May 2010

Poll Finds Strong Support for Collaboration on Research

Research!America, an ACT-AD member, released a poll earlier this month examining different aspects of the nation’s research enterprise. Some of the most compelling findings from the poll related to public attitudes on the role of the Food and Drug Administration (FDA) and the pace of health and medical research. Key findings revealed that nearly three-quarters of Americans are confident in our system for reviewing the effectiveness and safety of new medicines and medical devices. When asked the most important role of the FDA, 59% said protecting the safety of Americans; 17% said providing accurate information about benefits and risks associated with medicines and medical products; and 7% said regulating companies that produce medicines and medical products.

In addition to expressing their views on FDA’s primary role, 41% of respondents said it takes too long to approve a drug and allow it to be sold to consumers. A large majority (94%) support the idea that institutions conducting medical and health research—government, universities and private industry—should work together to advance greater knowledge, improve success rates and speed up the development of cures and treatments.

To view more results from the Research!America poll, click here.

ACT-AD Chair Stresses the Importance of Regulatory Science in Alzheimer’s Disease

On May 4, Daniel Perry, ACT-AD’s Chairman, spoke on a panel titled “Advancing Regulatory Science.” This panel took place during a super session at the BIO 2010 International Convention in Chicago,IL. Mr. Perry’s comments focused on challenges in therapeutic development for Alzheimer’s disease that may be improved with focused efforts on improving regulatory science at the Food and Drug Administration (FDA) and increased scientific capacity at the Agency. During his remarks, Perry highlighted the ACT-AD Coalition’s history of working with the FDA to shed light on the growing personal and societal burden of Alzheimer’s disease and the need for heightened attention from all stakeholders on neurological product development and review.

Other panelist during this session included:

  • Margaret Hamburg, MD – FDA Commissioner
  • Barry Gertz, MD, PhD – Merck SVP for Clinical Development and Regulatory Affairs
  • Harry Johns – President & CEO, Alzheimer’s Association
  • Alan Lewis – President & CEO, Juvenile Diabetes Research Foundation

To view Daniel Perry’s slides from this session, click here.

Launch of New Alzheimer’s Clinical Trial Database

On June 11, the Coalition of Major Diseases (CAMD) will publicly announce the first standardized database of pharma clinical trial data which includes more than 4,000 Alzheimer’s disease patients. This database will be made available to qualified researchers worldwide and is intended to accelerate research on the disease by providing a platform to assist researchers in designing more efficient clinical trials for new treatments. FDA Principal Deputy Commissioner Dr. Joshua Sharrfstein, Dr. Mark McClellan of the Engelberg Center for Health Care Reform at Brookings, and Dr. Raymond Woosley of the Critical Path Institute will make remarks at this event, among others.

CAMD is the first public-private partnership of its kind representing the FDA, the pharmaceutical industry, patient advocacy groups and international government entities, to address critical gaps in advancing drug development for Alzheimer’s and Parkinson’s diseases. This partnership includes participation and support from the Alzheimer’s Foundation of American and the Alliance for Aging Research, both ACT-AD members.