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Dr. Shanmugam: Welcome to the launch of the inaugural
NIH-wide strategic plan for autoimmune
disease research for fiscal years 2026-2030.
Thank you for joining us.
My name is Dr. Victoria Shanmugam.
I'm the chair of the Coordinating
Committee for Autoimmune Disease Research,
which is the NIH-wide committee
charged with developing this first
NIH-wide strategic plan for autoimmune disease research.
It is my very great pleasure to introduce
the Director of the National
Institutes of Health,
Dr. Jay Bhattacharya, to provide some opening remarks.
Dr. Bhattacharya: Thank you for joining us to celebrate the
launch of the inaugural NIH-wide strategic
plan for autoimmune disease research
for fiscal years 2026-2030.
This plan represents the NIH's unwavering
commitment to address the chronic disease
crisis in the United States and to improve
the health and well-being of the American people.
Autoimmune diseases influence every system
in the body and pose significant risks to
human health throughout the lifespan.
Between 23.5 and 50 million people in
America are estimated to be living with
one or more autoimmune diseases.
Collectively, autoimmune diseases
represent some of the most common
chronic diseases affecting the U.S.
population.
Autoimmune diseases carry substantial
costs, estimated more than $100 billion
per year for health care in the United States.
When we consider indirect costs such as
loss productivity and the broader impact
on dependents, families, and society,
the true costs of the American people are
likely much higher than that.
While significant progress has been made
and continues to be made in autoimmune
disease research across the NIH,
more work is needed to accelerate
diagnostics, therapeutics, and bring
scientific discoveries to the bedside.
The strategic plan proposes a coordinated
approach to foster collaboration and
innovation so the people can flourish.
We can prioritize research that addresses
the health needs of the American people.
We will work together with people living
with autoimmune diseases, integrating the
perspectives and experiences so that
scientific inquiry focuses on
their most pressing health needs.
This approach will not only enhance
understanding of disease pathogenesis but
also expedites the development of novel therapeutics.
Recent innovations offer unprecedented
opportunities to dissect the molecular
basis of autoimmune disease at a scale
that was never achievable before.
This strategy will promote collaboration
across scientific groups and disciplines,
bolster infrastructure and investments,
and support basic clinical, translational,
epidemiologic, and implementation
science work.
The plan is a testament the NIH's
dedication to advance human health.
It's my hope that this plan will serve
as a catalyst for transformative change,
ultimately improving the lives of
all people living with and at
risk of autoimmune diseases.
Thank you.
Dr. Shanmugam: Thank you, Dr. Bhattacharya.
I want to begin this presentation of the
inaugural NIH-wide strategic plan for
autoimmune disease research for fiscal
years 2026-2030 with a summary
of the background that led to the
development of this initiative.
Aligned with content from the 2022 report
from the National Academies of Sciences,
Engineering and Medicine, Congress
directed NIH to establish the Office of
Autoimmune Disease Research in the Office
of Research on Women's Health and tasked
the Office with the following six directives.
To coordinate the development of the
multi-IC strategic research plan with
concrete meaningful milestones to set
priorities. As part of the internal and
external outreach for the strategic plan,
to identify emerging areas of innovation
and research opportunity.
To coordinate and foster collaborative
research across the Institutes and
Centers. To annually evaluate the
autoimmune research portfolio to determine
progress made across the NIH.
To provide resources to support planning,
collaboration and innovation. And to
develop and oversee a publicly accessible
central repository for autoimmune disease research.
The NIH supports a broad range of basic
and clinical research on autoimmunity
and autoimmune disease.
The baseline landscape analysis of the
NIH-funded autoimmune disease research
portfolio included the more than 140
diseases and conditions included in the
NASEM report that are either autoimmune or
commonly co-occur with autoimmune
diseases as listed on this slide.
NIH's investment in autoimmune disease
research increased from $800 million in
fiscal year 2018 to more than $1 billion in 2022.
