUT WHAT DO YOU THINK THE ETHICAL IMPLICATIONS THERE, ESPECIALLY GIVEN THE FACT THAT AS PAUL MENTIONED THE PATIENT HAS ONE SENSE SET OF INFORMATION GOING IN BUT THEN IS THIS GOES ON YEARS AN YEARS AND I THINK YOU EXPRESS THE PATIENTS VIEW OF THE WHOLE PROCESS CHANGES OVER TIME. >> I THINK THIS IS AN EXIST TENIAL PHILOSOPHICAL CLINICAL PRAGMATIC RESEARCH INTERACTION. I THINK THAT WHAT I HAVE LEARNED OVER A LONG PERIOD OF TIME, THAT YOU HAVE TO BEND IT. YOU HAVE TO FIND YOURSELF AS A CLINICIAN, THERE'S WHAT I WANT FOR THESE PATIENTS BUT TO HAVE A SCIENTIFIC EQUIPOISE WHAT THE DATA CAN TELL YOU AT EACH STAGE, EVERY CLINICIAN IN AUDIENCE PARTICULARLY SURGEON MAKE THESE DECISIONS EVERY DAY AND THESE PARTNERSHIPS WE HAVE TO KIND OF BREAK IT INTO PIECES. SO I THINK AT THE BEGINNING, IN THINKING THE BIG PLAN, I THINK THAT OUR BEGINNING YOU HAVE THESE SICK PATIENTS AND WE HAVE NO IDEA IF IT WOULD WORK, THEY KNEW WE HAD NO IDEA IF IT WOULD WORK SO THE RELATIONSHIP WAS A COLLABORATION OF YOU HAVE TO TELL US WHAT'S HAPPENING GOOD OR BAD, WHATEVER IT IS BECAUSE WE HAVE NO IDEA. WHEN YOU SAY THAT AND IT'S BEING RECORDED PEOPLE SAY OH MY GOD, HOW CAN YOU SAY THAT? THAT'S PART OF THE STARTING PLACE FOR THESE EXPERIMENTS WHERE YOU HAVE PURE SCIENTIFIC EQUIPOISE, THAT IS RESEARCH. (INAUDIBLE) HAS SEEN THIS IN THEIR WORK. YOU HAVE THE PATIENT AS COLLABORATOR AND AS YOU LEARN SOMETHING YOU CAN GET INTO PURE MODE OF RESEARCH TO TEST IT. IF IT'S THERE OR NOT THERE. IT'S A CONSTANT INTERACTION -- ITERATIVE CHANGE WITH THE DEVICE BECAUSE IT ISN'T LIKE SOMEONE WORK OUT THE PILL AND AND YOU TAKE IT OR DON'T, YOU'RE WORKING TO HAVE A SPACE TO MAKE ITERATIONS ALL THE TIME. YOU DON'T WANT TO CHANGE EVERY PARAMETER, YOU HAVE NO IDEA WHAT YOU'RE DOING. BUT YOU DO HAVE OPPORTUNITIES TO BUILD INTO DESIGN TO DO THIS. I THINK THE THING THAT JOE SAID AND I LOVE -- I LOVE EVERYTHING TENDS TO SAY BUT THE CURSE OF THE MOSAICISM, THAT'S WHERE THIS BECOMES VERY IMPORTANT WHEN YOU START AND YOU KNOW NOTHING AND YOU START TO SEE SOMETHING YOUR ATTITUDE CHANGES, IT'S ALWAYS -- IT'S NEVER THE SAME FOR YOU OR THE PATIENT. AND WHEN YOU WORK IN MENTAL ILLNESS WHERE THE STARTING STATE MORPHS WHAT A PATIENT -- THIS MAYBE DIFFERENT FROM -- ARE YOU PARALYZED OR NOT, YOU HAVE A TRY MR. CXFC OR NOT, THE VERY THING YOU'RE TREATING, IS IN STATE, IF YOU'RE SUCKsFUL YOU MOVE THE PERSON TO A STATE WHERE THERE EVEN PERCEPTION OF WHAT'S HAPPENING TO THEM, CHANGES. YOUR INSIDES ARE ON FIRE WITH AN ILLNESS AND YOU TURN THAT OFF. YOUR GOAL AT THE BEGINNING IS PLEASE JUST MAKE THIS STOP. THEN YOUR GOAL IS I NEED A JOB, DO SOMETHING ABOUT MY CRAZY CHILD. I NEED A NEW HOUSE, YOUR WHOLE LIFE BECOMES DIFFERENT. I DON'T TREAT THAT. SO THE MORPHING OF THIS OVER TIME SO THERE ARE PRAGMATICS HOW WE SET UP THESE EXPERIMENTS BECAUSE IN FACT I DON'T -- WE DON'T GIVE PEOPLE NEW LIVES BUT ENABLE THEIR LIVES AND OUR METRICS AREN'T THERE AND IF WE DON'T HAVE CLEAR METRICS OR BIOMARKERS WE'RE CHASING SOMETHING THAT ISN'T WHAT WE DO. THAT'S THERAPEUTIC MISCONCEPTION, MEASURING, I'LL STOP THERE. THAT'S A START FRAME PRAGMATICS OF -- I HAVE TO HAVE INSURANCE, CATASTROPHIC INSURANCE AT THE BEGINNING. WE HAVE PROBLEMS WE DIDN'T THINK WE NEED REPLACING A BATTERY EVERY FIVE YEARS AND IT TURNED OUT EVERY 16 MONTHS, WE HAVE THE MONEY WE CHANGED THE IRB AND SAID LOOK, TAKING ADVANTAGE OF THE SUBJECT TO SAY GOING BETTER THAN WE THOUGHT BUT WE HAVE A PRACTICAL ISSUE. WE NEED TO CHANGE OUR PROTOCOL. YOU WILL NOW NEED TO BE RESPONSIBLE TO HELP DEFER COST TO REPLACE BATTERY AND WE WILL GET THE BATTERY FROM THE COMPANY SINCE WE -- WE WON'T REPLACE YOUR BATTERY BUT THEN YOU GET INTO A DANGEROUS POINT WHICH IS A THERAPEUTIC MISCONCEPTION, YOU NEED TO PAY NOW FOR US TO CONTINUE THE RESEARCH TO SEE IF IT'S WORKING WHAT YOU AS WELL. THIS BECOMES WHERE YOU HAVE TO PUT ON YOUR HAT CLINICALLY TO SAY WE HAVE TO FIGURE IT OUT IF YOU GET SO RIGID YOU'RE NOT DOING WELL BY THE PATIENT, NOT DOING WELL BY SUBJECT. DOING WELL BY YOUR OWN SELF SCIENTIFICALLY SO CUT OFF YOUR NOSE TO BE RIGID YOU DON'T GET THE SCIENCE, THE PATIENT ISN'T TAKING CARE OF. WHO WON THERE, PROTOCOL MONITOR AT THE IRB. SO I THINK THAT YOU REALLY HAVE TO GET TO WHERE THERE'S PRAGMATIC YOU HAVE MONITOR ETHICISTS YOU TRY TO LOOK AT IT AND CATCH YOURSELF SO YOU DON'T BUY YOUR OWN HYPE HUE YOU THINK IT IS AND YOU'RE SAFE, THAT'S WHY THE TEAMS WORK TOGETHER. IT HAS TO BE ITERATIVE AT THIS STAGE, WE'RE FUSING AVAILABLE DEVICE, WE'RE TALKING UNKNOWN TERRITORY FOR NEW DEVICE, IF EVERYBODY JUST HAS FREEDOM TO IT RATE AND IS CAREFUL WE'LL DO OKAY. >> PART OF THE INITIAL QUESTION WAS HOW DO WE EDUCATE PEOPLE BETTER ABOUT WHAT'S GOING TO HAPPEN? THE DBS SURGEONS HAS ME INVOLVED IN SEVERAL PROJECTS MEETING WITH PATIENTS. ONE PARTICULARLY INNOVATIVE PROJECT USING EXISTING DEVICE THEY ALSO HAVE ME MEET WITH THE SUBJECT AT THE END OF THE STUDY PERIOD WHEN THEY'RE -- WHEN STUDY IS ENDING TO ASK THE QUESTION WHAT WAS YOUR EXPERIENCE LIKE AND WHAT WOULD YOU LIKE TO HAVE KNOWN. PROJECT HOW TO EDUCATE BETTER BUT I ENCOURAGE YOU TO INCLUDE THIS IN THE STUDIES, SO YOU KNOW YOU HAVE GOTTEN TO KNOW THEM, HAVE A THIRD PARTY COME N NOT SURGEON, AND COME IN AND SAY WHAT WAS THE EXPERIENCE TO MAKE BETTER FOR THE NEXT PROTOCOL. HOW WE CAN PREPARE YOU BETTER FOR COMPLICATIONS YOU HAVE, EXPERIENCE OF PARTICULAR KIND OF TEST THAT MIGHT HAVE BEEN UNCOMFORTABLE, IN AN ITERATIVE PROCESS. >> I JUMP IN ON THAT DEPENDING ON THE DISEASE YOU HAVE, WONDERING WHAT OUR PATIENTS SAY, AT THE END OF WHATEVER THE ARBITRARY THING THEY SAID YOU NEVER TOLD ME HOW MUCH WORK I WAS GOING TO HAVE TO DOCUMENT -- DO. THAT IS PROFOUND FOUND. ONCE YOUR BRAIN RETURNS TO YOU WITH SOME THINGS WES TALK ABOUT, THE HARD WORK STARTS AND HAS NOTHING TO DO WITH THE INVESTIGATION. THIS IS TRUE IN EPILEPSY, ONCE YOU GET YOUR SEIZURE GONE SO AGAIN, LEARN FROM THAT EXPERIENCE ONCE WE START THE NEW THINGS WE FIGURE HOW TO ASK THE RIGHT QUESTIONS BUT WE'RE STILL LEARNING THE RIGHT QUESTIONS IN THIS VERY INDEFINITE SPACE. >> >> COMMENT, WHAT BRINGS UP THIS NOTION WHAT HENRY (INAUDIBLE) GEORGETOWN DESCRIBED AS ANCILLARY CARE OBLIGATION TALKING THE ROLE OF INVESTIGATORS WHO ARE OVERSEAS, CONFRONTING POVERTY AND PEOPLE WITH NO HEALTHCARE. WHAT IS THE ROLE OF THE INVESTIGATOR? TRADITIONALLY WE SEQUESTERED THE ROLE OF INVESTIGATOR AN CLINICIAN BECAUSE THERE'S A DUAL AGENCY CONFLICT OF INTEREST. BUT WHAT HELEN IS DESCRIBING IS OUR EXPERIENCE WITH PATIENTS WITH SEVERE BRAIN INJURY, THESE ARE UNDERSERVED POPULATIONS. THEY ARE NEGLECTED. AND THINK WE HAVE TO OVERCOME THAT DICHOTOMIZATION. BECAUSE THERE ARE A TALE TO THIS SUCCESSFUL IF THE LINES ARE CHANGED AND WE HAVE TO ALLOW INVESTIGATORS TO HAVE A CLINICAL ROLE BECAUSE THEY'RE COMPELLED TO DO IT. SOMETIMES THERE'S NO OTHER PEOPLE TO GET THIS KIND OF CARE. AT THE SAME TIME BEING COGNIZANT OF THE THERAPEUTIC MISCONCEPTION. THE OTHER POINT I ADD GETS TO IMPORTANT ABOUT FAMILY, ALSO WHAT FAMILIES THINK. THESE ARE DISEASES THAT AFFECT THE ENTIRE NEXUS OF INDIVIDUALS AND WHEN YOU THINK WE TALK ABOUT HOW PALLIATIVE CARE, THE FAMILY NOT THE INDIVIDUAL, THE OBJECT OF CARE FOR THESE PATIENTS IS THE WHOLE FAMILY AND FAMILIES ARE ALSO AFFECTED BY THESE -- THE CONSEQUENCES OF THIS WORK. SO WE HAVE TO DO THINK ABOUT THAT IN CONTEXT OF SUBSET OF PATIENTS WHO LACK DECISION MAKING CAPACITY, ONE OF THE BIG ISSUES OF DECISION MAKING AND HOW WE GET THE PREFERENCES IN INFORMED CONSENT WHERE PEOPLE LACK DECISION MAKING CAPACITY, BECAUSE THEY HAVE GOT SEVERE BRAIN INJURY OR DON'T HAVE (INAUDIBLE) CHANNEL LIKE LOCKED IN, COMMUNICATE HOW DO YOU APPROXIMATE AUTHORIZATION FOR THOSE STUDIES BECAUSE THEY ARE POTENTIALLY BENEFIT FEN AREAS OF THIS KIND OF WORK, ANOTHER SIDE BAR. >> LET ME ASK YOU, SO YOU ARE -- HEARD FROM THE BRAIN INITIATIVE WHAT THEY'RE DOING. THE QUAGMIRE PRESENTED TO YOU THE LAST COUPLE OF DAYS. AND THE BIO-- BEING ON THE BIOETHICS COMMISSION COULD YOU TALK TO US A LITTLE BIT ABOUT HOW DO YOU THINK ETHICS FRAMEWORK ETHICAL RESEARCH MIGHT BE PULL THAT IN TO TRY AND HELP US? >> ABSOLUTELY. THE FIRST THING I WANT TO SAY IS THAT -- AND I DON'T THINK THIS WILL COME AS SURPRISE, IT'S WORTH SAYING, THAT ETHICS IS INTEGRAL TO THIS ENDEAVOR FROM SOUP TO NUTS, WE HAVE HEARD -- WE HAVE HEARD IT IN TERMS OF SETTING UP PARTNERSHIPS, WE HEARD IT IN TERMS OF THE INTEREST OF THE VARIOUS PLAYERS, WE HEARD IT IN SOME OF JOE'S COMMENTS, WE HEARD FROM THE PERSPECTIVE OF THE PEOPLE DOING THE WORK, BUT YESTERDAY SOMEBODY SAID SOMETHING LIKE WE HAVE TO GET THROUGH ALL THAT CRAP AND THEN WE CAN GET ON TO THE REAL WORK. AND I THINK THE REFERENCE WAS TO GOING THROUGH THE IRB AND GETTING SOME OF THE REGULATORY STUFF DONE, AND UNFORTUNATELY IN SOME CASES THAT'S WHAT ETHICS GETS TO BE IN PEOPLE'S MINDS, THAT PART OF THE PROCESS, YET IT'S CLEARLY MUCH MORE THAN THAT. I THINK ETHICS CAN BE HELPFUL TO EVERY DECISION THAT'S MADE ALONG THE WAY AND PAUL AND JOE ACTUALLY GOOD EXAMPLES OF PEOPLE INTEGRATED TO TEAMS TO HELP WITH THOSE DISCUSSIONS AS THEY UNFOLD. SO THAT'S NOT THE QUESTION YOU ASKED ME BUT I COULDN'T HELP BUT SAY IT. FROM THE PERSPECTIVE OF RESEARCH ETHICS SO MANY ISSUES DISCUSSED ARE SO INTERESTLY NUANCED IN THIS ENVIRONMENT THAT I THINKITE WORTH TALKING ABOUT THEM CERTAINLY LEARNING ABOUT YOUR WORK YESTERDAY I REALIZE SOME OF IT IS HEAVY STUFF. TURNING -- LETTING PEOPLE HEAR WHO COULDN'T HEAR, LETTING PEOPLE FEEL THEIR LIMBS THAT CONFIRM THEM OR DIDN'T HAVE THEM BEFORE. PEOPLE FEELING HAPPY WHO THOUGHT THEY NEVER WOULD FEEL HAPPY IN THEIR LIFE. SO THIS IS HEAVY STUFF WHICH THEN MAKES IT IN MY PERSPECTIVE ANYWAY, ETHICALLY COMPLEX FROM A RESEARCH ETHICS PERSPECTIVE SO THAT WHAT DOES THAT MEAN? THAT MEANS ALL THE THINGS WE THINK IN ANY RESEARCH CONTEXT FROM ETHICS PERSPECTIVE HAVE LITTLE THINGS TO THINK ABOUT IN THIS CONTEXT. THE RISK ASSESSMENT AND MITIGATION, YOU HAVE TALKED A LOT ABOUT THAT YESTERDAY. CERTAINLY THERE'S MULTIPLE LEVELS THAT'S AN IMPORTANT CONSIDERATION FROM ETHICAL PERSPECTIVE. WE HAVE OBLIGATIONS AS RESEARCHERS TO MINIMIZE RISK AND TO ONLY INCORPORATE THINGS THAT PROVIDE RISK OR CAUSE RISK THAT ARE NECESSARY. SO THESE ARE OBLIGATIONS THAT ARE IMPORTANT IN THIS CONTEXT AS WELL. THEN THERE'S THE ASSESSMENT WHETHER THE RISKS THAT ARE NECESSARY AND MINIMIZED ARE WORTH IT. IN THIS CONTEXT AND ASSESSMENTS MADE BY THE IRB BUT ALSO BY THE PI AND BY PARTICIPANTS. ALONG THE WAY. AND PARTNERS IN THE ENDEAVOR. PEOPLE TALK ABOUT IRB REVIEW, I THINK IRBs FROM MY PERSPECTIVE FEEL NECESSARY AND IMPORTANT IN PROTECTING HUMAN SUBJECTS BUT I THINK PROBABLY EVERYONE KNOWS MAYBE HAS EXPERIENCED THEY'RE INCONSISTENT. INCONSISTENT IN JUDGMENT, OFTEN DON'T HAVE THE BACK GROUND AND EXPERTISE TO KNOW HOW TO REVIEW A PARTICULAR STUDY. I WOULD GUESS IN THIS SPACE THEY NEED GUIDANCE, THEY NEED GUIDANCE ABOUT THIS KIND OF RESEARCH WHAT ARE THE ISSUES, WHAT ARE THE CHALLENGES AND HOW DO THEY THINK ABOUT IT IN THEIR USUAL WAY THEY REVIEW STUDIES. CONSENT AS SOMEBODY MENTIONED, CONSENT, I THOUGHT ABOUT THIS YESTERDAY WE WERE TALKING ABOUT SOME OF THE PARTICULAR STRIKING EXAMPLES AND YOU CAN IMAGINE PEOPLE WITH CERTAIN ILLNESSES, THINKING, AND BELIEVING STRONGLY, THEY'LL DO ANYTHING. THEY'LL TRY ANYTHING. TO GET BETTER. THEY'LL TAKE ANY RISK. I THINK THAT'S PROBABLY TRUE AND THEY WILL TAKE RISKS THAT SOME OTHERS WOULDN'T IMAGINE. BUT I THINK THAT PUTS A LITTLE BIT OF ONUS ON US TO BE EVEN MORE CAREFUL ABOUT MAKING SURE THAT THEY UNDERSTAND CERTAIN THINGS LIKE THESE ARE INVESTIGATIONAL -- THESE ARE INVESTIGATIONS. WE DON'T KNOW IF THIS WILL WORK, HELEN MENTIONED THAT A FEW MINUTES AGO. THE INCREMENTAL NATURE OF WHAT WE'RE DOING. THE PLANS FOR WHAT HAPPENS IF SOMETHING BAD HAPPENS, THEY NEED TO KNOW THAT AHEAD OF TIME. MAYBE PLANS FOR COMMERCIAL POSSIBILITIES. MAYBE PLANS FOR LONG TERM ENGAGEMENT, WHAT -- HOW DO WE CHANGE THE BATTERIES TEN YEARS FROM NOW. AND ALSO PLANS FOR OPEN DATA SHARING. THOSE KINDS OF THINGS ARE NOT ALWAYS IN EVERY CONSENT PROCESS. THOSE ARE THINGS THAT SEEM LIKE WOULD BE RELEVANT TO LOTS OF PEOPLE. SOME CASES BECAUSE PEOPLE ARE SO DESPERATE FOR THESE KINDS OF INTERVENTIONS, IT MIGHT BE WORTH SOME FORMALIZED ASSESSMENTS OF UNDERSTANDING TALK ABOUT LIABILITY INSURANCE AND I THINK THERE'S A BROADER CONVERSATION ABOUT THIS, IN THE UNITED STATES FROM WALLER MENTIONED PART OF THE PRESIDENT'S COMMISSION. WE AS MANY PRIOR COMMISSIONS HAVE SAID FROM ETHICAL OR MORAL PERSPECTIVE, PEOPLE WHO PARTICIPATE AS COLLABORATORS IN RESEARCH ESPECIALLY RISKY RESEARCH SHOULDN'T BARE COST OF THINGS THAT HAPPEN TO THEM, BAD THINGS THAT HAPPEN TO THEM, YET UNITED STATES IS ONE OF THE FEW COUNTRIES IN THE WORLD THAT HAS NO SYSTEM FOR THAT. NONE FOR RESEARCH. EVEN THE VACCINE INJURY PROGRAM THAT JOE MENTIONED DOESN'T COMPLETELY COVER RESEARCH. VACCINE RESEARCH IS A BIG ISSUE IN VACCINE RESEARCH AS WELL. HUGE ISSUE. WE NEED A SYSTEM IN THE UNITED STATES WE DON'T HAVE ONE. TWO OTHER QUICK THINGS THEN I WILL STOP. ANCILLARY CARE ISSUES ARE HUGE, AS JOE MENTIONED THERE'S DEBATE ABOUT THIS IN THE LITERATURE, THERE'S A THEORY PUT FORWARD, THERE'S SOME -- THE THEORY THAT'S PUT FORWARD DESCRIBE THERE ARE SOME ETHICAL OBLIGATIONS ON THE PART OF THE RESEARCHER IN COLLABORATION WITH FUNDERS ABOUT SPONSORS TO PLAN FOR WHAT HAPPENS WITH ANCILLARY CARE THAT YOU CAN PREDICT IN MANY CASES, THAT IS GOING TO HAPPEN. THE SAME IS TRUE FOR POST TRIAL RESPONSIBILITY. WE TALKED ABOUT LONG TERM ENGAGEMENT WITH THESE INDIVIDUALS BUT THIS IS NOT AN ISSUE ONLY BEING DEBATED IN THIS CONTEXT. MANY OF YOU MAY KNOW THAT THE DECLARATION OF HELSINKI TEN, 15 YEARS AGO ADDED A PROVISION FOR POST TRIAL OBLIGATIONS ON THE PART OF THE INVESTIGATORS AND THE SPONSORS. AND IN THAT SINCE THAT FIRST ADDITION, IN 2000 IT'S BEEN CHANGED AT LEAST FOUR TIMES. AND THE MOST CURRENT FORMULATION OF THAT IS I WILL READ IT TO YOU BECAUSE IT'S INTERESTING TO THINK WHAT IT MEANS. IN ADVANCE OF A CLINICAL TRIAL, SPONSORS RESEARCHERS, AND HOST COUNTRY GOVERNMENTS SHOULD MAKE PROVISIONS FOR POST TRIAL ACCESS FOR ALL PARTICIPANTS WHO STILL NEED AN INTERVENTION IDENTIFIED AS BENEFICIAL IN THE TRIAL. THIS INFORMATION MUST BE DISCLOSED TO PARTICIPANTS DURING INFORMED CONSENT PROCESS. SO THIS IS THE 2013 DECLARATION OF HELSINKI THAT'S GOTTEN A LOT OF ATTENTION, THE KINDS OF DEBATES ARE WHO IS RESPONSIBLE? THERE ARE A LOT OF PLAYERS IN THAT SENTENCE, WHAT ARE THEY RESPONSIBLE FOR? HOW ARE THEY RESPONSIBLE FOR LONG TERM PROVISION? AND WHO PAYS? YET THERE ARE IMPORTANT IMPLICATIONS FOR PLANNING TRIALS, INFORMING PEOPLE IN THE PROCESS OF CONSENT, SETTING UP PARTNERSHIPS AND I THINK IN LISTENING TO YOU ALL SHARING BEST PRACTICES SHARING THE KINDS OF THINGS THAT YOU HAVE ALREADY FIGURED OUT HOW TO DO AND LEARN HOW TO DO COULD BENEFIT NOT ONLY THIS COMMUNITY BUT MANY OTHERS. I THINK LAST COMMENT. THIS KIND OF DISCUSSION LEAVES OVER INTERESTING QUESTIONS IN MY MIND. SO THAT ADDRESSES PEOPLE WHO ARE BENEFITING. WHAT ABOUT PEOPLE (LOST AUDIO) IT WAS INTERESTING BUT JUST LIKE I'LL CLOSE WITH THIS COMMENT HOW TO PLAN AND EXECUTE AND INTERPRET DATA THAT ARE RELEVANT TO RESEARCH ETHICS. I ENCOURAGE EVERYBODY TO READ IT, THE FDA SAYS THAT IF YOU SUBMIT DATA ABOUT PATIENT PRACTICES WE WOULD USE IT TO MAKE DETERMINATIONS AND APPROVAL ABOUT PARTICULAR ADVICE, WHAT'S INTERESTING IS NOWHERE IN THERE IS THERE A DISCUSSION ABOUT THE SAME KIND OF RIGOR THAT YOU WOULD REQUIRE OF DATA FROM USE OF THE DEVICES. SAME KIND OF REGISTRATION INTENT AND HOW YOU'RE GOING TO USE IT, WHAT'S THE DATA AND SO FORTH, THE VALID THETY OF THE DESIGN AND SO FORTH. SO THAT ISSUE IS RELEVANT ONCE YOU GET INTO THE DATA NECESSARY AND I