FDA to Hold Public Hearing on the Prescription Drug User Fee Act Reauthorization
The U.S. Food and Drug Administration (FDA) will hold a public meeting on April 12, 2010 inRockville,MD. The purpose of the meeting is to seek input on the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September of 2012, authorizes the FDA to collect user fees from companies wishing to submit their products for agency review. The intention is that the fees would be used to provide an additional revenue stream for FDA to hire more staff, improve systems, and establish a better managed drug review process to speed up the delivery of needed therapies to the public.
The PDUFA reauthorization process has historically been conducted through negotiations between the Agency and regulated industries, however the current round of negotiations will be open to broader participation and transparency. The FDA must seek feedback from patient and consumer groups as well as the general public before entering into formal negotiations with industry and also before submitting its recommendations to Congress. This meeting is the first opportunity the patient community will have to comment on how it views the performance of PDUFA and what elements should be reconsidered in the PDUFA V reauthorization. ACT-AD members are encouraged to attend.
To learn more about the meeting and the process for submitting comments to the FDA, click here.
ACT-AD Welcomes New Corporate Sponsor
JANSSEN Alzheimer’s Immunotherapy (JANSSEN AI) recently became a corporate sponsor of the ACT-AD Coalition. JANSSEN AI, a Johnson & Johnson company, is dedicated to developing treatments for Alzheimer’s disease. Their lead compound, bapineuzumab is in Phase 3 clinical trials. Bapineuzumab is a monoclonal antibody designed to enlist the body’s immune response to clear toxic beta amyloid from the brain. Other programs, including a subcutaneous formulation of bapineuzumab, and ACC-001 (active immunotherapeutic conjugate) vaccine are in earlier stages of development.
The compounds in JANSSEN’s Alzheimer’s Immunotherapy Program (AIP) were acquired from Elan Pharmaceuticals in September 2009 and are being developed in collaboration with Pfizer. JANSSEN AI is named in honor of Dr. Paul Janssen, the Belgian scientist whose vision and intellect was the cornerstone of Johnson & Johnson’s ability to become a global leader in neuroscience.
ACT-AD welcomes JANSSEN AI and takes this opportunity to thank them and our other sponsors for allowing the Coalition to more effectively highlight increasing scientific knowledge from the field AD research and the impact that could have on those affected by Alzheimer’s disease and their families and caregivers.
ACT-AD Member to Host Symposium on Mitochondrial Function in Alzheimer’s
On Thursday, May 13, the Alzheimer Drug Discovery Foundation, an ACT-AD member, and the New York Academy of Sciences will host a full-day symposium entitled, Mitochondrial Function as a Therapeutic Target for Alzheimer’s Disease. The meeting will take place at the New York Academy of Sciences’ conference center inNew York City. Dr. Howard Fillit, President and CEO of the Alzheimer’s Drug Discovery Foundation will speak at the meeting, among others.
Growing evidence indicates that mitochondrial dysfunction is one of the key mechanisms associated with the pathogenesis of Alzheimer’s disease. Recent findings from basic, clinical, and translational research will be presented at this forum designed to stimulate discussion about the role of the mitochondria and its relationship to age-related neurodegenerative disease. The goal of this conference is to critically examine potential therapeutics for mitochondrial dysfunction in Alzheimer’s disease.
To learn more about the event, click here.
Upcoming Patient Advocacy Reception on Imaging
The Coalition for Imaging and Bioengineering Research (CIBR) will host a Congressional reception on the evening of April 13. The reception, which will be held in Washington, DC on Capitol Hill, will provide an opportunity for patient advocates to meet and collaborate with top research scientists and academic center leaders in biomedical imaging. Attendees will include National Institutes of Health directors and staff, imaging researchers, members of Congress, congressional staff, and industry representatives. Presentations and poster sessions will provide information on biomedical imaging; stress the value of investment in imaging research; and highlight the impact that imaging research has on innovation related to many diseases and conditions. ACT-AD members and other interested parties are welcome to attend.
To learn more about CIBR, click here.