While autoimmune disease research is
currently funded across every single
institute and center at NIH, current funding
levels are not proportional to the
rising prevalence of autoimmune
diseases, highlighting a significant gap.
The autoimmune disease research
portfolio serves as a vital reference for
pinpointing areas that require additional
investment to ensure progress in the field
of autoimmune disease research.
Between 23.5 and 50 million Americans
are living with autoimmune diseases,
collectively making autoimmune disease
one of the most common chronic conditions
affecting the American people.
To place this in context, autoimmune
diseases affect more Americans
than coronary artery disease, chronic
obstructive pulmonary diseases,
and other chronic diseases as shown in this graph.
While autoimmune diseases more commonly
affect women, men with autoimmune diseases
tend to have more severe disease and in
some cases a higher risk of dying from their disease.
The mission of the NIH-wide strategic
plan for autoimmune disease research is to
coordinate and advance efforts to support
rigorous, high-priority, innovative and
collaborative autoimmune disease research.
One in four people living with autoimmune
disease has more than one and rates of
these conditions are rising more
rapidly than genetics alone can explain.
This suggests that both genes and
environmental factors play important roles
in the development of autoimmunity.
Many autoimmune diseases have a period of
asymptomatic autoimmunity known as
the prodrome, with the appearance of
autoantibodies and other markers of
immune activation before the development of symptoms.
In some diseases like type 1 diabetes,
the prodrome can be as short as a few months.
However, NIH research has shown that in
other autoimmune diseases like systemic
lupus erythematosus, autoantibodies
may develop more than five years before
the disease becomes clinically apparent.
In other diseases like multiple sclerosis,
this prodromal period can last
for a decade or even longer.
This window of asymptomatic autoimmunity
offers a unique opportunity for
early intervention and recent
groundbreaking research has led to the
approval of a new immunosuppressing
therapy for people in the prodromal stage
of type 1 diabetes, delaying the onset
of disease in those at high risk.
This is the first FDA-approved treatment
specifically aimed at preventing
progression during that prodromal
phase of autoimmunity.
And it provides promising evidence that
similar preventative strategies could be
possible for other chronic autoimmune diseases.
Various exposures and triggers likely
contribute to the development of autoimmuntity.
The field of exposome research looks at the
totality of these exposures ranging from
diet and stress to pollutants and
social conditions across a lifetime.
In 2010, an NIH convened expert panel
recognized clear links between autoimmune
diseases and various environmental
exposures.
However, studying these factors is
challenging due to the complexity
and timing of exposures.
Despite these challenges, understanding
how these cumulative exposures interact
over time is essential to uncovering
the biologic pathways behind disease.
And by following groups of people at risk
or living with autoimmune conditions and
using advanced data analysis, we can
better predict, prevent, diagnose, and treat
these diseases in the future.
Development of the NIH-wide strategic plan
for autoimmune disease research began in
2023 with the formation of the Office of
Autoimmune Disease Research in the Office
of Research on Women's Health.
The Office of Autoimmune Disease Research
convened an internal NIH coordinating
committee for autoimmune disease research
or CCADR with representatives from across
NIH institutes, centers, and offices.
The committee formed a strategic plan
working group which met regularly to
evaluate and integrate data from multiple
sources including responses to the request
for information, dialogues at community
roundtable sessions, input from NIH
institute, center, and office directors,
data from public health organizations,
the analysis of the existing NIH
autoimmune disease research portfolio and
recommendations from the scientific
literature and relevant reports.
Using the NIH Common Template to guide the
strategic planning process, the working
group identified key priorities in
multiple areas including research,
capacity and operational priorities
as well as cross-cutting themes.
In December 2023, in coordination with the
strategic plan working group, the Office
of Autoimmune Disease Research issued a
request for information to gather
input from the public on the
development of the strategic plan.