THINK THAT ONCE WE STARTED THINKING AND RUN INTO THESE ETHICAL PROBLEMS, IF YOU START SEEKING DATA, STUFF THAT'S BEEN GATHERED AS WELL AS DESIGNING FUTURE STUDIES, THE BEAUTY IS IF YOU DO IT RIGHT THEN IT DOES MAKE DEFINITE INCREMENTAL MOVEMENTS FORWARD. NOT JUST REPEATING THE SAME DEBATES. THANK YOU. >> (OFF MIC) >> SO THESE ISSUES AS YOU CAN SEE, I THINK PART OF OUR RESPONSIBILITY RUNNING THE BRAIN INITIATIVE TO MAKE INROADS WITH ETHICAL RESEARCH THAT'S GOING TO BE OF VALUE TO INVESTIGATORS ON THE GROUND. SO WE WILL WORK ON THAT AS WE GO FORWARD. THANKS A LOT, EVERYONE. [APPLAUSE] >> OUR NEXT -- THANK YOU FOR THAT DISCUSSION. OUR NEXT SESSION IS ON DATA CONSIDERATIONS. I KNOW THIS MORNING THERE ARE A NUMBER OF COMMENTS THAT WE DEFERRED UNTIL THIS SESSION. WE WILL HAVE THREE TALKS THEN A PANEL DISCUSSION AND WE'RE GOING TO ASK PEOPLE TO HOLD THEIR QUESTIONS UNTIL THE PANEL DISCUSSION. SO THE FIRST TALK IS BY MYCOLIC CRAIG FARBER FROM NIMH, HE TRAINED AS PHYSICAL CHEMIST AT MIT AND ASSOCIATE PROFESSOR WITH TENURE AT PENN STATE UNIVERSITY BEFORE COMING AS ROTATOR AT NSF. THE REASON WE INVITED HIM TODAY IS HIS EXTEN CIVIL EXPERIENCE WITH DEVELOPING LARGE DATABASES WHICH HE FIRST -- INITIATED AT NCRR AND AS CONTINUED THAT WORK AT NIMH. WHERE HE HOLDS MANY HATS. DIRECTOR OF TECHNOLOGY DEVELOPMENT, CO-LEAD OF THE MAIN GROUP RUNNING THE INITIATIVE AND HE RUNS THE NDAR AUTISM DATABASE WHICH IS A VERY LARGE EFFORT. GREG. THANKS FOR COMING. >> THANKS, NED. SO I'M GOING TO TRY TO DO I THINK BRIAN LITT AND I WILL DO A TAG TEAM HERE. I WILL TRY TO TALK A LITTLE BIT MORE ABOUT BROAD DATA SHARING TYPES OF THINGS THAT NEED TO BE THOUGHT ABOUT AND BRIAN WILL FOCUS MORE ON A PARTICULAR DATA INFRASTRUCTURE AS NED SAID ONE OF MY JOBS AT NIMH IS TO RUN A LARGE DATA ARCHIVE. THIS IS ONE GLIMPSE INTO THE DATA ARCHIVE, THIS IS THE NDAR PORTION OF THE INFRASTRUCTURE NATIONAL DATABASE FOR AUTISM RESEARCH. THROUGH RUNNING THIS SEEING -- HAVING HEARD WHAT'S GOING ON IN INFORMATICS AROUND NIH FOR QUITE A WHILE NOW, I DEVELOPED A SET OF STRONG OPINIONS ABOUT WHAT'S IMPORTANT, WHAT'S LESS IMPORTANT SO I WILL SHARE THOSE WITH YOU TODAY. THESE ARE MY OPINIONS, I'M NOT SURE HOW MANY FOLKS AT NIH COMPLETELY SHARE THEM BUT THEY'RE RIGHT ANYWAY. THE BRAIN INITIATIVE. THE TERMS OF DATA WE'RE THINKING ABOUT IN TERMS OF THE CONTEXT OF BRAIN INITIATIVE ARE SIMILAR TO OTHER AREAS OF RESEARCH. THE IMPORTANT QUESTIONS ARE FIRST OF ALL, DEFIN DATA STANDARDS, THERE'S A DISTINCTION BETWEEN DATA ELEMENTS AND COMMON DATA ELEMENTS, NOT SURE WE'RE GOING TO GET INTO THAT TODAY. BUT THERE IS A DISTINCTION THERE. THESE ARE RELATED TO RELIABILITY. I WILL TALK MORE ABOUT EACH OF THESE AS I GO ON. SECOND QUESTION, WHERE TO STORE DATA WHEN THE MAKE THE DATA AVAILABLE HOW TO TRACK THE USE OF THE DATA. GIVE CREDIT TO THOSE WHO MEASURE THE DATA AS WELL AS THOSE WHO ANALYZE. WHO PAYS FOR THIS? A PARENTHETICAL NOTE ETHANE THETCAL NOTE I USE THE WORD DATA TO MEAN THE DATA ITSELF, THE EEGs, THE MRI IMAGES THE CLINICAL ASSESSMENT, AS WELL AS DATA ANALYSIS WORK FLOWS BECAUSE EVERYTHING I WILL SAY APPLIES TO BOTH OF THOSE. DATA STANDARDS. SO THERE ARE A LOT OF COMPONENTS TO DATA STANDARDS AND THIS IS A DAY AND A HALF MEETING A GREAT DAY AND A HALF MEETING WE COULD HAVE HAD ONE ON RAREIOUS COMPONENTS OF DATA STANDARDS. SO WE'RE NOT GOING TO GET INTO DETAIL HERE. I THINK THE BRAIN INITIATIVE THE KEY QUESTIONS REALLY FOCUS AROUND FINDING CONSENSUS IN A RESEARCH COMMUNITY ABOUT HOW TO DESCRIBE THE DATA THAT COMES FROM THESE NEW TOOLS. SO FINDING THAT CONSENSUS MEANS MEMBERS OF THE COMMUNITY NEED TO TRY TO USE EACH OTHER'S DATA. THAT IS A BELIEF, NOT A FACT, BUT HAVING SEEN HOW THIS WORKS IN A VARIETY OF COMMUNITIES, THIS IS THE WAY WHEN YOU FIGURE OUT WHEN LABS ACTUALLY TRADE DATA SETS AND ONE LAB SEES ANOTHER IS MEASURING DATA OF A PARTICULAR TYPE AND ASK WHY YOU CHECK THAT, WE NOTICE SUCH AND SUCH HAPPENS, AS A MOMENT OF EPIPHANY THAT IS IMPORTANT. I WILL POINT OUT IN THE CELL CLASSIFICATION, CELL TYPE CLASSIFICATION COMPONENT IN THE BRAIN INITIATIVE, THIS IS GOING ON RIGHT NOW. ONE OF THE THINGS THAT MAYBE WE'LL TALK ABOUT DURING THE PANEL DISCUSSION IS THE TIME RIGHT TO DO THIS IN OTHER AREAS OF THE BRAIN INITIATIVE, I'M SPECIFICALLY LOOKING AT YOU HERE WHO ARE PART OF THE BRAIN INITIATIVE OR WOULD LIKE TO BE. FINALLY THESE DATA SHARING CONSENSUS BUILDING THINGS, REALLY ARE KEY CORESOLVE NON-REPRODUCIBILITY ISSUES. GOOD NEWS THAT'S A HARD PROBLEM WORKING THROUGH THE CONSENSUS IS HARD PROBLEM BUT ONCE DONE, NIH HAS MADE QUITE SIGNIFICANT INVESTMENTS IN INFRASTRUCTURE TO STORE DATA STANDARDS. I LIST AD COUPLE HERE UNDOUBTEDLY MANY MORE THESE DO EXIST, THERE ARE WEB SITES, YOU CAN GO TO EACH OF THEM, YOU CAN POINT AT THINGS IN THAT WEBSITE,K DOWNLOAD INSTRUMENTS TO USE, DOWNLOAD QUESTIONNAIRES, IT'S THERE. IT'S AVAILABLE. IT IS READY TO GO AND ALL THAT NEEDS TO BE DONE FOR COMMUNITIES TO JOIN IS FOR THEM TO SAY HERE IS OUR SETS OF DATA COLLECTION INSTRUMENTS AND PUT THEM SOMEWHERE. THAT'S EASY. THAT INVESTMENT IS THERE ALREADY. GOING TO SHIFT TO DATA STORAGE AND DISCOVERABILITY. THERE ARE A LOT OF PLACES WHERE RESEARCHER CAN IN THEORY DEPOSIT DATA. THERE ARE SPECIALIZED REPOSITORIES, BRIBE WILL TALK ABOUT ONE OFFER THOSE IN A MINUTE. GENERALIZED REPOSITORIES ASSOCIATED WITH PUBLICATION. REPOSITORIES MAINTAINED BY THE GOVERNMENT, BY ACADEMIC INSTITUTIONS, JOURNALS, OTHER INTERESTED PARTIES. AND REGISTRIES OF REPOSITORIES ARE STARTING TOE MERGE. THAT MIGHT BE TO EMERGE. THAT'S PART OF THE DISCOVERABILITY SOLUTION THOUGH FAIRLY EARLY ON IN THAT GAME T. THAT'S A SPECTRUM OF DATA STORAGE OPTIONS OF MATURE END OF THE SPECTRUM, YOU HAVE REAL REPOSITORY LIKE NIMH DATA ARCHIVE, PROTEIN DATA BANK GENE BANK, THERE ARE LONG LIST THERE. THOSE REPOSITORIES ARE REALLY WHERE GET MAINTAINED AND DEVELOPED IN MANY WAYS. THE DEFINITION OF HYDROGEN BOND IN A PROTEIN CHRISAL STRUCTURE REALLY DEPENDED ON AMASSING CRYSTAL STRUCTURES AND THE COMMUNITY EITHER AGREED WITH OR ALLOWED TO BE FORCED UPON IT THE DEFINITION THAT A HYDROGEN BOND IS BETWEEN DONOR, IT'S LINEAR, BETWEEN 2.8 AND 2.2-ANGSTROM AND THAT OPENS UP A BUDGET OF SCIENCE -- A BUNCH OF SCIENCE, BECAUSE IF IT'S 2.6-ANGSTROMS YOU NOTE THAT YOU HAD A SCREW UP IN YOUR EXPERIMENT OR YOU WOULD KNOW YOU HAVE SOME INTERESTING BIOLOGY GOING ON THERE SO THIS IS HOW THE -- THIS IS REALLY WHAT HAPPENS. IMPORTANTLY FEDERATION IS POSSIBLE. YOU DON'T NEED A SINGLE REPOTTSTORY IN A SINGLE AREA. THERE ARE HALF A DOZEN IMPORTANT REPOSITORIES IN THE AUTISM AREA. WE FED RATE. WE HAVE GOOD DEEP QUERIES ACROSS REPOSITORIES SO DATA IS DISCOVERED ACROSS ALL OF THEM. AT THE OTHER END IS A LONG TAIL. THESE ARE IN MANY CASES THE BUCKET OF DATA PUT SOMEWHERE WHERE IT DOESN'T DISAPPEAR BUT NOT NECESSARILY TIED IN VERY WELL WITH MUCH ELSE. OFTEN THESE ARE ASSOCIATED WITH PARTICULAR PAPER, DROP BOXES, GREAT TECHNOLOGY FOR SHARING DATA AMONG SMALL COMMUNITY, THERE'S OTHERS BUT IT DOESN'T MAKE IT PUBLICLY AVAILABLE. THERE HAVE BEEN DISCUSSIONS INSIDE THE BRAIN INITIATIVE, AND IN OTHER PLACES. ABOUT THE MASSIVE AMOUNTS OF DATA. AND I DON'T -- BIOMEDICAL RESEARCH I DON'T BELIEVE IT'S AND ALL TRUE, I HAVE BEEN WATCHING THIS CAREFULLY AND I THINK WE HAVE MEDIUM SIZE DATA. IT MIGHT BE TRUE TO GET TO BIG DATA IF IT TURNS OUT THAT THE WHOLE GENOME SEQUENCING EXPERIMENTS DO PRODUCE DATA FASTER THAN THE MOORE'S LAW THAT IS DRIVING THE DECREASE OF DATA STORAGE COSTS, MAYBE WE'RE GOING TO HAVE A PROBLEM. I HAVE BEEN WATCHING THAT CLOSELY, DOING THE CALCULATION. I DON'T SEE WE HAVE A PROBLEM. THERE ARE A VARIETY OF WAYS TO STORE DATA MIGHT OVERWHELM THE CAPACITY OF THEIR LABORATORY TO STORE DATA OR EVEN THEIR DEPARTMENT OR INSTITUTION. THAT DOESN'T MEAN AMAZON GOOGLE, OTHER CLOUD PROVIDERS DON'T HAVE GOOD SOLUTIONS. SO I WILL MOVE TO DISCOVERABILITY AND CREDIT SO THERE'S A LOT OF PLACES WE CAN STORE DATA. BUT FINDING DATA ONCE PUT WHERE IS A REAL PROBLEM, THERE'S NOTHING LIKE A GOOGLE SEARCH THAT LETS YOU REALLY FIND DATA. I BELIEVE THE DIGITAL OBJECT IDENTIFIER TECHNOLOGY IS GOING TO END UP BEING THE KEY COMPONENT OF THIS DISCOVERABILITY PROBLEM. BIG DATA TO KNOWLEDGE PROGRAM HERE AT NIH IS MAKING A SIGNIFICANT INVESTMENT IN TRYING TO SOLVE THE DATA DISCOVERABILITY PROBLEM. WE'LL SEE WHERE THAT GOES THE TECHNOLOGY IS THE KEY. ANOTHER IMPORTANT PROBLEM IS GETTING CREDIT IN SOME BIOMEDICAL RESEARCH COMMUNITIES THERE ARE EXPECTATIONS OF DATA BEING SHARED QUICKLY. THE PROTEIN DATA BANK IS A GOOD EXAMPLE, GENOMICS IS A GOOD EXAMPLE QUESTION IS HOW DO YOU MAKE THAT THAT HAPPEN IN THE COMMUNITY YOU'RE WORKING IN? I THINK THAT ACTIVE ONLY SEEN ONE WAY THIS ONE DRIVING FORCE TO MAKE THIS HAPPEN WHEN JOURNALS IN THE FIELD OR NIH SAY NOT AN OPTION YOU NEED TO DO THIS. THAT WORKS THERE'S SOME CONSEQUENCES AS WELL. BUT THIS MIGHT BE AN AREA TO HAVE DISCUSSION AS WELL AS DURING THE PANEL. AND I THINK THAT FINDING WAYS LIKE THIS DIGITAL OBJECT IDENTIFIER TO ACTUALLY MAKE A CITATION FOR DATA MEANINGFUL CITATION FOR DATA MIGHT HELP THIS PROCESS A LITTLE BIT HERE ARE THE DOIs WE HAVE BEEN GENERATING SOME OF THE DOIs AS PART OF THE NDAR PROJECT. YOU CAN DO A COUPLE OF THINGS WITH, YOU CAN PUT THE DOI NUMBER IN YOUR PAPER. ONE WAY TO DO CITATIONS IF SOMEONE REANALYZES DATA AND SAID THE DATA CAME FROM THIS, THIS, THIS, THIS, THERE'S A REAL CITATION. WE CAN FIGURE HOW MANY CLICKS ARE ASSOCIATED WITH EACH OF THE DOIs THAT WE MINTED, THERE'S ANOTHER METRIC, IT'S NOT PAPER BUT SOMEONE DOWNLOADED IT AND LOOKED AT THE -- WHAT I HAD. THESE TYPES OF CITATION INFRASTRUCTURE IS ALMOST THERE. NOT REALLY THERE. ALMOST THERE YOU CAN IMAGINE HOW THAT MIGHT HELP BIOMEDICAL RESEARCHERS SEE THE VALUE, SHARING THEIR DATA EARLY AND OFTEN. PAYING FOR IT, WALTER IS IN THE AUDIENCE AND WON'T LIKE WHAT I'M ABOUT TO SAY BUT NIH NEEDS THE PAY FOR THIS AND ANY OTHER FUNDING AGENCIES. THIS GROUP MAYBE ONE OF THE RARE CASES WHERE THERE IS ENOUGH INTEREST FROM THE COMMERCIAL COMMUNITY TO HELP OFFSET THOSE COST, THERE'S ANOTHER EXAMPLE OF CAMBRIDGE CRYSTAL GRAPHIC CENTER, WHERE A NUMBER OF PHARMACEUTICAL COMPANIES AND OTHERS BECAUSE THEY WANT ACCESS TO SMALL MOLECULE CRYSTAL STRUCTURES BECAUSE IT WAS CHEAPER TO MAINTAIN A DATABASE RATHER THAN RESOLVE THE STRUCTURES THEY CAN DISTRIBUTE CONTRIBUTE TO THE ONGOING COST OF THE INFRASTRUCTURE SO WE WIN. CHEAPER FOR THEM, GOOD FOR THE IMMUNITY BECAUSE WE GET TO USE THE DATA. MIGHT BE SOME DATA FITS INTO THAT SO THAT'S SOMETHING WE SHOULD EXPLORE IF NOT DURING THE CONFERENCE DURING THE PANEL LATER ON. GETTING CLOSE TO THE TEND HERE. SO I HEARD THE START OF SOME THINGS YESTERDAY AND I'M SHOT SURE HOW WIDESPREAD THIS IS I HAVE A VERY STRONG FEELING PROPRIETARY FILE FORMATS OR OTHER WAYS OF HIDING DATA FROM DIFFERENT MANUFACTURERS JUST KILL EVERYTHING THAT'S GOOD ABOUT A FIELD. I THINK THE MRI COMMUNITY SUFFERED GREATLY BECAUSE SEMENS -- SEIMENS AND PHILLIPS AN GE DO THIS, IT'S A STRONG CONTRIBUTING FACTOR TO NON-REPRODUCIBILITY ISSUES WE SEE IN MRI. I ENCOURAGE YOU IF THERE'S WAY TO AVOID THAT AMONG DEVICE MANUFACTURERS, YOU SHOULD TRY TO FIND THAT WAY BECAUSE IT DOESN'T HELP. LAST SLIDE, WHICH IS NEW TO NED AND WALTER AND THINGS I HAVE BEEN THINKING ABOUT, POTENTIAL WE SHOULD TALK ABOUT FOR SHARING PLANS MIGHT BE SOMETHING LIKE THIS. WE'RE STILL MOSTLY IN TO A DEVELOPMENT EFFORT BUT IT CLEAR LIKELY THAT WE'RE GOING TO PIVOT TO DATA COLLECTION EFFORTS IN THE NEXT FEW YEARS. WHILE WE'RE DOING TOOL DEVELOPMENT WE SHOULD REALLY MANDATE THE GROUPS WE FUND AS WELL AS OTHERS FROM THE FUN COMMUNITY GET TOGETHER TO BEGIN THE BROAD DISCUSSION ABOUT APPROPRIATE DATA SHARING STANDARDS. ONCE WE HAVE AN UNDERSTANDING OF WE HAVE DATA COLLECTING IN THE VARIOUS PROGRAMS WE'RE GOING TO FUND IT'S UP TO NIH TO PROVIDE APPROPRIATE DATA SHARING INFRASTRUCTURE. THAT DOESN'T NECESSARILY MEAN THAT WE'RE GOING TO RUN THE DATA SHARING INFRASTRUCTURE HERE, THERE MAY BE BETTER TO DO THIS IN THE ACADEMIC COMMUNITY BUT WE'RE GOING TO PROVIDE FUNDING TO GET THIS STARTED. I THINK THAT THERE ARE EXISTING INFRASTRUCTURES THAT WE CAN BUILD OFF OF TO MAKE THIS LESS THAN IN TERMS OF COST. I'M CERTAINLY INTERESTED IN HEARING YOUR VIEWS ABOUT THOSE IDEAS. THAT'S THE END OF MY PRESENTATION. >> THANKS, GREG. >> SO BRIAN IF YOU WANT TO COME UP, MAYBE TOO MANY FOR A COUPLE OF QUESTIONS IF YOU CAN BRING THE MIC UP WHILE BRIAN GETTING SET UP. >> OUTSTANDING TALK. AS A RECIPIENT OF AWARD FOR TOOL DEVELOPMENT IN DBS BASE I REALLY THINK THIS IS THE RIGHT TIME TO HAVE THESE STANDARDS DISCUSSIONS. SO ONE THING WE HAVE ALSO SEEN AND WRESTLED WITH Z AS WE ROLLED OUT SOFTWARE TO ALLOW NORMALIZATION OF MRI AND PHYSIOLOGICAL DATA IN ONE SPACE WAS THE PROJECT WE WERE INVOLVED IN. TWO THINGS THAT BECAME OBVIOUS, I WILL SHARE THE FIRST, THAT IS WE EXPECTED A LOT OF INVESTIGATORS WHO ARE PART OF A SMALL CONSORTIUM FOR TESTING THE NOTION OF DATA SHARING, TO BE FREE WITH THAT AND WE'RE INCREDIBLY SURPRISED AT THE RESISTANCE EVEN WITHIN MY OWN INSTITUTION FOR RESEARCHERS TO JUST USE THE TOOL SET AND PUT DATA INTO IT BECAUSE OF THE FEAR OTHERS PILFER THE DATA FOR PUBLICATION DESPITE MULTIPLE REASSURANCES IN SECURITY BUILDING MEASURES THAT ONLY THE OWNER OF THE DATA ACCESS OR ALLOW OTHERS TO LOOK AT AND I'M CURIOUS WHETHER OR NOT YOU THINK THAT'S A UBIQUITOUS PROBLEM OR JUST A UNIQUE SUBSET OF THIS COMMUNITY. THEN MY SECOND QUESTION HAD TO DO WITH ANY THOUGHTS YOU HAVE ON HOW YOU GO ABOUT VALIDATING THE DATA OPPOSED TO JUST CONCERT ODE >> THAT'S GREAT. I CAN ANSWER BOTH OF THOSE QUESTIONS. IT IS NOT A UNIQUE PHENOMENON, IT'S UBIQUITOUS, BASED ON VARIOUS NIMH COMMUNITIES WE DEALT WITH, PEOPLE IN THESE TIGHT FUNDING TIMES PEOPLE ARE WORRIED ABOUT BEING SCOOPED. THE NUMBER OF TIMES THAT HAPPENED YOU CAN COUNT FINSERS OF ONE HAND. IT CONTINUES TO BE A REAL CONCERN. THERE ARE -- THAT IS WHY PERHAPS MANDATES FROM NIH OR THE JOURNALS SPEAK WHEN YOU DEPOSIT DATA BECOME SO IMPORTANT. THE SECOND QUESTION WAS VALIDATION. IN ANY OF THESE DATA ARCHIVES, IT'S TRIVIAL TO BUILD GOOD VALIDATION TOOLS. FOR EXAMPLE, WHAT WE DO WITH NDAR IS WE HAVE DATA DICTIONARIES THAT DEFINE CLINICAL ASSESSMENT SO QUESTION NUMBER FOUR IN A PARTICULAR ASSESSMENT SHOULD HAVE RANGE OF VALUES ONE, 2002, THREE, A, B, C, WHATEVER. IF WE GET IN A VALUE THAT'S NOT ALLOWED, WE DON'T TAKE THE DATA IN AND GO BACK TO RESEARCHER AND SAY YOU HAVE A PROBLEM. BECAUSE WE REQUIRE DATA DEPOSITION EVERY SIX MONTHS, THIS GIVES THE RESEARCHER AN ABILITY TO FIND PROBLEMS IN THEIR DATA COLLECTION THEY WOULDN'T HAVE KNOWN ABOUT OTHERWISE UNTIL THEY ACTUALLY WENT TO ANALYZE THE DATA. WE HAVE YET TO HEAR A THANK YOU FOR THIS TOOL BUT I THINK THAT THIS SAKE VALUABLE THING THE INFRASTRUCTURE DOES, I KNOW PIs ARE DEEPLY EMBARRASSED THE FIRST TIME THIS HAPPENS, IT DOESN'T HAPPEN THAT MUCH AFTER THE FIRST TIME SO VALIDATION IS REALLY IMPORTANT. I AGREE COMPETELY. THERE'S DIFFERENT LEVELS OF VALIDATION, IN TERMS OF CAN YOU REPRODUCE DATA ANALYSIS. THAT TAKES MORE EFFORT AND WE DON'T TRY TO DO ANYTHING LIKE THAT. >> THANKS. WE HAVE TO GET MOVING ON. GREAT TALK, GREG. THANK YOU VERY MUCH. OUR NEXT SPEAKER IS DR. BRIAN LITT WHO MANY OF YOU KNOW IS PROFESSOR NEUROLOGY NEUROSURGERY AN BIOENGINEERING AT PENN. AND IN ADDITION TO ALL HIS GREAT WORK IN DEVELOPING DEVICES AND EPILEPSY FIELD HE ALSO HAS MANAGED OVER THE LAST FEW YEARS I WANT TO CHALLENGE THE GROUP THAN TELL YOU WHAT WE HAVE DONE THE. FIRST THING IS JUST KISS CLOSURES. WE WORK WITH A NUMBER OF COMPANIES I HOPE THIS LIST IS GOING TO GROW VERY LONG, THESE ARE PEOPLE WHO HAVE DONE SPONSORSHIP OF SOME OF THE WORK. SOME OF THE SPIN OFFS THAT HAVE COME ARE PATENTS LICENSED TO