SO TODAY WE'RE HERE TO LEARN ABOUT CAREERS IN REGULATORY AFFAIRS AND THIS EVENT IS SPONSORED BY FELCOM'S CAREER DEVELOPMENT SUB COMMITTEE. SO OUR NEXT EVENT WILL BE CAREERS IN BIODEFENSE SEMINAR AND THAT WILL BE MARCH 13th FROM 2-4 P.M. IN THIS BUILDING, IN THIS ROOM. SO BUILDING 50, ROOM 1227. IF YOU'RE INTERESTED IN GETTING INVOLVED IN JOINING OUR COMMITTEE, PLEASE COME AND TALK TO ME AFTER OUR PRESENTATIONS. SO FIRST WE'RE GOING TO HAVE A DISCUSSION AND EACH OF OUR SPEAKERS IS GOING TO GIVE A TALK ABOUT WHAT EXACTLY THEY DO IN THEIR JOBS AND HOW THAT'S RELEVANT TO YOU AND HOW, MAYBE, YOU COULD GET THAT JOB WHEN YOU'RE DONE WITH YOUR FELLOWSHIP HERE. SO FIRST, UM, WE'RE GOING START AT THE END DOWN HERE AND WE HAVE JANICE CHAPEL WORKING AT AERAS. SHE HAS 20 YEARS OF EXPERIENCE IN REGULATORY SUBMISSIONS IN COMPLIANCE AT SIX BIOPHARMACEUTICAL COMPANIES IN MARYLAND. SHE HAS WORKED ON VACCINES AND PRIOR TO HER CAREER IN REGULATORY AFFAIRS, SHE WAS A TECHNICIAN IN A MOLECULAR CLONING LABORATORY FOR SEVEN YEARS. SHE HAS A BS IN BIOLOGY. NEXT, WE HAVE WILLIAM DAVID DEBANY. HE IS A SENIOR ASSOCIATE IN THE REGULATORY OPERATIONS GROUP AT MILLENNIUM. MR. DEBANY IS RESPONSIBLE FOR ASSESSING TECHNOLOGY NEEDS, WORKING AS A BUSINESS ANALYST ALONGSIDE MEDICAL INFORMATICS TO DEVELOP AND IMPLEMENT NEW TECHNOLOGY INITIATIVES, AND HE HAS OVER EIGHT YEARS OF EXPERIENCE IN REGULATORY OPERATIONS AS A PUBLISHER, WRITER, TRAINER AND ANALYST. NEXT, WE HAVE DR. JASON URBAN WHO WORKS AS AN INTERDISCIPLINARY SCIENTIST IN THE OFFICE OF COMPLIANCE WITHIN THE CENTER FOR DRUG EVALUATION OR RESEARCH AT THE FDA-HE PREVIOUSLY SERVED AS A FELLOW AT THE NATIONAL XOL ABUSE. HIS AREA OF SPECIALTY WAS IN THE FIELD OF NEUROSCIENCE AND BEFORE NIH JASON HELD TWO POSTDOCTORAL POSITIONS WORKING IN GENE THERAPY AND EARLY ONSET OF NEUROLOGICAL DISORDERS, BOTH AT THE UNIVERSITY OF FLORIDA. DR. YOU ARE URBAN EARNED A BS IN BIOLOGY AND Ph.D. IN CELL BIOLOGY IN OHIO WHERE HE STU DID ACTIN BASE ARK THE TECH CHURS AND TRANSFORMED CELLS IN EPITHELIAL LUNG CANCER. IN HIS CURRENT POSITION, HE CONDUCTINGS RISK ANALYSIS AND APPLIES DECISION SCIENCE TO MANY AREAS INCLUDING INSPECTION SITE COLLECTION, RECALLS, POLICY GUIDANCE AND PHARMACEUTICAL CHAIN INTEGRITY AMONG OTHERS. TO FURTHER IMPROVE HIS KNOWLEDGE IN THE FIELD, JASON'S ALSO COMPLETING HIS MASTER DEGREE AT THE JOHNS HOPKINS UNIVERSITY IN HIS SPARE TIME. NEXT WE HAVE DR. GORMLEY AND SHE COMPLETED HER INTERNSHIP AND RESIDENCY IN INTERNAL MEDICINE AT THE UNIVERSITY OF MARYLAND MEDICAL CENTER AFTER COMPLETING HER M.D. AT THE MEDICAL COLLEGE OF OHIO APPROXIMATELY FOLLOWING HER RESIDENCY, SHE COMPLETED SCHOLARSHIPS IN THE HEMOLOGY BRANCH OF LBI AND CRITICAL CARE MEDICINE OF THE CLINICAL CENTER AT NIH. DURING PERIOD, SHE COMPLETED COURSE WORK IN THE NIH DUKE TRAINING PROGRAM IN CLINICAL RESEARCH AND HER PRIMARY AREA OF RESEARCH IS IN NON-INFECTION PULMONARY COMPLICATIONS OF [INDISCERNIBLE] TRANSPLANTATION. SHE IS THE PRINCIPLE INVESTIGATOR OF A PHASE TWO TRIAL FOR TREATMENT OF BON KIETS. SHE'S A CLINICAL REVIEWER EVALUATING SAFETY AND EFFICACY OF NEW DRUGS UNDER DEVELOPMENT AND MROOEFSLY-APPROVED DRUGS. -- PREVIOUSLY-APPROVED DRUGS. FINALLY ELIZABETH GLAZE WHO HAS OVER TEN YEAR'S EXPERIENCE IN STUDIES -- BIOLOGICAL AGENTS IN SUPPORT OF PHASE ONE CLINICAL TRIALS. ALL TEN YEARS HAVE BEEN SPENT AT THE NIH. THE DRUG AND BIOLOGICAL CANDIDATES THAT SHE'S BEEN RESPONSIBLE FOR HAVE INCLUDED INDICATION FOR CANCER, HIV/AIDS, TE BURG LOW SIS, TYPE I DIABETE, ANXIETY AND DEPRESSION AND PLAGUE, DUNGAE. SHE'S OVERSEEN THE SUCCESSFUL LAUNCHING OF 13 DRUG AND BIOLOGICAL CANDIDATES INTO THE CLINIC. PRIOR TO JOINING NIH, SHE DID HER POST DOCTORAL WORK IN UNIVERSITY OF PENNSYLVANIA -- DR. GLAZE HAS HER B.A. IN CHEMISTRY FROM STATE UNIVERSITY OF NEW YORK, HER M.S. IN BIO -- AND HER Ph.D. IN PHARMACOLOGY FROM THE UNIVERSITY OF MICHIGAN. WITH THAT, I'LL TURN OVER OUR PANEL DISCUSSION TO OUR SPEAKERS AND AFTERWARDS ZEL A BRIEF QUESTION AND ANSWER DISCUSSION. >>. >> GOOD AFTERNOON. GOOD AFTERNOON. DO I HAVE TO FIND MY FILE? OKAY. THANK YOU. IT'S A PLEASURE TO BE HERE TODAY. AS YOU CAN TELL FROM MY BIO, I CAN ONLY SPEAK FROM INDUSTRY EXPERIENCE. [LAUGHTER] UM, IN MY EXPERIENCE, THERE IS NO TYPICAL CAREER FAT PATH TO REGULATORY AFFAIRS. PEOPLE COME TO IT WITH BACKGROUNDS IN CLINICAL, MANUFACTURING, PROJECT MANAGEMENT, RESEARCH, AND PHARMACY, AND NOW CURRENTLY BEING IN THE LAST TEN YEARS OR SO, UM, THERE ARE BACHELORS AND MASTERS IN REGULATORY AFFAIRS THAT DIDN'T EXIST 20 YEARS AGO, AND, UM, AND MANY PEOPLE IN THE POSITIONS OF VICE PRESIDENT NOW SEEM TO HAVE Ph.D.s. BUT I THINK THAT ON-THE-JOB TRAINING AND EXPERIENCE ARE IRREPLACEABLE. REGULATORY AFFAIRS IS A CAREER WHERE THERE'S LIFELONG LEARNING. PEOPLE IN THE FIELD OFTEN HAVE NARROW EXPERIENCES, BACKGROUNDS. SOME PEOPLE MAY BE ESPECIALLY PROFICIENT IN DRUGS OR BIOLOGICS OR DEVICES AND THOSE CAN BE THREE VERY DIFFERENT PRODUCT AREAS, AND THERE'S A RANGE OF EXPERIENCE IN THE CLINICAL DEVELOPMENT PROCESS. ANYWHERE FROM A PHASE ONE THROUGH TO A PHASE THREE STUDY. SOME PEOPLE HAVE EXPERIENCED SUBMITTING MARKETING APPLICATIONS AND OTHER PEOPLE HAVE EXPERIENCE WITH POST MARKETING ACTIVITIES. AND THEN ALSO IT WILL BE VERY DIFFERENT IF YOU'RE WORKING FORBIG PHARMA OR SMALL BIOTECH ORHETOR GOVERNMENT OR GOVERNMENT OR NON-P ROFIT. TOR GOVERNMENT OOTOR GOVERNMENT ORRTOR GOV ERNMENT OR TOR GOVERNMENT ORTOR GOVERNMENT FOR ME I STARTED OUT WITH A BACHELORS IN BIOLOGY. I WORKED FOR SEVEN YEARS IN A MOLECULAR BIOLOGY LAB AND I WANTED TO GET OUT OF THE LAB AND FOUND AN AVENUE FOR THAT THROUGH PROJECT MANAGEMENT AT THE SAME COMPANY I WAS AT, AND THE HEAD OF PROJECT MANAGEMENT WAS ALSO HEAD OF REGULATORY AFFAIRS, SO I HAD THE OPPORTUNITY OF REALLY LEARNING THE FIELD ON THE JOB AND WAS LUCKY ENOUGH TO GET AN ENTRY LEVEL POSITION AGAIN AT THAT SAME COMPANY IN REG AFFAIRS. AFTER BEING THERE FOR SEVEN YEARS, I WENT TO A CRO FOR A YEAR AND THEN AFTER THAT, IT'S JUST BEEN A NUMBER OF SMALL TO MID. SIZED BIOTECH COMPANIES IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES. -- SIZED BIOTECH COMPANIES IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES.SIZED BIOTECH COMPANIES IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES.SIZED BIOTECH COMPANIES IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES.SIZED BIOTECH COMPANIES IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES.-SIZED BIOTECH COMPANIE S IN THIS AREA, AND MY ON-THE-JOB TRAINING CONTINUES. REG AFFAIRS IS AN ENORMOUS FIELD. EVERYONE CAN'T KNOW EVERYTHING. THE STANDARDS EVOLVE. THERE ARE DIFFERENT REGULATIONS AND GUIDANCES FOR INDIVIDUAL COUNTRIES. YOU'LL FIND DIFFERENCES IN SAFETY CONCERNS AND QUESTIONS BETWEEN REGULATORY AUTHORITIES IN DIFFERENT COUNTRIES, AND -- ME -- BUT SOMETIMES ALSO WITHIN DIFFERENT POSITIONS IN THE FDA AND EVEN IN THE FDA REVIEWER LEVEL, NOT JUST FDA, BUT ANY REG AUTHORITY REVIEWERS. SOMETIMES THERE CAN BE INDIVIDUAL DIFFERENCES ABUT THE RISK-BENEFIT ANALYSIS. SO YOU CAN'T KNOW EVERYTHING, BUT THE REALLY IMPORTANT THING IS TO KNOW HOW AND WHERE TO FIND AN ANSWER TO SOMETHING. SOMEONE WORKING IN THIS FIELD SHOULD ENJOY WORKING WITH A VARIETY OF STAKEHOLDERS, BOTH WITHIN YOUR ORGANIZATION AND EXTERNALLY. YOU SHOULD HAVE EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS INCLUDING BEING AN ACTIVE LISTENER. IT'S IMPORTANT TO KNOW THAT YOUR STAKEHOLDER, ALL THE STAKEHOLDERS, HAVE BEEN HEARD AND THIS ESPECIALLY COMES INTO PLAY WITHIN A COMPANY SETTING WHERE YOU'RE WORKING WITH A LOT OF DIFFERENT FUNCTIONAL AREAS. SOMEONE IN BUSINESS DEVELOPMENT OR RESEARCH MAY HAVE A CONCERN OR AN ISSUE THAT HAS NOTHING TO DO WITH THE REGULATIONS, BUT IT IS AN IMPORTANT ISSUE, UM, AND AFFECTS PRODUCT DEVELOPMENT. SO YOU HAVE TO, YOU HAVE TO BE SENSITIVE TO THAT AND, UM, AND LISTEN TO, YOU KNOW, WHAT -- YOU MIGHT BE CAUSING THEM A PROBLEM AND TO BE OPEN ENOUGH TO COMPROMISE AND FIND A WAY FORWARD. THE PERSON -- YOU SHOULD BE ABLE TO ADAPT EASILY TO CHANGE AND EVEN ACT AS A CHANGE AGENT BECAUSE PRIORITIES WILL BE CONSTANTLY CHANGING, AND AGAIN, WITHIN YOUR ORGANIZATION, YOU REALLY SHOULD DEVELOP REGULATORY STRATEGIES IN A CROSS-FUNCTIONAL WAY. AND YOU SHOULD BE OPEN MINDED. MANY TIMES THE ANSWER TO A PROBLEM OR A QUESTION H WILL NOT BE IN GUIDANCES OR WON'T EVEN HAVE, YOU CAN'T EVEN DRAW UPON YOUR EXPERIENCE AND YOU JUST REALLY NEED RELY ON COMMON SENSE. SO IN TERMS OF MOVING TOWARDS A CAREER IN REGULATORY AFFAIRS, YOU CAN JOIN THE REGULATORY AFFAIRS PROFESSIONAL SOCIETY. THEY OFFER A NUMBER OF TRAINING COURSES, AND ONLINE THERE'S A NUMBER OF RESOURCES. THEY HAVE AN ANNUAL MEETING WHICH HAS SESSIONS THAT ARE SIMULTANEOUSLY TARGETED FOR DRUGS AND BIOLOGICS AND DEVICES. YOU CAN TAKE THE RAPS EXAMPLE AND GET A CERTIFICATION, AND THIS CAN BE EITHER GENERAL OR IT COULD BE SPECIFIC FOR U.S. ORCA NAD YAN -- CANADIAN REGULATIONS. THE WEB OFFERS A NUMBER OF WEB CASTS WHICH ARE REALLY VALUABLE AND REALLY IS A HUGE ADVANTAGE TO GET AN INSIGHT AS TO WHAT THE CURRENT THINKING IS. AND EVEN JUST GOING ON THE NET YOU CAN FIND SLIDES FROM ALL THE PREVIOUS PRESENTATIONS. YOU SHOULD JOIN LINKEDIN. THERE ARE MANY, MANY REGULAR LA LA -- REGULATORY FORUMS IN THAT NETWORK. YOU SHOULD KEEP REGULATORY COLLEAGUES NOT ONLY FOR FINDING JOBS BUT THERE'LL BE MANY TIMES WHERE SOMEONE YOU KNOW WILL HAVE THE ANSWER TO SOMETHING YOU'VE NEVER BEEN FACED WITH. A YEAR OR TWO IN A CONTRACT RESEARCH ORGANIZATION CAN BE VERY VALUABLE. IT'S A REALLY ACCELERATED LEARNING WHERE YOU'LL BE EXPOSED TO A MILLION DIFFERENT, YOU KNOW, PRODUCTS, PROBLEMS, CLIENTS, PHASES OF DEVELOPMENT, UM, SO