A summary of the responses received is
published alongside this strategic plan
and is available for download on
our website by scanning the QR code.
The Office also hosted two virtual
community roundtable discussions in
February 2024 to garner additional
insights from academic, patients
and patient advocacy partners.
Responses from all branches of the
autoimmune disease community were received
including those from people living with
and at risk for autoimmune disease as well
as scientists and researchers
who helped study these diseases.
This insightful input was instrumental
in guiding the crafting of
the inaugural strategic plan.
And the quotes on this slide are simply a
select sample covering topics related to
the exposome and the design of research
studies involving people living with and
at risk for autoimmune disease.
Recommendations from the National
Academies report, Enhancing NIH research on
autoimmune disease, were also
incorporated into the planning process.
These included the need for long term
epidemiologic data and the development of
population cohorts beginning before
disease onset and addressing key gaps in
the current research portfolio.
This slide summarizes graphically the
inaugural NIH-wide strategic plan
for autoimmune disease research.
The five strategic priorities and
objectives are listed in the five circles
in this graphic and include, priority one,
accelerating scientific discovery in
diagnosis, treatment, prevention,
and cure of autoimmune diseases.
Priority two, promoting research focused
on enhancing health for people living with
and at risk for autoimmune diseases.
Priority three, supporting research
to understand the full complexity
of autoimmune diseases.
Priority four, building and maintaining
capacity for autoimmune disease research.
And priority five, building and
strengthening partnerships and
interdisciplinary collaborations across
the autoimmune disease community.
These five priorities are further
supported by five cross-cussing themes
which are woven throughout each priority and include,
harnessing technologies to
advance autoimmune disease research,
developing infrastructure for the
translation of autoimmune disease research,
supporting multimodal data
driven approaches for autoimmune disease research,
promoting the engagement of all
populations in autoimmune disease research,
and supporting community
partnerships for autoimmune disease
research.
Each of the priorities includes four
concrete meaningful objectives which are
outlined in the following slides and will
act as a roadmap for NIH-funded autoimmune
disease research for fiscal years
2026-2030.
Priority one recognizes that advances in
basic science are critical for improving
our fundamental understanding of
autoimmunity, catalyzing novel and
clinical research, and ultimately
translating knowledge into real benefits
for people living with autoimmune
diseases, those at risk and their communities.
Within this priority, there are four
objectives.
To support research into fundamental
mechanisms of autoimmunity and autoimmune
disease, to advance understanding of
drivers of autoimmune disease signs,
symptoms and flares, to optimize
development of research models for
studying autoimmune diseases, and to
improve understanding of predictors and
risk factors for autoimmunity across the lifespan.
Timely diagnosis, treatment and
intervention are critical for improving
outcomes in autoimmune diseases.
Research focused on developing accurate
diagnostics and effective treatments that
are accessible and deployable in
real-world settings are needed to support
tangible improvements in health for people
living with and at risk for autoimmune disease.
The objectives included in priority two
are to support research investigating
preclinical autoimmunity, to advance
research to accelerate accurate diagnosis
of autoimmune disease, to bolster research
focused on improving treatments for
autoimmune disease, and to support
implementation science for autoimmune
disease research across all populations.
The incidence of autoimmune diseases is
rising globally and there are many gaps in
understanding of how autoimmune diseases
affect health across the lifespan.
The objectives under priority three
include to support the study of human
cohorts for autoimmune disease research,
to promote research to understand how
different populations are affected by
autoimmune diseases, to advance research
that will facilitate clinical trials
for autoimmune diseases, and to expand
autoimmune disease research focused on
co-occurring and comorbid conditions.
Developing and maintaining infrastructure
and the scientific workforce are important
to ensure that high priority autoimmune
disease research can be completed and to
further accelerate the translation of
scientific discoveries into improvements in health.
Within priority four, the objectives
include to prioritize and support the
development of infrastructure for
autoimmune disease research,
to integrate clinical trial networks and
registries in autoimmune disease research,
to develop data science and computational
tools to accelerate autoimmune disease
research, and to support efforts to
develop and sustain the scientific workforce.
Developing and maintaining partnerships
and collaborations across the autoimmune
disease community is crucial to
stimulate innovation in research.
To build and strengthen these
partnerships, the objectives included in
priority five are to leverage
public-private partnerships to support
autoimmune disease research, to engage
people living with autoimmune diseases,
patient advocacy groups and caregivers
in research, to partner with people and
communities disproportionately affected
by autoimmune disease outcomes, and to
coordinate and foster collaborative
research.
As previously stated, interwoven
throughout the strategic plan,
five cross-cutting themes complement
the strategic priorities and objectives,
and these include harnessing technologies
to advance autoimmune disease research,
developing infrastructure for translation
of autoimmune disease research,
supporting multimodal data-driven
approaches for autoimmune disease
research, promoting the engagement of
all populations in autoimmune disease
research, and supporting community
partnerships for autoimmune disease research.
The strategic priorities and objectives
are available in the full strategic plan
and in the accompanying one-pager.
Clicking on this link or scanning
this QR code will lead you there.
The NIH-wide strategic plan for autoimmune
disease research sets forth a unified
approach to accelerate scientific
discovery, expand capacity and catalyze
critical partnerships in autoimmune
disease research.
This plan will serve as a framework for
priority setting for NIH-funded research
over the next five years, with the voices
of people living with autoimmune
diseases remaining paramount.
Implementing this strategic plan will
accelerate discoveries leading to improved
health outcomes and better well-being
for all people living with or
at risk for autoimmune diseases.
In this figure, you can see a schema
outlining the implementation plan,
including expanding on existing and
ongoing activities, employing a unified
approach to accelerate progress,
and achieving bold initiatives.
In collaboration with the Institutes and
Centers, we will closely monitor and
evaluate progress working together to
create opportunities, address gaps,
and encourage cross-disciplinary partnerships.
In closing, this strategic plan would not
have been possible without the hard work
of everyone who served on the NIH
Coordinating Committee for autoimmune
disease research, particularly the members
of the strategic plan working group listed here.
Thank you for everything you do every day
to support autoimmune disease research.
Thank you all for listening.
I hope you take an opportunity to read
the full strategic plan available on our website.
And now, I would like to introduce
Dr. Janine Austin Clayton, NIH Associate
Director for Research on Women's Health
and Director of the Office of
Research on Women's Health.
Dr. Clayton: Thank you for joining
us to celebrate the
launch of the inaugural NIH-wide strategic
plan for autoimmune disease research
for fiscal years 2026 through 2030.
The Office of Autoimmune Disease Research was
established in the Office of Research on
Women's Health in 2023 in response
to a congressional request to enhance
coordination across NIH autoimmune
disease research efforts.
As the director of the Office of Research
on Women's Health, it is my pleasure to
stand up the Office of Autoimmune Disease
research and to bring on
Dr. Shanmugam as the inaugural director.
But bringing this plan to fruition
could not have happened alone.
It took the work of many people across the NIH.
I want to sincerely thank the directors of
every institute, center, and office at NIH
for their willingness to participate
in this plan's development.
I also want to thank the incredibly
engaged members of the Coordinating
Committee for Autoimmune Disease Research.
This dedicated group worked diligently
over the past 18 months to make this plan
a reality and their passion and commitment
to autoimmune disease research is tangible.
Finally, I want to thank all people living
with or affected by autoimmune diseases
whose commitment and dedication to
advancing autoimmune disease research is
woven into every aspect of this plan.
Thank you for letting us hear your stories
and thank you for supporting the work of the Office.
As we look to the future for autoimmune
disease research, this plan will serve as
a framework for priority setting over the
next five years, ultimately improving the
health of all people living with
and at risk of autoimmune diseases.
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