THEM. THE OTHER THING I WANT TO PUT ON HERE THAT I DIDN'T IS ZACK IVES IS PROFESSOR COMPUTER SCIENCE AT PENN AND YOST WAGNER, YOST IS HERE ZACK IS NOT ARE THE BRAINS BEHIND WHAT I SHOW YOU TECHNICALLY. AND IT'S KIND OF A NICE COLLABORATION THAT WE HAVE GOING. SO THE FIRST THING IS I WILL TELL YOU ABOUT THE PLATFORM, IT WILL TOUCH CLOSELY ON A LOT OF ISSUES THAT GREG TALKED ABOUT. AND I'M GOING TO CHALLENGE THIS GROUP AND SAY THAT WE COULD WAIT AND KIND OF DEATHER AROUND AND WE CAN LOOK AT A BUNCH OF OPTIONS AND TALK ABOUT FUNDING STUFF. OR WE CAN ACTUALLY DO SOMETHING. AS A GROUP. REALLY MEANINGFUL, I'LL GIVE YOU AN EXAMPLE IN AN EXPERIMENT LAST DECEMBER. A LOT OF TOOLS THAT WE NEED THAT GREG DESCRIBED, IN A SPECIFIC SPHERE EXISTS THERE'S EXPERTISE FROM ANGLES IN THIS ROOM FOR PEOPLE WHO CAN MAKE SOMETHING REALLY MAGICAL HAPPEN. DOES THAT SOUND ANIMALCAL THINKING? >> NOT THROUGH NIH OR THIS MEETING TO REALLY TRY TO GET FEEDBACK ON DATA SHARING AND DATA AGGREGATION WHEN PEOPLE ARE DOING. THIS IS A SLIDE THAT YOU SHOULD NOT WRITE DOWN THAT ADDRESS ON THERE IN CASE -- AND YOU SHOULD NOT FILL THAT OUT WHILE ANYBODY IS LOOKING HERE. I WILL SEND THAT AROUND TO YOU GUYS. WHAT'S THE PROBLEM? THE PROBLEM IS DIVERSE DATA STREAMS THAT AREN'T INTEGRATED. WE HAVE PEOPLE HERE FROM A BUNCH OF COMPANIES FOR BUNCH OF DIFFERENT LABS AND THEY'RE VERY FEW OF US IN THIS ROOM THAT DO THINGS THE SAME WAY. LOTS OF CHILDREN PLAY WELL TOGETHER. BUT WE HAVE A COMMUNITY, WE HAVE INCENTIVE SYSTEM AND ATMOSPHERE THAT IS NOT SET UP TO MAKE US PLAY WELL TOGETHER. AND I'M GOING SAY TO SOME OF THE PEOPLE WHO ARE LEADERS HERE IN DIFFERENT WAYS THAT WE COULD CHANGE THAT DRAMATICALLY WITH DRAMATIC RESULTS. AT NOT GREAT COST. DATA STREAMS COME IN, NOT INTEGRATED. WE'RE MULTI-DISCIPLINARY, THERE'S PHYSICIANS, ENGINEERS NEUROSCIENTISTS, THERE ARE GREAT CORPORATE MINDS THEY SEND TO ENGINEER NEUROSCIENTIST MANIPULATE IN DIFFERENT WAYS THEY NEED TO WORK TOGETHER MAY NOT BE IN THE SAME PLACE POOR LEE HOTBERG TRIED TO GET HOLD OF HIM IF HIS CELL PHONE BATTERY IS NOT YOU WON'T FIND HIM BECAUSE HE'S DISTRIBUTED. THERE'S NO CONTINUITY. WITH WE TAKE THE SAME TECHNOLOGY TIM DENISON OR MARTY MORRELL OR ANY NUMBER OF PEOPLE, WARREN GRILL ARE DOING EXPERIMENTS IN ANIMALS IN THE LAB AND THEY USE ONE DATA FORMAT, AND ONE WAY OF LOOKING AT THINGS, THEN MOVE FORWARD TO LARGE ANIMAL TRIALS DIFFERENTLY WITH DIFFERENT EQUIPMENT, THEY MOVE TO EXPERIMENTAL PILOT TRIAL IN HUMANS, YET ANOTHER SYSTEM, ANOTHER PLACE TO PUT THE DATA. THEN MOVE TO CLINICAL TRIAL AND CLINICAL APPLICATION, DIFFERENT DATA STREAMS FOR EACH ONE. THAT DOESN'T MAKE SENSE TO ME. THERE ISN'T A COMMON LANGUAGE RIGHT NOW BETWEEN ACADEMIA AND INDUSTRY. NOW THERE ARE INDIVIDUAL GROUPS THAT SPEAK THIS COMMON LANGUAGE. SO IF YOU HAVE A COMPANY, IF DARRYL IS WORKING WITH A GROUP OF PEOPLE USING HIS EQUIPMENT OR ELECTRODES BACK WHEN HE WAS AT MICHIGAN, THEY WILL SPEAK THAT SAME LANGUAGE BUT THEY MIGHT NOT SPEAK THAT SAME LANGUAGE WITH RIPPLE OR ONE OF THE OTHER COMPANIES THAT'S HERE. THAT SLOWS US DOWN. YOU NEED TO PAY AS MUCH FOR THE PERSON WHO SETS UP THE GOAL AS THE PERSON WHO KICKS AND SCORES. SOMEBODY WHO COLLECTS TREMENDOUS DATA, TREMENDOUS VALUE, DOESN'T SHARE WITH ANYONE, AND YOU SEE PEOPLE ON THE SIDE TRYING TO DO THE SAME THING YOU DID A MONTH AGO, IT'S PAINFUL AND NOT APPROPRIATE. THEN THERE'S THE ISSUE OF NOISE. THERE'S AN UNDERCURRENT OF NOISE IN THIS ROOM THAT WE DONE TALK ABOUT. IT'S FUNNY, A PATIENT OF MINE CAME BACK FROM INDIA RECENTLY AND SHE BROUGHT ME A WOODEN ELEPHANT IN MY DESK AND SO NOW THAT'S THE ELEPHANT IN THE ROOM. THAT IS THAT WHEN WE DO TRIALS AND EXPERIMENTS PARTICULARLY IF THERE'S CLINICAL TRANSLATION LIKE DEEP BRAIN STIMULATION, NOT ALL NEUROSURGEONS ARE CREATEDDED A LIKE. -- CREATED A LIKE. SORRY TO TELL THAT BUT SOME RELIABLY HIT TARGETS WELL AND SOME MIGHT NOT BE HAVING A GOOD DAY. P P P P AND THE PEOPLE WHO MAKE THE VICES AND DO THE TRIALS TELL YOU WHERE THEY GO TO HAVE SURGERY AND WHERE THEY WOULDN'T. I'M NOT A NEUROSURGEON, I CAN'T DO THAT SO I'M NOT CRITICIZING ANYBODY BUT REALIZE IF DATA AREN'T PUT TO A CENTRAL LOCATION YOU CAN LOOK, AND THIS PERTAINS TO ANY EXPERIMENT WE TALK ABOUT FOR THE BRAIN INITIATIVE, THEN YOU DON'T KNOW HOW MUCH YOU LOOK AT NOISE AND HOW MUCH LOOKING AT SIGNAL. AND THAT'S A PROBLEM. IT'S EXPENSIVE AND SLOWS US DOWN. SO HERE IS THE SOLUTION. WE NEED A CENTRAL PLATFORM. WE NEED TO SPEAK A COMMON LANGUAGE AND WE NEED STANDARDS AND GREG OUTLINED THAT EXTREMELY WELL. THERE ARE DRIVERS PUSHK US IN THAT DIRECTION FROM GOVERNMENT FROM INDUSTRY AND ACADEMICS BUT AGAIN WE TALKED ABOUT THIS ENINCENTIVE THING BUT WE NEED AREAS THE TO PUSH IT. A LOT OF DEATHS IN MY NEIGHBORHOOD AT A JUNE YEAR HIGH SCHOOL BECAUSE THE KIDS WOULDN'T USE THE CROSSWALKS TO CROSS THE STREET. THEY DID EDUCATIONAL THINGS, THEY HAD CONSENSUS MEETINGS, THE NEIGHBORHOOD CAME UP, DIDN'T CHANGE THE DEATH RATE, THEY PUT UP A HUGE FENCE, IT WENT TO ZERO. IF THE NIH SAID TOMORROW YOU WILL SHARE ALL OF YOUR DATA FOR THE BRAIN INITIATIVE, YOU WILL PUT ANYTIME A COMMON PLACE, YOU WILL PUBLISH, YOU WILL POST-IT WITHIN A YEAR OF WHEN YOU PUBLISH YOUR FIRST PAPER ON IT, THEN IT WOULD HAPPEN. I THINK. I'M NOT SAYING YOU SHOULD DO THAT, I KNOW IT'S MR. CXFC COMPLICATED THAN THAT BUT JUST PUTTING IT OUT THERE. AND WE NEED CULTURE, WE NEED TO EDUCATE OUR STUDENTS THAT THIS IS THE WAY WE DO BUSINESS. VALIDATE STUFF, WHEN WE CAN SEE IN THE NEW YORK TIMES MONTH AFTER MONTH ANOTHER PAPER WHERE WORK WAS DECREDITTED. IT HAPPENED TWO WEEKS AGO. THAT'S SHOULDN'T HAPPEN TO US. IF YOU STORE YOUR DATA IN THIS WAY IN A PARTICULAR STRUCTURE BE IT ERRORS OR SOMEBODY ELSES, THAT COMPOUNDS OVER TIME, BECAUSE WHEN THE GRADUATE STUDENT LEAVES IT WON'T BE LIKE WHO HAS THE RECIPE FOR THAT. I WROTE RECENTLY AN ARTICLE THAT WAS IN NEURON ABOUT INSTITUTE OF MEDICINE ASKED ME TO WRITE ABOUT EDUCATING PEOPLE IN NEUROENGINEERING. AND WE ALL NEED TO KEEP THE STANDARDS IN OUR LAB SUCH THAT IF WE WERE TOLD THAT WE WERE GOING TO BE EDITED BY THE JOURNAL, OR EDITED BY THE UNIVERSITY TO SEE THE ACTUAL DATA, SEE THE ANNOTATION, SEE EVERYTHING TO THE PAPER WE OUGHT TO SAY VOILA, HERE IT IS LIKE WE DO FOR THE IRB. THERE AREN'T SO MANY OF US WHO COULD DO THAT. WE NEED TO CHANGE INCENTIVE T AND WHAT DR. FARBER SAID. THERE NEEDS TO BE SYSTEM FOR CREDITING AND REFERENCING FOR PARTICULAR DATA SETS AND WE SUGGESTED SOMETHING CALLING S INDECK, SHARING INDEX, EVERY TIME YOU USE A DATA SET, IT NEEDS TO BE REFERENCE AND THAT PERSON IS JUDGED HOW WELL THEY SHARE THE DATA. THEY'RE THE MID FIELD. THE UNIVERSITIES NEED TO PROMOTE BASED UPON THEIR S INDEX AND THE NIH NEEDS TO INCLUDE THAT AS ONE MEASURE BY HOW WELL THEY FUND PEOPLE. AND THE JOURNALS NEED TO HAVE A SYSTEM FOR QUOTING THAT, PEOPLE NEED TO GET PROMOTED BASED UPON IT. WE SHOULD FOCUS ON THE RESULTS. NOT ON OUR INDIVIDUAL GRANTS AND PUBLICATIONS. I DIDN'T TELL YOU I WAS GIVING A SERMON TODAY DID I? SO PEOPLE ARE KNOCKING OUR DATA AND SAYING WE DON'T HAVE BIG DATA BUT I WOULD TELL YOU THAT OUR DATA IS GETTING BIGGER. AND IT'S GOING TO BE BIG AND IF PEOPLE DIGITIZE EVERYTHING FROM CARL'S CLARITY, THE DATA SETS ARE BEING GENERATED BY MARK SNISTSER CALCIUM IMAGING, WE HAVE DOWNSTAIRS ONE SCOPE, THOSE ARE HUGE, IF YOU USE BLACK ROCK ARRAYS FOR LONG PERIODS OF TIME COLLECTING 32 KILL HERTZ DATA FOR TWO WEEKS THAT'S A LOT OF DATA. SO IT'S NOT PEDABYTES BUT IT WILL GET THERE SO WE SHOULD BE PREPARED. THIS IS AN EXAMPLE OF ONE THING WE'RE DOING IN THE LAB. I THOUGHT FUB TO SHOW YOU, THIS IS A TRANSPARENT GRAPHING ELECTRODE SIMILAR TO WHAT DR. DR. (INDISCERNIBLE) SHOWED YOU. TAKE A LOOK HERE, THIS IS THE SHADOW OF THE THE ELECTRODE, THE THIS IS FIELD POTENTIAL, FROM THE ELECTRODE, THESE ARE THE INDIVIDUAL CALCIUM TRACERS, HERE IS A SEIZURE LIKE BURST THERE ARE THE CELLS. THIS IS A HEART BEAT. THEN THERE WILL BE A SPIKE. YOU GET THE IDEA. START TO DO THAT IN MULTIPLE DIMENSIONS WITH LARGE ARRAYS YOU'RE TALKING A LOT OF DATA. DETAILS. WHAT EXACTLY DO WE NEED? THE KINDS OF DEVIL IN THE DETAILS THAT WE NEED TO TALK ABOUT. ONE IS FLEXIBLE ARCHITECTURE, WE NEED TO HAVE AID FEE -- HAVE TOFFEE -- HAVE IT, FEDERATED. WE'RE GOING HAVE A HARD TIME TO ELECT GOD HERE TO SAY THIS FORMAT BUT THERE ARE FORMATS OUT THERE THAT MAKE SENSE, WE DON'T REQUIRE ANYBODY COLLECT ANYTHING PARTICULAR FORMAT BUT WE CONVERT, IT'S PUBLISH, STANDARD, SOME MANUFACTURERS ARE STARTING TO USE IT, IT'S HIGHLY COMPRESSED. AND THAT'S WHAT WE CONVERT EVERYTHING UP TO. WE HAVE DATA QUALITY MEASURES RUN OVER THE DATA WHERE YOU CAN LOOK IN ONE SCREEN SHOT AND SEE WHAT THE QUALITY OF DATA ARE. THAT'S IMPORTANT. AUTOMATED PIPELINES DROP IN DROP BOX, UP LOADS AND CONVERTS. WE NEED SECURITY, THOSE ARE IMPORTANT. ANNOTATIONS, NEEDS TO BE WAY OF HAND THEM, YOU DON'T HAVE TO TELL WHAT THEY ARE BUT THEY HAVE TO BE A PARTICULAR FORMAT TO ATTACH TO DATA. WE NEED TO TRACK THE PROVIDENCE OF THE DATA. WHERE DOES IT COME FROM, INDIVIDUAL EXPERIMENTS RESULTS AND CREDIT. WE'RE SET UP SO WHEN AN EXPERIMENT IS DONE IN COMPUTATION AND CODE IS UP LOADED TO GET HUB IT'S THERE FOR EVERYONE, THE DATA ARE THERE AND EXPERIMENTS DONE THAT GENERATE AS UNIQUE IDENTIFYIER WHEN YOU CLICK IT IT PULLS UP THE DATA SET AND PULLS UP THE CODE. THAT'S CALLED VALIDATION. YOU CAN RERUN THE EXPERIMENT. THEN ATTRIBUTION. COLLABORATION, ACCESS CONTROL. YOU NEED CONTROL OVER WHO SEE YOURS DATA. PRIVATELY, MARTY MORRELL MENTIONED THE ARRANGEMENT WE HAVE WITH NEUROPACE. SO THEY HAVE A PRIVATE AREA OF THE PORTAL BY EEG THEY STORE AND WORK ON DATA WITH COLLABORATORS. I CAN'T LOOK AT IT. I DON'T HAVE PERMISSION TO LOOK AT IT. I WAS THINK ACT ASKING FOR PER -- THINKING ABOUT ASKING FOR PERMISSION. SHARING ALERTS SO WHEN PEOPLE DO THINGS IF YOU -- IT'S A FACEBOOK LIKE ENVIRONMENT THAT IF YOU DO THINGS YOU'RE COLLABORATIVE GROUP HEARS ABOUT IT AND YOU CAN SAY THINGS. CODE AND GET HUB, REPRODUCING THE RESULTS AND THEN CLINICAL TRANSLATION. DATA SHARING, I HAVE GOT EMAILS, THESE ARE REAL EMAILS. I WON'T SHARE MY DATA BECAUSE SOME RESEARCHER WILL DISCREDIT ME BY USING MY DATA WRONG. THAT'S A CONCERN. BUT IF THEY HAVE TO PUT THEIR CODE UP, THEIR ANALYSIS UP YOU CAN SHOW IT'S NONSENSE. SO THAT DOESN'T HOLD WATER. IT'S MY LIVELIHOOD MY GRANTS I WORK HARD TO GARTH HEAR'S IN IT FOR ME. IF YOUR CREDITED FOR SHARING THERE'S A LOT FOR YOU. I LIKE THIS ONE. MOST INVESTIGATORS WOULD RATHER SHARE THEIR TOOTHBRUSH WITH A HOMELESS PERSON THAN SHARE THEIR DATA. THAT IS UNFORTUNATE, I WON'T BE THE FIRST THE PULL DOWN MY PANTS IN PUBLIC. THAT WAS A MEETING I TOLD HIM I THOUGHT IT WAS UP PALATABLE HE SAID THAT. THE QUESTION ISN'T IF WE SHARE DATA, THE QUESTION IS WHEN. THE REASON TOUGH DO THIS, ONE FUNDING ORGANIZATIONS ARE GOING TO REQUIRE IT. PEOPLE SHOULD BE SET UP, COMMUNITY SHOULD SAY WE WON'T PAY YOU PUBLISH YOUR STUFF OR PROMOTE YOU IF YOU DON'T SHARE AND PUT DATA UP. IF YOU DON'T PUT IT UP, I DON'T BELIEVE YOU. YOU CAN EXCLUDE ME AS REVIEWERS FROM YOUR PAPERS. WE CAN DO STUFF FASTER. IEG.ORG. SO IT WAS FUNDED BY THE NIH, TOTAL COST I'VE FIVE YEARS EXIST THE PROGRAM STOPPED AND IT IS SELF-SUPPORTING RIGHT NOW. THERE IS MONEY COMING IN FROM PEOPLE IN GRANTS FOR DATA SHARING AND WE HAVE INDUSTRY, INVESTED FOR PRIVATE USE OF IT. SO RIGHT NOW IT'S GROWING 10 OR 15 GROUPS A WEEK. THAT ARE SIGNED UP, ABOUT 828 AS OF A COUPLE OF DAYS AGO AND THESE ARE WHERE THEY'RE LOCATE AROUND THE WORLD. USER BASE IS GROWING. COMPANIES DOING DATA AGGREGATION FOR THE DARPA PROJECTS, NIH PROJECTS STUFF FOR BIOELECTRONICS THERE'S A MAT LAB TOOLBOX TO PROCESS DATA ON THE CLOUD WE'RE WORK ON PYTHON. YOU CAN VIEW ANNOTATE ANALYZE DATA POST HOCK. SO THIS IS THE GRANT. WE NEED A NEW MODEL. THE NIH SAID THIS IS GREAT. WE WANT IT SUSTAINABLE AND WE'RE NOT GOING TO BE THE SUBSTANCE HERE. WE WOULD LOVE TO BE SUSTAINED. BUT THE NEW MODEL IS WE DECIDED TO GO THE A RED HAT LIKE MODEL. HOW MANY KNOW WHAT THAT? SO RED HAD HATH HAS AN OPEN SOURCE COMMUNITY COMPONENT, FOR LENNOX BUT IF YOU WANT A HIGHER LEVEL OF SERVICE, DO STUFF WITH COMPANIES, HAVE STUFF DONE THE RIGHT WAY, YOU WILL PAY FOR THE SERVICE. THIS IS A COMPANY CALLED BLACK FIN THAT WE HAVE INCORPORATED THAT WE'RE GOING TO START AND IT WILL HAVE A COMPONENT THAT EMBRACES THE ACADEMIC COMMUNITY WITH LEVEL OF SERVICE THAT'S PROVIDED FOR PEOPLE, BUT IF YOU WANT HIGH END SERVICE OR IF YOU'RE A COMPANY AND YOU NEED CUSTOM INTERFACES, SOME OF THAT WILL GO TO SPECIFIC, THE CODE FOR IGE IS OPEN SOURCE, COMMUNITY RESOURCE WE SHOULD BUILD ON. SO ONE SOLUTION R&D THROUGH DEVELOPMENT, YOU CAN PUT YOUR DATA UP, ANNOTATE IT, YOU CAN PROCESS IT, YOU CAN DISTRIBUTE THE SUPPRESSING ON THE CLOUD. OR FED RATE A IT ANDIUS YOUR OWN SERVERS. IF YOU WANT HIGH END FEATURE US YOU CAN PAY FOR THEM. I WOULD VENTURE TO SAY IF IF YOU LOOK AT WHAT YOU'RE PAYING IN THE LAB FOR THE HARDWARE, FOR THE PEOPLE WHO DO THE BACK UP, IN THE ANNOTATION, FOR PEOPLE THAT DUST OFF THE DVDs ON THE SHELF THAT YOU'LL NEVER TAKE DOWN, IT COULD BE DONE FOR THE SAME COST AND NOT MUCH MORE. HERE WHAT IT LOOK LIKE. TO GIVE YOU AN IDEA. YOU HAVE AN ENTITY, YOU'RE AN ENTITY AND YOU HAVE A GROUP THAT YOU WORK WITH. THAT YOU SET UP TO COLLABORATE WITH. AROUND ANY DATE SETS THAT YOU LIKE. HERE IS THAT GUY ONE OF THE CREATORS NOTICE WE HAVE THE SHARE INDEX HERE. IMPACT. BECAUSE WE CAN KEEP TRACK WHO DATA RUNS AND PUBLISHES. DATA SNAP SHOT IMPACTS 38 USERS AND 35 USERS, SNAP SHOT ANNOTATIONS, ALGORITHMS, HOW MANY USE THESE ALGORITHMS? AND PUBLICATIONS. IF YOU WANT TO DO ANALYTICS YOU LOG IN, YOU YOU HAVE A PROJECT TEAM, HERE IS ONE FROM GREG LAUREL. YOU CAN PUT YOUR DATA TO DROP BOX CONVERTED AND PUT UP SO YOU CAN ANNOTATE AND PROCESS IT. YOU CAN UP LOAD ALGORITHM.S AND ANALYZE DATA REAL TIME ON THE CLOUD OR STREAM DOWN TO YOUR MACHINE AND DO IT THERE. SO ONE QUICK EXPERIMENT, WE DID AN EXPERIMENT TO SHOW THE POWER OF SHARING DATA THIS IS A BLOG FRANCIS COLLINS WROTE ABOUT, THE ISSUE IS THIS, $40,000,000.15 YEARS SEIZURE PREDICTION RESEARCH, NOBODY SHARED THEIR DATA. 63% OR 64% ACCURACY WHERE 50% IS RANDOM. $40 MILLION NINDS PUT UP 20 MILL FOR EPILEPSY SOCIETY, IT WAS A UNIQUE DATA SET THAT'S NOT COLLECTED BEFORE, THE TRAINING SET UP ANNOUNCED THE COMPETITION, 514 SIGNED UP OVER THREE MONTHS, IT WAS 84% ACCURACY. THAT'S DRAMATIC. ALGORITHMS THEY CAM UP WITH THAT WE HAD NO IDEA, THESE ARE IDEAS WHAT THE LEADER BOARD LOOKED LIKE. THIS IS WHAT IT LOOK LIKE THE AREAS WHERE THE CODE IS STORED. SO I THINK AS A COMMUNITY WE COULD HAVE HUGE IMPACT TO CRAFT ARE RESOURCE LIKE THIS TOGETHER. I'M CONFLICTED A LITTLE BIT BECAUSE WE NEED TO HAVE CORPORATE ENTITY TO FUND THIS. BUT THE IDEA IS TO SUSTAIN IT THE IDEA IS TO MAKE A COMMUNITY, HAVE INPUT FROM THE SCIENTISTS THE NIH, IN THIS ISN'T SOMETHING THAT COULD BE DONE MOM AND POP WITH A GRADUATE STUDENT IN THE LAB. THIS IS SOMETHING THAT HAS TO BE TURNKEY, HIGH QUALITY, HIGH END, MANY ACADEMICS HERE, THAT WALK IN THAT AREA MOST PRODUCTIVE CITIZENS THAT WORK IN THIS AREA. WE NEED RAPID TRANSLATION AND WE CAN DECIDE AS A COMMUNITY TO DO IT. THERE IS MY SUPPORT. THANKS I WILL EXPECT YOU ALL IN CHURCH ON SUNDAY. APPRECIATE YOUR ATTENTION. >> GREAT TALK, IN THE INTEREST OF TIME, I'M GOING TO ASK THAT PEOPLE SAVE QUESTIONS FOR THE PANEL DISCUSSION. I'M GOING TO INTRODUCE CAMERON MCINTYRE WHO IS PROFESSOR SCHOOL OF MEDICINE CASE WESTERN, HE ALSO RUNS THE CASE NEUROMODULATION CENTER. HE IS BIOMEDICAL ENGINEER, HE COMBINES KNOWLEDGE OF DBS MECHANISMS AND MODELING AND HE'S HERE TO TALK ABOUT HOW DATA CAN BE USED WHAT THE REQUIREMENTS ARE. >> EXCELLENT. THANKS A LOT FOR THAT OPPORTUNITY TO TALK TO YOU TODAY. BEFORE I GET STARTED I HAVE FINANCIAL CONFLICTS OF INTEREST, I DO COLLABORATION INTERACTION WITH INDUSTRY. SPECIFICALLY FOR THIS TALK, THE MOST PERTINENT CONFLICT IS WITH SURGICAL INFORMATION SCIENCES WHICH A COMPANY ECO FOUNDED AND I'M GOING TO TALK ONE SLIDE ABOUT SOME OF THAT TECHNOLOGY. MY MAIN GOAL IS TO TRY AND TALK ABOUT ALMOST LIKE LESSONS LEARNED KIND OF APPROACH TO ANALYZING NEUROMODULATION DATA SETS IN CLINICAL CONTEXT. THIS IS OBVIOUSLY PERTINENT TO THIS CONFERENCE, PEOPLE IN THIS AUDIENCE YOU HAVE SEEN ME TALK BEFORE ON A SCIENTIFIC LEVEL, AUTOMOTIVE INDUSTRY OR WORLD, I THOUGHT I WOULD TRY TO HAVE FUN WITH THIS TALK. DRAW ON THE PARALLEL THAT I SEE BETWEEN CARS AND BRAIN RESEARCH WHICH THERE ARE A LOT, I HATE THE PHRASE BIG DATA. I DON'T THINK BIG DATA IS VALUABLE. I DO. IT'S THE WAVE OF THE FUTURE IT'S UBIQUITOUSLY USED TERM THAT WE HAVE LOST SIGHT OF WHAT DOES IT MEAN. HERE IS AN EXAMPLE TO DATABASES, OBVIOUSLY NEITHER ARE BIG ENOUGH TO BE BIG DATA BUT THE POINT IS SIMPLE. WE HAVE A DATABASE OF HYPERCARS THE ULTIMATE PINNACLE OF AUTOMOTIVE ENGINEERING. FOUR FROM FOUR DIFFERENT MANUFACTURERS, THE TOTAL VALUE OF THAT DATABASE OR VALUE OF MATERIAL CONTAINED IN THAT DATABASE APPROXIMATELY 5 MILLION-DOLLAR. WE HAVE A BORING CARD DATABASE, MINI VANS TOYOTA CAMRYS, THAT KIND OF THING. 