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Federal Environment for Medical
Research
A Presentation to UC Riverside
Karen Mowrer, Michael Ledford, and Kaitlin Chell
Lewis-Burke Associates, LLC
January 2014
Lewis-Burke Associates, LLC
Lewis-Burke Associates, LLC is a leading full-service government
relations firm specializing in advocating for the public policy
interests of institutions of higher education and other research
and education organizations
• Began working with UC Riverside in November 2012
• 23 professional staff members
• 26 clients, all nonprofits involved in research and/or education
– 15 universities
– 3 contractors running national research facilities
– 8 associations
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NIH Funding Trends
• IC directors are exploring new strategies to support innovative
science under constrained budgets
• Translational research emphasized, but support for basic
research remains
• Award trends
– Milestone-driven, collaborative “U” award mechanism utilized more
– Special consideration for first-time applicants continues despite cuts; new
concerns over achieving renewals and second grants
– Additional scrutiny to larger center and program project grants
– NIH considering rebalancing portfolio to support more individual researchers
instead of research proposals. Examples: Director’s Pioneer Award, NIDA
Avant Garde Award, NCI Outstanding Investigator Award
– Institute directors taking note of increase in R21 applications vs. R01s
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NIH Structure, Initiatives, Policies
• Changes in NIH structure
– NCATS finding its feet, but has little funding for new activities (CAN)
– NIDA-NIAAA merger cancelled; Collaborative Research on Addition at
NIH (CRAN) beginning to issue funding announcements
• NIH-wide initiatives
– Big Data to Knowledge: Supports development of data sharing
standards, software tools, enhanced training, centers of excellence
– Biomedical Research Workforce: Seeks to broaden graduate training
– Diversity in the Workforce: Capacity building, bias in peer review
• NIH policies
– NINDS leading pilots to support replication studies; experimental
design training; systematic review with checklists
– New peer review pilots, metrics for successful study sections
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National Cancer Institute
• NCI priorities: Provocative Questions Initiative; global
cancer research; tumor sequencing; cancer genomics to
leverage experimental drugs; Frederick National Lab for
Cancer Research; exceptional responders to treatment
• Preliminary recommendations to revise cancer center
guidelines include new funding allocation and
supplements for innovative activities
• Proposed NCI Outstanding Investigator Award would
provide long-term, stable support for experienced
investigators
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National Institute of Allergy and Infectious
Diseases
• In December, announced redirection of $100 million over
next three fiscal years to expand investment in research
toward development of HIV cure
• Exploring public-private partnerships for development of
diagnostics and novel therapeutics
• Continued interest in international research collaborations
– International Collaborations in Infectious Diseases Research (U01 and
U19 mechanisms)
– U.S.-South Africa Program for Collaborative Biomedical Research (R01,
R21)
– Indo-U.S. Collaborative Program on Affordable Medical Devices (R03)
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National Institute of General Medical
Sciences
• New NIGMS Director Jon Lorsch started August 2013
• Beginning new strategic planning process for the Institute,
opportunities to provide input
• Heavily involved in supporting training grants and
implementing the NIH ACD Biomedical Research Workforce
Recommendations
– New parent announcement for NRSA Institutional Research Training
Grant (T32) incorporates many aspects from previous NIGMS T32
– Now encourages career development advising, learning opportunities
for successful career transition
• NIGMS Feedback Loop Blog contains useful information for
researchers (https://loop.nigms.nih.gov/)
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Health Disparities and Diversity at NIH
• National Institute on Minority Health and Health Disparities
(NIMHD) leads dedicated efforts
• Also incorporated across NIH ICs
– Among NHLBI Director Gary Gibbons’ top priorities
– Reducing Health Disparities Among Minority and Underserved Children (NINR,
NIAAA, NIDCD); Health Promotion Among Racial and Ethnic Minority Males
(NINR, NIDDK); Behavioral and Social Science Research on Understanding and
Reducing Health Disparities (OBSSR-led)
– Supplements to promote diversity of health-related research workforce
• NIH Initiative based on ACD Working Group on Diversity in the
Biomedical Research Workforce Report
– Funding opportunities for building capacity, mentoring network
– Examining fairness in peer review process and improving reviewer diversity
awareness training
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Patient Centered Outcomes Research
Institute
• Part of ACA, PCORI supports research to assist patients, caregivers, and
providers in making informed, evidence-based decisions about health care
• Involves patients and stakeholders in each step of research
• Uses both investigator-initiated and “targeted” PCORI Funding
Announcement (PFA) mechanisms
• Investigator-initiated proposals within five general PCORI priorities
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Assessment of Prevention, Diagnosis, and Treatment Options
Improving Health Care Systems
Communication and Dissemination Research
Addressing Disparities
Accelerating Patient-Centered Outcomes Research and Methodological Research
• New “third path” in 2014 combines aspects of investigator-initiated and
targeted approaches to support comparative clinical effectiveness
research
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DOD – Service Branch Research Offices
• Some Members of Congress are open to using DOD biomedical
research to offset NIH cuts
– However must show distinction from NIH
• Army Research Office:
– Emphasis remains around broad scientific areas, but ARO is aligned with
crosscutting DOD priorities like big data, manufacturing, and materials
– Key Health areas: Molecular Genetics, Microbiology, Biochemistry,
Neurophysiology and Cognitive Neuroscience
• Office of Naval Research:
– Leading funder of basic research across service branches
– Key Health areas: undersea medicine, cognitive science and computational
neuroscience, biometrics, combat casualty care (TBI/blast), etc.
