ACTIVITIES

ACT-AD Activities

ACT-AD and our members conduct activities throughout the year to focus attention on the need to accelerate cures and treatments for Alzheimer’s disease.

April 6, 2016
ACT-AD has submitted a letter to the U.S. House and Senate Appropriations Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies requesting a $120 million increase in appropriated funding for the U.S. Food and Drug Administration (FDA) for fiscal year 2017. This would increase funding from $2.73 billion in FY16 to $2.85 billion in FY17. Read it here. 

March 30, 2016
The National Institute of Neurological Disorders and Stroke hosts Alzheimer’s Disease-Related Dementias: Research Challenges and Opportunities. At this conference leading neuroscientists, physicians, and public and private stakeholders discussed key challenges and special opportunities in research on Alzheimer’s disease-related dementias. The conference was convened under the National Plan to Address Alzheimer’s Disease to further develop recommendations on research priorities in the areas of frontotemporal, Lewy body, mixed, and vascular dementias. ACT-AD is a sponsor of the conference.
View Agenda
View Draft Recommendations

February 29, 2016, 2016
ACT-AD held the second in a series of webinars on the future of research, therapeutic development, and treatment of Alzheimer’s disease. The webinar titled Personalized Medicine and Alzheimer’s Disease featured presentations by experts involved in ongoing prevention trials for Alzheimer’s disease and the U.S. Food and Drug Administration on important issues related to genetic testing. Listen to the program here.
See Ms. Cynthia Bens’ Presentation
See Dr. Jason Karlawish’s Presentation
See Ms. Cara Tenenbaum’s Presentation

September 16, 2015
ACT-AD hosted its Eighth Annual FDA/AD Allies Meeting on September 16, 2015, at the Bethesda North Marriott in North Bethesda, Md. This year’s theme was “Assessing the Scientific Foundation for Alzheimer’s Disease Therapeutic Development.” Here’s more info on the day’s activities.
View Agenda
See Dr. George Perry’s Presentation
See Dr. Bryan Traynor’s Presentation

May 18, 2015
ACT-AD has submitted comments on the 21st Century Cures Act, which was approved by the House Energy & Commerce Committee this month.  Learn more.

April 13, 2015
ACT-AD held a webinar titled Targets for the Next Generation of Alzheimer’s Disease Treatment.  It is available for viewing.  Go here for more info.

February 10, 2015
ACT-AD Chair responds to House Energy and Commerce Committee draft 21st Century Cures legislation. These comments acknowledge Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO) for their desire to accelerate the development of treatments, particularly for diseases with high unmet need. They also recommend some modifications to sections of the draft bill related to Patient-Focused Drug Development, endpoint qualification, among others.
View Comments
View 21st Century Cures Draft Bill

December 15, 2014
ACT-AD submits comments to the National Institute on Aging (NIA) on its draft strategic directions document, Aging Well in the 21st Century. The comments thank the NIA’s director for the priority he has placed on advancing Alzheimer’s disease research and the commitment the NIA has shown to collaborating with other partners to more quickly translate research findings into new treatment options for people living with Alzheimer’s disease. ACT-AD encouraged the NIA to include greater emphasis on research to develop improved tools for measuring cognition and function in early stage AD and on advancing combination drug therapy for Alzheimer’s disease in the Institute’s final strategic plan.
View Comments

December 5, 2014
ACT-AD submits comments to the U.S. Food and Drug Administration on a proposed list of disease areas for patient-focused drug development meetings during fiscal years (FYs) 2016-2017. The patient-focused drug development meetings held to date covered aspects of diseases that are most important to those living with them and resulted in valuable publicly-available resources written in the voice of patients to help inform new endpoint development, outcome measure selection in clinical trials, and benefit/risk decision making by the FDA. ACT-AD’s comments urge the FDA to add Alzheimer’s disease to the list of nominated diseases and ask them to prioritize a meeting on Alzheimer’s disease in early FY 2016.
View Comments

November 6, 2014
ACT-AD hosts its 7th FDA/Alzheimer’s Disease Allies Meeting for patient groups, regulators, researchers and industry. This meeting explored challenges related to clinical meaningfulness in therapeutic development for early Alzheimer’s disease. For more information, contact Cynthia Bens at [email protected].
View Agenda
See Dr. Kun Jin’s Presentation
See Dr. Richard Keefe’s Presentation
See Dr. Paul Aisen’s Presentation

