ACT-AD Hosts Multi-Day Expert Retreat on Combination Therapies
Following a foundational meeting on combination clinical trials in November 2012, ACT-AD, the Critical Path Institute and the Alzheimer’s Association hosted two and a half day working sessions on May 28-30, 2013 made up of leaders from the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, the National Institutes of Health (NIH), 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- The regulatory environment following the FDA’s 2010 draft guidance on unmarketed drugs for combination use;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 from this working meeting will be issued by the meeting co-conveners. Dan Perry, Chair of ACT-AD, 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 has been coordinating meetings like this one to foster successful collaboration across stakeholder groups.
Additional information, including a meeting transcript, will be available on www.act-ad.org.
NIH Director Defends Budget Increase in the Senate
On May 15, Dr. Francis Collins, Director of the National Institutes of Health (NIH) and a number of Institute heads, including Dr. Richard Hodes of the National Institute on Aging (NIA) and Dr. Story Landis, of the National Institute of Neurological Disorders and Stroke (NINDS) appeared before the Senate Appropriations Subcommittee on Labor, HHS, and Education, to justify their portion of the Obama Administration’s Fiscal Year 2014 (FY14) Budget Request. The FY14 request contains just over $31 billion for NIH, representing a 7.4% increase over what is likely to be the final FY13 funding level after the sequester is applied.
During the hearing Dr. Collins described some of the promising research underway at NIH like the recently announced BRAIN mapping initiative. Several members of the panel requested updates on particular areas of research of interest. Dr. Collins also told the committee members that the NIH purchasing power had declined by 22% in the last 10 years and that if the reductions associated with sequestration are allowed to continue, NIH will lose and additional $19 billion over the next 10 years.
Many members of the committee, including Senator Barbara Mikulski (D-MD), who chairs the entire Senate Appropriations Committee, made it clear that NIH funding was a priority. Chairwoman Mikulski promised action on ending the sequester and writing a FY14 Appropriations bill that provides NIH with the funds it needs.
NIH Holds Summit on Alzheimer’s Disease-Related Dementias
On May 1-2, 2013 the National Institute of Health (NIH) with support from ACT-AD and other dementia stakeholder groups held a major summit to discuss research priorities for Alzheimer’s disease-related dementias, including frontotemperal dementia (FTD), Lewy body, mixed, and vascular dementia. The summit titled “Alzheimer’s Disease-Related Dementias: Research Challenges and Opportunities,” covered topics ranging from improving recognition across the dementia spectrum to health disparities in dementia research and treatment. ACT-AD did have a presence at the summit.
Led by the National Institute on Neurological Disorders and Stroke (NINDS) in collaboration with the National Institute on Aging (NIA) and the Foundation for the NIH, the two-day summit was recommended as part of the 2012 National Plan to Address Alzheimer’s Disease. This summit was complementary to the NIA’s “Alzheimer’s Disease Research Summit 2012: Path to Treatment and Prevention,” also sponsored by ACT-AD.
ACT-AD Member to Host 14th Annual International Conference on Alzheimer’s Drug Discovery
The Alzheimer’s Drug Discovery Foundation (ADDF) will be hosting the 14th International Conference on Alzheimer’s Drug Discovery on September 9-10, 2013 in Jersey City, N.J. The annual (ADDF) conference brings together academic and industry scientists intent on accelerating the development of innovative treatments for Alzheimer’s disease and related dementias.
The ADDF’s funded investigators and top level scientists in the field will present on their current research progress and stimulate discussion. The conference offers ample opportunities for collaboration and partnering. Guests will include over 150 key stakeholders from the pharmaceutical, biotechnology, government, and academic communities. ACT-AD and the Alliance for Aging Research are media partners for the event.
For more on the conference, click here.