NOT ONLY WILL YOU LEARN A LOT BUT YOU CAN ALSO GET A TASTE OF THESE DIFFERENT, YOU KNOW, PARTS OR DIFFERENT PARTS OF REGULATORY AFFAIRS AND MAYBE FIND THAT, YOU KNOW, THAT YOU LIKE POST MARKETING ACTIVITIES OR YOU LIKE DEVICES BETTER THAN DRUGS. AND I THINK IN TERMS OF FINDING A JOB, BUT EVEN FINDING OUT MORE ABOUT THE FIELD IS, IDENTIFY A COMPANY THAT YOU THINK YOU WOULD LIKE TO WORK FOR AND TARGET THEM. CALL UP THE REGULATORY AFFAIRS PERSON AT THAT COMPANY AND JUST ASK FOR AN INFORMATIONAL INTERVIEW AND MOST PEOPLE WILL BE HAPPY TO DO THAT. TAKE THEM OUT TO LUNCH. YOU CAN FIND OUT WHAT THEIR DAY-TO-DAY JOB LOOKS LIKE, WHAT KINDS OF THINGS THEY DO, WHAT CHALLENGES THEY HAVE, WHAT THEY LIKE OR THEY DON'T LIKE ABOUT THE COMPANY/THE FIELD, AND HOW THEY GOT THERE. AND THAT'S ALL I HAVE. THANK YOU FOR YOUR ATTENTION. [APPLAUSE] >> [LOW AUDIO]. HI. THAT'S LOUD. ALL RIGHT. SO MY NAME'S DAVE DEBANY. I'M A SENIOR ASSOCIATE IN THE REGULATORY AFFAIRS DEPARTMENT OUT IN MILLENNIUM. MILLENNIUM'S BEEN IN CAME BRIDGE SINCE 1993. WANTED TO TALK A LITTLE BIT ABOUT MY CAREER LEADING UP TO THAT POINT AND WHAT I DO CURRENTLY, AND IT'S SORT OF UNIQUE CAREER. I'M NOT A SCIENTIST FOR STARTERS. I KNOW A LOT OF YOU, PROBABLY ALL OF YOU ARE SCIENTISTS. I WAS AN ENGLISH MAJOR. I STUDIED ENGLISH AND PSYCHOLOGY. I'M ALSO A GRADUATE SCHOOL DROPOUT. STAY IN SCHOOL, KIDS. [LAUGHTER] I WANTED TO BE A PROFESSOR AND THROUGH A SERIES OF MISFORTUNES AND CRISES OF FAITH AND WHATNOT, I DECIDED TO EMBARK ON A DIFFERENT CAREER AND THE FIRST JOB THAT I GOT WAS RIGHT AT THE BOTTOM IN THE REGULATORY OPERATIONS DEPARTMENT AT GLAT SKOE SMITH CLIENT IN PHILADELPHIA. WHAT I DID WAS LOOK AT PDF DOCUMENTS CHECK TO SEE IF THE LINK WORKS, PAGE NUMBERS WERE ALL SEQUENTIAL. ESSENTIALLY A QC JOB FOR THE PUBLISHING DEPARTMENT WITHOUT REALLY ANY SENSE OF WHAT I WAS LOOKING AT OR WHERE IT WAS GOING OR WHAT IT WAS ACCOMPLISHING, AND WHAT IT WAS ACCOMPLISHING, OF COURSE, WERE REGULATORY SUBMISSIONS TO THE FDA AND OTHER HEALTH AUTHORITIES. EVENTUALLY I LEARNED HOW TO PUBLISH THOSE LARGE AND SMALL-SCALE SUBMISSIONS. EVERYTHING FROM AN MDA TO A 510 K, SAFETY REPORTS, PAPER, ECPD. I REALLY GOT THE RAN THE GAMUT OF MY REGULATORY OPERATIONS EDUCATION AT GSK AND THEN LATER ON AT BAXTER HEALTH CARE IN ILLINOIS. IN 2008, I STARTED AT MILLENNIUM A CAME BRIDGE, ALSO AS A REGULATORY PUBLISHER. . THAT ROLE WHAT WE DO IS COMPILE AND FORMAT DOCUMENTS. THEY COME FROM ALL THE VARIOUS FUNCTIONAL AREA; CLINICAL, NON-CLINICAL, CNC ETC. WE COMPILE THEM INTO PAPER OR ELECTRONIC. ELECTRONIC TECHNICAL DOCUMENT. THE FDA WAS PART OF THAT TO HAVE THE DOSE YEAS BE MORE COMMON DESPITE WHERE THEY CAME FROM. BEING A REGULATORY PUBLISHER IS FORMAT-INTENSIVE. YOU DON'T NEED TO KNOW THE FORMAT TO BE SUCCESSFUL. YOU REALLY NEED TO KNOW HOW TO RUN THE PUBLISHING TOOLS, HOW TO ORGANIZE THE INFORMATION. IN THE OLD DAYS, IT WAS HUNDREDS OF VOLUMES OF PAPER. SO A NEW DRUG APPLICATION, AN MDA MIGHT BE STACKS OF PAPER THIS HIGH FROM HERE TO THE DOOR, AND YOU WOULD LITERALLY LOAD THEM ON A TRUCK WHEN THEY WERE DONE. NOW BEFORE ALL THE MASS PRINTERS, BEFORE TOOLS LIKE ECTP PUBLISHER OR ISI EXPRESS, YOU WOULD ACTUALLY HAVE TO HAND STAMP THE PAGES. IT WAS VERY MUCH A CLERICAL KIND OF POSITION AND A LOT OF PEOPLE CAME UP THROUGH THE CLERICAL ROLES, A LOT OF ADMINISTRATIVE ASSISTANCE WERE BECOMING REGULATORY OPERATIONS PROFESSIONALS. SOME OF THEM WERE GETTING USED TO THE TECHNOLOGY THAT CAME, SOME DID NOT. NOW WHAT WE D DO IS ECTD, WE SEND THROUGHS THROUGH THE ELECTRONIC SUBMISSION GATEWAY THROUGH THE FDA. EVERYBODY FAMILIAR WITH THAT? IT'S AWAY SICKLY A FANCY E-MAIL. USED TO, YOU WOULD LOAD THEM ON TRUCKS. NOW IT JUST GOES ELECTRONICALLY. SO IF THIS IS A CAREER FOR YOU, COULD VERY WELL BE, IT'S EXTREME ATTENTION TO DETAIL IS YOUR FORTE. IF YOU LIKE THE PREDICTABILITY OF DOING KIND OF THE SAME THING, SORT OF KNOWING YOU'RE GOING BE DOING THE SAME THING EVERY DAY, MAYBE YOU DON'T KNOW WHAT TIME YOU'RE GOING GET HOME BECAUSE THINGS, IT CAN GET A LITTLE MEASURE IS I -- MESSY. IF YOU LIKE PREDICTABILITY, IT'S A GOOD ROLE FOR YOU. IT DIDN'T REALLY WORK OUT FOR ME. I LIKE TO CALL IT THE CABOOSE, AND THERE ARE A COUPLE OF OTHER WAYS YOU CAN LOOK AT THAT. EITHER IT'S THE END OF THE TRAIN OR IT'S THE REAR END, OR IT'S BASICALLY THE LAST IN LINE, AND I ALWAYS LIKED TO COMPLAIN THAT EVERYBODY ELSE'S TIMELINES COULD CHANGE BUT SUBMISSION OPERATIONS COULDN'T AND THAT'S CASE. SO IF YOU'RE UP FOR HIGH-PRESSURE, THAT'S ALSO A PRETTY GOOD OPPORTUNITY FOR YOU. THERE IS DEFINITELY A SOLID CAREER PATH WITHIN SUBMISSION OPERATIONS. WHAT I DO NOW, THOUGH, IS A LITTLE BIT MORE, I DON'T WANT TO SAY INVOLVED BECAUSE SUBMISSION OPERATIONS IS A VERY, YOU'RE VERY INTO THE REGULATORY AFFAIRS DEPARTMENT. WHAT I DO NOW IS WELL MY OFFICIAL TITLE IS STILL SENIOR ASSOCIATE REGULATORY AFFAIRS BUT IT DOESN'T REALLY MADE A WHOLE LOT, JUST FITS ON A CARD REALLY WELL. WHAT I'M NOW IS BUSINESS ANALYSIS, TECH ASSESSMENT, WEBMASTER... AND ALL AROUND NICE GUY. IF I COULD PUT IT ON THE CARD IT WOULD BE THE TECH GUY. UNFORTUNATELY IF YOU CALL YOURSELF THE TECH GUY THAT MEANS EVERYBODY'S GOING TO COME TO YOU WITH THEIR iPHONE PROBLEMS. IF ANYBODY HAS ANY iPHONE PROBLEMS WE'LL BE ABLE TO TALK AFTER THIS. BUSINESS ANALYSIS IS A, IT'S NOT PHARMACEUTICAL-SPECIFIC TERM. THERE'S BUSINESS ANALYSTS IN EVERY INDUSTRY YOU CAN IMAGINE. THE IIBA DEFINES IT -- AND I'M GOING READ THE WHOLE THING -- A LIAISON AMONG STAKEHOLDER IN ORDER TO UNDERSTAND THE STRUCTURE, POLICIES AND OPERATIONS OF AN ORGANIZATION AND TO RECOMMEND SOLUTION THAT ENABLE THE ORGANIZATION TO ACHIEVE ITS GOALS. ESSENTIALLY YOUR JOB IS TO KNOW THE BUSINESS VERY WELL, TO WORK WITH EITHER IT OR INFORMATICS, WHATEVER YOU CALL IT WITHIN YOUR GROUP, TO DEVELOP EITHER SOFTWARE INITIATIVES OR PROCESS INITIATIVES THAT MAKE EVERYTHING RUN SMOOTHER AND BETTER. AND YOU DO THAT BY ILLICITING AND GATHERING REQUIREMENTS FOR YOUR STAKEHOLDERS. YOU EXAMINE DOCUMENT, PROCESSES AND WORK FLOWS THAT YOUR DEPARTMENT USES. WRITE SPECIFICATION DOCUMENTS AND A LOT MORE. THERE'S A TON OF INFORMATION ON THE WEB. YOU CAN GO TO THE IIBA. IT'S AN INTERESTING ROLE, CAREER, AND IT GOES INTO JUST ABOUT EVERY CAREER PATH YOU CAN POSSIBLY IMAGINE. SOME OF THE KEY SKILLS YOU WOULD NEED TO PERFORM THAT BUSINESS ANALYSIS. ONE IS IN-DEPTH KNOWLEDGE OF THE BUSINESS IS HELPFUL. YOU COULD BE A B.A. AND I COULD GO INTO A FINANCE COMPANY AND GET A JOB AS A B.A. BUT I WOULDN'T BE QUITE UP TO SPEED BECAUSE I DON'T UNDERSTAND FINANCE. HOWEVER HAVING EIGHT YEARS OF REGULATORY OPERATION EXPERIENCE, IT GAVE ME A LEG UP IN BECOMING AN ANALYSIS AND A B.A. FOR A REGULATORY OPERATIONS GROUP, BUT THE THREE KEY SKILLS I WOULD POINT TO WERE COMMUNICATION. YOU'RE CONSTANTLY NEGOTIATING WITH YOUR STAKEHOLDERS. SOMEONE IN YOUR CMC GROUP MIGHT WANT YOUR SYSTEM TO DO A CERTAIN THING WHEREAS SOMEBODY IN YOUR NON-CLINICAL GROUP MIGHT WANT IT TO DO SOMETHING THAT COMPLETELY CONFLICTS WITH THAT. HOW DO YOU DEAL WITH THAT? EVEN MORE IMPORTANTLY THAN THAT IS TRANSLATION BETWEEN USERS AND DEVELOPERS. BEFORE I WAS IN REGULATORY, WHILE I WAS IN GRAD SCHOOL I WORKED FOR IBM AS A TECHNICAL WRITER AND WHAT I WAS DOING WAS I WAS TAKING ENGINEER SPEAK, TRANSLATING IT INTO WHAT I CALL NORMAL-PEOPLE SPEAK FOR USER MANUALS. SO IF YOU EVER OPEN UP YOUR USER MANUAL FOR YOUR TV, iPOD, WHATEVER -- iPOD, 2002, HUH -- YOU HAVE TO BE ABLE TO READ AND THIS UNDERSTAND IT. THE PEOPLE WHO DESIGN THAT DON'TNESSLY SPEAK ENGLISH, THEY SPEAK ENGINEER SPEAK. SO YOU HAVE TO TRANSLATE THAT. TO DO WHAT DO RIGHT NOW YOU HAVE TO DO THE OPPOSITE. TAKE WHAT PEOPLE IN REGULATORY AFFAIRS SAY AND TRANSLATE THAT INTO SOMETHING A DEVELOPER CAN UNDERSTAND. THIS CREATIVITY WHICH FOR ME WAS A REASON WHY P PUBLISHING WAS NOT THE ROLE FOR ME. YOU KNOW, I HATE TO USE THIS TERM BUT THIS IS A REAL OUT-OF-THE-BOX THINKING POSITION. YOU NEED TO COME UP WITH SOLUTIONS THAT EXIST AS WELL AS SOLUTIONS FOR PROBLEMS THAT DON'T EXIST. IF YOU'RE THE KINDS OF PERSON THAT LIKES TO THINK OF WHAT CAN GO WRONG IN EVERY POSSIBLE SCENARIO, THEN THIS IS A GREAT JOB FOR YOU, ACTUALLY. [LAUGHTER] THERE'S ALSO AN ELEMENT OF USER EXPERIENCE, THERE'S PSYCHOLOGY, THERE'S DESIGN. IF YOU HAVE THOSE SKILLS THIS, IS A GOOD WAY TO GO AS WELL. THEN THERE'S DETAIL. LIKE REGULATORY PUBLISHING, YOU TO HAVE A VERY HIGH LEVEL OF DETAIL. SO FUNCTIONAL SPECIFICATIONS, FOR EXAMPLE, HIGHLY-DETAILED DOCUMENT BECAUSE IF THEY'RE INCONSISTENT OR VAGUE THEN THE DEVELOPERS ARE NOT GOING TO KNOW WHAT TO DEVELOP AND YOU'LL RUN INTO PROBLEMS DOWN THE LINE. SO JUST A QUICK EXAMPLE OF WHAT I'VE DONE RECENTLY WITH THIS EXPERIENCE. I DEVELOPED OR CO-DEVELOPED ALONG WITH MEDICAL INFORMATIC AND THE REST OF THE REGULATORY AFFAIRS DEPARTMENT WHAT WE CALL GO PATS. WE'RE NO BOSTON SO THAT DOESN'T RING THREW TRUE HERE BUT UP THERE IT'S -- PATRIOTS, FOOTBALL, ANYBODY, LOST THE SUPER BOWL THIS YEAR? WHAT GO PATS IS IS AN INNOVATIVE SET OF TOOLS STREAM LINES ALL OF OUR SUBMISSION PLANNING AND TRACKING. WHAT WE CALL REGULATORY INTERACTIONS. EVERYTHING FROM OUR SUBMISSIONS TO THE PHONE CALLS THAT SOMEBODY IN REGULATORY AFFAIRS MAKES TO SOMEBODY HERE AT THE FDA, AND BECAUSE OF THAT, IT DOES BOOST OUR COMPLIANCE. BETTER YOU PLAN THINGS, THE BETTER YOU CAN TRACK THINGS, THE BETTER YOUR COMPLIANCE. STAKEHOLDERS CAME FROM ALL OVER, TO REGULATORY AFFAIRS, OPERATIONS, CMC, MEDICAL WRITING, IT, AND WHAT I DID WAS I, LIKE I MENTIONED IN THE SLIDE BEFORE, YOU ELICIT REQUIREMENTS, GATHER THOSE REQUIREMENTS, MAKE SURE THEY'RE REAL, THAT THEY'RE NOT CONFLICTING. I SAT WITH ALL THE GROUPS AND WORKED