May 30, 2014
ACT-AD submits comments in response to House Energy and Commerce Committee 21st Century Cures: Call to Action white paper. The coalition encourages further utilization of therapeutic repurposing for Alzheimer’s disease, a combination approach to Alzheimer’s therapy and more flexibility in early stage clinical trials for Alzheimer’s disease.
View Comments

February 3, 2014
ACT-AD Chairman Daniel Perry thanks House and Senate appropriators for increasing FDA’s funding in FY 2014 and restoring sequestered user fees.
View Letter

February 3, 2014
The Academy of Radiology Research hosted a one-day symposium at the National Institutes of Health where imaging researchers, neuroscientists, patient advocates and NIH program staff explored the potential imaging connections between three pressing national research topics: autism, Alzheimer’s disease and traumatic brain injury. This conference was an interdisciplinary forum where partners could discuss ways to leverage current imaging research investments. Cynthia Bens from the Alliance for Aging Research represented the ACT-AD Coalition at this symposium and presented on work the patient advocacy community has been engaged in to focus attention of regulators and payors on the importance of imaging to Alzheimer’s disease drug development.
View Slides
View Symposium Program

August 30, 2013
ACT-AD Chairman Daniel Perry urges House and Senate Budget Committee leaders to take action on bi-partisan legislation to exempt FDA user fees from sequestration. The letters convey the importance of the user fee programs in funding timely and predictable drug, device, and biologic review activities and also describes how the FDA has been trying to maintain their direct review activities and pursue many of the exciting new initiatives included in the most recent authorizations of the prescription drug and medical device user fee programs, without collecting the full fees planned for this year.
View House Letter
View Senate Letter

May 28, 2013
ACT-AD together with the Critical Path Institute and the Alzheimer’s Association host a 3-day working session with leaders from the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, the National Institutes of Health (NIH), the academic research community, the pharmaceutical industry, private philanthropy, and patient advocacy groups to address next steps in combination therapy development for Alzheimer’s Disease.
View Agenda
View Participant List
View Transcript
Read Alzheimer Research Forum Article

May 6, 2013
ACT-AD submits comments to the U.S. Food and Drug Administration on the Agency’s Draft Prescription Drug User Fee Act V Benefit-Risk Plan. The comments recognize the FDA for pursuing their planned patient-focused drug development activities despite having user fees to support these activities sequestered under the Budget Control Act of 2011. The comments also suggest that FDA’s final plan should include details on how early in the drug development and review processes patient views will now be included in conversations between the FDA’s product review divisions and a drug/product sponsors, the amount of information the Agency intends to solicit from patients, and the mechanisms it plans to use to garner patient and caregiver input.
View Comments

May 1, 2013
The National Institute of Neurological Disorders and Stroke hosts Alzheimer’s Disease-Related Dementias: Research Challenges and Opportunities. At this conference leading neuroscientists, physicians, and public and private stakeholders will discuss key challenges and special opportunities in research on Alzheimer’s disease-related dementias. The conference is convened under the 2012 National Plan to Address Alzheimer’s Disease to develop recommendations on research priorities in the areas of frontotemporal, Lewy body, mixed, and vascular dementias. ACT-AD is a sponsor of the conference.
View Conference Details

April 9, 2013
ACT-AD submits comments to the U.S. Food and Drug Administration (FDA) on the draft guidance for Early Alzheimer’s Disease Drug Development. The comments commend FDA for expressing interest in utilizing the accelerated approval pathway as a viable option for Alzheimer’s disease treatments. The comments also suggest that FDA should clarify the level of evidence it needs for inclusion of patients into either early-stage trials and that the agency should hold a public meeting before it begins incorporating any commenter feedback into its final guidance.
View Comments

February 11, 2013
Steve Usdin, Washington Editor of BioCentury, published an article in BioCentury The Bernstein Report on Business focused on the future of the FDA’s Division of Neurology Products following the expected retirement later this year of the current Division Director, Russell Katz, M.D. Representatives from the biopharmaceutical industry and the patient advocacy community were interviewed for this article, including Daniel Perry, President & CEO of the Alliance for Aging research and Chair of the ACT-AD Coalition. Mr. Perry highlighted ACT-AD’s positive relationship with Dr. Katz and expressed hope that Dr. Katz’s successor will approach the review of therapies for Alzheimer’s disease with similar openness and flexibility.
Read the BioCentury article