144 OF THEM. 144 SAME APPROXIMATE $5 MILLION VALUE. DOES THAT MEAN ONE OF THESE IS MORE VALUABLE THAN THE OTHER? NO. I SAY THEY'RE EXACTLY THE SAME VALUE. AND I THINK WE NEED TO APPROACH ANALYZING AND WORKING WITH HUMAN NEUROMODULATION DATA SETS IN THE SAME WAY. WHEN WE GO ABOUT THE O THE PROCESS OF CREATING A HUMAN NEUROMODULATION DATABASE, I THINK THAT THERE ARE FUNDAMENTAL QUESTIONS THAT WE GOT TO ASK OURSELVES. FIRST IS IT PURELY SCIENTIFIC INVESTIGATION OF ELECTROPHYSIOLOGICAL BIOMARKERS? OR IS IT REALLY FOR SOME BIGGER PURPOSE, SOME CLINICAL TRANSLATIONAL PURPOSE AND THAT GETS TO THE SECOND QUESTION, IF IT REALLY IS FOR CLINICALLY RELEVANT PURPOSE, WHAT IS THE REALISTIC CLINICAL UTILITY OF THAT SYSTEM, ONCE CREATED. IF IT DOES ACTUALLY HAVE REALISTIC UTILITY, THAT MEANS THERE IS A REAL POSSIBILITY FOR IT TO BE MONETIZED. THAT DOESN'T MEAN THE DATABASE ITSELF IS FINANCIAL DRIVER ALONE BUT IT BECOMES A FINANCIAL DRIVER IN COLLABORATION WITH SOME OTHER FEATURES. MEDTRONIC COULD USE THAT TO CREATE NEW PRODUCT ALGORITHMS, USE IT TO CREATE NEW DIRECTIONS WHICH THEY'RE GOING TO DEVELOP THEIR PRODUCTS. YOU MIGHT THINK WE'RE SCIENTISTS WE SHOULDN'T BE THINKING ABOUT THAT, MY PROPOSITION TO YOU IS IF WE DONE THINK ABOUT THAT, THE DATABASE IS GOING TO BECOME BASICALLY WORTHLESS. BECAUSE NO ONE WILL USE IT, OR IT'S NOT GOING TO BE MAINTAINED. THIS GETS TO THE POINT BRIAN WAS SPEAKING TO, IT'S ONE THING TO BUILD THESE DATABASES, QUITE ANOTHER TO MAINTAIN THEM AND KEEP THEM FUNCTIONALLY USEFUL, THAT TAKES MONEY, TAKES PEOPLE, INFRASTRUCTURE, THE COMPUTATIONAL INFRASTRUCTURE, AND IF SOMEONE ISN'T MAKING MONEY OFF THAT SYSTEM THEN IT'S NOT GOING TO CONTINUE TO LIVE IN THE FUTURE. LET'S THINK ABOUT FUTURE INTRACRANIAL RECORDINGS. THESE ARE ROUGH, NOT INTENDED TO BE EXACT CALCULATIONS. BUT I P PUT THESE TOGETHER JUST TO GIVE PEOPLE A SENSE OF PERSPECTIVE BECAUSE I'M NOT SURE EVERYONE KNOWS THESE THINGS. EPILEPSY FOR EXAMPLE, UNITED STATES BASED NUMBERS. 2000 APPROXIMATE PATIENTS PER YEAR. GO UNDER FULL INTRACRANIAL ELECTRODE RECORDINGS. THIS IS IN PREPARATION FOR POTENTIAL SURGICAL RESECTION FOR THE TREATMENT OF EPILEPSY. SO SOMETIMES THIS IS DONE WITH ECOG BUT A GROWING TREND IN THIS FIELD IS TO DO THIS WITH DEATH ELECTRODES. THAT RESOLUTION OCCURRED IN EUROPE AND IS NOW STARTING TO PERMEATE INTO THE UNITED STATES SYSTEM. ESTIMATE, 200 RECORDING CONTRACTS FOR PATIENT, THEY'RE MONITORED, AND DATA IS STREAMING ON THEM. EFFECT EFFECTIVELY 24 HOURS DAY FOR SEVEN DAYS THAT LEADS TO OVER 8 MILLION HOURS OF PER YEAR OF HUMAN INTRACRANIAL LOCAL FIELD POTENTIAL RECORDING DATA SETS. THAT IS A GIGANTIC, THAT IS BIG DATA. THINK ABOUT PARKINSON'S DISEASE, 5,000 PATIENT PER YEAR, UNDERGO SUBTHALAMIC NUCLEUS, DEEP BRAIN STIMULATION ELECTRODE PLACEMENT, AVERAGE TWO MICROELECTRODE RECORDING PASS FOR PATIENT. EACH PASS YOU RECORD APPROXIMATELY 20 UNITS, THAT'S 200,000 SINGLE UNIT RECORDINGS IN HUMAN BRAINS LEKKED PER YEAR JUST IN THE UNITED STATES. WHAT IS THIS WORTH NOW? PRETTY MUCH WORTH ABOUT THIS. NOT THE DATA ISN'T VALUABLE, IT IS VIABLE VALUABLE, IT'S NOT THE VALUE OF IT ISN'T MAXIMIZED BECAUSE IT ISN'T PROCESSED THE RIGHT WAY, IT ISN'T SAFE,S ISN'T AVAILABLE TO A BROADER COMMUNITY. SO HERE WE HAVE A JUNK CAR DATABASE, WE HAVE MORE CARS THAT WERE 200 BUT YOU KNOW OUR VALUE IS DROPPED TO $50,000 SO WE LOST SEVERAL ORDERS OF MAGNITUDE IN VALUE, THOUGH WE INCREASE NUMBER OF DATA POINTS WE HAD IN OUR SYSTEM SO HOW CAN WE START TO THINK ABOUT ADDRESSING THIS LIMITATION? FROM THOUGH BRIAN AND I DIDN'T PAIR THESE TALKS UP, BEFOREHAND I THINK THEY LINK TOGETHER ALMOST PERFECTLY. AND THE REASONING WITH --ING ARE BEEN THE ONLY WAY TO SOLVE THE DATA INTEGRATION PROCESS IS THINK ABOUT BUILDING A HYPERCAR OF OUR OWN. HOW WE'RE GOING DO THAT, RIGHT NOW WE'RE PROBABLY ABOUT 20 CENTERS ACROSS THE COUNTRY THAT I THINK ON THEIR OWN COULD BUILD A HONDA CIVIC LEVEL MODELS OF INDIVIDUAL PATIENTS. I'M NOT INTERESTED IN HONDAS I WANT TO WORK ON FERRARIS AND LAMBORGHINIS. THEY HAVE TO THINK ABOUT THE PIECES THAT GO INTO THIS SYSTEM. THE BIG DRIVER IS ALWAYS THE BIG DRIVER, GASOLINE ENGINE SOME THING ELECTRIC CARS WILL HAPPEN NOT SO MUCH ON MY SIDE. >> YOU HAVE YOUR GASOLINE, THAT'S YOUR CLINICAL PROGRAM. NOW MANY CLINICAL PROGRAMS AROUND THE COUNTRY DOING NEUROMODULATION, THERE ARE FEW CLINICAL PROGRAMS AROUND THE COUNTRY THAT HAVE THE RIGHT CLINICAL INFRASTRUCTURE AND THE INSTITUTIONAL BUY IN TO ACTUALLY DO THE KINDS OF DATA COLLECTION AND ANALYSIS THAT WE WAN. THAT'S REGULATORY, THAT'S RECOGNIZING THE FINANCIAL COST OF DOING THE RESEARCH IS BIGGER THAN THE RVUs THEY COLLECT OFF THE SURGERIES. THESE KINDS OF THINGS, IT'S A COMPLEX CLINICAL PROGRAM AND THAT IS THE DRIVER THE ENGINE OF THE MAIN SYSTEM. THEN YOU HAVE GOT YOUR TIRES AN BRAKES, ANY RACER WILL TELL YOU THE MOST IMPORTANT THING DICTATING THE SPEED OF YOUR CAR IS ASIDE FROM THE ENGINE, TIRES AND BRAKES SO THAT CORE DATA THAT WE NEED TO DRIVE THIS SYSTEM IS THE ELECTROPHYSIOLOGY. AND THAT'S THE SCIENCE IF YOU WILL THERE'S THE CHASSI IN THE BODY. THIS IS THE IMAGING SIDE. IF WE DON'T HAVE SUPER HIGH QUALITY MRI DATA SETS TO CHARACTERIZE ANATOMICAL LOCATION OF THIS DATA THE VALUE OF IT DRAMATICALLY DROPS, THEN YOU HAVE THE ECU OR THE ELECTRONIC CONTROL UNIT, I WOULD FOLLOW THAT TO MODELING AN SIMULATION SIDE OF THE WORLD. SOMEONE HAS TO DEVELOP THE ALGORITHMS THAT GOING TO MAKE USE OUT OF THIS COMBINED DATA SET. MAYBE THERE ARE 20 CENTERS AROUND HERE THEY CAN'T DO IT EXCEPTIONAL LEVEL, NOT IN ALL FACETS. SO HOW CAN WE DO THAT, WE HAVE TO THINK ABOUT A BIGGER PICTURE COLLABORATIVE SCHEME. THIS IS ONE EXAMPLE OF A TEAM THAT I THINK COULD DO THIS. THERE ARE DIFFERENT PERMUTATIONS OF SUPER CARS AND THERE ARE MANY PERMUTATIONS OF CENTER COLLABORATIVE GROUPS. THAT COULD ACHIEVE THIS BUT THIS IS ONE EXAMPLE, EXAMPLES OF GROUPS THAT HAVE REALLY IRONED OUT THE CLINICAL PROGRAM AND HOW YOU'RE GOING TO COLLECT THIS DATA. ADVANCE CONCEPTS AN IDEAS ABOUT HOW YOU'RE GOING TO GET ELECTRO PHYSIOLOGY, SUPER ADVANCE INFRASTRUCTURE TO COLLECT IMAGING DATA. SPEND CAREERS AND DEVELOP IDEAS OF LINKING COMPUTATIONAL MODELING WITH CLINICAL NEUROMODULATION. THAT'S FROM AN INFRASTRUCTURE PERSPECTIVE, SOUNDS VERY EXCITING TO ME. THERE'S ANOTHER LEVEL OF MAKING THAT HAPPEN. THERE IS THE PIECES OF THE DATA BUT THEN THERE'S ALSO INTEGRATION OF DATA AND THE COLLECTION OF IT AT THE POINT OF CARE. SO BRIAN TALKED ABOUT WONDERFUL DATABASE SYSTEM THAT THEY HAVE CREATED, FOR HOUSING DATA THAT HAS ALREADY BEEN ARCHIVED IF YOU WILL. BUT THE REAL LIMITING FACTOR IN MY EYES ANYWAY IS THAT WE HAVE A HARD TIME FROM POINT OF CARE DATA COLLECTION AND ANNOTATION ON THE SPOT TO DATA THAT ARE GOING TO BE PUT INTO THE IDEG TYPE ENVIRONMENT. (INDISCERNIBLE) UNIVERSITY HOSPITAL IN CASE, DEVELOPED A SYSTEM DESIGNED FOR (INAUDIBLE) WHICH IS A SIDE BAR EPILEPSY, NOT REALLY DIRECTLY PERTINENT TO NEUROMODULATION. BUT IT DOESN'T MATTER THE FUNDAMENTAL CONCEPTS OF THE SYSTEM THEY DEVELOPED, ARE PERFECTLY APPLICABLE TO WHAT WE ARE DOING HERE. AND THAT IS TRYING TO PUT INTO THE HANDS OF CLINICIANS A SIMPLE INTERFACE THAT ALLOWS THEM TO ARCHIVE DATA ON THE SPOT TO A WAY USEFUL TO PEOPLE LIKE RYAN AND MYSELF. WON'T GET INTO THE DETAILS RIGHT NOW BUT BUT CONCEPTS OF CLOUD BASED STORAGE AND BIG DATA ANALYTICS AND BLAH BLAH BLAH, FOR COMPUTER NERDS SO I WON'T BORE YOU WITH IT RIGHT NOW. LET'S SWITCH GEARS BACK TO NEUROMODULATION SIDE, AND ONE POINT AND PURPOSE OF DOING THIS IS WE WANT TO DO THE KIND OF STIMULATION MAPPING EXPERIMENTS THAT PROFESSOR HARKEN TALKED YESTERDAY. WE HAVE BEEN DOING THESE THINGS A LONG TIME, AND THERE'S SOME IMPORTANT RESULTS THAT CAN BE GAINED FROM THAT. YOU END UP WITH ANATOMICAL VARIABILITY AND ELECTRODE PLACEMENT, THAT'S IMPORTANT TO UNDERSTAND, THIS ISN'T ONE PATIENT WITH 12 ELECTRODES, THIS IS 12 ELECTRODE MAPPED TO SINGLE ATLAS SPACE. THANKS. WITH THAT WE CAN TEST STIMULATION THROUGH DIFFERENT LOCATIONS, STIMULATION PARAMETER SETS TO TRY AND SAMPLE A LARGE SPACE AND FROM THAT SAMPLING YOU CAN COME UP WITH PREDICTED TARGETS OF WHERE YOU SHOULD STIMULATE FOR VARIOUS THERAPEUTIC EFFECTS. SO THAT'S A USEFUL CONCEPT BUT THERE ARE CAVEATS DOING STIMULATION MAPPING LIKE THIS. THERE ARE TIME CONSTANTS, OF WASHING IN AND WASHING OUT STIMULATION. SO EVERY TIME YOU TRY ONE OF THESE PERMUTATIONS. YOU'RE BASICALLY INTERACTING WITH THIS VERY NON-LINEAR SYSTEM AND WE DON'T KNOW WHAT THE APPROPRIATE TIME OF SPACE BETWEEN TESTING REALLY SHOULD BE. THAT'S IN MOVEMENT DISORDERS THAT WE HAVE BEEN DOING FOR 25 YEARS. I CAN'T IMAGINE WHAT TIME CONSTANTS OF CALCULATION WE NEED TO BE WORRYING ABOUT IN NEUROPSYCHIATRIC DISORDER. OR WHO KNOWS WHAT ELSE MIGHT COME OUT OF BRAIN INITIATIVE IDEAS. IN ANY CASE WE'RE GOING TO NEED TO HAVE IN MY OPINION THE FOUNDATION IS ANATOMY OF THE PATIENT. HOW DO WE GET TO PATIENT SPECIFIC CONTEXT? THIS IS WORK FROM UNIVERSITY OF MINNESOTA, CLOSELY WORKING WITH OVER THE LAST FEW YEARS, AND DATA SETS, UNDERGOING DEEP BRAIN STIMULATION. HERE IS AN EXAMPLE OF THE DATA SETS WE COLLECT. ON PARKINSON'S PATIENTS UNDERGOING DBS. EACH PATIENT DETAILED ANATOMICAL MODELS WHICH ARE BEAUTIFUL AND FROM A PATIENT SPECIFIC RESEARCH PERSPECTIVE VERY POWERFUL ON THEIR OWN. THAT'S A VERY SMALL NUMBER OF THE BIG WORD IF YOU WILL. HOW DO YOU GO FROM LEVERAGING THAT CONCEPT TO A BROADER POPULATION OF SUBJECTS. ONE IDEA IS YOU TAKE THE 7 TESLA MRI DATABASE OF SAY A COUPLE OF HUNDRED PATIENTS THAT YOU HAVE ANNOTATED WITH INTENSE DETAIL AND ACCURACY AND YOU FEED NOW REGULAR CLINICAL MRI PATIENT DONE AT A DIFFERENT CENTER. YOU FEED THAT INTO 7 TESLA MRI DATABASE AND USE MACHINE LEARNING AN ARTIFICIAL INTELLIGENCE TO SEARCH THROUGH AND FIND NINE BRAINS FROM YOUR DETAIL DATABASE THAT HAVE ASSOCIATION OR CONNECTIONS WITH THAT PARTICULAR PATIENT IMAGE. THEN YOU CAN USE LIKE I SAID MACHINE LEARNING TECHNOLOGIES, TO THEN DEFINE A PATIENT SPECIFIC 3-D ANATOMICAL MODEL MATCHED TO THAT NEW DE NOVO PATIENT DOWN THE LINE. SO VERY BIG DATA APPROACH TO DEVELOPING DATA SETS CUSTOM TO INDIVIDUAL PATIENTS, THAT MIGHT NOT HAVE THAT KIND OF IMAGING RESOURCE AT THEIR FINGERTIPS AN LOCAL INSTITUTION. SO WHAT IS THE CLINICAL APPLICATION OF THAT? OBVIOUSLY STN TARGETING FOR EXAMPLE. YOU BURN IN 3-D REPRESENTATION ON THE PATIENT IMAGE, OF THE STN FOR EXAMPLE, AND THEN LOAD THAT INTO ANY TRADITIONAL STATION OR BRAIN LAB SURGICAL PLAN TARGETING SYSTEM. WE CAN GO AND DO THE ELECTROPHYSIOLOGICAL VERIFICATION. OF 7 TESLA DEFINE STN RELATIVE TO THE MICROELECTRODE RECORDING DATA COLLECTED FOR THAT PARTICULAR PATIENT. I THINK I'M OUT OF TIME. I WILL STOP THERE. BUT I DID WANT TALK ABOUT THE HUMAN CONNECTOME PROJECT. I HAVE SLIDES THAT GO ON AFTER THIS. THE CONCEPT THAT I WANT TO GET AT IS THIS IS A GREAT EXAMPLE OF SCIENTIFIC TEAMS WORKING TOGETHER TO BUILD A REALLY POWERFUL DATABASE OF IMAGING RESULTS. THE ISSUE FOCUSED ON NORMAL HUMAN. I'M NOT INTERESTED IN NORMAL HUMAN BRAIN. I'M INTERESTED IN PARKINSON BRAIN AND DEPRESSION BRAINS AND WHATEVER. SO HOW DO WE TAKE THE TOOLS THAT HAVE BEEN DEVELOPED IN THE CONTEXT OF THE HUMAN CONNECTOME PROJECT AND PUT THEM INTO THE CONTEXT OF CLINICAL NEUROMODULATION. I THINK THAT YOU WILL SEE A LOT OF REALLY EXCITING STUFF COMING ALONG THAT LINE IN THE NEAR FUTURE. I SEE IT OOZE A GREAT OPPORTUNITY FOR GROWTH FOR OUR FIELD. THANKS. [APPLAUSE] >> WE'LL HAVE TWO PEOPLE COME UP, TIM DENISON AND FLORIAN SOLZBACHER TO TALK ABOUT INDUSTRY AVAILABLE FOR DATA MINING AND HOW WE THINK ABOUT THAT. FLORIAN IS ALREADY INTRODUCED. HE HOLDS A FACULTY POSITION (INAUDIBLE) DAY JOB AND THEN NOT SURE WHEN HE SPENDS TIME WORKING FOR BLACK ROCK MICROSYSTEMS. THAT'S THE OVER NIGHT JOB. BUT -- >> DAY JOB, WE HAVE FULL EMPLOYMENT 24 HOURS A DAY. ACTUALLY TO BE CLEAR MY DAY JOB IS THE UNIVERSITY ON THE OTHER SIDE I'M ESSENTIALLY THE OWNER OF THE BUSINESS BUT OF COURSE THERE'S OPERATIONAL MANAGEMENT IN PLACE, SO DOESN'T MEAN YOU DON'T SPEND ENOUGH TIME THERE BUT I TRY THE MAKE SURE THAT IT'S CLEAR NORMALLY OPERATE AND THE OTHER IS ONE WHERE I'M TRYING TO TRANSLATE BUT I'M UP THERE DAY TO DAY RUNNING THE BUSINESS. I WANT TO KEEP THIS SHORT. IN MANY OF THE WORKSHOPS TO THE LAST FEW YEARS WE ENUP WITH POWERPOINT SLIDES AND TOOK TIME TO DISCUSS, I WANT TO BRING ACROSS THE FEW POINTS, YESTERDAY I HAVE SHOWN SOME THINGS IN THE DOCUMENTS THAT WERE SENT TO YOU WHAT WE CAN OFFER ON THE COMPANY SIDE. FEW OBSERVATION THAT I HAVE MADE SEVEN YEARS GOING FROM MY OWN RESEARCH LAB SELLING TO LABS OUT THERE. THERE THERE IS A LARGE LABORATORY OUT THERE, SOME ARE MERGING PEOPLE THAT ARE METABOLIC AND OTHER AREAS, SOME OF THE ACTIVITIES PROBABLY LOOK NOT AT TEN THOUSAND PROBABLY 30,000 LABS WORLDWIDE. AND MYRIAD OF DIFFERENT EXPERIMENTAL APPROACHES. ANIMAL PATIENT MODELS. SETTINGS. DOCUMENTATION, PROCEDURAL ASPECTS. SOMETHING TO CONSIDER. WHEN YOU LOOK AT THE HARDWARE, THINGS WE OBSERVE THERE, OBVIOUSLY THERE A PUSH FOR INCREASING COUNT, BRAIN INITIATIVE HELPED ADVANCE THAT WITH A HOPE OF SOMEBODY BEING ABLE TO MEASURE MILLIONS OF NEURONS, ALREADY HAVING A ROADMAP TOWARDS TEN THOUSAND CHANNELS GIVEN AMOUNT OF DATA THAT WE'RE GENERATING HERE. ONE OF THE ELECTRODES YOU CAN GENERATE A TERABYTE OF DATA WITH ONE PATIENT IN A DAY. 120 HD MOVIES SO THINK ABOUT IT SO YOU PUSH BOUNDARIES THERE. THERE'S CAPABILITIES BUILT UP FOR THAT. WHEN TRANSPORTING THE DATA SETS OPTICAL FIBER NETWORK. TWO DAYS WORTH OF DATA FROM THE PATIENT, WHAT WE SEE COMING MORE IS MULTI-MODAL TYPE OF DATA RECORDINGS, DIFFERENT TEMPORAL DOMAINS EEG LOCAL POTENTIAL SINGLE UNIT ACTION POTENTIAL OPTICAL BEHAVIORAL MOTION TRACKING VIDEO DATA HIGH RESOLUTION, ALL OF THAT NEEDS TO BE SYNCHRONIZED AND WORKED WITH. FURTHER TRENDS IS ALL THAT TIES INTO HOW TO SHARE ALL OF THAT AND WHAT IS NECESSARY, FLEXIBLE FIRMWARE WHEN YOU FIRST STARTED WE BELIEVE WE NEED TRY AND STANDARDIZE THAT SO WE GET REPRODUCIBLE RESULTS. STRIKE A BALANCE. RECENTLY RELEASED TOOLS WHERE WE ALLOW PEOPLE TO GO TO THE FIRMWARE. THEY WANT SIGNAL PROCESSES IN YOUR INSTITUTE TO DO THEIR OWN STUFF BUT FLIPPING THE SWITCH, BE ABLE THE TO REVERT BACK TO SOMETHING THAT IS LIKE THE SYSTEM THAT YOU MAY HAVE IN YOUR APPLE OR YOUR HARDWARE. THERE'S NO REASON WHY FOR EXAMPLE YOU HAVE SYSTEMS IN YOUR LAB THAT DO ELECTROPHYSIOLOGY RECORDING WHY WE COULDN'T JUST LIKE YOUR COMPUTER YOUR PHONE