OUT OUR PROCESS FLOWS. WHAT DO YOU DO WHEN WE SEND OUT A SAFETY REPORT? I GET NIT THE MAIL OR GET IT IN MY INBOX AND SEND IT OUT TO THE FDA. ALL RIGHT. WHAT DO YOU REALLY DO? THEN YOU BREAK IT DOWN INTO STEP-BY-STEP AND TRY TO FIND THE GAPS IN THOSE PROCESSES AND TRY TO FIGURE OUT HOW TO MAKE THEM BETTER. IF YOU CAN USE THE SYSTEM TO MAKE IT BETTER, GREAT, IF NOT, SAFES YOU MONEY. MOCK UPS IS MY FAVORITE PART BECAUSE IT INVOLVES DRAWING. I'M NOT A GREAT DRAWER BUT I CAN DRAW SQUARES AND ARROWS AND THAT'S WHAT SYSTEMS ARE. IF YOU'RE A CREATIVE PERSON, YOU LIKE TO EXPERIMENT WITH IDEAS, IT'S NOT A BAD ROLE. AGAIN, IF YOU EXPERIENCE IN THE SCIENCES OR REGULATORY AFFAIRS LATER ON OR NO MATTER WHAT YOU'RE DOING, IT'S CERTAINLY AN OPTION DOWN THE LINE. SO TO SUM UP, THERE'S REALLY NO CLEAR CUT PATH TO A CAREER IN THIS. I'VE HAD COLLEAGUES WHO HAVE BEEN ANTHROPOLOGISTS AND HAVE WHO HAVE HAD HIGH-LEVEL HAVE-WHO HAVE HAD HIGH-LEVHAVEWHO HAVE HAD HIGH-LEVEL WHO HAVE HAD HIGH-LEVEL CAREERS. I'VE HAD COLLEAGUES WHO DON'T EVEN HAVE COLLEGE DEGREES. YOU DON'T NEED TO NECESSARILY FOCUS ON THE SCIENCES. I KNOW WE'RE SPEAKING TO SCIENTISTS HERE, BUT FOR THE MOST PART, YOU DON'T HAVE TO HAVE EXPERIENCE IN THE SCIENCES IN OPERATIONS. NOW IF YOU'RE IN AFFAIRS, I IMAGINE THAT'S A HUGE BOOST, BUT IF YOU'RE IN OPERATIONS, IT'S NOT NECESSARY. UM, BUT YOU CAN'T HAVE REG AFFAIRS WITHOUT REGULATORY OPERATIONS. NOT SO SAY THAT WE ARE THE BACKBONE OR ANYTHING GRAND LIKE THAT, BUT WE CERTAINLY HELP MAKE THINGS RUN BY KEEPING THINGS COMPLIANT. THANK YOU. HERE'S A LITTLE BIT OF CONTACT INFO. YOU CAN FIND ME ON LINKEDIN THROUGH MY E-MAIL ACCESS OR MY SERIOUS FACEBOOK AND THANKS A LOT FOR LISTENING. [APPLAUSE] >> ALL RIGHT. I'M GOING CHANGE UP THE WAY WE'RE PRINTING. I ACTUALLY TOOK A MORE HOLISTIC POINT OF VIEW THIS TIME SO I'M GOING TO START OFF BY GOING INTO WHAT REGULATORY AFFAIRS ACTUALLY IS, A BROAD OVERVIEW. CAN EVERYONE HEAR ME ALL RIGHT, OR DO I NEED GET A -- WE'RE GOOD? I NEED ONE? >> YOU'RE ON THE WEB -- [LOW AUDIO]. >> OKAY. I WAS TRYING TO SEE IF I COULD GET AWAY WITHOUT GETTING PINNED. I WAS SUPPOSED TO TELL YOU AHEAD OF TIME, IS NOW TOO LATE. [LAUGHTER] >> JUST A TOUCH. >> ALL RIGHT. WE OKAY NOW? YEAH? CLEAR? GOOD. SO AS I MENTIONED I WANT TO TAKE A MORE HOLISTIC APPROACH AND KIND OF GIVE A BROAD OVERVIEW OF WHAT REGULATORY AFFAIRS IS KIND OF FROM THE FDA PERSPECTIVE, AND THEN KIND OF MOVE INTO HOW CAN A SCIENTIST OR ANYONE IN GENERAL PREPARE FOR A CAREER IN REGULATORY AFFAIRS? IF IT'S ACTUALLY SOMETHING YOU WANT TO DO, SOMETHING THAT ONLY YOU CAN ANSWER, OF COURSE, BUT YOU HAVE TO DO THAT THROUGH INVESTING YOUR TIME AND RESEARCH AND ATTENDING SEMINARS LIKE THIS, WHICH ARE REALLY HELPFUL. SO BEFORE WE BEGIN, JANICE AND DAVID DID AN EXCELLENT JOB. I'M PROBABLY GOING TO TOUCH A LITTLE BIT UPON WHAT THEY'VE ALREADY COVERED, BUT THIS VIN DIAGRAM HERE HAS THREE MAIN CATEGORIES; FDA, OFFICE OF COMPLIANCE AND [INDISCERNIBLE]. I'M BIASSED HERE BECAUSE I WORKED A [INDISCERNIBLE] [LOW AUDIO] BUT THERE ARE OTHER CENTERS WITHIN FDA SO I PUT THE MISSION STATEMENT IN EACH ONE OF THESE RIGHT BESIDE THEIR LITTLE CIRCLE. SO WHAT DO YOU SEE? WHAT KIND OF CONNECTION DO YOU SEE BETWEEN EACH ONE OF THOSE MISSION STATEMENTS? [LOW AUDIO]. PROTECTING PUBLIC HEALTH. THAT CAN BASICALLY SUM UP REGULATORY AFFAIRS, HOW IT WORKS. SO YOU HAVE MULTIFACETS TO REGULATORY AFFAIRS. IT'S NOT JUST ONE AREA, SO WHEN SOMEONE SAYS REGULATORY AFFAIRS, IT'S VERY GENERAL HOW THEY'RE SAYING IT. VERY -- YOU'RE TAKING A WORD THAT ACTUALLY ENCOMPASSES ALMOST ALL OF THE ENTIRE PHARMACEUTICAL PRODUCTION, PHASE ONE CLINICAL TRIALS. SO YOU CAN SEE IN THIS DIAGRAM RIGHT HERE, I CALL IT 360 DECISION OF REGULATORY [INDISCERNIBLE]. SO IT COVERS ANY ASPECT OF ANY TYPE OF PHARMACEUTICAL SUBMISSION, TO REVIEW, MANUFACTURING, POST MARKETING, PRECLINICAL. REGULATORY AFFAIRS IS NOT JUST ONE ASPECT OF IT. THAT'S SOMETHING I WANT TO REITERATE. WHEN SOMEONE SAYS REGULATORY AFFAIRS OR YOU WANT TO GO INTO REGULATORY AFFAIRS, YOU NEED SO START NARROWING DOWN AREA YOU WANT TO GO INTO BECAUSE IF YOU REGULATORY AFFAIRS, IT'S TOO VAST. YOU DIDN'T BE A JACK OF ALL TRADES. YOU BECOME SPECIFIC. YOU CAN LEARN SOMETHING IN BIOLOGICS AND THEN YOU CAN GO INTO DRUGS. SMALL MOLECULES. BUT EACH ONE OF THEM ARE ACTUALLY LINKED TO THEIR OWN TYPE OF REGULATION. SO BIOLOGICS HAVE THEIR OWN REGULATIONS, AND TO TRY TO BECOME A MASTER OF EVERYTHING, IT CAN BE FRUSTRATING AND STRESSFUL AT THE SAME TIME. SO THAT'S WHY THEY HAVE THE CENTER FOR DRUGS, CENTER FOR BUY LOGICS, NOW YOU HAVE TOBACCO AND VETERINARY MEDICINE. I KNOW I'M MISSING [INDISCERNIBLE] AND OTHER STUFF. SO REGULATORY AFFAIRS. SO WE SAW THAT THIS 360 DEGREES COVERS ALL ASPECTS OF DRUG DEVELOPMENT AND FROM HERE ON I'M GOING TO REFER TO DRUG DEVELOPMENT [LOW AUDIO]. WHEN YOU THINK OF REGULATORY AFFAIRS, IT'S ABOUT GETTING THE JOB DONE. YOU'RE GETTING A JOB DONE PROPERLY AND ON TIME. YOU CAN SEE IN THE DIAGRAM, YOU'RE GETTING THE JOB DONE BUT IS HE DOING IT CORRECTLY? I THINK DAVID HAD MENTIONED THAT YOU HAVE TO ANTICIPATE PROBLEMS. ANYBODY ANTICIPATE ANY PROBLEMS COMING FROM THIS? [LAUGHTER] HE'S GETTING IT DONE, WELDING, BUT THAT'S PART OF THE PROCESS. IF YOU SUBMITTING A NEW DRUG APPLICATION OR MDA, THERE'S ALWAYS PROBLEMS YOU HAVE TO ANTICIPATE BECAUSE YOU'RE DEALING WITH CLINICAL SUBJECTS, YOU'RE DEALING WITH HUMANS AS YOU'RE DOING THE CLINICAL TRIALS. THIS IS NOT SOMETHING THAT'S CLEAR-CUT AND OUT OF A TEXTBOOK THAT YOU CAN FOLLOW THIS PROCEDURE AND THIS PROCEDURE AND THAT'S IT, AND THEN THAT'S NO PROBLEM, YOU GET THAT NEW DRUG APPLICATION APPROVED AND YOU'RE [LOW AUDIO] -- IT DOESN'T WORK THAT WAY BECAUSE THERE'S ALWAYS PROBLEMS, AND THE REGULATORY AFFAIRS JOB ACTUALLY TO ANTICIPATE THESE PROBLEMS, BREAK DOWN THE PROBLEMS -- CAN I IT IN MY MOUTH -- AND TO ANTICIPATE THESE PROBLEMS AND THEN I THINK DAVID MENTIONED YOU KIND OF WANT WANT TO BREAK IT DOWN. YOU HAVE THIS IMMENSE PROBLEM IN FRONT OF YOU BECAUSE BUT IT CAN BE GRANIZED INTO LITTLE PIECES AND IN EACH ONE OF THOSE PIECES YOU CAN ATTACK IT. [LOW AUDIO] YOU JUST ATTACK THAT, YOU KNOW YOU ATTACK IT FROM DIFFERENT ASPECTS, ANGLES SAME THING WITH REGULATORY AFFAIRS. WHAT YOU'RE LEARNING HERE AS A SCIENTIST, YOU CAN EASILY TRANSLATE INTO REGULATORY AFFAIRS, BUT THAT'S IF YOU CAN CARRY THAT INTEREST OVER TO HAVE SOMETHING WHICH YOU REALLY WANT TO DO. SO WHAT KIND OF BACKGROUND WHEN WE TALK ABOUT REGULATORY AFFAIRS? WE HAVE EVERYONE HERE IS AN AUDIENCE OF SCIENTISTS. SCIENCE BY TRAINING, BUT REGULATORY AFFAIRS IS, YOU KNOW, ENGLISH MAJORS, YOU KNOW PEOPLE WHO'VE WORKED IN QUALITY, PHARMACEUTICALS, MEDICAL DOCTORS. YOU HAVE ALSO BIG ASPECTS P WHERE I WORK IN OFFICE OF COMPLIANCE, THERE'S A LOT OF LAWYERS BECAUSE YOU'RE DEALING WITH REGULATIONS. THESE ARE LAWS THAT ARE GOVERNED PHARMACEUTICALS -- WHAT? >> [LOW AUDIO]. [LAUGHTER] >> OKAY. GOOD. YOU JUST WANT TO BE IN THE VIDEO, RIGHT? [LAUGHTER] ON THE RIGHT SIDE SO WHAT DOES EVERYONE HAVE IN COMMON HERE? YOU HAVE ALL THESE DIFFERENT ASPECTS YOU'RE COMING FROM, BUT SCIENTIFICALLY ACCURATE. ON THE END WHEN YOU'RE SUBMITTING A NEW DRUG APPLICATION, HAS TO BE SCIENTIFICALLY ACCURATE. YOU DON'T HAVE TO KNOW THE SCIENCE, BUT YOU TO KNOW WHO TO ASK AND THAT'S ONE BIG PART OF IT IS PRODUCT MANAGEMENT, COLLABORATION. DO YOU KNOW WHERE TO GET THE INFORMATION? IS THIS INFORMATION CORRECT? ARE YOU DOING QUALITY CONTROL? SO THERE'S A LOT OF STEPS THAT ARE INVOLVED AND IT'S NOT JUST ONE PERSON. THESE ARE ENTIRE DEPARTMENTS. AND WHAT DOES REGULATORY AFFAIRS COVER? WHEN YOU LOOK AT THE SCIENCE ASPECT OF IT, [INDISCERNIBLE] AS I MENTIONED FROM BUY LOGIC TO VETERINARY MEDICINE TO THE DRUGS WE TAKE EVERY DAY AND FDA EVERYBODY COVERED CELL PHONES, MICROWAVES, THAT'S A DIFFERENT ASPECT BUT YOU HAVE BIOLOGICS AND THESE ARE THINGS THAT WE INTERACT WITH EVERY DAY. SO YOU'RE -- YOU SEE AND THAT'S ONE OF THE GREATEST THINGS ABOUT BEING -- YOU SEE YOU'RE AT THE FOREGROUND AND YOU ACTUALLY SEE SOMETHING GOING THROUGH DEVELOPING. IF THERE'S A RECALL OR SOMETHING THAT WAS INVOLVED LIKE THE LATEST RECALL -- THERE'S A LOT OF INJECTABLES THAT ARE BEING RECALLED FOR A LOT OF PROBLEMS IN MANUFACTURERS. YOU'RE AT THAT. YOU SEE WHAT'S OCCURRING AND YOUR GOAL IS TO -- EVERYONE? PROTECT THE PUBLIC HEALTH. THAT'S GREAT BECAUSE YOU'RE ACTUALLY, THAT INVOLVEMENT AND THAT'S ONE OF THE EXCITEMENT. I GET EXCITE GOING TO WORK EVERY DAY BECAUSE YOU [LOW AUDIO] -- YOU'RE THERE EVERY DAY, STRESSFUL BUT THAT'S OKAY, THAT'S WHAT MAKES IT ENJOYABLE. SO NOW I'M GOING SWITCH GEARS. I GAVE I MENTIONED THE WHOLISTIC OVERVIEW OF REGULATORY AFFAIRS, BUT UH HOW TO MAKE THAT TRANSITION OR HOW TO EVEN START TO THINK ABOUT DOING THAT. THE FIRST THING YOU HAVE TO ANSWER IS, IS THAT A CAREER YOU WANT TO DO? EVERYONE IS HERE FOR A REASON. YOU'RE NOT IN A CLASS THAT THEY MANDA MAN DATDED YOU HAVE TO COME TO. YOU'RE HERE BECAUSE YOU'RE CURIOUS AND YOU WANT TO DO. YOU'LL LEARN, IS THIS IS SOMETHING UH YOU WANT TO DO? NOT REALLY. MENTION THIS, DO YOU ENJOY TRAVEL? SOME REGULATORY AFFAIR DOS A LOT OF TRAVEL. TRAVEL ALL THROUGHOUT THE WORLD DOING INSPECTIONS. YOU CAN ASK JANICE, SHE DOES A LOT OF TRAVEL TO ALL OVER. YOU KNOW RIGHT NOW THE SKILL THAT YOU HAVE AND THEN AS YOU DO MORE RESEARCH, YOU'RE ALLOWED THE SKILLS THAT UH YOU NEED, AND THEN HOW WILLING ARE YOU TO INVEST THE TIME TO MOVE TO REGULATORY AFFAIRS? WHAT CAN YOU DO RIGHT NOW, TODAY, YOU'RE ALREADY DOING IT BUT ACTUALLY STRENGTHEN, YOU KNOW, YOUR BACKGROUND, YOUR SKILLS; IS THERE ANYTHING YOU CAN DO TO HELP YOU MOVE TO THAT NEXT [INDISCERNIBLE]? THAT GOES TO ONE OF THE MOST