July 2015

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ACT-AD Executive Director Testifies at Key FDA Meetings

ACT-AD’s Executive Director Cynthia Bens was invited by the Food and Drug Administration to participate in meetings focused on the reauthorization of the agency’s user fee programs. Bens participated in a July 13 meeting on reauthorization of the Medical Device User Fee Program (MDUFA) as part of a patient and consumer advocate panel. Bens then took part in a July 15 meeting on reauthorization of Prescription Drug User Fee Act (PDUFA) program.  At the meeting, Bens offered several suggestions for PDUFA’s renewal, including the continuation of Patient Focused Drug Development (PFDD) meetings.  Bens noted, “After such positive experiences with ACT-AD, we were fierce supporters of the Patient Focused Drug Development (PFDD) Initiative during PDUFA V…a priority of ours in PDUFA VI will be funding for the continuation of FDA-led PFDD meetings.” You can read more here.

SAVE THE DATE: ACT-AD FDA/AD Allies Meeting Set for September 16

Save the date! We are excited to announce that our 8th Annual FDA/AD Allies Meeting will take place on September 16, 2015, from 10:00 a.m. to 4:00 p.m. at the Bethesda North Marriott Hotel & Conference Center (5701 Marinelli Rd, North Bethesda, MD). More details will be available in the coming weeks at act-ad.org.  You can register or get additional details by emailing Ryne Carney.

Alzheimer’s Association International Conference Held This Month

On July 18-23 the Alzheimer’s Association International Conference® (AAIC®) was held in Washington, D.C. It brought together the global dementia community to share in the latest research in the field of Alzheimer’s disease. To find out more about what went on at this year’s AAIC conference, please go here.

ACT-AD Member to Host 16th International Conference on Alzheimer’s Drug Discovery

ACT-AD is proud to be a media sponsor of the 16th International Conference on Alzheimer’s Drug Discovery to be held on October 5-6, 2015, in Jersey City, N.J. Hosted by the Alzheimer’s Drug Discovery Foundation, a founding ACT-AD member, the conference “brings together academic and industry scientists intent on accelerating the development of innovative treatments for Alzheimer’s disease and related dementias.”  Those who wish to learn more can go here.

FDA Report on Collaboration and Research Needed to Develop Cures

Dr. Robert Califf, FDA’s deputy commissioner for Medical Products and Tobacco, published a blog this month releasing an FDA report comparing diseases where there is a robust pipeline of new therapies with diseases that have few known treatments or cures. Alzheimer’s disease is featured, and the report emphasizes that the scientific community lacks basic information about what causes the disease and how it can be slowed and treated. Despite these challenges, to encourage innovation, FDA collaborates with fellow government agencies and the health care community, including members of patient groups, academia, and industry. Dr. Califf stresses that it will take a collaborative effort to improve American understanding of certain diseases and to translate any resulting scientific discoveries into cures. To read his blog post, go here. 

An Update on Policy of Use of Single IRB for Multisite Research

A new post from the National Institute of Health’s “Under the Poliscope” blog gives an update on the status of its draft “Policy on the Use of Single Institutional Review Board (IRB) for Multisite Research,” which was presented on December 14. The blog outlines the comments the Office of Science Policy has received.  According to the blog, “As a result, the OSP received, reviewed, and analyzed 167 comments submitted by individuals, entities affiliated with academic institutions, patient advocacy groups, IRBs, private healthcare and research organizations, tribal nations, and the general public.”  Go here to read it.