September 2012

ACT-AD to Hold Annual FDA/AD Allies Meeting on Combination Therapies and Pre-Competitive Collaboration

ACT-AD, chaired by the Alliance for Aging Research, will host its fifth annual meeting which offers another opportunity for patient groups, researchers and industry to interact with the FDA. This meeting will explore the development of combination therapies for Alzheimer’s disease and the necessary pre-competitive collaboration to make them a reality. This is a public event that ACT-AD will host in partnership with the Critical Path Institute.

The meeting will take place on November 29, 2012 from 8:00 a.m. to 2:30 p.m. at the Hilton Rockville Executive Meeting Center (1750 Rockville Pike Rockville, MD 20852). There is no fee to attend but registration is required.

For further details contact Cynthia Bens, Director of Public Policy at the Alliance for Aging Research ([email protected] or 202-293-2856). To RSVP, please email [email protected]

ACT-AD to Have a Presence at CTAD 2012

In 2011, ACT-AD hosted a successful networking event at the 4th annual Clinical Trials in Alzheimer’s Disease (CTAD) Conference in San Diego, CA. This year, the Coalition submitted a symposium abstract for a session during the 2012 conference on harmonizing global regulatory requirements for Alzheimer’s disease. Recognizing that important standardization efforts for biochemical assays and neuroimaging protocols have been undertaken by the Alzheimer’s Association, the Critical Path Institute, and others in the public and private sectors, ACT-AD’s symposium abstract centered on the notion that few groups are addressing the differing regulatory authority requirements that are driven by principle or the structure of a particular regulatory body. ACT-AD’s symposium abstract has been selected and our session will occur on Tuesday, October 29, 2012 at 8:45 a.m.

More details on CTAD can be found at www.ctad.fr.

PhRMA Holds Inaugural Research and Hope Awards in Washington, DC

On September 12, the Pharmaceutical Research and Manufacturers of America (PhRMA) held the first annual Research and Hope Awards to honor those in the patient and caregiving community, as well as the biopharmaceutical sector, who have made significant contributions to the advancement of patient care and medical innovation in the U.S. This year’s inaugural celebration, held in Washington, DC, focused on advancements made in the therapeutic area of Alzheimer’s disease.

The awardees included the Institute of Medicine’s Katie Maslow, Neha Chauhan – founding member of Alzheimer’s Foundation of America (AFA) Teens chapter, and the heads of MERCK’s BACE Team making strides into beta-amyloid inhibitors.

PhARMA also used the night to release two new reports on the state of Alzheimer’s therapeutic sciences; “Medicines in Development for Alzheimer’s Disease (2012)” found here, and “Researching Alzheimer’s Medicines: Setbacks and Stepping Stones” found here.

To read more about this year’s Research and Hope Awards and Awardees, click here.

For more information on PhARMA’s “From Hope to Cures” initiative, visit www.fromhopetocures.org.

ACT-AD Chair Sends Letter to Congressional Leadership Concerning Sequester Cuts to FDA

On August 20, ACT-AD Chair Dan Perry sent a letter to House and Senate leadership to express deep concern over the threat of sequestration on funding at the Food and Drug Administration (FDA). The letter noted the effect sequestration would have on the ability of federal agencies like the FDA to continue engagement on the National Plan to Address Alzheimer’s Disease, and on implementation of the bi-partisan Food and Drug Administration Safety and Innovation Act (FDASIA). Both initiatives are integral to achieving breakthrough Alzheimer’s treatments will reach patients in a safe and timely manner.

The Alliance for Stronger FDA reports that the sequester cuts to FDA would amount to 8.2% or $318 million leaving only $67 million of fees exempt. Exact numbers are currently unclear however, as Congress is attempting to reconcile the mandated implementation of the new user fee programs and rates, and the six-month continuation of the former programs under a continuing budget resolution passed by congress just before their October recess.

Without question, capacity cuts to FDA pose a threat to recent and future advancements in regulatory science, and put the development and translation of breakthrough Alzheimer’s therapies in jeopardy. The ACT-AD Coalition is committed to supporting the agency during this on-going debate, and will continue to be active in protecting the fragile development pipeline for Alzheimer’s therapies.

To view ACT-AD’s letter to Congressional leaders, click here.

To view the Alliance for a Stronger FDA’s assessment, click here.

Join ACT-AD and Its Allies in Spreading Congressional Petition to End Alzheimer’s Disease

ACT-AD has partnered with dozens of other leading organizations in the Alzheimer’s community to support a national call to action. The effort seeks to put pressure on Congress, through a national petition drive, to recognize and encourage the recent breakthroughs in Alzheimer’s disease science. The goal it to demonstrate to elected officials that there is broad public support for a full-scale commitment to providing the resources needed to find more effective treatments and a cure for this terrible disease.

The petition drive has sample language available for editorial letters, congressional letters, web postings, and social media campaigns. ACT-AD member organizations are encouraged to participate and to use these tools for outreach to your own member.

For sample language, and materials, click here.