Research Subcommittee
Harry Johns, Jennifer Manly, Ronald Petersen, George
Vradenburg, Richard Hodes, Russell Katz, Donald Moulds
January 18, 2010
NOTE: Any mention of
recommendations in these slides was for subcommittee discussion.
These
slides do not reflect formal Advisory Council recommendations.
PDF Version:
http://aspe.hhs.gov/daltcp/napa/011712/Mtg2-Slides4.pdf
(8 PDF pages)
Introduction
- One overall goal, three strategies
- Strategy 3 is very much in development
- Some of the action steps have consensus, others are being developed
Overall Goal
- To prevent, effectively treat, substantially delay the onset, or slow
the progression of AD
- The implications of setting a 2020 vs. 2025 target date are being
discussed
Strategy 1
- Commit aggressive resources, with appropriate accountability, to
Alzheimers Disease research to match the current and growing impact of
the disease on society
Action 1A
- Immediately increase annual federal research funding investment to a
minimum of $2 billion in targeted, outcome-oriented Alzheimers research
initiatives spanning basic, translational and clinical research, and hold
recipients of funding accountable for progress toward the overall stated goal.
- Federal members cant opine on allocation of resources
- A systematic review of resource needs is currently underway by
the Alzheimers Association
Action 2A
- In order to achieve the goal, HHS should be required to develop,
execute and regularly update a scientific research plan and priorities to
accelerate breakthroughs in AD research, a review of research infrastructure
including public/private partnerships, and provide programmatic recommendations
for achieving these targeted research opportunities through sustainable higher
levels of annual funding
Action 3A
- A person or office should be identified who has responsibility and
accountability for execution of, and advocacy for, all aspects of the National
Plan, including responsibility for issuing reports to Congress and the Advisory
Council
- We share the desire to not add layers of bureaucracy but believe
strongly in the need for accountability
Strategy 2
- Accelerate public access to new therapeutic interventions by
compressing the current average time in the process of identification of
therapeutic targets, validation of those targets, development of interventions,
testing of efficacy and safety, and regulatory review.
- We are working on clarification of the component steps involved in
therapy development and potential interventions
Action 2A
- Develop behavioral and biological markers for potential therapeutic
targets or surrogate endpoints
- This is a common focus with framework
Action 2B
- The HHS Secretary, in consultation with the private sector, the
research community and NGOs, should by year-end 2012 model and prioritize
the action steps needed to reduce the time for moving therapies from target
identification and validation through regulatory approval and thereafter to
implement or cause to be implemented such action steps.
In undertaking the above, might include:
- Repurposing exiting drugs
- Develop and require adoption of clinical terminology and disclosure
standards for use in all new and ongoing Alzheimers clinical trials
(Federally-funded and industry-supported) to build an open source database for
qualified research use.
- Remap or otherwise integrate data from completed Federally-funded and
industry-sponsored Alzheimers clinical trials, including data from failed
clinical trials
- Develop common data standards and measurements for questionnaires
used to assess cognition and functional status.
- All Alzheimers-related standardized data standards should
promote interoperability between clinical research and healthcare information
systems.
Action 2C
- Develop a process by which research priorities would be set,
including input from scientific experts
Action 2D
- In order to address disparities, activities aimed at translation of
research findings into medical practice and to the public should include
specific targets for outreach to racial/ethnic and socioeconomic groups who
have been shown to be at the greatest risk for developing AD
Action 2E
- Develop metrics for assessing the effectiveness of therapies on the
healthcare economy
Strategy 3
- Explore the possibility of providing incentives to private industry
to invest in disease-modifying interventions
- A panel of experts from private industry will be convened to help
determine the nature of possible incentives that would accelerate discovery.
They may include:
- Tax reform/incentives to drive greater investment
- Patent law reform to include pharma incentives
- Enhanced market exclusivity
Next Steps
- Conference calls & meetings
- Incorporation of feedback from research community and public comments
Where to?
Top of Page
NAPA Home
Page
Home Pages:
Office of
Disability, Aging and Long-Term Care Policy (DALTCP)
Assistant Secretary for Planning and Evaluation
(ASPE)
U.S. Department of Health and Human
Services (HHS)
Last updated: 01/26/2011