IMPORTANT THINGS, SOMETHING THAT I REALIZE WHEN I WAS DOING MY POST DOC AND FELLOW POSITION IS YOU NEED TO HAVE A CAREER GOAL. IT'S EASY TO SAY I WANT TO DO THIS OR I'D LIKE TO DO THIS BUT REALLY HAVING A CAREER GOAL AND THAT'S SOMETHING THAT TOMORROW OR NEXT WEEK BUT ACTUALLY A FIVE-YEAR PLAN. YOU HEAR ABOUT IT, ALWAYS TALK ABOUT IT IN BUSINESS HAVING A FIVE-YEAR PLAN ARK A TEN-YEAR PLAN. TIMES YOU LOOK AT TEN-YEAR PLAN AND YOU SAY WELL THAT'S STILL MY FIRST POST DOC, RIGHT -- THAT'S THE RATE THEY'RE EXPECTING US TO GO RIGHT? [LAUGHTER] IT'S NOT STATIC. YOU KNOW THAT THAT FIFE-YEAR PLAN IS NOT STATIC. YOU CAN MOVE FROM DEVIATE ANY WAY YOU WANT ECAUSE IT'S YOUR PLAN, BUT HAVING SOMETHING THERE TO GO AFTER AND THEN INVESTING THAT TIME TO DO THE RESEARCH, THAT'S WHERE YOU GET THE VALUE. SO THIS IS SOMETHING -- I FINISHED MY SLIDES AT AROUND NOON TODAY, AND LET'S SEE IF I CAN PULL UP JUST ONE JOB I HAVE. I LOOKED AT, JUST TYPED IT INTO GOOGLE, REGULATORY AFFAIR AND THIS CAME UP. IT'S ACTUALLY FOR A, I THINK I [INDISCERNIBLE] [LOW AUDIO] THE IT'S ACTUALLY A COMPANY IN ROCKVILLE. I'M NOT ADVERTISING FOR THAT COMPANY [LOW AUDIO], BUT THIS IS WHAT I'M SAY. YOU NEED TO HAVE THAT CAREER PLAN. WHAT KIND OF SKILL DOS YOU NEED? LOOK AT THIS. THIS IS ACTUALLY FOR A SENIOR LEVEL REGULATORY AFFAIR. YOU LOOK AT IT AND SAY I DON'T HAVE FOUR YEARS OF REGULATORY AFFAIRS. TWO YEARS MINIMUM, TWO YEARS ADDITIONAL. THESE ARE JUST POINTS THAT I POINTED OUT, BUT THESE ARE SKILL SETS AND SOMETHING YOU COULD WORK TOWARDS. SO WITHIN FIVE YEARS YOU'LL HAVE THOSE FOUR YEARS. SO THIS IS SOMETHING THAT YOU HAVE THAT LIST OF SKILL SETS AND HOW ARE YOU GOING THE GET FROM POINT A TO POINT B? WHAT CAN YOU DO ALONG THE LINES TO GET TO THIS LEVEL? AND THIS IS PART OF HAVING THAT CAREER GOAL. AND THEN SO HOW DO YOU START? DOES EVERYONE HAVE A RESUME HERE? WHO DOES HAVE A RESUME? NOT TALKING CD. I SEE SOME HANDS WENT DOWN. SO THAT'S NOT EVEN A QUARTER OF [INDISCERNIBLE] [LOW AUDIO]. YOU NEED TO HAVE A RESUME THAT'S UP-TO-DATE. SAY YOU'RE AT A FUNCTION SOMEWHERE AND SOMEONE SAYS DO YOU HAVE A RESUME, SEND IT TO ME. >> [LOW AUDIO]. >> BUT IF THEY'RE BUSY AND THEY WANT A RESUME RIGHT AWAY AND YOU'RE LIKE, I GOT TO QUICKLY PUT SOMETHING TOGETHER AND THEN YOU HAVE A SPELLING MISTAKE IN THERE, IT'S NOT TABBED PROPERLY OR YOU FORGET TO ADD SOMETHING IN THERE AND THEN YOU SEND IT LATER SAY, WELL THIS IS MY NEW ONE, YOU CAN'T DO THAT. YOU HAVE ONE-SHOT WHEN YOU HAVE A CHANCE LIKE THAT. THAT'S PART OF IT. SO MAKE SURE YOU HAVE A RESUME, MAKE SURE IT'S UP-TO-DATE BECAUSE YOU NEVER KNOW WHEN IT'S GOING TO BE NEEDED OR REQUIRED. AND THEN AS JANICE HAS HAD MENTIONED [INDISCERNIBLE] SOCIETY FUNCTIONS, THEY ALWAYS HAVE ONE A MONTH, THERE'S LIKE A RA RAPS BALTIMORE OR DVM C. IT'S RIGHT ON FISHERS LANE AND THEY'LL TALK ABOUT THE LATEST DEVELOPMENTS THAT ARE COMING FROM FDA. A GOOD PLACE TO MEET PEOPLE. I DID THAT WHEN I WAS DOING MY FELLOWSHIP HERE. I WENT TO FUNCTIONING AND ORGANIZATIONS. [LOW AUDIO] TO GO THERE TO MEET PEOPLE AND TO LEARN ABOUT WHAT REGULATORY AFFAIRS REALLY IS. YOU HAVE TO BE WILLING TO MAKE THAT INVESTMENT BEYOND WHAT YOU'RE DOING NOW, AND THEN, UH, ALSO IT'S ALWAYS EVOLVING. CONTINUOUSLY MOVING. IT'S REALLY A YOUNG FIELD. SEE , IF YOU LOOK AT IT, FDA IS NOT THAT OLD. YOU'RE LOOKING AT TURN OF THE 1900s, 1901, 1902. IT USED TO BE CALLED A DEATH SQUADS IN WHICH YOD GO AND TASTE FOOD AND WHOEVER DIED, WELL THAT FOOD'S NOT GOOD. IT'S EVOLVED A LOT FROM THAT POINT. THAT'S THE THING IT'S ALWAYS CHANGING. JUST A COUPLE OF DAYS AGO THERE WAS A NEW SIMILAR GUIDANCE THAT WAS PUT OUT, AND THESE ARE KIND OF THINGS YOU WANT TO STAY UP-TO-DATE IF YOU DO GO TO AN INTERVIEW OR ARE TALKING WITH SOMEONE AT A FUNCTION YOU ARE UP-TO-DATE, YOU KNOW WHAT'S GOING ON AND YOU CAN ACTUALLY HAVE A CONVERSATION WITH THEM. THAT'S A LOT OF READING TO DO, BUT A LOT OF TIMES YOU'RE GOING BE RUNNING INTO A LOT OF ACRONYMS THAT YOU'VE NEVER SEEN BEFORE LIKE IND, NDA AND THESE ARE ALL THINGS THAT OVERTIME YOU'LL DEVELOP AND THEN YOU'LL BE ABLE TO THROW THEM OUT LEFT AND RIGHT. AND THEN CONTINUING EDUCATION. THERE'S ALWAYS THEY HAVE JOHNS HOPKINS HAS SEVERAL CLASSES, REGULATORY AFFAIRS DEGREE, AND I THINK THERE'S FREDZ RICK, CAN'T REMEMBER THE NAME BUT THEY ALSO HAVE [LOW AUDIO] AND THEN YOU ALSO HAVE THE RAPS EXAM. THESE ARE THINGS YOU CAN BUILD YOUR REGULATORY BACKGROUND. IN THE END IT'S THE VALUE THAT YOU'RE LOOKING FOR. I'M GOING TO CONCLUDE NOW WITH REGULAR HATORY AFFAIRS. AND IN THE END WHEN YOU'RE DELIVERING THAT PRODUCT -- ALBEIT AN MBA, A RESULTS OR COMPLAINT FILING COMPLAINTS OR DOING AN INSPECTION -- IT'S ACTUALLY THE QUALITY. YOU WANT TO MAKE SURE YOU PUT THROUGH QUALITY AND INTEGRITY AND THAT'S SOMETHING THAT HAS TO BE MAINTAINED THROUGHOUT AND THE BIGGEST THING IS ALSO KEEPING UP THE EVER-EVOLVING FIELD. I'LL LEAVE IT AT THAT. [APPLAUSE] >> SO UM FOR THOSE OF YOU THAT CAME IN LATE MY NAME'S NICOLE GORMLEY AND I AM A CLINICAL REVIEWER, MEDICAL OFFICER AT THE FDA IN THE DIVISION OF HEMATOLOGY PRODUCTS. I WAS GIVEN THE TASK TO DESCRIBE A TYPICAL CAREER PATH TOWARDS REGULATORY AFFAIRS AND I THINK ONE OF THE RECURRING THEMES WE'RE SEEING SHEER THAT REGULATORY AFFAIRS, GENERALLY, IT'S A VERY LARGE FIELD AND THERE'S MULTIPLE AREAS WITHIN REGULATORY AFFAIRS SUCH THAT IF YOU'RE INTERESTED IN CERTAIN THINGS, THAT THERE'S LOTS OF OPPORTUNITIES. I AM A CLINICIAN AND I AM IN A CLINICAL REVIEWER AT THE FDA. I DID MY TRAINING HERE AT NIH. I AM A PHYSICIAN. I WENT TO MEDICAL SCHOOL IN OHIO, AND DID MY RESIDENCY IN AT THE UNIVERSITY OF MARYLAND IN BALTIMORE AND WHEN I INITIALLY STARTED EVERYTHING, I REALLY HAD NO PLANS OF GOING INTO THIS FIELD AT ALL. I SAW MYSELF AS A CLINICIAN AND PLANNED TO PURSUE PATIENT CARE. DURING MY FELLOWSHIP HERE, I DID A FELLOWSHIP IN HEMATOLOGY AND CRITICAL CARE. WHEN I WENT THROUGH RESIDENCY PROGRAMS, I WANTED TO DO JUST HEE MOCK AND I FOUND THAT THE PATIENT INTERACTIONS WERE VERY INTERESTING AND I THOUGHT AS WELL THAT HEMATOLOGY WAS JUST SUCH APP INTERESTING FIELD. IT REALLY HELD MY INTEREST AND THAT WAS WHY I INITIALLY DECIDED TO DO THAT, BUT I FOUND THAT I WAS ALSO ENJOYED CRITICAL CARE. SOMEWHAT OF AN UNCONVENTIONAL UNION. AND NIH WAS ONE OF THE FEW PLACES I COULD DO BOTH, SO IT WAS INITIALLY HOW I ENDED UPCOMING HERE AND AT NIH EVERYONE'S VERY EXCITE AID BOULT THAT. IT'S NOT UNCOMMON TO MIX AND MATCH THINGS TOO BAD HAVE OPPORTUNITIES TO PURSUE UNIQUE TRAINING PATHS HERE. SO I CAME HERE AND I DID FELLOWSHIP TRAINING IN BOTH HEMATOLOGY AND CRITICAL CARE AND ALSO THERE'S AN NIH DUKE MASTERS PROGRAM IN WHICH YOU CAN OBTAIN MASTERS IN CLINICAL RESEARCH, AND I FOUND THAT I REALLY ENJOYED CLINICAL TRIALS THROUGH MY EXPERIENCE HERE AT NIH, AND PART OF MY FELLOWSHIP TRAINING YOU'RE INVOLVED WITH THE CLINICAL TRIALS BECAUSE EVERYTHING HERE IS REALLY PROTOCOL-DRIVEN AT NIH FROM THE SCIENCES DONE IN THE LAB TO TRANSLATING THAT INTO CLINICAL TRIALS WITHIN THE CLIN CLINIC WITHIN THE CLINICAL CENTER, AND SO THE DUKE MASTERS CLASS REALLY COMPLIMENTED THAT. IT SDIS CONSISTS OF DIDACTIC COURSE WORK IN CLINICAL TRIALS DESIGN, STATISTICS AND [INDISCERNIBLE] IN TERMS OF TRIAL MANAGEMENT AND A LOT OFS A ASPECTS THAT ARE IMPORTANT AS INVESTIGATOR IN TERMS OF SETTING UP YOUR TRIAL DESIGN BUT ALSO COMPLIMENTED A LITTLE BIT IN TERMS OF THE CRITERION AND SOUNDNESS OF CLINICAL TRIAL DESIGN THAT THE FDA AND REGULATORY AGENCIES LOOK FOR. SO IT WAS A REALLY GOOD KAFRMENT COMPLIMENT, ACTUALLY AND ANOTHER OPPORTUNITY THAT I HAD HERE AT NIH THROUGH DR. WONG IN THE CLIN PHARM DEPARTMENT, THEY HAVE A A PARTNERSHIP WITH THE FDA THAT I WAS ABLE TO SPEND A MONTH AT THE FDA WHILE I WAS DOING ANY NIH FELLOWSHIP, AND, UH, I FOUND WHEN I WENT AND SPENT MY MONTH AT THE FDA AS A FELLOW HERE THAT I WAS REALLY INTEREST AND FOUND THAT EVERYTHING THAT THE FDA WAS CONCERNED ABOUT IN TERMS OF TRIAL DESIGN AND THE PHYSICAL ARE RIGOR WAS REALLY A COMPLIMENT TO EVERYTHING THAT I FOUND REALLY INTERESTING IN THE NIH DUKE MASTERS PROGRAM AND THEN ALSO WHAT I WAS SEEING AS WELL IN THE CLINICS. SO I INITIALLY, YOU KNOW, THOUGHT THAT, WELL, HOW AM I GOING TO BALANCE THAT? YOU KNOW, I ENJOY PATIENT CARE AND ENJOY HAVING MEANINGFUL INTERACTIONS WITH MY PARENT PATIENTS BUT I ENJOY CLINICAL TRIAL DESIGN AS WELL. AS I SPENT MORE TIME TALKING WITH PEOPLE AS WELL I FELT THAT ACTUALLY THE FDA WOULD PROVIDE ME WITH A GOOD MIX AND AN OPPORTUNITY TO DO BOTH. SO AS A CLINICAL REVIEWER AT THE FDA, AS YOU'VE HEARD MENTIONED EARLIER THAT THE GOALS OF THE FDA ARE REALLY TO ENSURE THE PUBLIC HEALTH AND ENSURE PUBLIC SAFETY AND TO EVALUATE THE FOOD AND DRUGS AND TO MAKE SURE THAT THEY ARE SAFE. AND SO AS A CLINICAL REVIEWER THE DIVISION OF HEMATOLOGY, I REVIEW INDs, THAT'S INVESTIGATIONAL NEW DRUG APPLICATIONS. IF SOMEONE, FOR EXAMPLE IN THE CLINICAL CENTER WHEN YOU'RE INITIATING A CLINICAL TRIAL, YOU HAVE TO SUBMIT YOUR PROPOSAL, THE CHEMISTRY, MANUFACTURING, AND CONTROLLED ASPECTS AND PHARM TOX PRECLINICAL TRIALS TO SUPPORT THE STUDY YOU'RE GOING TO CONDUCT AND THEN ALSO A DRAFT OF THE PROTOCOL. AS A CLINICAL REVIEWER ON THE TEAM AND I SHOULD EMPHASIZE THAT IT IS A MULTI-DISCIPLINARY TEAM, MY JOB IS TO REVIEW THE PROTOCOL, TO MAKE SURE THAT IT'S GOING TO BE SAFE IN TERMS OF THE ASPECTS OF THE TRIAL AND THE WAY IT'S DESIGNED AND TO A LESSER EXTENT ALSO TO MAKE SURE THAT THE TRIAL AS THEY'VE DESIGNED IT WILL BE ABLE TO MEET GOALS THAT THEY'VE SET OUT. AND THAT'S JUST, YOU KNOW, THE INITIAL IND PHASE. TYPICALLY YOU FOLLOW A PRODUCT ALONG IN ITS DEVELOPMENT SO, UM, SPONSORS, INDUSTRY WILL COME IN WITH END-OF-PHASE-1 MEETINGS OR THEY'LL COME