June 2013

ACT-AD Meeting on Combination Therapies Featured in the Alzheimer Research Forum

The Alzheimer Research Forum ran a feature this month on an ACT-AD hosted meeting on May 28-30, 2013. As a follow-up to a foundational meeting held in November 2012, the 3-day was convened to further explore the feasibility of a combination approach to Alzheimer’s disease treatment. The meeting was co-hosted by the Critical Path Institute and the Alzheimer’s Association and was attended by representatives from a number of advocacy groups, the US Food and Drug Administration, the National Institute on Aging, the Department of Health and Human Services, philanthropic organizations, and five pharmaceutical companies. The meeting resulted in a number of recommendations that would further establish the scientific rationale for combining treatments, inventory possible compounds to combine, and identify data needed to inform modeling and simulation tools facilitating early decision making in novel trials. The recommendations will be summarized in an upcoming paper developed by ACT-AD. Additional post meeting coverage is available on the Scrips Capitol Capsule and PharmaLive.

To read the Alzheimer Research Forum feature, click here.

ACT-AD Supports National Memory Screening Day

ACT-AD is pleased to support The Alzheimer’s Foundation of America (AFA), an ACT-AD member, as it hosts the 11th annual National Memory Screening Day on Tuesday, November 19, 2013. Community sites nationwide will offer free, confidential memory screenings and educational materials to the public. Qualified healthcare professionals will provide the confidential screenings and educational materials about memory problems, caregiving and successful aging at community sites from coast to coast. The test consists of a series of questions and tasks, and takes about five to ten minutes to administer. These memory screenings do not represent a diagnosis. Individuals who score poorly or who have normal scores but are still concerned will be advised to follow up with their clinicians. National Memory Screening Day coincides with National Alzheimer’s Disease Awareness Month.

For more information, visit www.nationalmemoryscreening.org or call 866-232-8484.

Congress Acts on FY 2014 Funding for the FDA

During the week of June 17, the Senate Appropriations Committee considered its proposal to fund the Food and Drug Administration (FDA) in FY 2014. The committee provided FDA with a budget authority appropriation of $2.552 billion, a $96 million increase over the FY 2013 enacted level (post rescission, pre-sequester). In addition, the Committee included $11 million for buildings and facilities repair, a $6 million increase. The Senate bill is $102 million more than the FY 2013 enacted level and $78 million above the House FY 2014 bill adopted the prior week. The Senate Appropriations committee indicated that it will include language that will prevent the sequester of FDA user-fee funds and, possibly, restore the FY 2013 funds that were taken away. However, the bill text and committee report are not yet available to confirm that.

The House intends to bring its FY 2014 FDA Appropriations bill for a vote prior to the July 4th Congressional Recess. Further action on the FY 2014 and finalization of the FY 2014 appropriations process for FDA will likely be delayed due to large discrepancies in House and Senate allocations that will prove challenging to conference any of the stand-alone spending bills this year. ACT-AD and its members will continue to work for the largest possible appropriation for the FDA this, reminding legislators that the FDA’s responsibilities for promoting innovation keep growing every year.

The House FY 2014 Appropriations bill can be found here.

The House FY 2014 Committee Report can be found here.

A summary of the Senate FY 2014 Appropriations bill can be found here.

HHS Releases Revised National Plan to Address Alzheimer’s Disease

The Secretary of the Department of Health and Human Services released the second iteration of the U.S. National Plan to Address Alzheimer’s Disease as mandated under the 2011 National Alzheimer’s Project Act (NAPA). The plan includes: finding ways to prevent and effectively treat Alzheimer’s disease by 2025; enhancing care for Alzheimer’s patients; expanding support for people with dementia and their families; improving public awareness; carefully tracking data to support these efforts. The revised plan includes the development of curriculum and training programs to improve the delivery of high-quality dementia care. Specific to the Food and Drug Administration (FDA), the timeline for implementation includes the finalization of draft guidance for the development of treatments for early Alzheimer’s disease by December 2013. The draft guidance was released earlier this year and ACT-AD submitted comments in March for consideration.

To read the updated National Plan, click here.

ACT-AD Member Hosts Women’s Health Research Conference

ACT-AD member the Society for Women’s Health Research will hold its 4th annual State of Women’s Health Research Conference “What a Difference an X Makes” on July 18-19, 2013 at the Pew Charitable Trusts (901 E Street, NW, Washington, DC 20004). The conference Combines basic science, medicine, and policy to transform women’s health. Janine Clayton, MD, Office of Research on Women’s Health, National Institutes of Health will give a keynote presentation during the conference on “Clinical Trials: Current Challenges for Women.”

Discounted student and government rates are available. For more information contact, Dr. Erika Davies at [email protected] or 202-223-8224.

To register, visit www.swhr.org .

Critical Path Institute Marks Milestone Regulatory Decision

On June 12, the Coalition Against Major Disease (CAMD), which is part of the Critical Path Institute, announced that the U.S. Food and Drug Administration (FDA) issued a positive regulatory decision on a submission made by CAMD for an Alzheimer’s Disease Quantitative Clinical Trial Simulation Tool. This clinical trial simulation tool was deemed “fit-for-purpose” by the FDA as a scientifically-supported drug development tool, suitable for the purpose of aiding in the design of future clinical trials in patients with mild and moderate AD. As the first regulatory decision on a stand-alone modeling and simulation drug development tool, this decision represents a step towards model-based drug development as first outlined in the vision of FDA’s Critical Path Initiative Document.

For more information, visit c-path.org/CAMD.cfm .