Press Release

Recommendations to Develop a Roadmap to Alzheimer’s Disease Combination Therapy Issued From Meeting of Regulatory, Industry, Research and Funding Leaders

ACT-AD Coalition Coordinates Action Steps to Facilitate Further Collaboration on Future R&D

May 30, 2013 — Washington, D.C., May 30, 2013 – The ACT-AD (Accelerate Cure/Treatments for
Alzheimer’s Disease) Coalition, The Critical Path Institute and leaders in the
Alzheimer’s community today announced preliminary recommendations for a
“roadmap to combination therapies for Alzheimer’s disease” (AD) at the final
session of a three-day event in Washington, D.C. ACT-AD Chairman, Daniel
Perry, called the meeting “a vision of what is possible with interdisciplinary
collaboration and commitment to defeating one of the greatest health threats of
our generation, just as it has led to successful combination therapy against other
complex diseases.”

Following an exploratory meeting on combination clinical trials in November
2012, also coordinated by ACT-AD and the Critical Path Institute, this week’s byinvitation
working sessions brought together leaders from the U.S. Department of
Health and Human Services, the U.S. Food and Drug Administration, the
National Institutes of Health, the academic research community, the
pharmaceutical industry, private philanthropy, and patient advocacy groups to
address three key areas:
– The regulatory environment following the FDA’s 2010 draft guidance on
unmarketed drugs for combination use;
– Adaptive clinical trial design and data sharing strategies to streamline next
phases of research; and
– New approaches to leverage public/private funding for collaborative
programs.

A publication detailing the recommendations will be issued by the meeting coconveners.
Mr. Perry preliminarily described the paper as “offering concrete
steps toward overcoming many of the obstacles that previously kept us from
taking what we learned from years of clinical trial results on drugs that alone
were disappointing and efficiently studying how the right combinations may make
AD treatable or even preventable.” Since 2006, ACT-AD, a coalition of more than
50 national organizations seeking to accelerate better treatments and potential
cures for Alzheimer’s disease, has been coordinating meetings to foster
successful collaboration across stakeholder groups.

Diane Stephenson, Ph.D., Executive Director of the Critical Path Institute’s
Coalition Against Major Diseases (CAMD), also co-host for the meeting, added
that “learnings across complex diseases are what inspired the engagement of

C-Path, whose core mission is to accelerate the development of drug
development tools through a regulatory path for diseases of unmet need, such as
AD and tuberculosis.” “It was very encouraging to hear consensus among the
FDA, researchers and the pharmaceutical industry that a new generation of
clinical trials can proceed without the costly burden of duplicating past research.”

Presenters and panelists included:
– Don Berry, Ph.D., Berry Consultants
– Chas Bountra, Ph.D., University of Oxford
– David Dilts, Ph.D., MBA, CMA, Dilts Partners
– Debra Hanna, Ph.D., Critical Path Institute
– Rusty Katz, M.D., U.S. Food Administration
– Steven Potkin, M.D., University of California at Irvine
– Reisa Sperling, M.D., MMsc, Harvard Brigham and Women’s
– John Trojanowski, M.D., Ph.D., University of Pennsylvania

For more information on the Roadmap to Combination Therapies for Alzheimer’s
Disease, please visit the coalition’s website at http://www.act-ad.org/ or call 202-
293-2856. To arrange an interview with Daniel Perry, please contact Harry Wade
at [email protected] or call 917-482-9057.

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About ACT-AD

ACT-AD is a coalition of more than 50 national organizations representing patients, providers, caregivers, consumers, older Americans, researchers, and employers seeking to accelerate development of potential cures and treatments for Alzheimer’s disease.

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