IN AGAIN TO THE AGENCY AND REQUEST INFORMATION AS THEY CONTINUE ALONG THEIR DRUG DEVELOPMENT, AND THEN EVENTUALLY THE IDEA IS THAT YOU FOLLOWED THIS PRODUCT ALONG AND THEN ONCE THEY'VE COMPLETED ALL THEIR PHASE ONE, PHASE TWO, PHASE THREE TRIALS YOU WILL THEN REVIEW THEIR APPLICATION FOR APPROVAL, THE NEW DRUG APPLICATION NDA AND THAT'S GENERALLY A VERY LARGE SUBMISSION, THOUSANDS AND THOUSANDS OF PAGES WITH DATA AND YOU'RE REVIEWING IT TO THE SOURCE DATA LEVEL SO THAT SUCH THAT I'M LOOKING AT THE INDIVIDUAL PATIENT DATA AS WELL AND ANALYZING THE DATASETS USING STATISTICAL PROGRAMS AND FROM THE DATA THAT THEY'VE SUPPLIED AND THEN ALSO LOOKING AT THE TRIAL, JUST LARGER. BUT AGAIN THE PRIMARY FOCUS IS SAFETY. SO IN MY JOB THERE'S A LOT OF REVIEW OF TRIALS AND A LOT OF PAPERWORK, AND SOMETIMES THAT MAY SEEM DAUNTING. HOW DID YOU MAKE THIS TRANSITION FROM CLINICAL TO REVIEWING TRIALS? BUT IT'S EXTREMELY INTERESTING AND NOT EVERYONE WOULD FIND IT INTERESTING, BUT I FIND IT VERY INTERESTING. ADDITIONALLY, THERE'S LOTS OF OPPORTUNITIES. YOU'RE COLLABORATING, YOU'RE STILL ON A MULTI-DISCIPLINARY TEAM WITH OTHER ASPECTS OF THE REGULATORY REVIEW OR OTHER REVIEWERS AND SO IT IS REALLY COLLABORATIVE AS WELL AND YOU GET TO HAVE WHAT SEEMS LIKE A REALLY LARGE IMPACT AT A BROAD IN TERMS THAT YOU'RE PROTECTING THE PUBLIC HEALTH GENERALLY. SO, UH, I WOULD ALSO MENTION THAT THE FDA IS BEEN A WONDERFUL PLACE TO WORK IN THAT THEY WANT THE REVIEWERS, THEIR CLINICAL REVIEWERS TO BE RELEVANT. SO THEY PROVIDE THE OPPORTUNITY FOR AS PART OF YOUR FDA JOB TO CONTINUE TO HAVE INVOLVEMENT IN THE COMMUNITY IN CLINICS, ETC. SO AS PART OF MY FDA JOB, I HAVE PROFESSIONAL DEVELOPMENT WHERE ONE DAY A WEEK I CAN GO AND WORK IN A CLINIC OR WHEREVER ELSE. I COME BACK AS PART OF MY FDA JOB ONE DAY A WEEK AND STILL INVOLVED IN MY RESEARCH I WAS DOING AS A FELLOW HERE AT NIH. SO AND AS AN EXAMPLE I'M CURRENTLY THE PRINCIPLE INVESTIGATOR ON A PHASE TWO TRIAL, AND IT'S BEEN A WONDERFUL OPPORTUNITY BECAUSE I ACTUALLY FEEL LIKE I GET TO SEE THINGS ON BOTH SIDES IN THAT, YEAH, I'M REVIEWING PROTOCOLS AND SUBMISSIONS FROM INDUSTRY OR FROM OTHER SPONSORS OR OTHER INVESTIGATORS, AND YET ON THE FLIP SIDE THE TOOLS AND THE SKILLS THAT I'VE LEARNED AT THE FDA IN TERMS OF HOW TO REALLY CONDUCT A SOUND TRIAL I'M ABLE TO APPLY THAT, THEN, IN MY OWN TRIAL THAT I'M CONDUCTED HERE AT THE NIH AND THEN ALSO JUST IT'S BEEN AN INVALUABLE EXPERIENCE ON BOTH ENDS, ACTUALLY. SO THE OTHER ASPECT THAT I JUST WANTED TO TALK BRIEFLY UPON IS JUST I FEEL LIKE AT NIH YOU HAVE A VAST NUMBER OF OPPORTUNITIES TO REALLY GET INTO THE REGULATORY FIELD. FOR A GOOD NUMBER OF PEOPLE I WOULD RECOMMEND CONSIDERING TAKING SOME OF THE NIH EITHER THE NIH DUKE MASTERS PROGRAM, ALTERNATIVELY, THERE'S A LOT OF PROGRAMS WITHIN NIH LOOKING AT JUST STRUCTURE OF TRIAL DESIGN. THERE'S A PHARM TOX CLASS THAT'S OFFERED HERE AT NIH FOR INDIVIDUALS THAT ARE INTERESTED IN LEARNING MORE INFORMATION ABOUT THAT AREA IN PARTICULAR, UM, AND THEN ALSO THERE'S OPPORTUNITIES IN TERMS OF DOING ROTATION AT THE FDA. THERE'S A LOT OF COLLABORATION BETWEEN NIH AND FDA AND IF IT'S SOMETHING YOU'RE REALLY INTERESTED IN TO PURSUE THAT FURTHER. SO I THINK THAT'S IT FOR NOW AND I'LL IF YOU HAVE ANY QUESTIONS LATER. [APPLAUSE] >> AGAIN, MY NAME IS ELIZABETH GLAZE. I'M GOING TO REITERATE FIRST WHAT SOMETHING THAT ALL THE OTHER PANELS HAVE STATED BEFORE AND THAT IS REGULATORY AFFAIRS IS A VERY BROAD FIELD. IN MY GROUP AT NIAID, I'M @ @ THE NATIONAL INSTITUTE OF ALLERGIES AND INFECTION DISEASES HERE AT THE NIH IN THE DIVISION OF OFFICE OF REGULATORY AFFAIRS AND WITHIN THE GROUP WE ARE 20 MEMBERS STRONG AND THERE ARE PEOPLE WITH VERY DIFFERENT AREAS OF EXPERTISE. FOR INSTANCE, WE HAVE FOLKS THAT FOCUS ON COORDINATING, PREPARING, REVIEWING, DEREGULATORY SUBMISSION TO THE FDA. WE HAVE FOLKS THAT SPECIALIZE IN ASSAY DEVELOPMENT, ASSAY WORK, IN MANUFACTURING, FORMULATION, PHARMACOKINETICS, AND MY AREA OF EXPERTISE IS TOXICOLOGY. SO UNLIKE MOST OF THE OTHER PANELISTS, I DON'T HAVE A CERTIFICATE IN REGULATORY AFFAIRS SCIENCE, BUT I DO HAVE A CERTIFICATE IN TOXICOLOGY, SO I CHOSE TO HONE MY SKILLS IN TOXICOLOGY AS OPPOSED TO MORE BROAD REGULATORY AFFAIRS OR STRATEGIC REGULATORY AFFAIRS PLANNING. AND SO THE CERTIFICATE OF SORTS IS THAT I'M CERTIFY BID THE AMERICAN BOARD OF TOXICOLOGY. SO I UNDERGO AND SIT THROUGH AN EXAM AND HAD TO JUST QUITE RECENTLY RECERT FIE. OKAY. SO, UM, WHAT ROLE DOES A TOXICOLOGIST HAVE IN REGULATORY AFFAIRS? WELL, THINK OF PRODUCT DEVELOPMENT AS THE PREVIOUS SPEAKER JUST MENTIONED, UM, IF THE PACKAGE IS -- IF ONE IS PUTTING TOGETHER A PACKAGE TO SUPPORT A PRODUCT FOR IND TO GET INTO PHASE ONE CLINICAL TRIAL, UM, THERE WILL BE A NUMBER OF STUDIES THAT NEED TO BE CONDUCTED IN ANIMALS TO DEMONSTRATE SAFETY OR TO IDENTIFY THE ADVERSE EFFECTS OF THAT PRODUCT. FOR INSTANCE, IF THE COMPOUND IS AN ANTIBIOTIC FOR IN AMY KNOW GLYCOCRIED GLASS FOR PLAGUE OR IF YOU'RE IN AREA OF BIOTHREAT, YOU NEED TO KNOW THAT AMY KNOW GLYCOCRIEDS AND DRUGS IN THAT CLASS WILL CAUSE KIDNEY DAMAGE, HEARING LOSS, AND SO WHEN THE STUDIES ARE DESIGNED, THE TOXICOLOGISTS NEED TO MAKE SURE THAT THE APPROPRIATE PARAMETERS ARE INCLUDED IN THE STUDIES. SO YOU'D BE INVOLVED FROM THE VERY START IN TERMS OF DESIGNING OR REVIEWING THE PRECLINICAL PROTOCOLS. AFTER THE STUDIES ARE ONGOING, YOU WOULD REVIEW THE INTERIM DATA AND PERHAPS FEEDBACK THE INFORMATION TO YOUR STAKEHOLDERS MAYBE DECISIONS NEED TO BE MADE TO CONTINUE DEVELOPMENT OF THAT PRODUCT OR TO STOP DEVELOPMENT OF THAT PRODUCT BASED ON WHAT YOU SEE; RISK VERSUS BENEFIT. PERHAPS THE RISK IS GREATER THAN THE PERCEIVED BENEFIT. WHEN THE STUDY REPORTS ARE AVAILABLE, YOU MIGHT HAVE TO REVIEW THOSE REPORTS TO MAKE SURE THAT THE DATA SUPPORT THE CONCLUSIONS THAT ARE DRAWN FOR THAT PARTICULAR STUDY. AT THE END, YOU MIGHT HAVE TO LOOK AT THE ENTIRE PACKAGE. HAVE WE PREPARED AN APPROPRIATE PACKAGE TO SUPPORT THE PRODUCT AS IT'S INTENDED FOR CLINICAL USE? OF COURSE, SOME OF THIS WOULD HAVE TO OCCUR EARLIER. DO YOU HAVE THE APPROPRIATE ROUTE OF ADMINISTRATION IN OUR ANIMAL STUDY THAT'S SIMILAR TO OR EXACTLY THE SAME AS THE INTENDED ROUTE IN THE CLINICAL TRIAL? DO YOU HAVE THE APPROPRIATE DOSE? DO YOU HAVE THE APPROPRIATE SAFETY MARGIN THAT WILL SUPPORT STARTING AT A NON-TOXIC DOSE IN HUMANS FOR NON-CANCER DRUGS, UM, AND ESCALATING UP? AND I SAY, I SPECIFY FOR NON-CANCER DRUGS STARTING AT A NO-ADVERSE EFFECT LEVEL BECAUSE FOR CANCER DRUGS YOU ACTUALLY START MUCH HIGHER BECAUSE THE RISK VERSUS BENEFIT IS QUITE DIFFERENT IN TERMS OF TERMINALLY ILL PATIENTS. SO YOU WOULD START AT OR PROPOSE A STARTING DOSE FOR THE CLINIC AT MAYBE 1/10 OF THE MAXIMUM TOLERATED DOSE IN THE MOST SENSITIVE SPECIES. SO WHEN YOU'RE REVIEWING YOUR PACKAGE, YOU NEED TO MAKE SURE THAT THE STUDIES AS DESIGNED ARE APPROPRIATE TO SUPPORT THE CLINICAL TRIAL. THAT YOU HAVE IF IT'S A SMALL MOLECULE, YOU MIGHT NEED RODENT AND NON-RODENT SPECIES AND THEN YOU WOULD LOOK AT THE MOST OR THE MORE SENSE TIFF OF THE TWO SPECIES AND CHOOSE SOME FACTOR, SOME FRACTION OF THE NO-EFFECT DOSE, NO-EFFECT LEVEL DOSE FOR NON-CANCER AGENTS, AGAIN, AND PROPOSE THAT AS YOUR CLINICAL STARTING DOSE. SO HOW DID I GET HERE? THAT'S PRETTY MUCH WHAT I DO. DO A LOT OF READING. WELL, HOW DID I GET HERE? I STARTED OFF DOING BASIC RESEARCH LIKE I GUESS EVERYONE ELSE HERE, AND I DECIDED THAT I DIDN'T FOR ME, I DIDN'T LIKE IT AS MUCH BUT I STILL LOVED SCIEN SCIENCE SO I DIDN'T WANT TO LEAVE THE SCIENTIFIC FIELD, BUT I WANTED TO STEP BACK A BIT AND NOT WORK ON A PARTICULAR PATHWAY OR A PARTICULAR ENZYME. SO NOW I LOOK AT WHOLE SYSTEMS, AND TO ME IT'S FASCINATING. I WOULDN'T SELECT ANY OTHER JOB, SO I STARTED OFF AT THE NCI HERE AT NIAID BUT I WAS A TOXICOLOGIST, SOY -- SO I USED TO PLAN THE PRECLINICAL STUDIES, AND WELL ACTUALLY PRIOR TO THAT I HAD TO DESIGN THE STUDIES, LAY OUT THE PLAN FOR MY INTENTION FOR THE LIST OF STUDIES THAT WILL BE REQUIRED TO SUPPORT THE, UM, CLINICAL TRIAL AS THE INVESTIGATOR HAS DECIDED. AND THEN DESIGNED THE STUDIES, REVIEW THE INTERIM DATA, FEED THE INFORMATION BARK TO THE STAKEHOLDERS, WHICH WOULD BE ANY SUPERVISOR AND HIS SUPERVISOR, WRITE THE TOX SUMMARY THAT WOULD BE INCLUDED IN THE IND APPLICATION, PROPOSE A CLINICAL STARTING DOSE, AND, UM, ANSWER ANY QUESTIONS THAT THE FDA REVIEWERS HAVE ONCE THEY RECEIVE THE PACKAGE. AND THAT EXPERIENCE WAS INVALUABLE. I MEAN, SURE, THERE ARE AREAS WHERE ONE CAN GET STARTED IF ONE WANTED TO LEARN ABOUT SOME OF THE GUIDANCE DOCUMENTS ON HOW TO PLAN SOME OF THESE STUDIES. FEEL FREE TO JUST GO TO THE FDA WEB SITE, FDA.GOV, AND THERE'S A LINK WHERE YOU CAN LOOK AT SAFETY AND TOXICOLOGY GUIDANCE DOCUMENTS FOR DRUG DEVELOPMENT. AND THAT'S INVALUABLE. I DON'T WANT TO KNOCK IT, BUT ALSO THE EXPERIENCE IN DEALING WITH DIFFERENT TYPES OF COMPOUNDS, IN NETWORKING WITH OTHER PEOPLE IN DRUG DEVELOPMENT HAS BEEN INVALUABLE. SO I'LL LEAVE IT THERE. [APPLAUSE] >> [LOW AUDIO]. >> [LOW AUDIO]. >> SO IT DEPENDS ON THE COMPANY. MOST OF MY EXPERIENCE I WOULDN'T SAY A STRICT DEMARCATION BETWEEN THE TWO. AFFAIRS PEOPLE TEND TO COME FROM TOXICOLOGY, THEY COME FROM THE SCIENCES AND THEY HAVE PRETTY INTIMATE KNOWLEDGE ABOUT WHAT GOES INTO THE APPLICATIONS, SO THERE'S PROBABLY A LOT OF CONTENT KNOWLEDGE. APPLICATIONS TENDS TO BE FOCUSED ON SUBMISSIONS, TECHNOLOGY AND ARCHIVE SPOPG THE TECHNOLOGY THAT HELPS GET THOSE SUBMISSIONS IN, THE ACTUAL SUBMISSION WORK, ITSELF, AS WELL AS BEING SORT OF KNOWLEDGE MANAGEMENT EXPERTS, KNOWING WHERE THE ARCHIVED MATERIAL GOES, HOW TO RETREAT IT, AND WHAT IT'S USED FOR. >> UM, I HAVE A QUESTION FOR