November 29, 2012
ACT-AD, together with the Critical Path Institute, hosts an FDA/Alzheimer’s Disease Allies Meeting for patient groups, researchers and industry to interact with the FDA on how best to foster more robust pre-competitive collaboration in Alzheimer’s disease in order to encourage the development of combination therapies. This meeting explored the challenges of these collaborations and potential opportunities for future partnership.
View Agenda
View Meeting Report
View Article
View Transcript
Read Alzheimer Research Forum Series

November 1, 2012
ACT-AD submits comments to the U.S. Food and Drug Administration (FDA) on behalf of a number of Alzheimer’s disease stakeholders urging the FDA to continue making Alzheimer’s disease a priority, particularly with respect to their activities to develop a transparent risk/benefit evaluation framework. The comments applaud FDA’s inclusion of patient-focused drug development enhancements in PDUFA V, but encourage FDA to continue considering needs of people with Alzheimer’s disease as the agency implements these enhancements over the next five years.
View Comments

October 29, 2012
ACT-AD holds its first symposium at an internationally-recognized conference. The program titled “Harmonizing Global Regulatory Standards to Benefit Future Alzheimer’s Disease Patients” takes place during the 5th Clinical Trials in Alzheimer’s Disease (CTAD) Conference. The program is 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 is 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 could expedite drug development.

On October 30, ACT-AD sponsors an informal meeting of leading Alzheimer’s experts from the U.S. and Europe to provide an opportunity for these experts to share their insights into how the development of novel AD therapies could be improved.
Read Alzheimer Research Forum Article

August 20, 2012
ACT-AD Chairman Daniel Perry urges House and Senate leadership to find a balanced approach to deficit reduction that averts sequestration. The letter expresses deep concern over the threat of sequestration on funding at the Food and Drug Administration (FDA) and how it would affect FDA’s ability to continue engagement on the National Plan to Address Alzheimer’s Disease, and implementation of the bi-partisan Food and Drug Administration Safety and Innovation Act (FDASIA).
View Letter

June 15, 2012
ACT-AD expresses support for Food and Drug Administration Safety and Innovation Act (FDASIA) because of provisions aimed at accelerating drug development through greater focus on regulatory science; supporting the development of innovative clinical trial designs; re-evaluating how the FDA assesses benefits and risks of therapies and communicates benefit-risk information; and ensuring that Risk Evaluation and Mitigation Strategies (REMS) do not serve as a barrier to patients in need of treatments.
View Letter

May 18, 2012
The Food and Drug Administration’s (FDA) Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), holds an Inaugural Patient Network Annual Meeting. The meeting, titled Patient Input into FDA Benefit-Risk Decision-Making: Opportunities and Challenges, was convened to discuss opportunities for FDA to enhance its regulatory decision-making, through the inclusion of patients and patient advocate groups during benefit-risk assessments of drugs and devices.

ACT-AD Coordinator Cynthia Bens presents on a patient panel during the meeting. Ms. Bens’ remarks stress the importance of considering disease severity and unmet need in FDA’s risk/benefit decision-making on early stage treatments for Alzheimer’s. Ms. Bens also highlights that for chronic, progressive diseases like Alzheimer’s the views of caregivers on benefit and risk must be taken into account along with patient reports at every phase of the regulatory process.

May 14, 2012
The National Institute on Aging (NIA) hosts Alzheimer’s Disease Research Summit 2012: Path to Treatment and Prevention. As part of the National Plan to Address Alzheimer’s Disease, the Summit is the first in a series of workshops and conferences to identify research strategies and priorities to prevent and treat Alzheimer’s disease (AD). ACT-AD is a sponsor of the Summit.
View Summit Program

March 26, 2012
ACT-AD urges House and Senate Appropriations Subcommittee leadership to increase appropriations for the U.S. Food and Drug Administration (FDA) in FY 2013.
View House Letter
View Senate Letter

