] Federal Environment for Medical Research A Presentation to UC Riverside

1. ]Federal Environment for Medical ResearchA Presentation to UC Riverside Karen Mowrer, Michael Ledford, and Kaitlin Chell Lewis-Burke Associates, LLC January 2014

2. 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 2

3. 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

4. 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

5. 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

6. 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)

7. 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/)

8. 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

9. 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

10. 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

11. 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

12. 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 12

13. 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

14. 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 14

15. 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 15