THE, UM, PANELISTS FROM FDA AND NIAID. IS THERE ANY ON-CAMPUS RESEARCH? YOU MENTIONED THAT IT'S A FAST-PACED FIELD, THINGS ARE CHANGING A LOT. IS THERE ANYTHING LIKE A JOURNAL CLUB OR AN INTEREST GROUP LIKE THAT, THAT'S EITHER ON CAMPUS OR AT THE WHITE OAK CAMPUS THAT PEOPLE CAN GO AND LISTEN TO TALKS? >> NOT SO MUCH -- I DON'T KNOW OF A JOURNAL CLUB, PER SE, BUT WE DEFINITELY HAVE WEEKLY SEMINARS AND STUFF WHERE WE HAVE INVESTIGATORS THAT ARE EITHER PUSHING A PRODUCT AND WANT BUY INAND WANT NIAID'S SUPPORT OR INVITED GUESTS. IN PARTICULAR WE HAVE SOMEONE THAT'S GIVING AN OVERVIEW BUT IT'S A BASIC OVERVIEW BUT SOME OF YOU MIGHT BE INTERESTED. IT'S IN PRECLINICAL DRUG DEVELOPMENT AND IT GOES THROUGH ALL THE DIFFERENT STAGES OF DRUG DEVELOPMENT. IF ANYONE IS INTERESTED, FEEL FREE TO E-MAIL ME. MY E-MAIL AIDE DRESS IS GLAZEE@MAIL@NIH.GOV. THEY'RE DEFINITELY SEMINARS THAT ARE AVAILABLE TO HELP US TO LEARN ABOUT PRODUCTS THAT ARE COMING DOWN THE PIPELINE OR KEEP WITH OUR CONTINUING EDUCATION. MAINTAIN CONTINUING EDUCATION. >> SO ACTUALLY FDA DOES HAVE LIKE A OPEN TOWN HALL MEETINGS IN WHICH IT'S OPEN TO THE PUBLIC AND THEY LIST THOSE ON THE WEB SITE, SO IF YOU WANT TO FIND OUT THE LATEST ON ANY GUIDANCE OR ANY DISCUSSION THAT THEY'RE HAVING TO THEY'LL ACTUALLY HAVE CERTAIN TOPICS AND YOU CAN ACTUALLY SEE THEM, BUT THERE'S AN iPOD APPLICATION THAT I BELIEVE IT'S CALLED FDA NEWS AND THEY'LL ACTUALLY LIST EVERYTHING THAT'S COMING FOR THE UPCOMING MONTH THAT'S OPEN TO THE PUBLIC AND IT'S IN ONE OF THE BUILDINGS ON THE WHITE OAK CAMPUS. >> UM, I MIGHT HAVE MISSED THIS, BUT IS THERE LIKE A DETAIL OPPORTUNITIES THAT NIH POST DOCS CAN DO AT THE FDA? I'M NOT QUITE SURE. >> I THINK THAT THERE ARE. UM, I THINK SOME OF IT IS PARTLY KNOWING THE VARIOUS INDIVIDUALS, BUT, UM, WHAT I WOULD DO IS I WOULD E-MAIL LATORA, HE HAS A PROGRAM THROUGH THE CLIN PHARM DEPARTMENT HERE AT NIH THAT HAS OPPORTUNITY FOR ROTATION AT THE FDA, UM, AND, UM, I'M OBVIOUSLY NOT A CLINICAL PHARMACOLOGIST, BUT IT'S OPEN TO A WIDE RANGE OF DISCIPLINES IS ANY UNDERSTANDING. EVEN IF HE MAY NOT BE APPLICABLE OR BE ABLE TO DO THIS PROGRAM BECAUSE IT IS A TWO-MONT REQUIREMENT, HE MAY KNOW OF OTHER OPPORTUNITIES FOR ROTATIONS OR THINGS LIKE THAT.H REQUIREMENT, HE MAY KNOW OF OTHER OPPORTUNITIES FOR ROTATIONS OR THINGS LIKE THAT. >> THANK YOU. >> HI. YOU GUYS MENTIONED THERE WERE DIFFERENT TRAININGS ONE MAY TAKE TO GET INTO REGULATORY AFFAIRS. I GUESS ONE WAS MENTIONED A MASTERS IN REGULATORY AFFAIRS AND ANOTHER WAS THE RAPS CERTIFICATE. IS ONE OF THESE ADVANTAGEOUS OVER ANOTHER FOR SOMEONE WHO HAS POST DOCTORAL EXPERIENCE AND WANTS TO GET INTO REVIEW OF INDs OR EVEN WRITING INDs IN THE PHARMACEUTICAL COMPANIES? >> I THINK IF YOU ALREADY HAVE, UM, A Ph.D. THAT'S WHAT YOU'RE SAYING COMING FROM? YEAH. I MEAN, IN THAT CASE THEN, I THINK I WOULD RECOMMEND JUST TAKING THE REP EXAM BECAUSE THAT WILL BE THE QUICKEST WAY TO REALLY BUILD YOUR REGULATORY KNOWLEDGE AND, YOU KNOW, IT WILL DEFINITELY BE HELPFUL HAVING A Ph.D. IN TERMS OF JOB ENTRY AND BACKGROUND IN SCIENCE, BUT I THINK THE RACK EXAM WOULD BE THE MOST HELPFUL. >> TO ACTUALLY TO ADD TO THAT, SO YOU HAD MENTIONED THERE ARE THE MASTERS PROGRAMS. IT'S A BIG INVESTMENT UP FRONT, BUT AT THE SAME TIME, YOU DO HAVE, LIKE, THE RACK EXAM AND THERE'S ALSO SMALLER CERTIFICATE PROGRAMS IN WHICH CAN TAKE ABOUT A YEAR-AND-A-HALF OR A YEAR TO COMPLETE. ALL OF THEM -- THAT'S WHAT I WAS TALKING ABOUT -- IT'S HOW MUCH DO YOU WANT TO INVEST AND HOW WILLING ARE YOU TO MOVE TO THAT NEXT STEP AND THAT'S GETTING THAT BACKGROUND EXPERIENCE AND KNOWLEDGE AND AS JANICE MENTIONED T REPS EXAM DOES COVER ALL ASPECTS SO THAT'S PART OF THE ASPECT THAT THE U.S. GENERAL EXAM WILL COVER REFRG FROM DEVICES ALL THE WAY TO DRUGS AND HOW WOULD YOU APPROACH IT FROM A REALLY REGULATORY ASPECT? KEEPING IN MIND WITH REGULATIONS AND SO THAT'S IN ITSELF IS A CRASH COURSE ON INTRODUCTION AND ACTUALLY THE APPLICATION OF REGULATORY AFFAIRS, BUT IT'S AN EXTENSIVE EXAM, NOT SOMETHING THAT ONE WEEK YOU CAN PREPARE FOR IT. IT'S ACTUALLY SEVERAL MONTHS. I BELIEVE THEY OFFER IT TWICE A YEAR OR THREE TIMES A YEAR? >> I'M NOT SURE [LOW AUDIO]. >> BUT IF YOU GO TO THEIR WEB SITE IT'S JUST RAPS.ORG, I BELIEVE, BUT THEY HAVE A LOT OF INFORMATION THERE, AND EVEN GOING AS I MENTIONED GOING TO SOME OF THEIR MIXERS THAT THEY HAVE AND YOU'LL MEED METE A LOT OF PEOPLE IN THE FIELD AND THAT'S A GOOD WAY TO INTERACT AND FIND OUT WHAT AREA YOU'RE INTERESTED IN, BUT AS MENTIONED WITH THE Ph.D. SO YOU ALREADY SHOW THEM THAT YOU HAVE ANALYTICAL MINDSET, BUT IT'S SHOWING THAT YOU WANT TO ACTUALLY BUILD UP A LOT OF THE REGULATORY FRAMEWORK. SO, YEAH, THE EXAMS ARE VERY HELPFUL IF YOU'RE STARTING FROM GROUND ZERO. >> ONE OTHER THING TOO, NOW, THEY HAVE THESE RACK STUDY GROUPS, UM, WHICH THEY DIDN'T HAVE THAT WHEN I TOOK IT YEARS AGO, BUT IF YOU GO ON THE WEB SITE YOU CAN FIND THAT AND I WOULD ASSUME THAT WOULD BE VERY HELPFUL. I DON'T KNOW IF THEY'RE VIRTUAL OR FACE-TO-FACE, BUT A STUDY GROUP WOULD BE HELPFUL BECAUSE I JUST SPENT HOURS ALONE WITH THE CODE OF FEDERAL REGULATIONS AND IT WAS NOT FUN. [LAUGHTER] >> I THINK IT ALSO -- IF I COULD -- IT MIGHT ALSO DEPEND YOUR AREA OF INTEREST. ARE YOU INTERESTED IN REGULATORY STRATEGY, UH, LIKE PLANNING FOR THINKING ABOUT WHICH AGENCY TO SUBMIT AN APPLICATION AND MORE OF A BROADER KIND OF REGULATORY AFFAIRS FOCUS? OR, YOU MENTIONED WRITING IND INDs -- DID YOU MEAN PREPARING AND ASSEMBLING AN IND PACKAGE OR OVERSEEING THAT EFFORT, OR WRITING THE TOX SUMMARY OR -- >> [LOW AUDIO]. >> WRITING WHAT? THE TOX SUMMARY? >> [LOW AUDIO]. >> SO THERE ARE DIFFERENT PARTS, LIKE THERE'S THE CMC SEK THAT MIGHT FOCUS ON MANUFACTURING. THEN THERE'S THE TOXICOLOGY SECTION. THERE MIGHT BE ANOTHER SECTION WITH BACKGROUND INFORMATION. THEN THERE'S ALSO THE CLINICAL PROTOCOL SECTION. SO IT WOULD KIND OF HELP IN TERMS OF, YOU KNOW, AS YOU THINK ABOUT HOW YOU WANT TO -- WHICH PATHWAY YOU'D LIKE TO TAKE, IT WOULD HELP IF YOU HAD AN IDEA OF WHAT YOUR TRUE INTEREST IS. >> JUST TO CONTINUE ON THE SAME DISCUSSION, SO WHAT WOULD BE THE ENTRY LEVEL, FOR EXAMPLE, I'M ALSO POST DOC AND HAVE BIOLOGY [INDISCERNIBLE] WORKING WITH PROTEINS AND FOR SOME [INDISCERNIBLE] COMPANIES IT'S RACK EXAM AND BAUECAUSE WHEN I LOOK AT THIS FOR EXAMPLE REGULATORY AFFAIR AND [INDISCERNIBLE] THAT THEY REQUIRE ON LIKE [INDISCERNIBLE] SO I'M KIND OF OVERQUALIFIED FOR IT AND AT THE SAME TIME, THEY NEED LIKE, UH, LIKE TWO YEARS OF EXPERIENCE IN LABORATORY AFFAIRS, AND I'M THINKING, WHAT -- I MEAN, POTENTIALLY, I COULD I DON'T KNOW. SO AT THE SAME TIME I'M OVERQUALIFIED BUT I DON'T HAVE EXPERIENCE. WHAT WOULD BE LIKE A POSSIBLE ENTRY POSITION FOR ME? >> WELL, I THINK AGAIN IT DEPENDS ON YOUR AREA OF INTEREST. YOU MENTIONED PROTEINS. SO IF YOU'RE INTERESTED IN PRODUCTION OF PROTEINS OR ASSESSMENT, YOU KNOW, CHARACTERIZING PROTEINS, I MEAN, THERE'S PLENTY OF ROOM FOR FOLKS IN A LOT OF DIFFERENT AREAS OF DISCIPLINE AND SO THERE ARE CMC EXPERTS, FORMULATION EXPERTS. YOU KNOW, THINKING ABOUT A PRODUCT, WELL YOU CAN'T JUST INJECT HUNDRED PERCENT DSO INTO A HUMAN LIKE YOU CAN A MOUSE, THERE WILL BE SOME PROBLEMS. SO FORMULATION EXPERTS ARE REQUIRED AND AGAIN, TOXICOLOGISTS AND MEDICAL OFFICERERS. SO IT DEPENDS ON YOUR AREA OF INTEREST. >> I THINK FROM WHAT I'VE SEEN IN OUR REGULATORY AFFAIRS OFFICE IS THAT THE DOCTORAL EDUCATION CAN MAKE UP FOR SOME OF THAT EXPERIENCE. I KNOW MAYBE YOU'VE SEEN SOME THAT SAY Ph.D. AND TWO YEAR ES EXPERIENCE. THAT'S NOT ALWAYS THE CASE. YOU MAY START AS A MANAGER LEVEL, BUT THERE'S A LOT OF ROOM FOR GROWTH ESPECIALLY IF YOU HAVE THAT DOCTORAL DEGREE, THAT OR AN M.D., SKY'S THE LIMIT OR J.D. AND YOU COULD GO UP RISE UP PRETTY QUICKLY AS LONG AS YOU'RE, I THINK, TO DR. GLAZE'S POINT -- >> [INDISCERNIBLE]. >> I'M SORRY, SAY THAT AGAIN. >> I GUESS IT RISES TO INTERACTIVE LIKE HIGHER MANAGER AND LIKE THE SKY'S THE POSSIBILITIES. >> SURE, SURE. DEFINITELY. SOMEBODY BROUGHT UP SOMETHING ABOUT INFORMATIONAL INTERVIEW. JANICE. THAT'S SORT OF POSSIBILITY. YOU MIGHT TALK TO SOMEBODY HIGHER LEVEL AND SAY WHAT CAN I DO WITH WHAT I'VE GOT. >> ALSO, TOO, GET AROUND THE POSSIBLE BRICK WALL OF HAVING TO HAVE TWO YEAR'S EXPERIENCE, I THINK IF YOU FIND, IF YOU TARGET A COMPANY THAT'S DEVELOPING PROTEINS YOU CAN LEVERAGE YOUR SCIENTIFIC EXPERIENCE AND I THINK ANY COMPANY WOULD THAT'S DEVELOPING PROTEINS WOULD LOVE TO HAVE A REGULATORY PROFESSIONAL WITH YOUR BACKGROUND. >> [LOW AUDIO]. >> HOW COMMON IS IT FOR PEOPLE WITH THE Ph.D. WITHOUT PRIOR REGULATORY AFFAIRS GETTING HIRED EITHER AT FDA OR ANY OTHER INDUSTRY THAT REQUIRES -- LIKE I KNOW A LOT OF IT REQUIRES WORK EXPERIENCE. SO CAN WE LEVERAGE OUR POST DOC EXPERIENCE AND Ph.D. IN LIEU OF THE ON-THE-JOB TRAINING OR EXPERIENCE? >> WELL, I THINK YOU CAN. I THINK IT AGAIN GOES TO FINDING AN ORGANIZATION THAT, YOU KNOW, WOULD REALLY VALUE WHATEVER YOUR PARTICULAR SCIENTIFIC EXPERTISE IS. YOU KNOW, I PERSONALLY DON'T, I DON'T KNOW OF Ph.D.s THAT COME IN AT LIKE A LATORY ASSOCIATE LEVEL -- REGULATORY ASSOCIATE LEVEL, BUT I USUALLY RARELY TAKE NO FOR AN ANSWERS. IF YOU SHOW THEM HOW YOU CAN BE VALUABLE TO THEM, UM, I THINK IT'S POSSIBLE TO, YOU KNOW, TO TALK YOUR WAY INTO ANY JOB, ULTIMATELY. [LAUGHTER] >> I WOULD ALSO ADD -- NOT ADVOCATING THIS -- BUT SOMETIMES JUST GETTING YOUR FOOT IN THE DOOR IS THE FIRST STEP AND I THINK AS WELL HERE AT NIH YOU DO HAVE A LOT OF OPPORTUNITIES TO MeSH AND INTERACT WITH THE FDA. I DO KNOW INDIVIDUALS WHO HAVE COME TO THE FDA WHO HAVE DONE A POST DOC AND DONE VARIOUS POSITIONS WHETHER IT BE TOXICOLOGY OR CMC AS WELL. UM, SO, AND I HAVE