DOES THAT, IT DOES A SELF-ANALYSIS SINCE DATA, ELECTRODES, SOMETHING ELSE YOU MEASURED. MAYBE THE SYSTEM ASKS YOU CAN YOU PUT IN THE FOLLOWING DATA? THAT DATA COULDN'T BE FORWARDED TO A CENTRAL DATABASE WHERE IT'S PROCESSED. PROVIDED IMPROVE ACCESS COMFORTABLE WITH THAT. FINAL POINT IS INCREASING NEED TO INTERFACE WITH CLINICAL SYSTEMS SOME OF THAT IS MONETARY. INCREASINGLY HARDER TO RAISE SOME OF THE FUNDING FOR THE TOOLS. IF YOU'RE ABLE TO LEVERAGE SOMETHING WHERE THE HOSPITAL SIDE THAT MAKES MONEY WITH THESE THINGS CAN BUY EQUIPMENT OR TOOLS, THAT OPENS UP OPPORTUNITY FOR YOU, IN ADDITION IT LOWERS THE BARRIERS TO TRANSLATION OF ADVANCES THAT YOU HAVE ON THE RESEARCH SIDE. IF IT'S ESSENTIALLY RUNNING ON TOOLS, THAT CAN ALSO BE USED IN A CLINICAL SETTING. WHICH IN THE PAST HASN'T ALWAYS BEEN THE CASE. THAT'S HARDWARE SIDE, SOFTWARE SIDE IS -- NUMBER OF STANDARD TOOLS OUT THERE AND DATA PERFORMANCE, IN ADDITION EVERY LAB DEVELOPS ALGORITHMS, MAT LAB CODE PIE THOUGHT CODE ET CETERA, YOU WON'T BELIEVE HOW OFTEN WE SEE QUESTIONS COME BACK WHERE PEOPLE KEEP DOING THE THE SAME THING. AND AT THE IN SOME CASES IT WORKS, PEOPLE COLLABORATIVE IN NATURE WANT THE TO WORK OUT OR THEY KNOW SOMEBODY, TALK TO THAT PERSON HE'S PROGRAM THAT, THEY MAY HELP YOU, MORE OFTEN THAN NOT PEOPLEN CYST BETTER AT IT OR THEY FEEL THEY MAY LOSE SOME OF THE KNOWLEDGE THEY MAY HAVE GAINED AND COMPETITIVE ADVANTAGE. >> ALL RIGHT. SO TODAY THE SHARING THAT WE OBSERVE TECHNICALLY HAPPENS THROUGH DIRECT COLLABORATION, YOU AND I HAVE A GRANT TOGETHER WE WORK ON IT TOGETHER WE PUBLISH TOGETHER, THERE'S NOT NECESSARILY A COMMON DATABASE OR PLATFORM, WELCOME THE THINGS I HAVE SEEN THE FIRST TWO TALKS. RIGHT OF REFERENCE SHARING OF DATA IS DIFFICULT. TIES TYPE ASPECT OF IMMEDIATE NEED AND OPPORTUNITIES AND THE FIRST POINT ADDRESSING THE CULTURE, RIGHT NOW ALL OF US ARE NOT INCENTIVIZED THIS WAY. FROM THE RBD PROCESS TO PROMOTION THE TENURE PROCESS TO FUNDRAISING, FOR MANY OF US THE DATA THAT WE HAVE IS CURRENCY THAT WE USE TO RAISE MORE FUNDING. IF YOU FEEL THAT YOU'RE GIVING THAT AWAY, AND YOU'RE NOT GETTING OUT MORE THAN WHAT YOU HAVE IT'S A REAL ISSUE. SOME OF THE NEEDS I SEE IS SOME WAY OF MAKING SURE YOU GET MORE TOWARDS COOK BOOK RECIPE, SOMETHING SEEN IN PREVIOUS LIFE ON THE MICROFABRICATION STATE DEVICE SIDE MAKE SURE THESE ARE DONE SO THAT EVERYBODY CAN TECHNICALLY REFULLY KATE CERTAIN STANDARDS REPRODUCIBILITY SO YOU CAN ASSESS THE VALUE OF THE DATA. MANDATE SHARING. THESE THINGS SOMETIMES REQUIRE LEGISLATION OR FUNDING BODIES -- GO BACK TO CARS AGAIN, LEAD FREE GASOLINE, ALL THE COMPANIES, IT'S IMPOSSIBLE, IT'S WAY TO EXPENSIVE UNTIL THE LEGISLATIVE BODIES IN -- YOU HAVE TO USE IT AND NOBODY WOULD ARGUE, THERE'S ASPECT AS WELL AND YOU WANT TO INCENTIVIZE THAT IF POSSIBLE. CLOUD BASED STORAGE COMPUTING IS MAYBE THE WAY TO GO IF YOU TAKE CARE OF THE ETHICAL DATA PROTECTION PATIENT ET CETERA ALL THESE OTHER ASPECTS, JUST BECAUSE THERE'S SO MUCH COMPUTING POWER OUT THERE. THAT WILL VERY SOON IT'S SO FOR OUTPACES WHAT ANY SINGLE ONE OF US OR EVEN A SINGLE COMPANY CAN AFFORD TO PUT PUTT IN PLACE GIVEN AMOUNT OF DATA. AND AGAIN DATA IS NOT ONLY NEUROSCIENCE SIDE, IT INCLUDES INFORMATION ON ELECTRODES ON ALL THE OTHER ASPECTS THAT ARE OFTEN FORGOTTEN IN A CRITICAL TRYING TO WHY SOMETHING WORK OR NOT WORK. AND PARTICULARLY GIVEN SMALL N OF ONE, FINALLY SOME OF THOSE THINGS YOU CAN READ DOWN HERE, THE MAIN POINT I WANT TO MAKE IS IN TERMS OF NEXT STEPS, I DON'T BELIEVE WE HAVE A LOT OF HARDWARE WE HAVE THE COMMUNITY, THERE'S WORK GOING ON SOFTWARE OR APPS CREATE MORE VALUE FOR THAT WE HAVE TO ESSENTIALLY FIND A WAY OF CHANGING SOME OF THE CULTURE MAYBE THE STARTING POINT THE THINK ABOUT POLICIES GUIDELINES AND MECHANISMS WHERE SOMEBODY SEES THIS PROGRESS IS ONLY POSSIBLY, GOT A TON OF FUNDING AND PUBLICATIONS AND PATIENTS WERE HELD BECAUSE THIS WAS SHARED. THIS WAS NOT I'M IN MY OWN LAB AND ONE GENIUS WHO MADE IT HAPPEN. WE'LL BE DISCUSSING AFTERWARDS. >> YES. THANK YOU, THE FLORIAN. NEXT WE HAVE TIM DENISON FROM MEDTRONIC WHO HAS REALLY PLAY AD BIG ROLE GETTING ALL THIS GOING. SO HE'S GETTING PLUGGED IN. I WANT TO REMIND PANELISTS COMING UP RIGHT AFTER TIM'S TALK IN TEN MINUTES. SO I'M GOING TO TRY TO GIVE A LITTLE COMPLIMENTARY VIEW BECAUSE WE HAVE HEARD GREAT IDEAS ALREADY COMING BACK TO THIS ROADMAP, DATABASES MODELING AND LEARNING. HOW CHOSE THOSE CAN WORK TO INFORM BETTER UNDERSTANDING OF MECHANISMS OF ACTION AND HOPEFULLY CLASSIFIERS AND CONTROL LOOPS IN THE FUTURE I THINK AS SYSTEM ENGINEER TECHNOLOGY, WE OFTEN BREAK DOWN, MY CELL PHONE. SO THE -- MANAGEMENT OF INFORMATION INTERFACES AND ENERGY, THIS IS IMPORTANT BECAUSE WE TALK ABOUT DATA, LIKE THE -- OFTENTIMES THERE'S ONE OF THESE LOCAL POWER PLANT. WE DON'T WORRY ABOUT ENERGY. SO ONE OF THE THINGS TO THINK ABOUT GRANT OPPORTUNITY AND DESIGNING RELIABLE PROTOCOLS AND DEVICES FOR THE FUTURE IS HOW MUCH ENERGY IS REQUIRED TO TELEMETER THAT INFORMATION OUT. FEEDBACK FROM THE PC PRIMARY CELL, PEOPLE WANT A LOT MORE DATA. THEY WANT TO STREAM DATA OUT OF DEVICE 24, 7, THAT'S PART OF MOTIVATION TOWARDS RECHARGEABLES AND I THINK A LOT OF WHAT WE'RE GOING TO SEE IN RESEARCH PLATFORM SPACE FUTURE IS GOING TO BE DRIVEN TO RECHARGEABLE SPACE, TO GET AROUND ENERGY LIMITATION. THAT'S WHAT I WANT TO COMMENT THERE, BIG MOTIVATION FOR HEADING IN THAT DIRECTION, AND SHARE OBSERVATIONS ON INFORMATION INTERFACE MANAGEMENT HOW THOSE COULD IMPACT THINGS GOING TO THE FUTURE. SO THE OTHER THING ABOUT THE SYSTEM ENGINEERING STARTING WITH THE END IN MIND, SO WHAT IS IT YOU WANT TO DO WITH DATA SCIENCES, DATA AGGREGATION, THIS IS ONE EXAMPLE WE THINK ABOUT -- THAT'S A LASER POINTER. PRECISION MEDICINE IS BUILDING ON POINTS MENTIONED YESTERDAY FROM THE NEUROPACE EXPERIENCE IF COMPLEX THIS CARTOON SHOWS CONCEPT THE SUBJECT COMES IN, DOWNLOAD PHYSIOLOGICAL PARAMETER ON SUBJECT A, WE THEN PUT TO IT THE DATABASE AND THROUGH DATA SCIENCE MACHINE LEARNING WE CAN SELECT BEST MATCH OR BEST PRECISION OVERLAP. PULL ON THAT RECORD OF TENS OF THOUSANDS OF PRIOR SUBJECTS, DOWNLOAD PARAMETERS SENT BACK TO THE SUBJECT. THAT'S THE VISION EVERY ONE IN MIND GOES TOWARDS. SO PART OF OUR PROJECT, WE HAVE A CANNED ROUTINE, THIS IS IMPORTANT THE MONTAGE SUITE WHERE WE CAN GO TO ELECTRODE AND SAMPLE THE SIX COMBINATIONS OF MEASUREMENT OFF ELECTRODE AND LOOK FOR THE RHYTHM SO HOW MUCH POWER IS THERE DISCRETE FREQUENCIES. SO HERE IS AN EXAMPLE FROM ONE OF OUR SUBJECTS OF THE SIX COMBINATIONS, STN, GETTING UP TO TEN MICROVOLTS BUT WE CAN LOOK THERE'S A RAREIATION AMONG SIGNALS WE CAN LOOK AT THOSE DIFFERENT SIGNATURES AND THEN BECAUSE NOW WE HAVE HUNDREDS OF DATA SETS TO COMPARE, WE CAN LOOK AT TRAINING. AND WHAT'S INTERESTING ABOUT THIS IS YOU HEAR A LOT ABOUT SOME OF THESE -- THAT'S THE MAGIC. AND WHAT WE ARE FINDING AND SHARING SOME OF THIS WITH OUR CROSS TEAM COLLABORATIONS IS THAT IT'S PROBABLY MORE NUANCED THAN THAT. IT'S ONE AND TWO. TO MARTY'S POINT YESTERDAY WE SEE SIMILAR ELEMENTS OF PARKINSON, NOT THE SIMPLE HYPOTHESIS, IT'S MORE COMPLEX WE HAVE TO GATHER THE DATABASE AND START TO UNDERSTAND WHAT WE'RE DEALING WITH. BUT ONE OF THE THINGS THAT WAS INTERESTING SO WE START WITH THE INITIAL DATABASE, WE HAVE SUMMER INTERN COME IN, AND HAVE A LOOK. AND SHE DID A GOOD JOB, 91% ACCURACY OF SELECTING THE ELECTRODE. IN A STANDARD TRAINING SET. AND THIS IS NOISE. I WANT TO BRING OUT CHALLENGES, THE MANAGEMENT INFORMATION, IF WE'RE GOING TO RELY ON MACHINE LEARNING, THAT REQUIRES A GOLD STANDARD, BY WHICH WE'RE ANNOTATING THE DATA SET I NOTICE BRIAN IS A NEUROLOGIST, MENTION NOISE SOURCE BEING NEUROSURGEON. AND KIND OF LEFT OUT NEUROLOGIST AS POTENTIAL NOISE SOURCE. AND SO THAT'S WHY KIND OF PUT UP PIERCE BROSNAN. IN THIS CASE WE HAD 7 ERRORS OUT OF THE 83, FOUR OF THOSE ERRORS WERE THE TIME IT TOOK FOR THE NEUROLOGIST TO MATCH WHAT OUR INTERNS ALGORITHM PREDICTED. SO THERE'S NOISE EVERYWHERE IN THE SYSTEM THAT WE HAVE TO BE AWARE OF AND THINK ABOUT THOSE SOURCES. SO WHY IS PIERCE UP HERE? LOOKING DOWN. SO I GAVE THE ANSWER, THIS IS PIERCE BROSNAN, WHEN I WAS AT GOOGLE THEY'RE EXPLORING IMAGE AUTOMATED EXTRACTION PROGRAMS. GOOGLE RELIES ON THE SAME CONTENT, WE TRAIN ALGORITHMS, NO ONE KNEW WHO THIS WAS. SO AUTOMATIC IDENTIFICATION, SAID THIS IS JAMES BOND. SO IT POPPED UP JAMES BOND. BECAUSE THAT'S HOW EVERYBODY ASSOCIATED WITH IT. I WANT TO DRIVE THAT HOME AS WE THINK ABOUT THE DATABASES AND PREPARING THESE PROTOCOLS, THE CLINICIANS ARE GOLD STANDARD, SURGICAL STANDPOINT NEUROLOGY STANDPOINT, ENGINEERS CREATE NOISE AND AMPLIFIERS WE SEE THE NOISE IN DATA SETS. WE HAVE TO GET IN FRONT OF IT. THE OTHER THING WE DIDN'T THINK CAREFULLY ENOUGH AT THE BEGINNING OF THE PROJECT CLOCK SYNCHRONIZATION. SO I SHOW THIS YESTERDAY, THAT'S HOW WE SYNCHRONIZE CLOCKS ON QUEUE. THANK YOU. YOU CREATE A PERTURBATION IN THE SIGNAL, THAT'S THIS -- WITHIN THE STEWART LAB AT THE BEGINNING OF THE DATA SET THEY CREATE A NON-STANDARD SEQUENCE. THAT CAN BE PICKED UP WITH EXTERNAL AMPLIFIER. THAT ALLOWS INTERNAL AND EXTERNAL CLOCKS TO BE ALIGNED FOR LATER DATA ANALYSIS. FIRING ON ALL SIN DARES HERE. WE WANT TO CAPTURE A COUPLE OF DOS AN DON'TS. BUT EMPHASIZING THE EBB IN MIND WHAT DOES THE NIH WANT OUT OF THIS, AND WORK BACKWARDS THE TO MAKE THAT HAPPEN. I WANT TO EMPHASIZE THE SYSTEM, WE TALK ABOUT DATA FORMAT COLLECTION WITH THESE ULTIMATE ANALYSIS NEEDS, LESSONS LEARNED, THE SYSTEM INCLUDES PRACTICAL THING, PATIENT INFORMED CONSENT. IRRB, -- IRB INTERNATIONAL LAWS OF PATIENT PRIVACY AND HOW THIS APPLIES TO YOU WHEN WE DIDN'T HAVE THE END IN MIND WE WANT TO COLLECT THE DATA, WE HAD TO BACK TO PATIENTS AND MODIFY THE PICK. SO THINK ABOUT THE LONG TERM PLANS MAKING THE WHOLE PROCESS EFFICIENT. I HIT ON THIS, WHAT IS THE GOAL STORE TAN CARD ANNOTATION CROSS VALIDATION AND PRACTICALLY WHAT IS SOMETIMES HIT US AS A ROADBLOCK IS POWER USAGE, THIS IS HARDWARE CREATING THE THE DATA IS FLOWING. HOW MUCH POWER IS IT REQUIRING. I HAVE MY ONE MINUTE, I WILL JUMP TO THE OTHER ONE AND MAKE THIS AVAILABLE ON THE WEB. IT DISSEMINATES SO JOE I CAN'T WITH THE 787. WE DON'T HOLD THAT UP AS A GREAT LESSON OF TECHNICAL DEVELOPMENT RIGHT NOW. THERE'S LESSONS LEARNED, RELYING ON EVERYONE WORKING NICELY TOGETHER GETTING IT RIGHT THE FIRST TIME. THE TELLMENT HERE, CHALLENGE BACK TO THE NIH AND OTHER GOVERNMENT AGENCIES IS HOW DO WE PUT SOME MILESTONES IN PLACE AFTER THE FIRST WAVE OF THE GRANTS THERE'S A SECOND WAVE OF SUPPORTING RESEARCHERS WHO COME IN WHO ANNOTATE THE DATABASE AND GIVE US FEEDBACK ON IT. AND YOU HAVE TO DO THAT AT A TIME WHERE YOU CAN COURSE CORRECT. YOU CAN'T -- YOU DON'T WANT TO BE TWO YEARS AFTER, YOU DON'T WANT TO BE AT THE TIME WE SHUT DOWN THE PROJECT AGREEMENTS ARE OVER, THE MONEY IS SPENT, BY THE WAY YOU DIDN'T ANNOTATE ANY DATA SET, WHAT CAN YOU DO TO CREATE A CHECK AND BALANCE PROCESS IN THE SYSTEM AND WE HAVE GOOD DATA INTEGRITY. THANK YOU. [APPLAUSE] >> NOW WE HAVE A PANEL DISCUSSION, I WILL ASK ALL THE PANEL MEMBERS TO COME UP. THIS WILL BE MODERATED BY MY COLLEAGUE GREG FARBER SO I WILL STEP ASIDE. SO WE ARE ON SCHEDULE TO START LUNCH BY 1:00 P.M. WHICH IS A LITTLE MIND BUT WE'RE GOING TO BE OKAY. THANKS. >> SO WITH WE HAVE A LOT OF THINGS THAT WE CAN TALK ABOUT BUT I THINK THAT THE BEST WAY TO START THIS SESSION IS REALLY TO START WITH QUESTIONS FROM THE AUDIENCE. WE HAD A NUMBER OF GREAT PRESENTATIONS, WE SHOULD START THERE AND TALK ABOUT OTHER THINGS AS SOMETIME ALLOWS. >> NOT A QUESTION, IT'S A NEED. TWO NEEDS. NUMBER ONE IN YOUR TALK HELP ME GET PAST MY INSTITUTIONAL CONTRACTING AND COMPLIANCE OFFICES, THE SAME WAY THESE TEMPLATE AGREEMENTS TWO THINGS DATA SHARING NUMBER ONE YOU'RE RIGHT THERE'S GOOD CLOUD SERVICES OUT THERE. I'M BANNED BY INSTITUTIONAL POLICY PUTTING DATA THAT DEIDENTIFY DATA ON ANY OF THEM BECAUSE IT MIGHT SOMEHOW BE REIDENTIFIABLE. THERE NEEDS TO BE GOOD HOUSEKEEPING SEAL OF APPROVAL ON SOME PLATFORMS. NUMBER ONE. TWO, CLOSELY RELATED IS I HAVE BEEN TOLD I'M NOT -- THAT IF I HAVE A PUBLIC DATA SHARING PLATFORM, IT HAS TO HAVE A DATE USE AGREEMENT THAT PREVENTS REIDENTIFYING AND A CORPORATE ENTITY WANTS THE TO DOWNLOAD THE DATA I HAVE TO REQUIRE THEM TO SIGN AN INDEMNITY CLAUSE SAYING THEY WILL INDEEM US AGAINST ANYTHING BAD THAT HAPPENS FROM ANY PRODUCT THEY MAKE ANY WAY DERIVED FROM MY DATA. THE PROBABILITY THE MANUFACTURERS HERE GOING TO WANT TO SIGN THAT CLAUSE IS LOW, WHICH MEANS MY DATA IS STUCK AND APPRECIATE HELP GETTING PAST THAT. I THINK THOSE ARE BOTH GOOD POINTS AND VALID. THERE'S A VARIETY OF REPOSITORIES TRYING THE FIND DIFFERENT WAYS TO RESOLVE THOSE ISSUES. GOVERNMENT REPOSITORIES END UP HAVING SOMEWHAT OF AN ADVANTAGE IN THIS REGARD BECAUSE WE CAN FORCE INSTITUTIONAL OFFICIALS TO COSIGN GET DATA ACCESS AGREEMENTS, THAT GIVES NIH OR OTHER GOVERNMENT AGENCIES A PRETTY BIG STICK. BUT THESE ARE -- WE HAVE SOME DISCUSSION EARLIER ABOUT HOW IRBs AROUND ALWAYS UP TO THE TASK INSTITUTIONS IN TERMS OF DATA SHARING POLICIES MAYBE THE SAME WAY. >> INTERESTING POINT IN SETTING UP THE STRUCTURE. IF YOU WANT TO DO IT THROUGH THIS PROGRAM ON THE STRUCTURE ONE THAT STRUCK ME WAS AT SOMETIMES DIFFERENT INTERPRETATIONS AT UNIVERSITIES, TO SHARE A STORY. WE RANDOMIZE THE DATA THAT THE DATA WAS CHECKED AND UP LOAD SOD THERE'S A CONCERN IF SOMEONE GOT THE RECORD APPOINTMENT BOOK FOR THAT CLINIC, WE CAN SEE WHAT DAYS THE DATA WAS UP LOADED THERE BY IDENTIFY THE PATIENT. THAT'S ONE OF THOSE YOU SCRATCH YOUR HEAD, THEY HAVE AN INTERESTING POINT. THAT WAS LATE IN THE GAME. THAT'S USEFUL FOR THE COMMUNITY. >> WE HAVE TO DEAL WITH THESE ISSUES, IT SET US BACK A YEAR IN OUR PROJECT. WHEN WE DID THIS. BUT THE UNIVERSITY MANAGED TO WORK IT OUT SO UNIVERSITIES FALL TO A COUPLE OF CATEGORIES. THOSE THAT HAVE WORKED AND MADE PEACE AN THOSE THAT HAVEN'T. I IMAGINE WITH THE NIH AS A BROKER, AGAIN IT COMES BACK TO DAD OR MOM USING THE BIG STICK. IF YOUR UNIVERSITY WAS TOLD THAT U YOU WEREN'T GOING GET MONEY UNLESS YOU CAME ON BOARD IT PROBABLY WOULD HAPPEN. >> BRUCE THANK YOU FOR A WONDERFUL PANEL, THIS IS YOUR REALLY ADDRESSING HIGHLIGHTING THE ETHICAL SCIENTIFIC IMPERATIVES WHICH ARGUE STRONGLY TOWARDS DATA SHARING AN OPEN SOURCE WAY SO I WON'T REITERATE THOSE, I THINK YOU DID A LOVELY JOB, I WILL BRING OUT ONE THAT HAS NOT YET BEEN TOUCHED ON AND RELATES TO THE STARTING WITH THE END IN MIND. SO WITH THE END IMPROVING PUBLIC HEALTH, WE WANT TO COLLECT AND USE DATA IN A WAY THAT'S GOING TO ANSWER PUBLIC HEALTH ISSUES. AND IF WE LOOK WHERE WE ARE IN THE FIELD OF PSYCHIATRY TODAY, IN PARTICULAR OUTCOMES NEUROMODULATION STUDIES ON CATEGORICAL DIAGNOSES OF PSYCHIATRIC DISORDERS, WE HAVE NOT YET SOLVED THAT PROBLEM AND WE ARE CHANGING HOW WE'RE THINKING ABOUT THIS, I THINK WE WILL NEED LARGER NUMBERS AND THE ABILITY TO COMBINE ACROSS SAMPLES AN STUDIES TO LOOK AT THINGS IN A DIMENSIONAL WAY. THE COMMENT WAS MADE BEING INTERESTED IN PARKINSON OR DEPRESSION BRAIN, I DON'T THINK THAT HAS YET LED TO AN ANSWER FROM STANDPOINT OF PSYCHIATRY. WITH WE SEE OUR CONDITIONS AS HETEROGENEOUS, HETEROGENEITY AND COMORBIDITY IS THE NORM NOT THE EXCEPTION. TO GET AROUND THAT ISSUE OF THE HETEROGENEITY AND EVOLVING UNDERSTANDING OF WHAT OUR DISEASES ARE IN PSYCHIATRY, IT'S GOING TO REQUIRE THE ABILITY TO OPEN SOURCE SHARE IN A WELL ANNOTATED WAY ACROSS THESE DATA SETS. SO I WANT TO ADD THAT TO THE OTHER ETHICAL AND SCIENTIFIC IMPERATIVES Y'ALL HAVE EACH ARTICULATED THAT ARGUE STRONGLY FOR ADOPTING THIS, I WILL MAKE A LAST POINT, HEALTH SYSTEMS WHICH IS WHERE I SIT HAVE BEEN MANDATED TO ADOPT ELECTRONIC HEALTH RECORDS IN THE INTEREST OF PUBLIC HEALTH AND IMPROVING QUALITY OF