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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.

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Federal environment for medical research a presentation to uc riverside

]Federal Environment for Medical ResearchA 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

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

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


Nih structure initiatives policies

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


National cancer institute

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


National institute of allergy and infectious diseases

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)


National institute of general medical sciences

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/)


Health disparities and diversity at nih

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


Patient centered outcomes research institute

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

    • 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


Dod service branch research offices

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


Federal environment for medical research a presentation to uc riverside

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


Other key defense health engagement areas

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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Federal environment for medical research a presentation to uc riverside

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

Multiple Sclerosis

Neurofibromatosis

Ovarian Cancer

Peer Reviewed Cancer

Peer Reviewed Medical

Prostate Cancer

Psychological Health/TBI

Spinal Cord Injury


Looking forward

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 large-scale 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

Contact

Kaitlin Chell

Lewis-Burke Associates LLC

1341 G Street, NW

Eighth Floor

Washington, D.C.  20005

e: [email protected]

p: 202.289.7475

f: 202.289.7454

www.lewis-burke.com

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