COME SOME EVEN FROM NIH. SO I THINK THERE ARE OPPORTUNITIES FOR THAT, AND THEN AS WELL, I THINK LOOKING AT WHERE PEOPLE GO FROM THE FDAA LOT OF PEOPLE DO USE THE FDA AS A STEPPINGSTONE OR TO GO TO INDUSTRY AND THAT AFTER YOU HAVE THE EXPERIENCE OF WORKING AT THE FDA, YOU SORT OF KNOW WHAT THE FDA WANT AND THEN HELPFUL TO INDUSTRY SAYING WELL THAT'S THE AGENCY THEY'RE CATERING TO ON ONE SIDE. SO I THINK SOMETIMES YOU JUST HAVE TO THINK ABOUT WHAT AVENUES YOU HAVE OPEN TO YOU. >> I JUST WANT TOO FURTHER ECHO THAT POINT TO DROOIFT HOME IS THAT HAVING EXPERIENCE HERALITY NIH, FDA, COMING FROM MY PERSPECTIVE WHICH IS INDUSTRY IS HIGHLY VALUABLE FOR THE SAME POINT NICOLE MADE IS THAT WE LOOK AT YOU AS SOMEBODY WHO MAY HAVE KNOWLEDGE THAT -- I DON'T WANT TO CALL IT INSIDE KNOWLEDGE OR ANYTHING LIKE THAT -- BUT SAME CONCEPT. THE IDEA THAT YOU MAY HAVE SOME KNOWLEDGE OF THE INNER WORKINGS HERE THAT ARE GOING TO BE VALUABLE AND TO ECHO JANICE'S POINT SO THAT S THAT YOU MAY NOT HAVE A LOT OF EXPERIENCE BUT GETTING YOUR RAC OR WORKING TOWARD SOMETHING LIKE THAT, THAT THE EXPERIENCE DOESN'T HAVE TO NECESSARILY SHOW. >> THAT'S WHERE EXPERIENCE AT A CONTRACT RESEARCH ORGANIZATION CAN BE HELPFUL. IF YOU'RE REALLY STYMIED BY HAVING TO HAVE ONE OR TWO YEAR'S EXPERIENCE, UM, YOU CAN GO TO A CONTRACT RESEARCH ORGANIZATION AND YOU'VE JUST BRIDGED THAT GAP. >> YEAH. SO DON'T BE DISCOURAGED WHEN YOU SEE THAT THEY WANT TWO YEARS OR THREE YEARS OF EXPERIENCE. WHEN THEY'RE ASKING FOR TEN, OKAY, THAT'S SOMETHING ELSE. IT'S DIFFERENT LEVEL WHAT THEY'RE WANTING, BUT, IT COMES DOWN TO NARROWING DOWN WHAT YOU WANT TO DO. SO I KNOW AT FDA THEY HIRE REVIEWERS; TOXICOLOGY REVIEWERS, PHARM TOX THAT HAVE Ph.D.s. IF YOU'RE STRONG WITH STATISTICS, THERE'S A LOT OF STATISTICIANS COMING FROM NIH. SO IT JUST DEPENDS WHICH AVENUE YOU WANT TO GO INTO AND ARE YOU LOOKING MORE ON THE REVIEW SIDE OR MOVING MORE TOWARDS LIKE A COMPLIANCE SIDE IN WHICH YOU'RE ACTUALLY LOOKING AT INSPECTIONS AND RECALLS? THAT'S THE BRANCH WHERE I'M IN, SO I'M MORE NOT ASSOCIATED WITH THE REVIEW SIDE, BUT I KNOW THAT WITHIN JUST THE RECALLS AND THAT THEY'RE LOOKING FOR PREVIOUS EXPERIENCE, BUT AT THE SAME TIME IT GOES SHOW THAT YOU HAVE THAT YOU'RE ACTUALLY PROACTIVELY LOOKING AND DOING SOMETHING ABOUT IT. YOU KNOW, YOU'RE TAKING THAT EDUCATION, TAKING THOSE CLASSES, YOU'RE GETTING THAT EXPERIENCE AND IT COMES TO NETWORKING. DAVID MENTIONED LINKEDIN. EVERYBODY HAS ONE OF THOSE ACCOUNTS? RIGHT? YES, NO, HANDS? NO, YOU DON'T HAVE TO. OR AT LEAST TWITTER. BUT IT'S REALLY MAKING THAT DETERMINATION THAT YOU'RE READY TO MAKE THAT MOVE AND I KNOW BEING IN A POST DOC POSITION IT'S, IT CAN BECOME A COMFORTABLE POSITION THAT FOR A FIRST YEAR, TWO YEARS, AND IT BECOMES ROUTINE THAT YOU KNOW, OKAY, TODAY YOU'RE GOING TO DO THIS. THE EXPERIMENTS WILL CHANGE OR YOU CAN SET THEM OUP AND THERE'S A LOT MORE FREEDOM, BUT THAT, AND SOMETIMES IT'S APPREHENSIVE ABOUT MOVING TO ANOTHER AVENUE OR MAKING THAT TRANSITION AND THAT CAN BE SCARY AT POINT BECAUSE YOU DON'T KNOW, WELL, AM I GOING TO ENJOY IT? IT'S SOMETHING I DO AND THAT GOES TO THE INFORMATIONAL INTERVIEWS, YOU KNOW, TALKING TO PEOPLE AND FINDING OUT WHAT'S YOUR DAY LIKE. IS THAT SOMETHING YOU'D ENJOY. GETTING THAT MAYBE ONE DAY YOU'LL GET AN EXTRA GRAY HAIR THAT YOU DIDN'T REALLY WANT AT THAT POINT IN TIME, BUT, UH, IT JUST COMING TO KNOWING WHAT YOU WANT AND THAT GOES THROUGH RESEARCH AND TAKING THE CLASSES AND JUST TALKING TO PEOPLE AND NETWORKING. BUT DON'T GET DISCOURAGED BECAUSE YOU SEE THAT. ALL APPLICATIONS ARE GOING TO ASK FOR EXPERIENCE. ALL THOSE JOB -- THAT ONE I SHOWED WAS FOUR YEARS. OF COURSE THAT WAS AT THE SENIOR LEVEL BUT THAT JUST GOES INTO FORMULATING A CAREER GOAL AND HAVING A CLEAR PATH OF THE DIRECTION YOU WANT TO GO IN. SO BUT IT'S NOT GOING THE HAPPEN OVERNIGHT. IT'S SOMETHING THAT YOU REALLY HAVE TO BE WILLING TO MAKE THAT CHANGE AND MOVE AWAY FROM YOUR COMFORT ZONE. >> SO, UM, JUST TO REITERATE WHAT JANICE SAID, STARTING AT A CRO, LIKE THERE MIGHT BE AVENUES THAT ONE COULD PURSUE BEFORE GETTING INTO REGULATORY AFFAIRS, EITHER STARTING AT A CRO AND THERE ARE MANY OF THEM. I THINK MOST DRUG COMPANIES IF NOT ALL WHEN IT COMES TO DOING THE DEFINITIVE STUDIES T LAST STUDY TOSS DEMONSTRATE SAFETY OR IDENTIFY THE ADVERSE EFFECTS OF PRODUCTS GO TO CROs TO HAVE THEIR WORK DONE, OR WORKING AS FORMULATIONS EXPERT IF THAT'S YOUR INTEREST, WORKING AS CHEMISTS IF THAT'S YOUR INTERESTS OR AS A TOXICOLOGIST AND THEN MAKE YOUR WAY TO REGULATORY AFFAIRS BECAUSE UNLESS YOU HAVE A MEDICAL DEGREE IT WILL PROBABLY BE VERY DIFFICULT FOR YOU TO WRITE CLINICAL PROTOCOLS. I MEAN, LET'S FACE FACTS. IT PROBABLY WOULD BE DIFFICULT FOR TO YOU BE A MEDICAL OFFICER AT THE FDA REVIEWING CLINICAL PROTOCOLS UNLESS YOU HAVE A MEDICAL DEGREE, AND MY COPANELISTS CAN WEIGH IN. SO, YOU KNOW, THERE ARE OTHER PATHS THAT YOU CAN TAKE ALONG THE WAY IN PREPARATION FOR A JOB IN REGULATORY AFFAIRS KIND OF OVERSEEING THAT EVERY TIME. MAYBE, YOU KNOW, FIVE OR SO YEARS DOWN THE LINE, TEN YEARS DOWN THE LINE. >> HI. THIS IS FOR THE GOVERNMENT PEOPLE. CAN YOU DO A REGULATORY AFFAIRS IN GOVERNMENT IF YOU'RE NOT A U.S. CITIZEN? [LAUGHTER] >> YES, BUT WITH LIMITATIONS. SO WHEN YOU SAY NOT A U.S. CITIZEN, SO YOU HAVE DIFFERENT -- LIKE I DON'T WANT TO GO INTO IMMIGRATION STATUS, BUT YOU HAVE DIFFERENT LEVELS. SO YOU HAVE LIKE NON-CITIZEN, PERMANENT RESIDENT, AND THEN YOU ALSO HAVE -- WHAT WAS THE OTHER ONE? NON-RESIDENT ALIEN, I BELIEVE SO. SO THE THING IS WHEN YOU'RE AT THE FDA SO YOU HAVE ACCESS TO PROPRIETARY INFORMATION, SO YOU'RE SEEING EITHER REVIEWED DATA THAT'S SOLE THAT BELONGS TO THE SPONSOR, SO IT'S ALL, YOU KNOW, YOU HAVE TO SIGN A DISCLOSER FORM AND EVERYTHING, AND THAT BY LAW THEY CANNOT, UNLESS YOU ARE A PERMANENT RESIDENT OR A U.S. CITIZEN, YOU CAN'T BE PRIVY TO ANY OF THAT INFORMATION. SO YOU'D BE LIMITED ON WHAT YOU CAN DO. I KNOW THERE'S A COMMISSIONER'S FELLOWSHIP PROGRAM, WHICH I -- YOU COULD ACTUALLY LOOK THAT UP, BUT I'M NOT SURE IF H 1 B IS ALLOWED -- NO. OH, YOU HAVE TO HAVE PERMANENT RESIDENCE, SO SCRATCH THAT. >> [LOW AUDIO]. >> I FEEL LIKE THE COMMISSION AT FELLOWSHIP IS JUST ABOUT THE ONLY THING YOU CAN DO WITH FDA EVEN WITH A GREEN CARD BECAUSE EVERYTHING ELSE YOU LOOK AT IS EITHER STATUS OR U.S. CITIZEN. SO VI A GREEN CARD BUT I FEEL LIKE THERE'S NOTHING ELSE EXCEPT FOR THE COMMISSION [INDISCERNIBLE] FELLOWSHIP; DO YOU THINK THAT'S TRUE OR -- >> NO. [LAUGHTER] WELL, THERE ARE POSITIONS REFERRED TO AS STAFF FELLOW FISSION -- POSITIONS. IT'S A POSITION DEPENDING ON, SO EVERY DIVISION OFFICE GETS A CERTAIN ALLOCATION OF FULL-TIME EQUIVALENTS AND STAFF FELLOW POSITIONS CAN ACTUALLY BE A SLOT THAT IF YOU HAVE A GREEN CARD BUT THEY HAVE TO BE ADVERTISED. SO THEY DON'T COME AROUND THAT OFTEN, BUT THERE ARE WITHIN FDA, THERE ARE STAFF FELLOW POSITIONS, SENIOR STAFF FELLOW POSITIONS THAT ARE EITHER TRANSITION TIME FOR SOMEONE WITH A GREEN CARD OR EVEN CITIZENS FOR A PERMANENT POSITION OPENS UP. THEY DO EXIST, AND THERE ARE WITHIN THE FDA, THERE ARE PEOPLE. >> SO THEY EXIST TOO AT THE NIH, BUT THERE ARE FEW, AND IF YOU HAVE THE APPROPRIATE SKILL SET AND THERE'S A JOB THAT'S OPEN THERE ARE WAYS THAT PEOPLE CAN GET YOU IN THROUGH CSC POSITION OR SOMETHING LIKE THAT, BUT IF YOU DON'T HAVE A LONG JOB HISTORY, IT WOULD BE HARD TO JUSTIFY GETTING THAT CSC POSITION. I, MYSELF, AM A -- WAS A RESIDENT ALIEN, AND NOW I'M A CITIZEN, IT'S JUST EASIER AND MORE OPPORTUNITIES ARE AVAILABLE. SO IF YOU'RE THINKING ABOUT A CAREER IN THE GOVERNMENT, UM, I WOULD SAY ALSO CONSIDER GETTING YOUR CITIZENSHIP. >> ANY OTHER QUESTIONS? ALL RIGHT. ONE MORE. >> UM, ARE THERE A LOT OF REGULATORY AFFAIR OPPORTUNITIES AT NIH, UM, OUTSIDE OF THE FDA, LIKE HERE AT NIAID OR AND HOW DO WE HEAR ABOUT THEM? >> UH, THAT'S A GOOD QUESTION. UM, AND I'LL TELL YOU HONESTLY. SO AT NIAID IT SEEMS AS THOUGH, UM, FOLKS LOOKING TO FILL CERTAIN POSITIONS ARE USING THE GENERAL NIH POSTING, AND BUT IT'S VERY GENERAL. YOU DON'T KNOW WHAT YOU'RE APPLYING FOR, AND YOU DON'T KNOW WHO'S GOING TO BE LOOKING AT THAT, AT YOUR APPLICATION. SO HOW DO YOU EVEN KNOW? YOU JUST HAVE TO GO ON BLIND FAITH, RIGHT? AND HOPE THAT IF YOU GET CALLS, YOU KNOW, YOU ASK THE RIGHT QUESTIONS AND FIND OUT ABOUT THE JOB AND YOU KNOW THAT YOU'LL LIKE IT. AND SO YOU MIGHT NOT KNOW THAT JOBS ARE OPEN AND THAT THERE ARE FOLKS LOOKING TO FILL THE POSITION BECAUSE THE POSITION IS NOT SPECIFIC ENOUGH FOR YOU TO IDENTIFY THAT IT'S FOR REGULATORY AFFAIRS. AT NCI, I FOUND THAT MOST OF THE JOB POSTINGS WERE MORE SPECIFIC FOR A POSITION. SO IT WAS EASIER TO IDENTIFY. I DON'T KNOW IF THAT'S STILL THE CASE NOW, BUT, UM, IT WOULD BE IDENTIFIED AS FOR NCI THE CLINICAL THERAPEUTICS EVALUATION PROGRAM, WITHIN THAT PROGRAM IS THE REGULATORY AFFAIRS BRANCH, AND WHENEVER THEY'RE LOOKING FOR POSITIONS, THEY WOULD IDENTIFY THE LIST OF CRITERIA THAT THEY'RE LOOKING FOR. SO IT WOULD DEPEND. >> I JUST FROM THE OTHER ASPECT OF THINGS, I THINK AT NIH, AS WELL, UM, THOSE IN REGULATORY AFFAIRS HERE -- AND CORRECT ME IF I'M WRONG IF YOU DISAGREE -- BUT THE ONE POSITIONS THAT I'VE SEEN ARE GENERALLY COMING FROM PEOPLE THAT HAVE HAD BEEN HAD MORE EXPERIENCE ON THE OUTSIDE AND THAT THEY'VE HAD REGULATORY EXPERIENCE EITHER AT INDUSTRY OR OTHER PLACES KIND OF LIKE CROs ET, AND THEN COMING IN INTO THE STRICT REGULATORY AFFAIRS THAT I'VE SEEN AT HLBI TOR CLINICAL CENTER. I DON'T KNOW IF YOU WOULD AGREE WITH ME OR NOT, BUT... ORTOR CLINICAL CENTER. I DON'T KNOW IF YOU WOULD AGREE WITH ME OR NOT, BUT... TOR CLINICAL CENTER. I DON'T KNOW IF YOU WOULD AGREE WITH ME OR