HEALTHCARE AND WE HAVE DONE IT. SO I THINK -- WE HAVE ADDRESSED AND SYSTEMS ARE AVAILABLE, TECHNOLOGICAL SOLUTIONS ARE AVAILABLE THE ADDRESS ISSUES OF PRIVACY AND SOME OF THE OTHER INCENTIVES THAT IMPEDED ADOPTION OF THIS BUT THE SCIENTIFIC COMMUNITY ULTIMATELY IS GOING TO NEED TO GO IN THIS DIRECTION SO THANK YOU FOR MAKING THOSE ARGUMENTS. >> SO I CAN COMMENT. I'M PAT DELGOWAN, I RUN THE DATABASE THE TBI DATA REPOSITORY WHICH IS GREG HAS NICE ADVANCED DATABASE, WE ARE LIKE A STEP AHEAD OF YOU, YES A STEP AHEAD OF THE DATABASE, WE FACE CHALLENGES AND WE HAVE A HETEROGENEOUS POPULATION. WHAT'S REALLY WHAT WE'RE FINALLY GETTING TO KEY TO MAKING THIS WORK IS GETTING THE COMMUNITY TO BUY IN SO IT'S SOCIOLOGICAL QUEUES AND DEVELOPING SOME OF THE THINGS YOU GUYS TALKED ABOUT TODAY WAS INCENTIVIZING PEOPLE TO SHARE DATA IS KEY BECAUSE THAT KEEPS COMING UP OVER AND OVER IN THE TBI COMMUNITY. I THOUGHT THAT SHARE INDEX IS SOMETHING TO BUY INTO, WE'RE TRYING TO NEGOTIATE THAT NOW. THE WARNING FROM THE FITBER SIDE IS THAT REALLY MUCH EASIER TO GO FORWARD TO DEVELOP YOUR DATA ELEMENTS THAT GREG TALKED ABOUT, GET THE STRUCTURES AND AGREEMENT TO MOVE FORWARD. WE TRIED TO DO FORWARD AND BACKWARD AND I THINK WE SPIN OR WHEEL AS LITTLE IN THE BACKWARD, AND USED UP RESOURCES DOING THAT. >> JUST FOLLOWING ALONG WITH THE PREVIOUS COMMENT HERE I MAY TAKE FOR GRANTED THE FACT THAT RED CAP HAT ORIGIN AT OUR INSTITUTION IT BRINGS IN ONE CONCEPT I HADN'T HEARD ABOUT, MARRIAGE OF CLINICAL OUTCOMES OR MANAGEMENT STRATEGIES WITH HARD ELECTROPHYSIOLOGICAL IMAGING DATA MODELING DATA, ET CETERA. ARE THERE THOUGHTS ABOUT FOR INSTANCE THAT PARTICULAR BRAND WHICH IS OPEN SOURCE AND USED AT 60,000 SITES AROUND THE WORLD RIGHT NOW. AND HOW THAT MIGHT FIT IN WITH THINGS. >> MY SENSE IS RED CAP DOES PROVIDE A LOT OF VALUE FOR A VARIETY OF DIFFERENT APPLICATIONS. THERE ARE OTHER WAYS TO GO, OTHER POSSIBILITIES IS NOT THE ONLY SOLUTION. I DO THINK THE I 2 B 2 SOLUTION OUT OF HARVARD OFFERS A GOOD WAY TO MARRY CLINICAL DATA AND DEIDENTIFY THEN PERHAPS MARRY ARE IT TO A DATABASE THAT COMES WITH THE ELECTRO PHYSIOLOGY TYPES OF THINGS. BUT THAT ALL REALLY DOES NEED TO BE WORKED OUT AND THEY'RE NOT EASY. THESE FEDERATION AGREEMENTS WHILE POSSIBLE AND DO ALLOW EVERY DATA BASE TO MAINTAIN COMPLETE CONTROL OVER WHO ACCESSES THE DATA, SOME INSTITUTIONS JUST HEARING ABOUT, PLAY NICELY AND OTHERS THAT DON'T, THE FEDERATION AGREEMENTS ARE THE SAME, SOMETIMES AN INSTITUTION WITH REPOSITORY IS HAPPY TO BE PART OF THE TEAM OTHERS NOT SO MUCH. WE'LL HAVE TO WORK THROUGH THOSE AS WE MOVE -- >> WHATEVER SOLUTION WE USE HAS TO TOUCH THE MR, THE MEDICAL RECORD. IT HAS HAS TO HAVE AS A RULE TO UNDERSTAND CLINICIAN TIME, IS REALLY LIMIT SOD THERE CAN'T BE REDUNDANT DATA ENTRY. IT HAS TO TOUCH THE PRIMARY INTERDATA AND ABSTRACT IN ONE WAY OR ANOTHER. WHETHER RED CAP AND SOMETHING ELSE OR OUT OF EPIC OR -- I THINK THAT NEEDS TO BE WORKED OUT. >> ONE THING, I'M NOT IN THIS COMMUNITY, BUT IF THE DOD IS INVOLVED THAT BRINGS IN ANOTHER LEVEL OF COMPLEXITY BECAUSE THE DOL WILL NOT LET YOU USE A CLOUD SOURCE. THEY DON'T ALLOW ANY OTHER DATA ON THE CLOUD SOURCE. IF YOU'RE THINKING ABOUT THAT. >> I HAVE BEEN ON A LOT OF STUDY SECTIONS AND THE DATA SHARE PLAN SNOT SCORABLE, IT'S NOT A SCORABLE CRITERIA. IT NEVER GETS DISCUSSED, IF I BRING IT UP, IT'S DISMISSED. I SAY 90% PROPOSALS HAVE UNACCEPTABLE DATA SHARING PLANS, I ALWAYS MARK THEM THAT WAY. AND NOTHING HAPPENS. THERE'S SOME THINGS THAT CAN BE DONE WITHIN THE CURRENT SYSTEM. >> I AGREE COMPLETELY, BOTH HALVES OF THAT STATEMENT. I WILL SAY NIH IS LOOKING VERY CAREFULLY NOW BRINGING THE DATA SHARING PLAN INTO -- MAKE IT HAVE MORE MEANING IN REVIEW THAN CURRENTLY DOES, THAT'S I THINK BEING SPEARHEADED MOSTLY THROUGH THE BD 2K EFFORT AND I'M CAUTIOUSLY OPTIMISTIC SOMETHING GOOD WILL HAPPEN. >> THE WAY THAT WE HANDLE THAT IS I RESTRICT FUNDS 75% UNTIL THEY -- UNTIL THEY SHOW THEY CAN ACCESS DATA AND PUT DATA N. GOING FORWARD WE'RE GOING TO HAVE BASICALLY A PLAN THEY HAVE TO FOLLOW AND IT'S NOT REVIEWED BUT IT'S PART OF THE NOTICE OF AWARD. >> OTHER INSTITUTES DO THAT AS WELL. WE CERTAINLY FOR THOSE WHO HAVE REPOSITORIES, IF YOU'RE MANDATED TO SHARE THERE ARE CONSEQUENCES FOR GETTING YOUR NEXT YEAR'S FUNDING. HELEN. >> >> I WAS SORT OF TRUISM AS WHAT EVERYONE SAYS HOW TO COME UP WITH SOMETHING THREATENING PEOPLE TO DO IT. PEOPLE WOULD IF THEY KNEW WHAT THEY NEEDED TO DO. I'LL MAKE AN OBSERVATION FROM THE NIMH. FOR SCHIZOPHRENIA, THEY SPENT TWO, THREE YEARS, GOT A SMALL SUBCOMMITTEE TO COME UP WITH SOMETHING THAT EVERYONE WOULD AGREE THEY WOULD MEASURE. WE'RE NOT TALKING A DEVICE UP LOADING CLINICAL THINGS TO LOOK AT BIOMARKERS, BLAH, BLAH, BLAH. AND CENTRICS THEY FINALLY CAME UP MOSTLY COGNITIVE. AND THEN EVERYBODY TAKES O NOT HELPFUL BECAUSE AS YOU START TO USE IT YOU ALWAYS FIND THE PIECE YOU MIS. SO ONE OF THE THINGS TRYING TO OPEN UP ARCHITECTURAL A LITTLE BIT IS TRYING TO GET YOU GIVE BEST SHOT WHAT IS MINIMUM REQUIREMENT. SO IF THE LEK FROM PHYSIOLOGISTS HAVE THAT -- ELECTROPHYSIOLOGISTS HAVE THAT THEY CAN GET START. WE IMPLODE OURSELVES BECAUSE ONCE WE DECIDE TO DO IT WE WANT SO MUCH P BECAUSE WE DON'T WANT TO FORGET ANYTHING BUT THEN WE CAN'T DECIDE AND WE DO NOTHING. SO HOW WITH EACH TIME ONE OF THESE INCENTIVIZE THAT YOU GO WHAT DO CLINICIANS THAT DECIDE -- IT'S NOT JUST THE PRIMARY END POINT BUT WHAT ARE THE BASIC THINGS THAT IF I HAD THAT WE CAN GET STARTED, AND WITH YOUR EXPERTISE, PARTICULARLY BUILDING THESE, HOW TO LEAVE SOME OPEN SLOTS SO THEN WHEN YOU GOT SMART YOU CAN ADD IT. THAT CERTAINLY MY EXPERIENCE, WE KEEP ADDING THINGS IN THE DATABASE PERSON SAYS PLEASE DONE DO THIS. IT'S LIKE BUT WE JUST GOT A LITTLE SMARTER. WHY ARE YAPPY ACCOMPLISHING US? AND I THINK THAT YOU KNOW HOW TO BUILD THESE ARCHITECTURES AND THEN WE CAN TRY TO COMPLY. >> MY SENSE FOR THIS COMMUNITY IS WITH COMMON DATA ELEMENTS WHICH IS WHAT YOU'RE TALKING ABOUT HAVING A WHOLE FINE COMMUNITY MEASURE THE SAME DATA -- COMMUNITY SO YOU CAN MEASURE AND STITCH RAREIOUS DATA SETS, YOU WANT TO START SMALL AND YOU CAN'T BE LOCKED DOWN FOREVER, IN A NEW VERSION OF THE COMMON DATA ELEMENT EFFORT AT NIMH WE TRIED TO DO THIS WITH PTSD AND WITH SUICIDE I KNOW NINDS IS IN THE LEAD ON COMMON DATA ELEMENT EFFORTS. I BELIEVE THEY THINK THE SAME WAY COMMON DATA ELEMENTS ARE NOT STATIC BUT WILL EVOLVE AS KNOWLEDGE MOVES FORWARD. KEEPING REQUIRING MORE DATA IS UNACCEPTABLE. THAT IS NEVER GOING TO WORK. >> I WOULD ADD INFRASTRUCTURE. THE DAYS OF DATA STRUCTURES WHERE YOU INITIATE THE DATABASE AND YOU HAVE A SET NUMBER OF BOXES AND YOU HAVE TO HAVE THE DATA ENTRY PERSON GO THROUGH AND PUT IN EACH FIELD ARE GONE. THAW EAR NOT EXTENSIBLE AND CHANGE ALL TIME. GOOGLE GIVES A GREAT EXAMPLE, THEY DON'T REQUIRE SPECIFIC FIELDS FOR COMPANY OR PERSONAL PROFILE OR OTHER THINGS, THEY'RE SMARTER AND SMARTER SEARCH ENGINES THAT I ALLOW YOU TO DO KEY WORD SEARCHES ON ELEMENTS THAT ARE STOREED THAT COA DARN GOOD JOB PULLING UP WHAT U YOU NEED SO THAT KIND OF SEARCH AN INFRASTRUCTURE, SOMEBODY IS GOING TO INVENT A NEW TECHNOLOGY TOMORROW, YOU'RE NOT EVEN MEASURING YET. WHEN THAT HAPPENS YOU NEED TO ADD IT AND SAY LET'S DO OVER. THAT'S NOT GOING TO WORK. >> >> I APPRECIATED ALL THE DIFFERENT SPEAKERS, I THINK CAMERON HAD A VERY NICE ANALOGY WITH THE CAR TO WHAT ALL PIECES YOU NEED. POTENTIALLY TO HAVE FULL FUNCTIONING SYSTEM. IT WOULD BE NICE I THINK TO WORK ON POTENTIALLY STANDARDIZING -- THESE ARE THE PIECES THAT YOU NEED. IN ORDER TO PAINT THAT PICTURE. BECAUSE WHILE YOU CAN TRY TO DRAW A PICTURE BY HAVING DISPARATE PIECES, AT LEAST FOR A GIVEN PATIENT IT'S VERY DEALT TO MAKE STATEMENTS WITHOUT SOME BASELINE TO WHAT YOU NEED. >> I THINK THAT'S A GREAT IDEA, CAMERON? >> MY LESSON LEARNED OVER TEN YEARS OF BUILDING PATIENT SPECIFIC REPRESENTATIONS OF NEUROMODULATION IS THAT I WOULD MUCH RATHER HAVE FIVE PATIENTS THAT HAVE BEEN SUPER-WELL ANNOTATED, ALL APPROPRIATE DATA PUT IN ONE GOOD PLACE THEN TO HAVE 150 THAT HAVE DISPARATE UNINTEGRATED REPRESENTATION. SO IF YOU HAVE THAT WELL ANNOTATED VERY COMPLETE DETAILED DATA SET WE CAN LEARN SO MUCH FROM THAT THAN WE CAN FROM A JUNK DATABASE. MAYBE THAT'S NOT TRUE IN OTHER FORMS OF NEUROSCIENCE, I'M SURE THAT'S NOT TRUE IN OTHER FORMS OF NEUROSCIENCE BUT THIS IS A UNIQUE FORM OF NEUROSCIENCE. AND SO THAT WOULD BE MY SUGGESTION, LET'S FOCUS ON EVERYONE OF THESE PATIENTS THAT ARE GOING TO BE IN THESE VERY SMALL SCALE PILOT TRIALS THEY ARE THEIR OWN UNBELIEVABLY UNIQUE DATA SYSTEM A LOT OF EXPENSIVE DECISIONS ARE MADE ON THE FEST FIVE PATIENTS THAT ARE PART OF THE PILOT TRIAL. INVESTING THE EXTRA $50,000 TO POPULATE THE APPROPRIATE DATABASE INFORMATION ON THAT PATIENT IS A VERY SMALL INCREMENTAL COST INITIAL TRIAL, IN MY OPINION AND MY EXPERIENCE COULD HAVE A GIGANTIC CHANGE IN THE OVERALL VALUE OF WHAT THAT TRIAL HAS CREATED IN THE END. SO THAT WOULD BE MY PERSPECTIVE. I'M INTERESTED, BRIAN WORKS ON THE POLYPI SY SIDE, COMPLETELY DIFFERENT WORLD, MASSIVE DATA COLLECTED ON EVERY SINGLE PATIENT. AND ACTUALLY ONLY A SMALL AMOUNT OF IT ACTUALLY GETS USED FOR CLINICAL DECISION SUPPORT. SO MAYBE HE HAS A TOTALLY DIFFERENT PERSPECTIVE. >> WHAT I WOULD SAY IS FOR CASES WHERE THE QUESTIONS ARE VERY CLEARLY DEFINED, IN YOUR FIELD I THINK THEY'RE VERY STRAIGHT -- AT LEAST THE LITTLE BIT THAT WE KNOW, THEY NEED HIGH RESOLUTION IMAGING WITHIN THIS PRECISION, THEY NEED TO HAVE SIGNAL TO NOISE RATIO FOR THEIR DATA. THAT MAKES SENSE, I WILL SAY CREATEK AN ECOSYSTEM FOR THE QUESTIONS THAT WE DON'T KNOW YET, IF WE HAD A SYSTEM WHERE PEOPLE PUT UP DATA AND KEPT TRACK OF HOW MUCH IT WAS USED, VERY CLEAR OVER TIME THESE DATA SETS WERE THE MORE VALUABLE ONES BECAUSE THEY WERE COLLECTED IN THIS WAY AND THE ONES THAT DIDN'T HAVE THE THINGS THAT PEOPLE NEED WOULD FALL BY THE WAYSIDE AND WOULDN'T GET USED AT ALL. SO PROBABLY COMBINED APPROACH. >> ONE I WANT TO MAKE IN ALL OF THIS IS IT'S IMPORTANT TO RECOGNIZE THE POWER OF NUMBERS AS WELL. BECAUSE YOU HAVE STUDIES THAT ARE CLOSE TO CLINICAL REALM WHERE PATIENT POPULATIONS ARE LARGE, WHERE SOME LEVEL OF STATISTICAL RELEVANCE IS GIVEN AND THERE ARE OTHERS WHERE A LOT OF IE STUDIES WITH WE TALKED ABOUT WANT TO ENABLE THINGS IS N OF 1, 2, 3, 4, 5, WHICH CASE YOU DO WANT TO COLLECT ALL THE DATA BUT YOU WANT TO BE CAREFUL HOW YOU EVALUATE THAT BECAUSE THERE'S SO MANY THINGS YOU DON'T KNOW YET THAT COULD GO WRONG. SO YOU CAN HAVE THINGS ONE DIRECTION SAYING THIS IS VALUABLE, EVERYTHING IS WONDERFUL OR THE OTHER EXTREME USUALLY WHERE IT ENDS UP, SOMETHING TO CONSIDER IN ALL THESE DISCUSSIONS, THE STRUCTURE OF THE DATABASE THE WAY YOU SEEN IT IN NO WAY DIFFERENCE FROM WHAT WE HAVE WITH GOOGLE TODAY WHICH IS EQUIVALENT OF MY DAD'S DESKTOP ON THE COMPUTER WHO DOESN'T SORT ANYTHING, AND ELECTRON YOU KNOW AS WELL ACTUALLY THEN YOU HAVE TO HAVE A CLEVER SEARCH ENGINE, IN THIS CASE SOME SORT OF FIRST-IN, FIRST-OUT TIME MEMORY, KNOW WHEN HE PLACED SOMETHING SOMEWHERE USES TO FIND IT AND ON THE COMPUTER YOU HAVE A GOOD SEARCH ENGINE AND OVER TIME AS THE AMOUNT OF DATA STACK UP YOU CAN START DEVELOPING MAYBE SOME GUIDELINES. >> I HAVE A BIG CONCERN WITH WHAT'S GOING ON, QUALITY CONTROL DATA SET, PERHAPS NOT SO MUCH THE CASE WITH ELECTROPHYSIOLOGICAL DATA, BUT THAT DATA DOES NOT HAVE A GREAT DEAL OF VALUE UNLESS IT'S PLACED WITHIN CLINICAL CONTEXT. AND WITH ALL DUE RESPECT, TO THE INVESTIGATORS 32 SITES WE HAD IN OUR STUDY, WE HAVE SITE MONITORS THAT GO OVER EVERY SINGLE DATA ELEMENT O AND COMPARE TO SOURCE DOCUMENT AS WITH WE KNOW IN CLINICAL TRIALS. I CAN'T TELL YOU HOW OFTEN THERE WERE QUESTIONS DISPARITIES BETWEEN SOURCE DOCUMENT AND WHAT WAS FILLED OUT IN THE CASE REPORT FORM THAT REQUIRED MULTIPLE ITERATIONS TO GET RIGHT BECAUSE DATA MAYBE ENTERED BY A PHYSICIAN KNOWLEDGEABLE ABOUT BUT MAYBE BY COORDINATOR UNDERGRADUATE OR A STUDENT THEREFORE THE SUMMER F AND SO WITHOUT QUALITY CONTROL WE COULD RUN INTO WHAT I CONSIDER TO BE THE MOST DANGEROUS PLACE CERTAINLY THINKING ABOUT NEUROPACE, IT'S MUCH BETTER TO NOT KNOW SOMETHING THAN TO THINK YOU KNOW SOMETHING THAT IS NOT TRUE. BECAUSE THAT HAPPENS AND YOU ARE YOU MAY NEVER RECOVER YOUR WAY SO THE QUESTION IS DATA QUALITY TO TRUST IT. >> I WANT BRIAN TO COMMENT BUT MY SENSE IS THAT DEPOSITING THE DATA IS ENOUGH. IF RESEARCHERS REALLY KNOW THE COMMUNITY IS GOING TO SEE WHEN YOU BUILD VALIDATION TOOLS THAT I TALKED ABOUT THAT'S HELPFUL AS WELL. >> I WOULD AGREE WITH THAT -- SOMEWHAT THAT I WORRY THERE HAS TO BE WALL CONTROL, IT'S EASY, THE ELECTROPHYSIOLOGY, IF THE NOISE IS THERE'S A BIG PROBLEM. IF THE EMR DATA IS WRONG, IF IT MIXES UP RIGHT AND LEFT FOR WHICH SIDE THE PATIENT HAD THEIR EPILEPSY FROM, THAT'S A HUGE PROBLEM BUT I THINK YOU CAN PUT IN CHECKS AND BALANCES FOR THOSE STUDIES. I'M NOT SURE IT ALL HAS TO BE DONE MANUALLY. LIKE THAT, LEFT AND RIGHT YOU CAN SORT FROM THE ELECTROPHYSIOLOGY, YOU CAN ALMOST DO THAT IN AUTOMATED WAY IF SEIZURE DETECTED PICKED UP ON THE WRONG SIDE. SUPPOSE CLINICIAN ENTERED RIGHT BUT MADE THE WRONG DIAGNOSIS, THERE'S LEVEL OF NOISE THAT JUST GOT TO BE TOLERATED. BUT YOU'RE RIGHT THERE HAS TO BE SOME DATA SCREENING FOR SURE. >> I'LL PUSH BACK GENTLY ON THAT. I'M GOING TO SECOND THE ON VARIATION TO MARTY'S EXPERIENCE, IT IS -- WHERE THEY'RE TREMORS, NOT TREMORS ON MEDS OFF MEDS, SO IT'S HARD TO DRAW A CONCLUSION SO PUTTING THE DATA UP ISN'T GOOD ENOUGH AND WE STARTED TO DO CHECKLIST SO FOR REPEATED VENDORS WILL HAVE A CHECKLIST AND SAY PLEASE GO DOWN THE CHECKLIST. BUT I THINK THE KEY IS ASKING JUST THE QUESTION, SO THE EXPERIENCE BROUGHT UP SHARING SOME OF THESE EXPERIENCES, FROM AN ENGINEERING STANDPOINT WE HAVE THE THAT SAYING WHAT YOU DON'T MEASURE, WILL NEVER IMPROVE OR THE WAY YOU IMPROVE SOMETHING IS BY STARTING TO MEASURE IT. I THINK THE NICE THING ABOUT CREATING THE DATABASES AND LOOKING AT USE CASES IS THERE AS A FIELD IT STARTS TO GIVE A METRIC THAT WE CAN SAY ARE WE HEADING IN THE RIGHT DIRECTION. THAT'S WHY I'M OPTIMISTIC BUT I WANT TO HOLD PEOPLE ACCOUNTABLE AS WELL. >> SO THERE COULD BE A DIFFERENT KIND OF S INDEX WITH A DIFFERENT MEANING OR SOME OTHER WAY OF TRACKING PEOPLE KNOWN TO BE GOOD DATA PROVIDERS AND BY SPOT CHECKING IS A WAY TO DO IT ALSO. >> ONE ITEM IS DOING SOME OF THOSE SPOT CHECKS, ANOTHER ONE IS IF YOU LOOK AT APPLICATIONS THAT UPHOLSTERED, ONLINE STORES FOR OTHER APPS YOU COULD HAVE TWEETERS OF QUALITY DATA, SOME CERTIFIED, SOME NOT CERTIFIED BUT YOU CAN POTENTIALLY PROVIDE OPPORTUNITIES OPT ECONOMIC OR THE NON-PROFIT SIDE TO SAY, THERE'S WAYS JUST LIKE EQUALITY MANAGEMENT SYSTEM WHERE PEOPLE CAN GET THAT STAMP OR GOLDEN MEDAL OF APPROVAL, CHECK REGULAR LAYER, UP LOAD IT AND CHARGE MORE FOR YOUR DATA, THE COMPANY WOULD WORK WITH THOSE PEOPLE. IF YOU ARE SMALL LAB NOT TO INTEREST YOU WANT TO GIVE TO IT THE COMMUNITY YOU MAY HAVE MADE MISTAKE, IT COMES WITHOUT IT AND IT'S THE FREE WARE SOMEBODY PROGRAMMED RUN ON YOUR MACHINE, SOMETHING CRASHES, IT THAT'S AT YOUR OWN PERIL BUT THERE'S WAYS THE MARKET TO REGULATE THAT, IT'S AN OPPORTUNITY -- >> THIS IS A GREAT DISCUSSION. AND HELPFUL FOR MANY. AT -- AT THE BEHEST OF THE FDA THEY STARTED THE INITIATIVE FIVE YEARS AGO AND TRAN SIGNATURED TO US AS SOMETHING THAT NOT QUITE ABLE TO DO. WE HAVE A MULTI-TIERD APPROACH WHERE THE TOP TIER IS INTENDED TO BE REGULATORY GRADE INFORMATION EITHER THROUGH SOMETHING LIKE THE FDA MEDICAL DEVICE DEVELOPMENT TOOLS PROCESS OR WE HAVE ALSO PILOTED A METHOD WHERE WE CONSTRUCT A PANEL TO REVIEW A MODEL AND VALIDATION DATA AND GIVE IT THE EQUIVALENT OF HOUSE KEEPING SEAL OF APPROVAL AGAINST EXISTING STANDARDS SO THEY CAN COMPARE IT TO. MIDDLE LEVEL