Advisory Council October 2015 Meeting Presentation: Research Progress

Monday, October 26, 2015

NAPA Research Progress Report

Richard J. Hodes, M.D.
Director
National Institute on Aging

Bypass Budget Language

SEC. 230. Hereafter, for each fiscal year through fiscal year 2025, the Director of the National Institutes of Health shall prepare and submit directly to the President for review and transmittal to Congress, after reasonable opportunity for comment, but without change, by the Secretary of Health and Human Services and the Advisory Council on Alzheimer’s Research, Care, and Services, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institutes) for the initiatives of the National Institutes of Health pursuant to the National Alzheimer’s Plan, as required under section 2(d)(2) of Public Law 111–375.

NIH Meetings Provided the Basis for Priorities, Milestones, and Budget Estimates

• 2012 Alzheimer’s Disease Research Summit
• 2013 meeting on Alzheimer's Disease-Related Dementias: Research Challenges and Opportunities
• 2013 meeting on Advancing Treatment for Alzheimer’s Disease in Individuals with Down Syndrome
• 2015 Alzheimer’s Disease Research Summit

The recommendations and milestones that emerged from these meetings were used to create a comprehensive set of milestones for the budgeting process

Trans-NIH Input

• Thirteen Institutes and Centers provided feedback on potential scientific gaps and priorities in the combined milestones.
  • NIA
  • NINDS
  • NIMH
  • NINR
  • NIBIB
  • NICHD
  • NIEHS
  • NIDDK
  • NIDCR
  • NHLBI
  • FIC
  • NIAAA
  • NCATS

Combined External and Internal Input

Input at 2012-2015 meetings: Academic research community Industry Non-governmental organizations

Development of comprehensive milestones (NIH staff) -- based on recommendations and milestones from meetings

Trans-NIH staff review and discussion; milestones edited to ensure comprehensive inclusion of priorities for FY17

NIH staff “price” the milestones

Final budget estimate for FY17

Baseline Estimates

FY16 Alzheimer’s Disease	Est. $638,000,000
FY16 Vascular Cognitive Impairment/Dementia	Est. $ 46,000,000
FY16 Frontotemporal Dementia	Est. $ 38,000,000
FY16 Lewy Body Dementia	Est. $ 15,000,000

• All four estimates above are from the FY16 President’s Budget.
• Categories are not mutually exclusive; they cannot be totaled to create an overall funding baseline for Alzheimer’s disease plus Alzheimer’s disease related dementias (ADRDs).
• NIH does not currently report a total for AD+ADRD funding but may in the future.

Using CADRO as a Framework

• The eight CADRO (Common Alzheimer’s Disease Research Ontology) categories provide the overarching framework for the AD Bypass Budget and narrative.
• CADRO provides the framework for IADRP (the International Alzheimer’s Disease Research Portfolio) and will allow tracking of implementation in the budget areas in future years.

FY17 Professional Judgment Budget

CADRO Category	FY17 Proposed Increase
Category A. Molecular Pathogenesis and Physiology	$68,680,000
Category B. Diagnosis, Assessment and Disease Monitoring	$36,500,000
Category C. Translational Research and Clinical Interventions	$92,800,000
Category D. Epidemiology	$45,100,000
Category E. Care and Caregiver Support	$9,800,000
Category F. Research Resources	$31,050,000
Category G. Consortia and Public Private Partnerships	0
Category H. Alzheimer's Disease Related Dementias	$35,375,000
Staff Needs, Support, and Miscellaneous	$4,050,000
Total Additional Resources	$323,355,000

About Public Private Partnerships

• No dollars are assigned for “Category G -- Consortia and Public Private Partnerships” because no additional funding is requested for these partnerships in FY17.
• The NIH currently engages in a number of ongoing partnerships and will continue to support current partnerships and will evaluate future partnership opportunities as they arise.

Alzheimer’s Disease Funding Opportunities

• PAR-15-349 -- Health Disparities and Alzheimer’s Disease (R01)
• PAR-15-350 -- Emerging Directions for Addressing Health Disparities in Alzheimer’s Disease (R03)
• PAR-15-348 -- Research on Informal and Formal Caregiving for Alzheimer’s Disease (R01)
• PAR-15-351 -- Research on Informal and Formal Caregiving for Alzheimer’s Disease (R21)
• PAR-15-356 -- Major Opportunities for Research in Epidemiology of Alzheimer’s Disease and Cognitive Resilience (R01)
• PAR-15-357 -- Understanding Alzheimer’s Disease in the Context of the Aging Brain (R01)
• PAR-15-358 -- Capturing Complexity in the Molecular and Cellular Mechanisms Involved in the Etiology of Alzheimer’s Disease (R01)
• PAR- 15-359 -- Novel Approaches to Diagnosing Alzheimer’s Disease & Predicting Progression (R01)
• PAR-16-365 -- Pilot Clinical Trials for the Spectrum of Alzheimer’s Disease and Age-related Cognitive Decline (R01)
• PAR-16-364 -- Phase III Clinical Trials for the Spectrum of Alzheimer’s Disease and Age-related Cognitive Decline (R01)

AHRQ-IOM Study

• The NIH has launched a two-part assessment of the science of prevention strategies for Alzheimer’s-type dementia, amnestic MCI, and age-related cognitive impairment
• The University of Minnesota School of Public Health Evidence-Based Practice Center (EPC) will conduct a systematic literature review
• The IOM will establish a committee of experts to review the EPC’s findings and make recommendations regarding:
  • What we can tell the public about prevention and intervention strategies
  • The research gaps that still exist in the literature
• Public input will be solicited at multiple points throughout the process
• This study will complement but not duplicate the IOM Cognitive Aging Study

AHRQ-IOM Study Timeline

• First IOM meeting -- December 15-16, 2015 - focused on topic refinement
• Second IOM meeting -- October 25-27, 2016 -- focused on the review of the draft EPC report
• Third IOM meeting -- January 24-25, 2017 -- focused on IOM discussion of the final EPC report

Retirement of Neil Buckholtz

Director of the NIA
Division of Neuroscience since October 2012