• Air Force Office of Scientific Research:
– Recent realignment under five new thrust areas reflects increasing
interdisciplinary approach to funding research
– Key Health areas: collective behavior modeling, complex networks
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Other DOD Research Entities
• DARPA :
– Focused on game-changing R&D around threats of the future; program
managers enjoy broad autonomy in funding projects
– Cyber/cloud computing, big data, and health/biological research top
priorities under new Director Prabhakar
• DTRA:
– Basic and applied research on bio/chemical/nuclear/information sciences
geared towards countering weapons of mass destruction
– Small, but underutilized research opportunity for universities
• Chemical-Biological Research (~$60 m)
– Targeted BAAs released throughout the year
– Non-medical: Nano, Cognition, Information Science, Bioscience
– Medical Biological Defense Transformational Medical Technologies
Initiative: Diagnostic Technology, Vaccine, Therapeutic – viral, toxin,
bacterial
– Medical Chemical Defense – Smallest Area: Respiratory, Cutaneous and
Ocular, Neurological, Toxicology
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Other Key Defense Health Engagement Areas
• Congressionally Directed Medical Research Program (CDMRP)
– Broad umbrella with active solicitations throughout the year (typically
1/year for each sub-program – e.g. Breast Cancer Research, TBI, etc.)
• Combat Casualty Care
– Device, mobile, on site interventions, traumatic brain injury
• Telemedicine and Advanced Robotics (TATRC)
– Medical devices, trauma, neuroscience, biomaterials
• Social and Behavioral Research:
– Cross DOD - Human Social Cultural Behavioral Modeling (~$20 million)
• Minerva Program (basic research)
– U.S. Army Research Institute for the Behavioral and Social Sciences
– ARO - Cultural and Behavioral, Institutional and Organizational Science
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CDMRP
CDMRP: Congressionally Directed
Medical Research Program
Amyotrophic Lateral Sclerosis
Autism
Bone Marrow Failure
Breast Cancer
Defense Medical R&D
Duchenne Muscular Dystrophy
Gulf War Illness
Lung Cancer
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Multiple Sclerosis
Neurofibromatosis
Ovarian Cancer
Peer Reviewed Cancer
Peer Reviewed Medical
Prostate Cancer
Psychological Health/TBI
Spinal Cord Injury
Looking Forward
• Universities have to adjust to changing science bureaucracy as NIH
struggles with its budget reality
• Biomedical research remains a TOP priority on both sides of the aisle in
Congress, but there is competition for limited dollars
• Public-private partnerships will remain the favored mechanism for largescale efforts, especially to promote translational research
• Advisory committees still key to determining and influencing agency policy
and research directions
• NIH continues to place an increased emphasis on cooperative agreements
(with shared milestones) for new initiatives
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Contact
Kaitlin Chell
Lewis-Burke Associates LLC
1341 G Street, NW
Eighth Floor
Washington, D.C. 20005
e: kaitlin@lewis-burke.com
p: 202.289.7475
f: 202.289.7454
www.lewis-burke.com
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