November 2012

ACT-AD Represented at the 5th Clinical Trials in Alzheimer’s Disease Conference

On October 29, ACT-AD held its first symposium at an internationally-recognized conference. The 1-hour program titled “Harmonizing Global Regulatory Standards to Benefit Future Alzheimer’s Disease Patients” was held at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in Monaco and was comprised of presentations by regulators from the US and Europe as well as representatives involved in global efforts to standardize data, biochemical assays, and neuroimaging protocols for Alzheimer’s disease (AD).

The purpose of the symposium was to shed light on similarities and differences between FDA and EMA requirements for achieving disease modification in pre-symptomatic AD patients—with a goal of highlighting how, in addition to guidance, new regulatory science initiatives to qualify drug development tools could provide clarity to industry on particular biomarkers, endpoints, or outcome measures that are acceptable to regulatory authorizers for use in clinical trials. Gabrielle Strobel, Executive Editor of the Alzheimer’s Research Forum, published a feature on this symposium.

On October 30, ACT-AD hosted a working dinner with the CTAD co-conveners for key opinion leaders in the Alzheimer’s community to discuss the direction of AD drug development post-release of Phase III announcements for bapineuzumab and solanezumab. Remarks were made at the dinner by Paul Aisen, MD, UCSD; Reisa Sperling, MD, Harvard Medical School; and Dennis Selkoe, MD, Harvard Medical School, among others.

To view Strobel’s feature, click here.

ACT-AD Holds Annual FDA/AD Allies Meeting on Combination Therapies

Yesterday, ACT-AD hosted the fifth in a series of working meetings with senior representatives from the U.S. Food and Drug Administration (FDA), leading scientists, drug developers, and Alzheimer’s advocates to address critical issues affecting the development and review of new Alzheimer’s disease therapies.

The presentations, panels, and open dialog during the meeting focused on how to foster more robust pre-competitive collaboration in Alzheimer’s disease in order to encourage the development of combination therapies and bring new treatments to market.

The meeting explored the challenges of these collaboration and potential opportunities for future partnership. Individuals involved in current and past collaborative efforts, reflected upon their experiences and prescriptions for the field moving forward.

The meeting was organized by ACT-AD and co-hosted by The Critical Path Institute. More than 50 leading stakeholders in the Alzheimer’s community and representatives from the Food and Drug Administration and National Institutes of Health attended the meeting.

A summary of the meeting and a transcript will soon be available at www.act-ad.org.

ACT-AD Leads Advocacy Group Comments to FDA Regarding Patient-Focused Drug Development

On November 1, ACT-AD sent a letter on behalf of a number of Alzheimer’s disease stakeholders to the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Theresa Mullins, urging the FDA to continue making Alzheimer’s disease a priority at the agency.

The letter applauds FDAs inclusion of patient-focused drug development enhancements in the newest user fee agreement with the Pharmaceutical Industry, but encouraged FDA to continue to represent the needs of individuals with Alzheimer’s disease as the agency implements and executes these enhancements over the next five years. The letter included a number of recommendations for building on the successes FDA has seen in this space over the past several years, including expanding the understanding of risk-tolerance of toxicity by early-stage and pre-symptomatic populations.

It also contained a request for more information on the considerations that went into selecting the diseases to be included in the new programs, published in the September 24th Federal Register notice, in order to bolster advocacy involvement in those specific patient-focused meetings.

To view the letter, click here.