March 18, 2012
ACT-AD Chairman Daniel Perry is interviewed by BioCentury This Week to share his thoughts on U.S. funding of Alzheimer’s research and the use of biomarkers to speed Alzheimer’s therapy development. During the interview, Mr. Perry commends the Obama Administration for repurposing and committing additional funds for Alzheimer’s research, but says additional steps must be taken to help speed the delivery of better treatments and cures to those in need.
View Interview

December 15, 2011
The Engelberg Center for Health Care Reform at the Brookings Institution hosts an expert workshop on Expedited Drug Development for Promising Therapies. This workshop brings together a diverse set of stakeholders to discuss existing tools for facilitating expedited market access, opportunities for improving and expanding upon these tools, therapeutic areas most in need of an expedited development pathway and how promising therapies can be defined. The second half of the workshop explores methodological approaches to enable a compressed drug development timeline and potential evidence gaps that may result in the post-market environment for products approved through an expedited pathway.

ACT-AD Chairman Daniel Perry speaks about the coalition’s experience working with regulators on issues related to the development and review of Alzheimer’s disease therapies. Mr. Perry also highlights that the review of neurological products could be improved by additional clarity and transparency around the application of existing pathways like Fast Track and Accelerated Approval to new Alzheimer’s treatments.
View Agenda
Read Meeting Summary

December 9, 2011
ACT-AD, together with the Cure Alzheimer’s Fund and Leaders Engaged on Alzheimer’s Disease (LEAD), hosts an FDA/Alzheimer’s Disease Allies Meeting 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 workshop focus on phase II experiences in current drug development programs and the potential application of scientific insights to support decision-making by drug developers and regulators in order to bring new treatments to market.
View Agenda
View Transcript

November 4, 2011
The 4th Clinical Trials on Alzheimer’s Disease (CTAD) Conference took place from November 3 to November 5, 2011. At this conference, Alzheimer’s leaders involved in clinical trials from around the world gathered to discuss the full spectrum of Alzheimer’s disease from an asymptomatic stage through dementia, the development of the next generation of Alzheimer’s disease treatments and learn to harmonize various neuroimaging techniques and their analyses. ACT-AD had a presence at this conference.

On November 4, ACT-AD sponsors an informal meeting of leading Alzheimer’s experts attending the conference from the U.S., Europe and Asia. The meeting provides an opportunity for these experts to share their insights into how the development and evaluation of novel AD therapies could be improved.

October 24, 2011
ACT-AD Chairman Daniel Perry presents on a patient panel during an FDA public meeting on the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA). In his remarks, Mr. Perry emphasizes the need for FDA to have the ability to play a more significant role in encouraging the development of new therapies for diseases like Alzheimer’s by increasing their capacity to qualify biomarkers and other endpoints for use in development, and to continue assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them.
View Transcript
View Remarks

June 26, 2011
ACT-AD Chairman Daniel Perry is interviewed by BioCentury This Week to share his impressions on the fifth reauthorization of the Food and Drug Administration’s (FDA) Prescription Drug User Fee program (PDUFA). During the interview, Mr. Perry commends Congress for giving ACT-AD members and other active patient group, the ability to lend an early voice in shaping how user fees might be employed to help speed the delivery of better treatments and cures to patients in need of relief from a multitude of diseases including Alzheimer’s.
View Interview Part 1
View Interview Part 2

April 12, 2010
ACT-AD Chairman Daniel Perry presents on a patient panel during an FDA public meeting on the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA). In his remarks, Mr. Perry emphasizes the need for FDA to have the ability to play a more significant role in encouraging the development of new therapies for diseases like Alzheimer’s by increasing their capacity to qualify biomarkers and other endpoints for use in development, and to continue assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them.
View Transcript

November 30, 2010
ACT-AD, together with the Alzheimer’s Foundation of America, and the Alzheimers Drug Discovery Foundation, hosts an FDA/Alzheimer’s Disease Allies Meeting to bring together researchers, clinicians, regulators, drug developers and advocacy groups to discuss challenges in recent Alzheimer’s disease drug development and explore novel approaches to improving the way in which Phase II trials for disease-modifying therapies are designed in the future.
View Agenda
View Transcript

July 11, 2010
The 13th Annual International Conference on Alzheimer’s Disease (ICAD) took place from July 9 to July 15, 2010. At this conference, Alzheimer’s experts from around the world gathered to discuss significant breakthroughs in the field of Alzheimer’s research and present results from clinical trials of potential AD therapies. ACT-AD had a presence at this conference.

