] Federal Research Environment for Aging A Presentation to UC Riverside

1. ]Federal Research Environment for Aging A 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. Aging as a Federal Priority • The percentage of U.S. population over 65 will grow from 12.4 percent in 2000 to 19 percent by 2030, increasing demand on government entitlement programs and healthcare system • Affordable Care Act (ACA) • Patient-Centered Outcomes Research Institute (PCORI) • Broadens health professions included in training programs for geriatrics care workforce • National Alzheimer’s Project Act (NAPA), signed into law in 2011, mandated development of National Plan to Address Alzheimer’s Disease • National Institutes of Health (NIH) leads federal biomedical and behavioral research on aging

4. Alzheimer’s Disease • NAPA created a National Plan to Address Alzheimer's Disease • Advisory Committee enables cross-agency coordination of Alzheimer’s research (NIA), care (CMS), and services (AoA) • HHS updates National Plan annually with recommendations and actions to advance stated goals • On the research side, Congress and the Administration making Alzheimer's funding a priority • Francis Collins designated $40 M for Alzheimer’s research in FY 2013 • FY 2014 President’s budget request and Senate appropriations bill included $80 M for NIA to lead Alzheimer’s disease research and “expects a significant portion of the recommended increase for NIA to be directed to this area” • Additional targeted NIA funding opportunities likely to continue in support of the National Plan

5. NIH - National Institute on Aging • Major Divisions include: Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, Neuroscience • Centers: Claude D. Pepper Older American Independence Centers, Nathan Shock Centers of Excellence, Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences, Resource Centers for Minority Aging Research • Examples of Alzheimer’s targeted funding: • Interdisciplinary Approach to Identification and Validation of Novel Therapeutic Targets for Alzheimer’s Disease • Alzheimer’s Disease Prevention Trials • Estimating the Economic Costs of Alzheimer’s Disease and Related Dementias • Recent program announcements for “Advancing the Science of Geriatric Palliative Care” with NCCAM and NINR • Inside NIA: new blog for researchers (http://www.nia.nih.gov/research/blog)

6. NIH – Geroscience Initiatives • Coined in 2007, “geroscience” refers to study of physiological effects of aging as common major risk factors for most chronic diseases • Created in 2011, the trans-NIH Geroscience Interest Group (GSIG) includes 20 NIH institutes and centers (ICs) committed to geroscience research efforts • As its first activity with external scientific community, GSIG held October 2013 Geroscience Summit to discuss existing knowledge gaps and opportunities for future research and collaboration • Topics included inflammation, adaptation to stress, epigenetics and regulatory RNA, metabolism, macromolecular damage, proteostasis, and stem cells • Research could be targeted for special funding opportunities (budget dependent) or encouraged through traditional mechanisms • ICs encourage discussion of related research ideas with program officers • GSIG Winter Seminar: “Human T Cell Aging: Telomere Loss, Inflammation, and Links to Disease” scheduled for February 5

7. PCORI • 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 (new combined path in 2014) • Investigator-initiated proposals within five general PCORI priorities may address aging populations, a PCORI population of interest • 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 • First round of targeted PFA topics included “Preventing Injuries from Falls in the Elderly”

8. 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

9. 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

10. 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 10

11. CDMRP 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 Congressionally Directed Medical Research Program

12. Looking Forward • Universities have to adjust to changing science bureaucracy in a flat budget environment at NIH • Aging research is a TOP priority on both sides of the aisle in Congress because of potential for cost savings, but there is competition for limited dollars • Public-private partnerships will remain the favored mechanism for large-scale efforts (and a guiding principle of NAPA) • Advisory committees still key to determining and influencing agency policy and research directions (Advisory Council on Alzheimer’s Research, Care, and Services; National Advisory Council on Aging) • NIH is placing an increased emphasis on cooperative agreements (with shared milestones) for new initiatives 12

13. 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 13