TIER WES ENVYINGS BUILDING OUT TO EQUIVALENT OF DATA JOURNAL WHERE SUBMISSIONS ARE JURIED BY EDITORIAL PANEL AND REVIEWERS. THE GOAL OF THIS IS TO HOPEFULLY (OFF MIC) MY QUESTION IS AROUND THIS IDEA OF MINTING DOI WHICH SOMETHING THAT WE'RE PLANNING ON DOING AS WELL, AND HOW DO WE THEN -- THIS IS MAYBE AN NIH QUESTION HOW WE GET THAT INDEXED ON PUBMED? HOW DO WE START MAKING THIS DISCOVERABLE IN THAT FASHION? AND THEN IF WE THINK ABOUT THIS AS A DATA JOURNAL, I WANTED TO ASK IF THERE ARE ANY ADDITIONAL CONSIDERATIONS FOR IMPACT FACTOR AND HOW WE MIGHT BE ABLE TO START ENABLING THAT. >> PART OF ANSWER AND PART OF A DREAM. THE BIOCADDY AWARD THROUGH THE BD 2K PROGRAM AT NIH IS REALLY GOING TO HELP WITH DATA DISCOVERY ISSUES. MY DREAM IS TO HAVE A BIOSKETCH LIST OF DOIs RELATED TO DATA OR SOFTWARE YOU MADE AVAILABLE ALONG WITH THE APPROPRIATE COUNTS. THIS SHOULD BE AUTOMATED. THE CLICKS THAT I TALKED ABOUT THE PAPERS REFERENCE YOU SHOULD HAVE THE DOI IN YOUR BIOSKETCH AND THAT SHOULD GET AUTOMATED ON AN UPDATE ON A DAILY BASIS. AS THINGS CHANGE, WHEN YOU SUBMIT A GRANT YOU HAVE AN UPDATED NUMBER WITHOUT HAVING TO WORK ON IT. I THINK THE DATA SITE FOLKS IN CHARGE OF DOI COULD DO THAT. I'LL NOT SURE THEY KNOW HOW VALUABLE THEY MIGHT BE BUT WE HOPE TO TRY TO WORK WITH THEM TO MAKE THOSE SORTS OF SUGGESTIONS. QUESTION HERE. ONE MORE QUESTION. SOMEBODY ELSE HAS THE MIC. (OFF MIC) >> ONE QUICK QUESTION FOR THE GROUP. HOW MUCH VALUE DOES THIS GROUP STILL PLACE ON THE THE PEER REVIEW PROCESS AN JOURNALS? WHICH IS THE TRADITIONAL VALIDATING DATA, IS IT JUST TOO SLOW OR DOES IT STILL HAVE VALUE? >> I WOULD SAY IT'S NOT GOOD ENOUGH FOR THIS. BECAUSE THIS IS A TECHNICAL ISSUE. THE PEOPLE DOING PEER REVIEW DON'T GET TO SEE THE DATA. IT MIGHT BE INTERESTING TO ARE THE INSTITUTE OF MEDICINE OR SOME OTHER SCIENTIFIC BODY WEIGH IN. MAYBE THE S INDEX IS A SIMPLE AVERAGE OF THE IMPACT FACTOR OF THE JURY ROOM REQUIRED TO REFERENCE DOI FOR EACH PAPER MULTIPLIED BY DOI NUMBERS. >> I SEE THIS AS NEXT GENERATION OF PEER REVIEW. THAT'S -- THAT WOULD BE MY FEEDBACK TO YOU, OLD PEER REVIEW WHAT LEVEL OF INFORMATION THIS IS NEXT GENERATION OF PEER REVIEW. THAT'S HOW I SEE IT. >> THANKS SO MUCH, THANK YOU ALL FOR HANGING OUT UNTIL THE VERY END. >> THE WORKSHOP IS NOT OVER. WE HAVE LUNCH IN THE BACK. AND WHAT OUR PLAN IS TO HAVE A WORKING LUNCH WHERE WE'LL HAVE AN OPEN BRAINSTORMING SESSION WHERE WE CAN DISCUSS PEOPLE'S IDEAS THAT ARE MORE IN THE LONG TERM SPACE FOR THINGS THAT WE MIGHT DO IN TERMS OF INDUSTRY PARTNERSHIPS OFFICECAL YEAR 2016 SO WE'RE GOING TO ASK -- WE'RE ASKING PEOPLE TO GET YOUR LUNCH, WE'LL GIVE YOU FIVE MINUTES FOR THAT. AND BRING IT BACK TO YOUR SEAT AND KIP AND I I BELIEVE WILL LEAD THE BRAINSTORMING SESSION. WHAT WE'RE SAYING IS WE HAD A SHORT TERM GOAL OF FY 16 AND SPECIFIC THINGS. BUT WHILE WE HAVE THE PEOPLE STILL IN THE ROOM TO WHO ARE INTERESTED TO MAKE GENERAL COMMENTS ON THINGS THAT WE HAVE -- THINGS THAT COULD BE CAPITALIZED ON FOR FUTURE YEARS, THINGS THAT WE SHOULD BE FOLLOWING UP WHETHER THIS IS A KEY QUESTIONS QUESTION UNEARTHED HERE TODAY, A SEPARATE DEDICATED WORKSHOP FOR, MECHANISMS, WHAT HAVE YOU THIS IS YOUR FORUM TO GIVE FEEDBACK ON WHATEVER YOU WANT TO PART OF THE BRAIN PLANNING TEAM. YOU CAN ALSO JUST EAT YOUR LUNCH BUT IF YOU RAISE YOUR HAND WE'RE GOING TO BRING A MIC TO YOU AND GO FROM THERE. >> I HAD A FOLLOW-UP ON A COMMENT BEFORE, NOT SURE WHETHER THERE WAS RESOLUTION, YOUR FLOWCHART LETTED THIS XO 1 PROCESS OF PRE-PROPOSALS. >> YEP. >> AND I HAD COMMENTED THAT SOME PEOPLE ALREADY KNOW WHO THEY WANT TO WORK WITH MY IMPRESSION IS IN THIS COMMUNITY, THAT'S A RELATIVELY SMALL NUMBER OF COMPANIES MAKING DEVICES SO UNLIKE THE DRUG MODEL BIG PHARMA COMPANIES AN LOTS OF THEM. HERE WE HAVE A RELATIVELY SMALL NUMBER OF COMPANIES, EVERYBODY KNOWS EACH OTHER. IT'S STILL A FAIRLY SMALL COMMUNITY. LIKE THE COCHLEAR IMPLANT COMMUNITY, HAS BEEN OVER THE LAST 30 YEARS, THERE'S ONLY THREE MAJOR COMPANIES, TWO SMALLER ONES, WE KNOW THE PEOPLE WE WANT TO WORK WITH AND WE GENERALLY PAIR UP WITH THE COMPANY THAT HAS THE DEVICE THAT GIVE US US THE PROPER CAPABILITY OR THE COMPANY THAT HAS PEEP WELL LIKE TO WORK WITH. SO I DON'T THINK THERE'S A NEED FOR A DATING SERVICE TO PAIR UP INVESTIGATORS WITH COMPANIES, BOTTOM LINE, YOU DON'T WANT TO DO A FOUR PAGE PROPOSAL AND HAVE ADDITIONAL REVIEW. >> FINE TO DO THAT BUT NOT NECESSARY TO FIND A COMPANY TO PAIR WITH BECAUSE WE KNOW WHO. >> JAMIE HAS A COMMENT TO ADD TO THAT. WHAT WE'RE ENVISIONING IS PEOPLE WORKING WITH COMPANIES TO IF PARTIES WANT TO, TO DO THIS EARLIER, IT'S POSSIBLE TO ALLOW THOSE PEOPLE TO COME IN AFTER THE PRE-PROPOSAL STAGE, IT IS A SERVICE TO THE COMPANY FOR PEOPLE THEY HAVEN'T WORKED WITH BEFORE TO GET AN IDEA WHETHER THE IDEA IS FUNDABLE, IT ALSO MEMBER A USEFUL THING TO DO A PAGE PRE-PROPOSAL EVEN IF YOU HAVEN'T TO GET AN IDEA OF A INITIAL FOUR PAGE OVERVIEW, A PEER REVIEW WHAT THEY THINK OF THAT FOUR PAGE IDEA AND WHAT CONCERNS ARE. (OFF MIC) >> YOU WANT TO SKIP TO LATER, I THINK THAT'S A REASONABLE POINT AND WE SHOULD CONSIDER. I DON'T KNOW HOW N CATS NECESSARILY HANDLES IT. LEGALLY WE'RE NOT ALLOWED -- WE CAN'T PREVENT YOU FROM SUBMITTING TO THE MAIN APPLICATION POOL. SO LEGALLY YOU'RE ALLOWED TO DO IT THAT WAY. >> SOME TEND TO WORK WITH CERTAIN COMPANIES THAT MAY NOT KNOW MUCH ABOUT WHAT OTHER COMPANIES MAY HAVE TO OFFER. WHETHER CAPABILITIES THERE ARE. I FOUND IT INSTRUCTIVE TO LOOK THROUGH EXHIBIT C AND D TO SAY WOW LOOK AT THESE COOL CAPABLES OUT THERE I NEVER KNEW ABOUT. SO TO ME THIS IS CLEARS HOUSE -- CLEARINGHOUSE, PEOPLE ARE RELUCK TAN TO TALK ABOUT CASUALLY BUT IN A MORE STRUCTURED WAY LIKE THIS, IT -- IN A MORE GENERAL WAY THAT MAY NOT GET OUT IN OTHER FORUMS YOU CAN SEE THOSE CAPABILITIES. SO I THINK THE DEVIL WILL BE IN THE DETAILS AND THINGS THAT WE TALKED ABOUT TODAY ARE JUST SUCH DETAILS BUT BASIC IDEA OF IT, I THINK IS REALLY NEAT. >> I WANT TO AMPLIFY WHAT JANIE SAID. IN MY EXPERIENCE IT IS ACTIVITY FOR AN INVESTIGATOR TO KNOW WHAT THE TECHNICAL CAPABILITIES OF A DEVICE ARE. EVEN WITH OUR BRIEF DESCRIPTION AND OF COURSE THERE'S STUFF THAT'S ABOVE THE HOOD AND STUFF UNDER THE HOOD. SO RESEARCH COLLEAGUES HERE WILL KILL ME BUT IT MAKES SENSE FOR US TO HAVE CAB SOMEBODY CONTACT US BEFORE THEY DO THAT. I ALSO DON'T WANT PEOPLE TO WAIST TIME F THEY THEY CAN THEY CAN DO SOMETHING WITH OUR DEVICE WE KNOW THEY CAN'T. OR IF THERE IS PATIENT POPULATION, THEY WANT TO LOOK AT WE KNOW WON'T WORK AND FINALLY THE REGULATORY PATH. IT'S UNUSUAL FOR ACT DENIMMIC INVESTIGATOR TO -- THERE'S NO WAY TO KNOW WHAT IT IS. I WOULD ALSO SAY THAT WE FIND GOING TO FDA EARLY IS BETTER. AND IT MIGHT BE BASED ON THAT FOUR PAGE WE SAY BEFORE A MORE COMPLETE PROPOSAL, IS DEVELOPED IF WE HAVE TIME LET'S TALK TO FDA ABOUT WHAT THAT I BELIEVE THE REGULATORY REQUIREMENTS WOULD BE, YOU CAN'T DO THAT TOO EARLY. >> SO WE CAN MAKE THAT PARTICULAR ASPECT POTENTIALLY COMPANY BY COMPANY BASED OFF PREFERENCE IF THERE IS WIDER CONCERN WITH SOME OF THE COMPANIES VOICE THAT THEY KIN WANT TO BE INUNDATED WITH PRE-PROPOSALS THAT MAY HAVE NO MERIT BECAUSE OF BACK WIDTH, ET CETERA, WE CAN ALSO MAKE IT COMPANY BECOMPANY. >> MIGHT BE A GOOD IDEA. >> OTHER COMMENTS, FEEL FREE TO RAISE YOUR HAND OTHERWISE FEEL FREE TO CHEW. >> ONE THING KIP EMPHASIZED, WHAT ARE WE MISSING IN THIS INITIAL EFFORT. SO WE HAD A DISCUSSION ABOUT PROCESS FOR THIS COMING YEAR BUT REAL IDEA WE HAD FEEDBACK WHILE PREPARING FOR PEOPLE THAT WANTED TO THINK OTHER ISSUES THAT WE AREN'T PLANNING, FOR THIS YEAR BUT MIGHT BE GOOD THINGS TO CONSIDER. THAT'S THE MAYBE REASON WE DECIDED TO SET ASIDE THIS TIME WAS TO GIVE PEOPLE SOME TIME TO RAISE THOSE QUESTIONS. >> OR THINGS AMPLIFY, I HAVE HEARD SOME SUGGESTIONS ABOUT PEER REVIEW, ET CETERA, AND HOW WE SHOULD BE LOOKING AT IT FOR THIS UNIQUE MECHANISM PARTNERSHIP CONSTRAINT THE REGULAR RO-1 STUDY SECTION SOMETIMES DOESN'T UNDERSTAND AND THAT SORT OF THING. >> SO ONE THING NOTED ON ONE SLIDE IS ONE LINE IS FAILURES OF CLINICAL TRIALS IN RECENT TIMES. I PERSONALLY THOUGHT ABOUT THIS, BEEN INVOLVED IN A NUMBER OF FAILURES. OCCASIONAL SUCCESS, AND WE IN THE AMERICAN SOCIETY OF STEREO TACTIC NEUROSURGERY AS GROUP THE LEADERSHIP TEAM IS CONCERNED ABOUT THIS AND RECENTLY BEGAN REACHING OUT TO COMPANIES TO TRY TO THINK HOW CAN WE CHANGE THAT SEQUENCE OF EVENTS WITH THINGS GOING TO EITHER INAPPROPRIATE PILOT STUDIES AND PROGRESSING TO SOMETIMES INAPPROPRIATELY DESIGNED TO CAPTURE THE WHOLE PICTURE CLINICAL TRIALS. I THOUGHT FOR A NUMBER OF YEARS THAT WE NEEDED TO HAVE SOME PEER REVIEW FOR TRIALS SO WE SEE SOME WHAT WE WOULD THINK AS WE SEE PUBLICIZED DOING STEM CELL TRANSPLANTATION. THEY SCRAPE CELLS OUT OF THE BRAIN AMPLIFY FOR -- STICK IT BACK AND THEN REPORT ON FIVE PATIENTS WITHOUT ANY CONTROLS WHATSOEVER. SO I'M INTRIGUED BY XO 2 PHASE AS POTENTIAL FOR A BREAK AND PEER REVIEW OF POTENTIAL EARLY STAGE CLINICAL INVESTIGATION. IT IS AN ETHICALLY DIFFICULT AREA BECAUSE WE HAVE ISSUES OF CAN IT BE BINDING, AND CONFLICT OF INTEREST, SO FORTH BUT I'M INTRIGUED BY THAT AND INTERESTED TO SEE HOW IT GOES AND HOW THE FIELD DEVELOPS IN CONTEXT OF THAT. YOU CAN IMAGINE IF ALL OR MOST COMPANIES BUY INTO THE MECHANISM, THIS IS ONLY WITHIN THE DEVICE NEUROMODULATION SPACE, THAT REVIEW BECOMES AN EFFECTIVE AND FAIR REVIEW BASED ON OUR EXPERT PEERS AND THEY SAY YES THAT'S WE SEE THE SCIENCE IS REASONABLE. AND SHOULD GO FORWARD AND THE THINGS THAT COME OUT ARE FAVORABLE OR AT LEAST REASONABLY BASED. MORE CRAZY THING FILTERED OUT. YOU CAN IMAGINE COMPANY X WHEN SOMEBODY APPROACHES A NOVEL POTENTIALLY SOMEWHAT WACKY IDEA, THEY SAY YOU KNOW WHAT, WE DON'T WORK OUTSIDE OF THAT, WE STAY INSIDE THE SYSTEM, YOU PUT THIS TOGETHER AND GO TO STUDY SECTION AND SEE WHAT THEY SAY. AND IF THEY VET YEAH WE'LL WORK WITH YOU THE NEXT STAGE. SO I'M VERY INTRIGUED AND THIS IS POTENTIAL FOR THAT PEER REVIEW MECHANISM IF DONE RIGHT AN CAREFULLY WITH THE RIGHT GUIDELINES THAT THE TYPE OF THING WE'RE LOOKING TO SEE. >> OFF TOP OF MY HEAD THAT SOUNDS INTERESTING AND PROMISE FROM A COMPANY STANDPOINT I IMAGINE SOME CONCERN THINGS THAT AREN'T NECESSARILY FOR FINANCIAL FUNDING TO GET PEER REVIEW THAT COULD GET SOME NEGATIVE COMMENTARY FROM A REVIEW THAT THEY MAY NOT KNOW OR POTENTIALLY TRUST AS MUCH. AND THAT INFORMATION WILL CAUSE POTENTIAL INVESTMENT, AND THAT DOESEN MEAN THERE'S NOT TRACTABLE WAYS AROUND THAT BUT CURIOUS TO HEAR MY COMPANY COLLEAGUES TALK ABOUT THAT BUT I IMAGINE THAT'S CALCULUS THE COMPANY I CAME FROM WOULD BE DOING, SOME CASES MIGHT BE USEFUL AND SOME CASES WE WOULD BE WANT TO DO IT. -- WOULDN'T WANT TO DO IT. >> I HAVE TO CONGRATULATE YOU GUYS ON TODAY'S SESSION. THIS HAS BEEN TERRIFIC. WITH REGARD TO THE QUESTION OF FUNDING FUNDING TARGETS FOR 2017 AND BEYOND, ONE THING I SEE WITH THIS MECHANISM YOU'RE TALKING ABOUT, IT'S GEARED TOWARDS THOSE TECHNOLOGIES THAT COMPANIES, PARTICULARLY FAVORING LARGER COMPANIES, LIKE MEDTRONIC, WHO HAS THE SAFETY DATA AND THE CAPABILITIES THAT THEY HAVE IN THEIR CURRENT DEVICES THEY PERHAPS HAVEN'T UNLOCKED YET, THE PC THAT TYPE OF TECHNOLOGY THAT'S TERRIFIC AND NECESSARY. THE NEXT LEVEL OF FUNDING WHERE I WOULD LIKE TO SEE NIH FOCUS ON IS REALLY IF MORE EMERGENT TECHNOLOGIES SO THINGS THAT ARE NOT QUITE -- TO THE LEVEL OF NEUROPACE THAT TYPE OF TECHNOLOGY IS ABSOLUTELY TERRIFIC BUT WE DISCUSSED NEUROPACE IS A SMALLER COMPANY WHEN YOU COMPARE TO MEDTRONIC BUT THERE ARE SMALLER COMPANIES THAN NEUROPACE, THE NEUROPACE IS A SUCCESS, BUT THERE ARE FOR EVERY ONE NEUROPACE THERE'S PROBABLY MANY OTHERS THAT HAVEN'T GOTTEN TO THE LEVEL AND I WONDER WHETHER GIVEN THAT BRAIN INITIATIVE TO SET UP NEW TECHNOLOGIES THINGS THAT DOESN'T EXIST NOW, THE UO-1 BRAIN INITIATIVE SINCE THAT WAS ONE AWARDEE I WAS THERE FOR THE KICK OFF MEETING, THERE ARE SOME INCREDIBLE TECHNOLOGIES THAT'S DEVELOPED. SO I WONDER IF YOU COULD AS THOSE TECHNOLOGIES MATURE HOW DO YOU THEN TAKE IT TO THE NEXT LEVEL NEW COMPANY FUNDING EARLY STAGE DEPLOYMENT TO OTHER INVESTIGATORS, RECOGNIZE LEVEL OF FUNDING ALSO REQUIRE MORE THAN WHAT YOU INVEST SO IT'S TERRIFIC OPPOSED TO THE TYPICAL RO-1 MECHANISM 250,000 A YEAR, WE'RE NOW TALKING 1 MILLION, 1 MILLION, 1.5 AFTER THE SUBSEQUENT YEARS. BUT I ARGUE IF YOU DEPLOY THOSE TECHNOLOGIES IT MAY REQUIRE MORE THAN THAT. TO THINK OUTSIDE THE BOX ABOUT HOW DO YOU FUND THAT BRAIN INITIATIVE PROJECTS NOT ONLY FROM NIH, BUT FROM -- WHEN I THINK OF PRIVATE NOT ONLY HAVE YOU BUT I ALSO THINK OF PHILANTHROPY, HUGE AMOUNT OF PHILANTHROPY. >> I AGREE. SO RIGHT NOW WE HAVE THIS YEAR CAME OUT THE UH-2, 3 MECHANISM WE'RE AWARE OF WHERE THE PHASE IS TO DO NON-CLINICAL TESTING NECESSARY FOR THINGS THAT HAVE NEVER HAD IDE TO GET THE FIRST IDE IDEALLY FOR NEXT GENERATION LATER GENERATION DEVICES, ET CETERA, HOW FAR THE COST OF THAT, CUB SUBSTANTIAL AND BEYOND THE NUMBERS WE HAD PROPOSED. SO THERE IS -- I AGREE TO A CERTAIN EXTENT BUT ALSO BEFORE YOU LOCK -- SO TO DO SOMETHING THAT WILL -- YOU HAVE TO GET TO LOCKED IN FINAL DESIGN. RIGHT NOW THAT PROGRAM SAYS ESSENTIALLY GET TO A LOCK IN FINAL DESIGN, WE WILL PAY FOR NON-CLINICAL TESTING FOR REGULATORY APPROVAL AND SUBSEQUENTLY EXPLORE IN CLINICAL TRIALS. WE HAVE OTHER MECHANISMS TO SUPPORT BEFORE THAT, WHETHER PARTNERSHIPS THAT EXIST, THE PROBLEM, THOSE ARE LOW MONEY. TO CLARIFY, WHERE IN THE PROCESS DO YOU THINK NEEDS MORE MONEY TO ACCELERATE? THIS WAS PARTLY THE REASON I ASK EARLIER QUESTION, COMPANIES LIKE MEDTRONIC HAVE THEIR OWN R&D BUDGET SO HOW DO YOU ACCESS THAT SO YOU HAVE REACHED THE MONEY FROM NIH? >> HOW DO YOU LEVERAGE THE HAND OFF. >> EXACTLY. YOU MENTION SMALL COMPANIES AND WE BELIEVE SBIR BUDGET IS IN PLACE FOR THESE COMPANIES. >> THE CURRENT MECHANISMS ARE UNDER DISCUSSION OF ALSO CREATING MECHANISMS SPECIFICALLY FOR SOMETHING BUSINESSES IN THIS AREA. >> THAT'S NOT FOR THE BRAIN INITIATIVE, IS THAT CORRECT? >> WE HAVE AT LEAST IN TERMS OF DEVELOPING THE ACADEMIC TOOLS, REFINE USERS AN PROFIT DISSEMINATION. BERELEASE FOA TO THE SMALL BUSINESS PROGRAM AS WELL BEING THAT ARE A LOGICAL AVENUE TO DEVELOP TOWARDS SUSTAINABILITY OF USEFUL -- WE CAN IMAGINE THAT INCORPORATED CLINICAL RESEARCH TOOLS AN THERAPY TOOLS. AND SOMETIMES FOR STIMULATING RECORDING BOTH. THAT IS UNDER DISCUSSION AND A GREAT ONE. >> ON A DEFERENT NOTE ONE THING I THOUGHT WAS INTERESTED THAT A NUMBER OF THE PHYSICIANS BROUGHT UP WERE IN PARTICULAR ETHICS OF OF DOING THIS WORK IS REPOSITORY FOR DIDEVISES. I GUESS IT WAS DISCUSSED IN PASSING THERE ARE CHALLENGES WITH IT IN TERMS OF BATTERIES ARE DEPLETE SOD EVEN IF YOU HAVE A REPOSITORY IF YOU NEED TO REPLACE SOMETHING TEN YEARS FROM NOW, BATTERIES ARE PROBABLY DEAD AND WHERE IS PERSON WHO SUPPORTS THAT AND HOW DO YOU CON TO SUPPORT PATIENTS AS TIME GOES ON. THAT IS DESERVING OF THE OWN SESSION. SOMETHING TO THINK ABOUT FROM ETHICS STANDPOINT. IT WOULD BE I THINK HELPFUL TO CONTINUE THAT DISCUSSION. AND FURTHER IT. >> THAT'S A GREAT POINT AS WELL, WE CAN FIGURE OUT THE FORUM TO DO THAT. INTERESTING QUESTION BECAUSE TO DO A RESEARCH STUDY, YOU SHOULD BE DEDICATED TO THAT PATIENT FOR ANYTHING DURING THAT PERIOD OF TIME, SMALL BUSINESSES MAY NOT BE THERE THREE OR FOUR YEARS DOES THAT MEAN SMALL BUSINESSES DON'T GET TO DO EXPLORATORY CLINICAL TRIALS? IT'S A COMPLICATED QUESTION, YOU'RE RIGHT. DESERVES SOME FASHION. >> A LOT OF EMPHASIS IS EXPLORATORY NEW NOVEL IDEAS AND I'M IN FAVOR OF INNOVATION. BUT WE ALSO HAVE A SAYING FUNCTIONAL NEUROSURGERY THAT GOES BEYOND FUNCTIONAL BUT NOTHING NEW UNDER THE SUN. A LOT OF THINGS WE DO, PRIOR ART LIKE IRVING COOPER AND I'M CONCERNED NOT SO MUCH ABOUT NEW THINGS BUT TOLD THINGS WE DISCARDED. BECAUSE OF PREVIOUS STUDIES, RECOGNIZED -- FETAL CELL TRANSPLANTATION FOR PARKINSON DISEASE, DOES IT NOT WORK? DBS FOR DEPRESSION, REALLY NOT WORK? CEREBELLAR -- SO A LOT OF THOSE THINGS DON'T HAVE IP ASSOCIATED WITH THEM BUT GD AND F, THIS IS A PILE OF THINGS. I'M CONCERNED THERE'S NO REAL MECHANISM FOR THOSE STUDIES WHERE THERE'S GREATER PROMISE IN THOSE STUDIES THAN IN SOMETHING THAT'S COMPLETELY NOVEL. CAN YOU TELL US WHERE THOSE TYPE OF STUDIES, SOMEONE WANTS TO COME IN AND DO FETAL CELL TRANSPLANTATION, NOTHING NOVEL EXCEPT DO IT RIGHT THIS TIME. WE HAVE SIMILAR APPLICATIONS AND CONVINCE PEER REVIEW THAT IS COMPELLING ENOUGH YOU CAN GET FUNDED FOR IT BUT IS NOT THE EASIEST THING TO DO IN THE WORLD. WHETHER LIMITED FUNDS AND WE HAVE INNOVATION AS ONE OF THE SCORERS? IT HAS HAPPENED, IT DOES COME IN BUT YOU'RE RIGHT, THE QUESTION IS THOUGH WHEN DO YOU STOP BEATING THE DEAD HORSE? BECOMES HARDER TO JUDGE, MORE PROMISE THOUGH IT FAILED VERSUS SOMETHING THAT HAS NO HISTORY VERSUS -- WE THINK ABOUT PORTFOLIO BALANCE, REALISTICALLY WE SHOULD PROBABLY HAVE MECHANISMS TO FUND A SPECTRUM, NEW IDEAS, PERHAPS SOME OLD IDEAS IF YOU THINK ABOUT PRODUCT DRUG REPURPOSES EFFORT, TAKING DRUGS THAT DIDN'T WORK WHAT THEY WERE SUPPOSED TO AND SEEING WHAT ELSE THEY WORK FOR. SEVERAL CLINICAL TRIALS ARE QUITE PROMISING ON ACUTE DATA. DIDN'T PASS EFFICACY END POINT, LITTLE AS WE KNEW BIOLOGY FANTASTIC TITRATING RESPONSE THAT IS WORTH FURTHER EXPLORATION. >> I WILL MAKE A COMMENT YOU WEARING YOUR REPRESENTATION OF NINDS, PERHAPS YOU CAN -- ATTITUDE, BECAUSE IT -- I MEAN THROUGH BRAIN, THEN ALL COMERS FOR EVERY WILD IDEA WHERE IT MIGHT BE IN AGING, MIGHT BE IN ADDICTION, MIGHT BE IN ALCOHOL, MIGHT BE IN NIMH, WILL ALL BE CHANNELED WITH THIS SAME LOGIC, YOU HAVE NEW IDEA, SMALL ENDS ARE MEANINGFUL AND IMPORTANT. I'M TRYING TO BE TRANSPARENT W. THE FACT THAT I DO HAVE BIAS BUT AN EXPERIMENT WHERE DEPRESSED PATIENTS ARE WELL AND IF I HAD NO DATA AND PROPOSE WHAT I KNOW NOW I WOULD FLY, HAVING DATA AND HAVING WELL PATIENTS I DON'T HAVE A CHANCE, DOESN'T FLY TO NIMH, WILL A TRIAL FAIL, WHO CARES WHEN WE KNOW ALL OF THE ISSUES THAT CAN BE FIXED PRESENTED SMALL SAMPLE TO TEST AND NEMH HAS DIFFERENT ATTITUDE THAN BRAIN. SO PART IS HAVING THERE BE MECHANISMS ACROSS INSTITUTES SO IT ISN'T ONLY THE NEW THINGS THAT GET ACCESS TO BRAIN WHEN THE GOAL IS TO HAVE PARODY TOWARD DOING THINGS THAT MEET NEUROPSYCHIATRIC DISORDERS BROADLY. SO I THINK -- I'M WATCHING THAT'S INCONSISTENT TALKING POINT AND HOPEFULLY YOU CAN BE HELPFUL TO INITIATIVES THAT WON'T FIT TO YOURS BUT INFORM WHAT YOU'RE TRYING TO DO. >> HOPEFULLY TO THAT END THIS WHOLE MEETING ET CETERA HAS BEEN IN OUR MINDS IMPORTANT FOR BRAIN ET CETERA BUT ALSO FOR HAVING NIH STAFF AND FEDERAL GOVERNMENT OFFICIALS ET CETERA HEAR YOUR CONCERNS, THINGS THAT DON'T WORK AS WELL FROM YOUR PERSPECTIVE SO THAT WE CAN CAN CONSIDER THEM. BUT THERE'S ALSO AN EDUCATIONAL COMPONENT TO PEER REVIEW AS WELL. WE SET UP MECHANISMS AN PEER REVIEW IMPLEMENTS THEM HOWEVER THEY'RE SCORED WE GO BY THOSE SCORES AND A LOT OF THE PROBLEM IS A LOT OF YOUR PEERS OR AT LEAST THE PEOPLE VOLUNTEERING AREN'T AS KNOWLEDGEABLE IN THESE AREAS PERHAPS WE SHOULD BE. SO I WILL ENCOURAGE EVERYBODY HERE TO SERVE ON PEER REVIEW IF ASKED FOR THAT REASON. , IT WON'T HAPPEN TOMORROW BUT THIS IS VISIBILITY TO THIS PROBLEM AND HOPEFULLY CHANGES THE CULTURE. >> I'M GOING TO FOLLOW-UP A LITTLE BIT ON BOB'S POINT AND MAYBE SAY IT IN A LITTLE BIT OF A MORE BLUNT WAY. I AM GOOD AT THAT, VERY BLUNT. I APOLOGIZE IN ADVANCE. I GUESS THE QUESTION DO WE THINK THE INDUSTRY IS BEST PEOPLE DESIGNED IN THEIR OWN CLINICAL TRIALS? THAT'S THE BIG QUESTION. WHAT CLINICIANS ARE TRYING TO GET FROM YOU IS MORE SUPPORT. CLINICAL TRIALS CLINICAL TRIAL, PEER REVIEW AND EVALUATE CRITIQUE INDUSTRY STUDIES BECAUSE CHAI WHAT'S HAPPENING IS NOT THE RIGHT THING. INDUSTRY DESTROYED GOOD TECHNOLOGY, WE HAVE MULTIPLE EXAMPLES, COMPANIES GOING OUT OF BUSINESS BECAUSE THEY DID THE TRIAL WRONG. >> I COMPLETELY AGREE, THE HARD POINT THOUGH WE HAVE A LIMITED BUDGET, $150 MILLION CLINICAL TRIAL IS TEN PERCENTILE POINTS ON THE NINDS PAY LINE. >> THIS IS WHAT PARTNERSHIP IS ABOUT. THEY HAVE TO PROVIDE THE FUNDING. BUT PEER RERUE IS THROUGH EXPERTS, THE PEOPLE WHO ARE AT NIH AND WHO ARE THE REVIEWERS FOR NIH. I WOULD SAY I THOUGHT I WAS EXPERT UNTIL NEUROPACE FROM ACADEMIA. I DIDN'T REALIZE -- NO, NO, NO. I THINK THAT IT IS IN THE COMPANY'S BEST INTEREST TO CONSULT THOSE WHO ARE HIGHLY KNOWLEDGEABLE ABOUT CLINICAL TRIALS DESIGN. AND HIGHLY KNOWLEDGEABLE ABOUT DISEASE STATE. BUT THE COMPANY PERSPECTIVE IS UNIQUE TO ACADEMIC PERSPECTIVE. AND YOU HAVE TO UNDERSTAND THESE STUDIES, THAT ARE DONE, ARE REGULATORY STUDIES. AND I KEEP TRYING TO EXPLAIN THIS TO PEOPLE WHEN THEY SAY WHY DIP YOU DO THIS AND THAT AND THIS AND YOU DON'T UNDERSTAND MECHANISMS. I HAVE TO SAY WE DID A STUDY TO LEAD TO APPROVAL OF OUR DEVICE. NOW WE CAN DO ALL THE OTHER STUDIES. EACH STUDY CANNOT ADDRESS ALL THE END POINTS AND REGULATORY STUDIES, TEND NOT TO BE FUNDAMENTAL SCIENCE STUDIES. >> THIS IS A LEARNING CURVE IN A FIELD THAT IS NEW THOUGH THERE'S EXAMPLES. IN IS PSYCHIATRY SPHERE, HDE THERE'S FAILED TRIALS, THEY WERE DESIGNED AS THOUGH DRUGGIST IS. -- DRUG STUDIES. YOU CAN CONSULT AND SEE AND THAT'S AN EDUCATION PROCESS FOR EVERYONE LIKE YOU LEARN SO IT'S NOT JUST WHAT'S GETTING REGULATORY APPROVAL. THESE ARE NOT DRUG STUDIES IF WE DON'T KNOW HOW THE BRAIN WORKS ABOUT DESIGN IN THAT WAY, IT WILL FAIL AGAIN. SO THAT IS HAPPENING ACROSS THE BOARD SO MAYBE THE MECHANISM WILL GET AT HOW DO YOU COLLECT BIOLOGY SO THOSE MISTAKES DON'T CONTINUE TO BE MADE. IT'S NOT LIKE EVERY DEVICE IF YOU DID IT RIGHT IS GOING TO BE A WIN. HAVING A FAILURE, MEASURING THE WRONG THING YOU TREAT IT LIKE SOMETHING IT'S NOT. >> TALKED TO A LOT OF COMPANIES I CAN SAY THEY HAVE BEEN SAYING AT CONFERENCES ET CETERA, THEY'RE LEARNING THINGS HAPPEN, THERE'S FAILED CLINICAL TRIALS BUT ALSO WE WISH IN SEVERAL CASES WE WENT SLOWER, WE WISH WE IDENTIFIED BIOMARKERS, ET CETERA AND THEY UNDERSTAND. YOU LOSE 150 MILLION DOLLARS A CLINICAL TRIAL YOU START LOOKING AT WHAT YOU'RE DOING CAREFULLY. THEY'RE TRYING TO GET REGULATORY APPROVAL AND BALANCE FINANCES AS WELL. I'M IN THE GOING TO CLAY CLAIM TO SAY UNDERSTAND THE TYPE MICKS INTO THAT. I HAVE -- THE DYNAMICS THAT GO INTO THAT. ANY STRETCH OF THE IMAGINATION BUT BECAUSE OF OUTSIDER POINT OF VIEW YOU THINK THEY MADE A MISTAKE HOW THEY DESIGNED IT, THERE'S HARD CHOICES THAT YOU WEREN'T PRIVY TO, NEGOTIATIONS FOR REGULATORY APPROVAL, THE TIME LINE THEY HAD FOR WE HAVE TO GET THIS FUNDED BY THIS OR WE'RE DONE. THAT IS WHY PEER RERUE IS HARD TO REVIEW THOSE THINGS BECAUSE IF -- THEY DON'T HAVE THAT PERSPECTIVE. >> I WANT TO SIGH THIS IS REALLY INFORMATIVE BUT WE ARE RUNNING -- WE'RE GETTING TO THE END OF THIS SESSION AND I JUST WANTED TO MAKE SURE SINCE WE'RE A LITTLE BIT OFF TOPIC TALKING ABOUT SOMETHING THAT WE CAN'T GET TO IN FY 17 OR 18 OR 19 I WANT TO MAKE SURE THAT WE HAVEN'T LEFT ANYTHING ON THE TABLE. IN TERMS OF THE THINGS THAT NIH MIGHT DO FOR PUBLIC PRIVATE PARTNERSHIPS. >> ONE THING THAT WAS DISCUSSED THIS MORNING WAS HOW RADIO LOGIC COMPANIES NEED TO HAVE A CENTRAL STANDARD. WE TALK ABOUT HOW THE DATA STANDARDIZING THE DATA. ONE THING THAT I THINK IS JUST AS IMPORTANT, NOW THAT THERE ARE MORE COMPANIES GOING INTO NEUROMODULATION, HOW WE STANDARDIZE INTERCONNECTS. SO NOW THERE IS OVER 100,000 PEOPLE IMPLANTED WITH MEDTRONIC SYSTEM, BOSTON SCIENTIFIC SYSTEM COMING OUT SOON. CAN WE INTERCONNECT THESE COMPANIES SO NOT JUST IN THE DATA, BUT IS IT POSSIBLE NIH SUPPORTS SOME WAY OF STANDARDIZING THE CONNECTIONS SO THAT ONCE PATIENTS IMPLANT STUDY IS DONE, THAT STUDY FAILS WHAT WE WERE DISCUSSING ABOUT, NOT FORGETTING ABOUT THE PATIENT'S LONG TERM ONCE THEY ENTER INTO A STUDY. THIS COMMENT IS MOTIVATED BY DR. GROSS MENTIONED, LONG TIME AGO DR. COOPER AND OTHERS PUT IN ALL THESE DEVICES, SOME OF WHOM I HAVE ACTUALLY HAD TO CHANGE THEIR BATTERY BUT THERE WAS NO WAY TO CHANGE THEIR BATTERY BECAUSE THE INTERCONNECTS DIDN'T WORK. SO STANDARDIZING THE STIMULATION SYSTEM, I SPOKE TO SOMEBODY THAT SAID I THINK JUDY TALKED ABOUT A STILL LAY DOOR, THIS IS A FASCINATING IDEA, THAT ALL NEUROMODULATION COMMUNITY COULD USE SO ONE NOT GIVEN TO A COMPANY, EVERY TIME WE WANT TO DO A STUDY, WE HAVE TO ASK THE COMPANY WHETHER WE CAN GET DEVICES, IS IT POSSIBLE TO HAVE NIH SUPPORT DEVELOPMENT ABOUT A DEVICE THAT IS MULTI-PURPOSE? >> NIH SUPPORTED THE DEVELOPMENT OF DEVICES THAT ARE MULTI-PURPOSE TO A CERTAIN EXTENT YOU CAN ACTUALLY SAY HUNTER AND CASE JUST GOT FOR THEIR NETWORK NEUROPROSTHETIC SYSTEM, GOT IDE SUPPORTED THROUGH VARIOUS FUNDING. THE FDA IN NOVEMBER PUT THE BCI WORKSHOP WHERE THERE WAS A LARGE TOPIC OF CONVERSATION, AND WITHOUT GETTING TOO MUCH DETAIL, THERE'S LIKELY A WHITE PAPER OUT ON IT, DISCUSSION WAS INFORMATIVE BECAUSE YOU GET HOW DO YOU DEFINE MODULES INPUTS AND OUTPUTS, HOW YOU GET COMPANIES THAT BUY IN THOSE THAT PUSH IT IN AND PUSH IT OUT, COMPANIES THAT BUY IN, THERE ARE STANDARDS TO THE IPG MOST USE IS 1 CONNECTOR. AND THOSE DEVELOPED OVER TIME THAT COMMUNITY DRIVEN BECAUSE THERE'S A VALUE. BUT HAS TO BE LARGE -- HAS TO BE INDUSTRY BUYS IN, FDA BOYS IN THESE AREN PUTS AND OUTPUTS DO THIS WITH NCI WAY INTEROPERABILITY DOESN'T CREATE ISSUES AND THEY'RE HAPPY TO PARTICIPATE IN THESE THINGS BUT CERTAIN EXTENT WE CAN'T BE DRIVERS BECAUSE THERE'S A REQUIREMENT THAT INDUSTRY BUY IN AND THAT ABSOLUTELY HAS TO HAVE THE MODULES HAVE TO BE APPROVED BY THE FDA. IF YOU CHANGE A MODULE FOR THE MOST PART YOU CHANGE THE ENTIRE SYSTEM AND YOU HAVE TO REAPPROVE THE ENTIRE THING. THEY'RE AWARE OF THAT AND TRYING TO THINK OF WAYS AROUND THAT, WE'LL ADDRESS THE SAFETY ISSUE BUT THAT'S A LONGER CONVERSATION I SUSPECT. >> WE HAVE TIME FOR ONE MORE QUESTION OR COMMENT. >> MAKE I CAN FOLLOW-UP ON MY COMMENT BECAUSE I WAS PLAYING DEVIL'S ADVOCATE AND I THINK IT IS ALWAYS IN A COMPANY'S BEST INTEREST TO CONSULT, I WAS TALKING WITH BOB GROSS WITH EVERYBODY WHO MIGHT KNOW ANYTHING ABOUT THE DISEASE STATE, ABOUT CLINICAL TRIALS, I MEAN, WE TALKED TO EVERYBODY. ALL THE TIME. YOU BUT AT THE END ACADEMICS MAY NOT UNDERSTAND -- THEY CAN'T BE PRIVY TO THE CONVERSATIONS WITH FDA, THEY CAN'T BE PRIVY HOW MUCH MONEY THE COMPANY HAS OR HOW MUCH THE COMPANY IS LIKELY TO RAISE. WHAT TIME LINE WOULD BE FOR DIFFERENT TRIALS OF DIFFERENT DESIGNS. THEY'RE HARD CHOICES. AN EXAMPLE WITH NEUROPACE WE DID A FEASIBILITY TRIAL AND THE IMPACT WAS EVIDENT. FOR A PIVOTAL TRIAL WE HAVE TO HAVE A LONGER RUN IN THAN WE HAVE TO DO FOR A PERIOD OF TIME, I WANTED TO WAIT FOUR MONTHS WHICH NOW WE KNOW ACTUALLY IS HOW LONG THAT IMPLANT LASTS BUT NOBODY KNEW THAT AT THE TIME. OUR CEO AND CFO DID A CALCULATION HOW MUCH THAT COSTS THE COMPANY. AND HOW MUCH MONEY WE HAD. AND WE COULDN'T AFFORD TO DO THAT. IT HE WANTED -- ENDED UP BECAUSE EVERYTHING TAKES LONGER WE ENDED UP HAVING TO DO MORE FUNDRAISING. THESE ARE THE HARD THINGS, WHETHER YOU CAN AFFORD TO HAVE A TRIAL THAT GOES ANOTHER 30 DAYS WHEN THE COMPANY BURN RATE MAYBE A COUPLE OF MILLION DOLLARS A MONTH. THAT'S A SMALL COMPANY. THEY ARE HARD DECISIONS AND ONES YOU LOSE A LOT OF SLEEP OVER. >> FAILURES AREN'T INDUSTRY. SOMETIMES THEY'RE INVESTIGATOR INITIATED TRIALS, THEY ARE MORE NARROW BECAUSE THEY'RE GARNERING THEIR TERMS. WE ARE THE EXPERTS IN THE FIELD. THERE ARE FAILURES ALL AROUND. WE DO LEARN ONE OF THE THINGS THAT I THINK I DON'T KNOW WHAT THE FORM IS FOR THE DISCUSSION BUT YOU JUST DESCRIBED A BIOLOGICAL FACT EXTERNAL TO YOUR SYSTEM. SAY YOU DIDN'T HAVE MONEY TO DO IT BEYOND THREE MONTHS. THAT WAS THE DIFFERENCE BETWEEN HAVING OUTCOME AND NOT HAVING AN OUTCOME. YOU AS A COMPANY ELECT TO DO IT ANYWAY BECAUSE YOU'RE IN THE GAME. BECAUSE OF THAT DIFFERENCE YOU GET .06 INSTEAD OF .04. AND THEN THAT GETS ENCODED AS A LOSS AND STUDY SECTIONS WE'RE TALKING ABOUT WHY SHOULD I EVEN LOOK AT ANOTHER ONE BECAUSE EVEN KNOWS THAT DOESN'T WORK AND IT SETS THE FIELD BACK BY 20 YEARS, THAT'S EXACTLY HOW MUCH TIME THE FETAL CELL FIELD HAS BEEN SET BACK BY TWO CLINICAL TRIALS. THAT MADE MISTAKES. ONE BECAUSE THEY DIDN'T VALIDATE THE OUTCOME MEASURE. IT EFFECTS A BIGGER COMMUNITY THAN JUST THE INDIVIDUAL INVESTIGATOR AND THE INDIVIDUAL COMPANY. IT AFFECTS OUR PATIENTS, 20 YEARS SOMETIMES THEY GO INTO NUCLEAR WINTER SO THEY THAT'S WHY WE NEED TO HAVE AS MUCH CONSULTATION ON THIS, SOMETIMES IT WILL BE NIGHT X COMPANY NO, YOU CAN'T DO THAT BECAUSE IT'S NOT JUST YOU WHO WILL FAIL, WHEN YOU FAIL, IT'S GOING TO BE THE EPILEPSY PATIENTS THE NEXT 20 YEARS. BUT THAT'S WAY BEYOND WHAT E EAR DOING HERE BUT AT LEAST IF WE CAN HAVE A DIALOGUE ABOUT ALL THIS. >> HELEN GETS THE LAST WORD. >> I DON'T WANT THE LAST WORD. JESUS, OKAY. I ACTUALLY -- I THINK THERE IS SOMETHING ABOUT THIS LAST SET OF POINTS, BACK TO ETHICS ISSUE BACK TO -- THE GOAL IS TO GET NEW TOOLS THAT BENEFIT EVERYBODY, TOTALLY THINK BIG -- OUTSIDE THE BOX. I DON'T KNOW HOW TO THINK OUTSIDE THE BOX SO A NICE EXPERIENCE TO TRY. SO WHAT I DO NOTICE AND MAYBE IT'S PART OF THE CAUTIONARY NOTE, IT WINS OR LOSE, BUT PART OF THE RECIPROCITY DISCUSSION, SENSE OF COMMUNITY, COMMITMENT TO EACH OTHER, IS SOMEBODY DOES SOMEBODY REALLY, REALLY WACKY AND IT DOESN'T -- IT DOESN'T NECESSARILY -- MAYBE IT GOES WRONG, I'M TALKING ABOUT WHEN IT GOES WRONG AND NOT RIGHT AND NO ONE ELSE WANTS TO DO IT ANYWAY, BUT EVEN THAT HAS BLOW BACK ON EVERYBODY ELSE. SO WHEN WE TALK ABOUT -- WE ALL GET UNCOMFORTABLE WHO WILL BE THE PEER, WHO WILL DECIDE WHEN PEOPLE HAVE EXPERIENCE TOE KNOW WHAT ARE THE TALKING POINTS IN THE COMMUNITY ARE. THINGS IN PSYCHIATRY, PEOPLE HAVE BIG IDEAS OR WACKY IDEAS AND IT VACILLATE AND YOU GO FOR SNAG DOESN'T GO WELL AND THE PENDULUM SWINGS REALLY, REALLY FAR THE OTHER WAY. AND I DON'T SEE THAT WHEN I WEAR MY NEUROLOGY HAT, THAT THE RISK AND -- THE RISKS THAT PEOPLE ARE WILLING DO TO DO WITH DIFFERENT DISEASES REALLY DIFFERENT AND THE COMMUNITY OF FAMILY MEMBERS THAT SUPPORT HIM OR THERE AREN'T ANTI-NEUROLOGY PEOPLE THAT YOU HEAR ABOUT BUT THERE ARE A LOT OF ANTI-PSYCHIATRY PEOPLE OUT THERE. SO THAT YOU REALLY HAVE TO BE CONSIDERING THAT WHEN YOU MAKE A DECISION AND COMPANY YOU'RE HAVING REPERCUSSIONS THAT RIPPLE IN A WAY YOU CAN'T IMAGINE AND EVERYONE SHOULD THINK ABOUT IT A LITTLE BIT. >> WE MIGHT HAVE THE LAST WORD HERE. ON THAT WHAT I CAN SAY IS INTEREST HAVING COME FROM A COMPANY WE WATCH THE COMPANY DECISIONS CLOSELY BECAUSE WE REALIZE IF THEY SCREW UP OUR VALUE JUST WENT DOWN. WE PAY VERY CLOSE ATTENTION TO THAT. THEY PAY VERY CLOSE ATTENTION TO THAT. I HOWEVER AM A GOVERNMENT BUREAUCRAT SO IS MY FRIEND NED. WHAT WE LIKE TO SAY, YOU ARE EXPERTS ON THIS AND THE POINT FOR ALL OF THIS IS TO GET YOUR EXPERTISE AND SYNTHESIZE IT AND TRY TO COME UP WITH SOMETHING THAT IS VALUABLE TO THE COMMUNITY, THANK YOU VERY MUCH FOR YOUR EXPERTISE BUT I THINK THE GREAT THING ABOUT THIS DISCUSSION IS EVERYBODY IS ENGAGE AND WE REALIZE THERE'S A LOT OF PROMISE HERE. WE REALIZE WE DIDN'T SOLVE ALL PROBLEMS HERE. KIP.LUDWIG@NIH.GOV THERE'S AN RFI ON THE 2016 PARTNERSHIPS HOWEVER WE'LL ALSO DO A WEBINAR TO IDENTIFY SPECIFIC STICKING POINTS. WE WILL POLL PEOPLE WHO IS WILLING TO PARTICIPATE IN THE WEBINAR BUT I THINK THIS IS THE SORT OF THING HAVING TALKED TO MANY PEOPLE OFFLINE THAT DESPITE STICKING POINTS EVERYBODY THINKS THINK IS STILL VERY MUCH WORTH DOING SO WE'LL DO THAT AND THAT WAS VERY IMPORTANT FOR US TO HEAR BECAUSE IF IT WASN'T WE WOULD STOP. >> YES. AND EDTAGLE.NIH.GOV. THANKS TO EVERYBODY FOR PARTICIPATING. (OFF MIC) [APPLAUSE]