On July 11, ACT-AD sponsors an informal meeting of leading Alzheimer’s experts from the U.S. and Europe. The meeting provides an opportunity for these experts to share their insights into how the development and evaluation of novel AD therapies could be improved. ACT-AD and its members are recognized during this meeting for the work they do to help move the Alzheimer’s field forward on scientific issues that affect the way new therapies are developed and reviewed, as well as to provide forums where thought leaders can present possible solutions to regulators.

September 24, 2009
ACT-AD commissions a voter sentiment survey to gauge American’s attitudes towards Alzheimer’s disease, the importance they place on finding a cure for the disease, and what policies they would support to ease the burden of the disease on patients and caregivers. Key findings are presented at the Rockstars of Science briefing on Capitol Hill.
View Full Survey Data
View Key Findings
See Press Release
Read Alzheimer Research Forum Article
View Rockstars of Science Agenda

July 21, 2009
ACT-AD, together with the Alzheimer’s Association and LEAD (Leaders Engaged in Alzheimer’s Disease), hosts an FDA/Alzheimer’s Disease Allies Meeting to stimulate an open discussion with FDA officials, scientists, drug developers, academics and advocacy organizations on standards of clinical meaningfulness and exploring novel approaches regarding the state of the science in this vital field.
View Agenda
See Press Release
View Transcript
Read Neurology Today Article

March 1, 2009
Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association publishes a policy forum article written by ACT-AD Chairman Daniel Perry titled “Advancing Alzheimer’s disease drug review as a national priority.”
Read Article

May 14, 2008
ACT-AD Chairman Daniel Perry participated in a panel presentation at Dialogue on Diversity’s 2008 Health Care Symposium.
View Slides

March 31, 2008
ACT-AD urges House and Senate Appropriations Subcommittee leadership to increase funds for FDA drug review activities in FY 2009.
Read Letter

March 13, 2008
ACT-AD, together with the Alzheimer’s Association and the Alzheimer’s Study Group, hosts and FDA/Alzheimer’s Disease Allies Meeting to stimulate an open discussion with FDA leadership on the subject of clinical meaningfulness in new AD therapies and help advance the dialogue regarding how best to measure the clinical effectiveness of emerging therapies.
View Agenda
See Press Release
Read Alzheimer Research Forum Article
View Transcript

November 2, 2007

Congressman Tom Latham’s holds a roundtable discussion on aging and Alzheimer’s disease with Dr. Molly Wagster, Ph.D., Dan Perry and Stephen McConnell. Wagster is Chief of the Behavioral and Systems Neuroscience Branch of the Neuroscience and Neuropsychology of Aging Program at the National Institute on Aging (NIA), a branch of the National Institutes of Health (NIH). Perry is the Executive Director of the not-for-profit Alliance for Aging Research. McConnell is the Vice President for Advocacy and Public Policy at the Alzheimer’s Association.

October 17, 2007
FDA convenes a meeting of neurological disease advocacy and research organizations focused on constructive engagement in the area of Alzheimer’s disease and other neurological disease.
See Dr. Russell Katz’s Presentation
See Dr. Celia Witten’s Presentation

September 27, 2007
ACT-AD hosts a member summit in Washington, DC to recap progress the coalition has made in 2007 and showcase planned activities for 2008.
See Speaker Presentation
Read FDA Letter

July 25, 2007
Avalere Health holds an audio conference to discuss the ACT-AD-sponsored study on the way the FDA reviews potential Alzheimer’s disease, HIV/AIDS, and cancer therapies.
See Speaker Presentation

June 5, 2007
An ACT-AD-sponsored study by Avalere Health reveals differences in the way the FDA reviews potential Alzheimer’s disease, HIV/AIDS, and cancer therapies.
See Press Release

April 25, 2007
ACT-AD submits letters to House and Senate subcommittees that handle FDA appropriations outlining FDA’s need for more resources to review promising AD therapies.
Read House Letter
Read Senate Letter

May 14, 2007
ACT-AD press briefing to release study of first economic projection of social value of treatments that delay onset of Alzheimer’s Disease.
See Press Release
Read Report
Speaker Bios

April 27, 2006
First major study of Baby Boomer Attitudes on Alzheimer’s released by ACT-AD.
View Survey Results
See Press Release