NOT, BUT... HTOR CLINICAL CENTER. I DON'T KNOW IF YOU WOULD AGREE WITH ME OR NOT, BUT... E CLINICAL CENTER. I DON'T KNOW IF YOU WOULD AGREE WITH ME OR NOT, BUT... >> SO MY QUESTION IS THE REGULATORY AFFAIRS DEPARTMENTS IN EACH -- DOES EACH INSTITUTE HAVE A REGULATORY AFFAIRS DEPARTMENT? YOU DON'T THINK SO. >> SOME OF THE BRANCHS ARE SMALLER. UM, I THINK THE ISSUES ALMOST ALL OF THE INSTITUTES MOST OF THE INSTITUTES HAVE CLINICAL TRIALS THAT THEY'RE CONDUCTING, AND SO YOU DO NEED SOMEONE THAT HAS REGULATORY KNOWLEDGE TO PREPARE THE INDs, BUT THEY'RE GENERALLY POOLED AND IT'S A SMALLER UNIT SUCH THAT, YOU KNOW, IF YOU'RE JUST STARTING OUT IN PARTICULAR OR YOU DON'T HAVE ANY EXPERIENCE WITH IT, THERE'S NOT NECESSARY LAY LOT OF TRAINING OR THINGS LIKE THAT. WHEREAS I WOULD SAY AT THE FDA OR AT INDUSTRY, YOU KNOW, THEY ARE ACCUSTOMEDED TO BRINGING PEOPLE IN THERE ARE ACTUALLY, UM, MORE JUNIOR AND THEY HAVE FOR EXAMPLE AT THE FDA WHEN YOU'RE A NEW REVIEWER, THERE ARE A SLEW OF COURSES THAT YOU TAKE AND THEY HAVE A STRUCTURE SET UP SUCH THAT YOU ARE GETTING SO TO SPEAK EDUCATION ON THE JOB OR TRAINING. SETTINGS AT NIH THAT DOESN'T EXIST. IT'S SORT OF YOU NEED TO KNOW WHAT YOU'RE DOING WHEN YOU COME HERE IN THE REGULATORY AFFAIRS DIVISIONS WITHIN THE INSTITUTES. >> SO DO ALL THE INSTITUTES HAVE REGULATORY AFFAIRS PROGRAMS? I DON'T THINK SO. I AGREE WITH NICOLE THAT THERE ARE A LOT OF SMALLER GROUPS LIKE MAYBE THERE WOULD BE ONE OR TWO PEOPLE THAT, UM, PERFORM THAT FUNCTION WITHIN A GROUP. FOR INSTANCE, YOU KNOW, NCI HAS THE REGULATORY AFFAIRS BRANCH THAT I MENTIONED, BUT THERE'S ALSO A SIMILAR REGULATORY AFFAIRS GROUP IN FREDERICK THAT'S PART OF NCI, AND THEY SPECIALIZE MORE IN BIOLOGICALS, AND THEN THERE ARE ALSO INDIVIDUALS THAT PERFORM THAT FUNCTION AT NCI BUT THEY'RE WITHIN A PARTICULAR LAB OR CLINICAL GROUP AND THEY H HELP WITH THE ASSEMBLY OF THE INDs AND REVIEW THE PACKAGES AND REVIEW THE REPORTS AND SUCH. SO AND THE ONLY REASON WHY I HESITATE TO SAY THAT ALL GROUPS DO IS BECAUSE I THINK IT WAS FOUR MAYBE SIX YEARS AGO THERE WAS A PROGRAM CALLED NIH RAID, AND THAT PROGRAM STARTED IN THE NCI AND IT WAS PATTERNED AFTER THE NCI RAID, RAPID ACCESS TO INTERVENTION DEVELOPMENT. AND SO ETCH THOUGH IT WAS NIH-WIDE FOR ALL NIH PRODUCTS IN ANY DISCIPLINE, THE PRECLINICAL WORK, THE MANUFACTURING, THE, YOU KNOW, THE WORK THAT GOES INTO, UM, EVENTUALLY BEING PART OF THE IND PACK ABLG THAT WILL BE SUBMITTED TO THE AGENCY IN SUPPORT OF A PHASE ONE CLINICAL TRIAL WAS ALL DONE AT THE NCI THROUGH THE NCI CROs, AND SO I THINK, I THINK DIFFERENT INSTITUTES OR HAVE INSTITUTED THEIR OWN REGULATORY AFFAIRS AND THEIR OWN DRUG DEVELOPMENT SHOPS BUT I JUST DON'T KNOW IF THAT'S TRUE. >> UM, SO, UH, IN CASE IF SOMEBODY COULD BE OUR CANDIDATE FOR INTERVIEW, WHAT WOULD ROUGHLY THE INTERVIEW LOOK LIKE AND WHAT MAIN FEATURE WILL YOU LOOK FOR THIS PERSON LIKE FOR THE SOME POSITION? FOR EXAMPLE FOR US AS A POST DOC, WE HAVE A LOT OF [INDISCERNIBLE] EXPERIENCE, BUT OTHER THAN THAT, WHAT ARE THE OTHER MAIN FEATURE YOU WOULD LOOK FOR? >> SO I AGAIN WOULD ASK THE PERSON, UM, WHAT IS HIS OR HER INTERESTS? YOU KNOW, WHERE WOULD THEY LIKE TO FIT IN BECAUSE THAT'S GOING TO BE CRUCIAL. ARE THEY MORE INTERESTED IN MANUFACTURING, ASSAY DEVELOPMENT? SO IT WOULD DEPEND. THAT WOULD BE MY VERY FIRST QUESTION; WHERE'S YOUR AREA OF INTEREST? >> SO WITHIN OUR OFFICE, WE WORK IN THE RISK ASSESSMENT, RISK MANAGEMENT ONE OF THE FIRST THINGS WE LOOK AT IS ANALYTICAL THINK SPOPG IT'S MORE THAN ON YOUR RESUME IF YOU SAY YOU HAVE BIOSTATS OR STATISTICS, WE'LL TEST IT AND MAKE SURE THAT YOU ACTUALLY DO HAVE THAT. THOSE ARE THE KIND OF THINGS THAT WHEN WE HAVE INTERVIEWS, THAT'S WHAT WE'RE TYPICALLY ASKED. WE TRY TO SEE THE SCOPE OF KNOWLEDGE. IT'S NOT AN EXAM. WE JUST WANT TO MAKE SURE THAT EVERYTHING THAT'S THERE FITS AND AT THE SAME TIME WE WANT TO SEE THAT YOU ACTUALLY HAVE A GENUINE INTEREST AND IT GOES BACK TO THAT PLAN AND WHERE YO DO YOU SEE YOURSELF FIVE YEARS FROM NOW. THOSE ARE THE MAIN THINGS. ANALYTICAL IS A VERY STRONG PART. SO EVEN THOUGH YOU DON'T HAVE THE CANDIDATE DOES NOT HAVE A STRONG REGULATORY OR UNDERSTANDING OF ALL THE REGULATIONS, BUT THAT'S SOMETHING THAT CAN BE DEVELOPED THROUGH TIME AND THE ALSO IT DEPENDS ON WHICH PROJECTS WE'RE LOOKING FOR AND WHAT KIND OF PROJECTS HE OR SHE WILL BE INVOLVED IN. >> ONE OTHER SKILL THAT WE SEE A LOT WHETHER IT'S AFFAIRS, OPERATIONS OR ANYTHING IS JUST THE ABILITY TO JUGGLE EITHER SHIFTING TIME LINES, SHIFTING PRIORITIES, THE ABILITY TO I DON'T WANT TO SAY MULTI-TASK, THAT'S AN OVERVIEW USED WORD, I THINK, TO KNOW YOU HAVE CONFLICTING PRIORITIES OR CONFLICTING DEADLINES AND THE KNOWLEDGE OR THE SKILL TO BE ABLE TO MAYBE PUT SOMETHING DOWN THAT YOU MAY HAVE SOME SORT OF ATTACHMENT TO BECAUSE YOU WANT TO SEE IT GET FINISHED BUT THERE'S SOMETHING ELSE THAT IS COMPETING FOR THAT PRIORITY LEVEL. THE ABILITY TO TURN ON A DIME IS CRITICAL ALONG WITH THE ANALYTICAL THINKING. THE TWO ARE INTERTWINED. >> WOULD YOU RECOMMEND A REGULATORY AFFAIR JOB TO SOMEONE WHO LOVES SCIENCE RESEARCH BUT DON'T LIKE WRITING? IF SO, WHAT PART OF REGULATORY AFFAIR JOB CAN BE RECOMMENDED? >> I WOULD NOT. [LAUGHTER] UNLESS THERE ARE, I THINK, IN ALL OF THE FIELDS, BUT EVEN WHEN YOU'RE DOING SCIENCE, YOU HAVE TO WRITE. YOU HAVE TO PUBLISH IF YOU'RE DOING BENCH RESEARCH, AND I THINK THERE ARE VARIOUS GRE DAGSS. MAYBE NOT TOO MUCH ON THE PRODUCTION SIDE OF PRODUCING IND OR PRODUCING THE SCIENCE AND THEN WRITING IT UPPER SAY BUT MAYBE ON THE REVIEW SIDE THERE MIGHT BE A LITTLE LESS WRITING. SO IT IS A POTENTIAL. I THINK THE OTHER ASPECT OF IT IS, UM, HOW MUCH BENCH RESEARCH OR HOW MUCH LAB WORK DO YOU FEEL LIKE YOU NEED TO BE SATISFIED? I THINK SOME OF THESE, YOU KNOW, SOME -- THERE ARE OPTIONS TO CONTINUE DOING BENCH RESEARCH EVEN WITHIN REGULATORY AFFAIRS, AND, UM, AND LIKE IN MY SITUATION AS WELL, THERE'S OPPORTUNITY FOR ME TO STILL DO CLINICAL WORK EVEN THOUGH I AM WITHIN REGULATORY CLINICAL REGULATORY AFFAIRS. SO I THINK THOSE OPPORTUNITIES, I THINK, ARE MORE NARROW. BUT YOU DO HAVE LIKE TO WRITE AND YOU HAVE TO LIKE TO READ A LOT. >> IT'S ACTUALLY A DIFFERENT KIND OF WRITING. ACTUALLY I'M SPEAKING FROM THE COMPLIANCE SIDE, AND THIS GOES BACK TO ALSO THAT WHEN WE INTERVIEW IT'S WHAT WE LOOK FOR IS INTERPERSONAL SKILLS, THE ABILITY TO TALK AT A MEETING, TAKE INITIATIVE AND TALK AND IF SOMETHING GOES WRONG AT THE MEETING, HOW NOT TO FREEZE AND JUST PANIC BUT ACTUALLY GO WITH THE FLOW. LIKE MY MICROPHONE WASN'T WORKING, IT DIDN'T STOP ME BUT IT'S SOMETHING LIKE YOU KIND OF LEARN AS YOU GO AND THAT'S WHY IT'S AN EXCELLENT OPPORTUNITY THAT YOU CAN ACTUALLY GIVE TALKS AT CONFERENCES HERE. THIS IS GREAT BEGINNING, GOOD EXPERIENCE TO TALK IN FRONT OF A LARGE GROUP OF PEOPLE WITHOUT STUTTERING AND BREAKING OUT INTO A SWEAT, BUT STILL MAINTAIN SOME FORM OF COHERENT THOUGHT THROUGHOUT THE PROCESS. THE WRITING ITSELF IS DIFFERENT THAN WRITING AN ARTICLE OR SOME JOURNAL. THE WRITING IS QUICK, SO AND AS AN EXAMPLE I WORK IN ALSO ONE OF THE PROJECTS I'M CURRENTLY WE HAVE ABOUT 10 OR 11 PROJECTS THAT I'M WORKING ON, AND ONE OF THEM IS PHARMACEUTICAL SUPPLY CHAIN, TO LOOKING AT THE MOVEMENT OF PHARMACEUTICAL PRODUCTS, ACTIVE PHARMACEUTICAL INGREDIENTS ACROSS BORDERS AND INTO THE UNITED STATES AND WE HAVE TO TURN OVER OUR REPORT AND SOME DIRECTORS WANT IT TURNED OVER WITHIN A WEEK. YOU HAVE TO GET IT DONE WITHIN TWO DAYS. IT'S A DIFFERENT TYPE OF WRITING. IT'S NOT MA TICK LOUSE BUT YOU WANT TO MAKE SURE IT'S QUALITY. THAT'S SOMETHING YOU HAVE TO LEARN. YOU NEED TO HIT YOUR OBJECTIVES AND YOUR ACTION ITEMS AND THEN I MAKE A DELIVERABLE THAT MAKES SENSE AND SOMETHING CAN BE EXTRAPOLATED FROM THAT AND MOVE ON TO THE NEXT STEP. YOU MIGHT SAY, YOU KNOW, YOU DON'T LIKE WRITING, BUT, YOU HAVE TO TRY A DIFFERENT TYPE OF WRITING A QUICK WRITING IS QUITE ENJOIB JOYABLE SNLS YOU HIT WRITER ES BLOCK. THERE'S NOT ENOUGH TIME FOR WRITERS BLOCK AND THEN PRESENTATIONS TOO. YOU HAVE TO ENJOY TALKING IN FRONT OF CROWDS AND INDIVIDUALS AND IF THEY HAVE A A COMMENT OR CRITICISM YOU HAVE FOE HOW TO HANDLE IT POLITICALLY AND PROFESSIONALLY AND STILL MOVE ON AND ACTUALLY A LOT OF TIME THEY HAVE CRITICISM FOR A RM BECAUSE IT'S SOMETHING THAT'S NOT -- THERE'S SOME DI de EFFICIENCY AND YOU HAVE TO LEARN THAT YOU CAN'T ALWAYS BE PERFECT BUT THAT'S PART OF GETTING THE QUALITY REPORT. YOU WANT TO GET INPUT AND HOW DO YOU GET INPUT FROM EVERYONE ELSE. >> JUST TO PIGGYBACK ON THIS, IT IS A DIFFERENT KIND OF WRITING. YOU MAY GO THROUGH FOUR OR FIVE DRAFTS BEFORE SOMETHING'S COMPLETE, NOT TO SAY YOU DON'T DO REVIEWS OR DRAFTS, BUT IT IS A LITTLE BIT MORE RAPID FIRE. YOU WILL HAVE PEOPLE WHO HAVE PRETTY STRONG OPINIONS BECAUSE THEY MAY NOT -- YOU MAY NOT BR B WRITING THIS FOR YOURSELF, YOU'RE WRITING IT FOR AN ORGANIZATION OR A GROUP. FROM AN INDUSTRY PERSPECTIVE, I WOULD SAY TO SORT OF GET BACK TO ONE OF THE FIRST THINGS YOU HAD MENTIONED WAS THAT AT LEAST FROM MY EXPERIENCE IF YOU WANT TO MAINTAIN THAT SORT OF BENCH SCIENTIST LIFESTYLE AND BE IN REGULATORY AFFAIRS, THOSE TWO ARE VERY MUCH SEPARATED IN INDUSTRY. NOT TO SAY YOU COULDN'T GO BACK AND FORTH, DEPENDING ON THE COMPANY YOU'RE BE W YOU COULD DO A ROTATION, BUT GENERALLY SPEAKING THERE'S NOBODY I'VE EVER MET IN REGULATORY AFFAIRS WHO DOESN'T KNOW UP ONE DAY BECAUSE THEY'RE IN THE LAB, THEY JUST DON'T EVER CROSS PATHS THAT POINT. >> OKAY. WELL LET'S THANK OUR SPEAKERS AGAIN FOR COMING. [APPLAUSE] AND JUST AS ANOTHER ANNOUNCEMENT, WE ACTUALLY DO HAVE A SHORT LITTLE HANDOUT FROM THE RACS SOCIETY ON OUR WEB SITE. SO IF YOU'D LIKE PLEASE GO CHECK THAT OUT.