] 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 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 professional staff members 26 clients, all nonprofits involved in research and/or education –15 universities –3 contractors running national research facilities –8 associations Lewis-Burke Associates, LLC 2

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 3 NIH Funding Trends

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 4 NIH Structure, Initiatives, Policies

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 5 National Cancer Institute

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) 6 National Institute of Allergy and Infectious Diseases

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 ( 7 National Institute of General Medical Sciences

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 8 Health Disparities and Diversity at NIH

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 9

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 10 DOD – Service Branch Research Offices

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 11 Other DOD Research Entities

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

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 13 CDMRP

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

Contact Kaitlin Chell Lewis-Burke Associates LLC 1341 G Street, NW Eighth Floor Washington, D.C e: p: f: