Coalition Against Major Diseases 2017 Annual Meeting and Regulatory Science Workshop
September 26, 2017
Overview and Objectives:
The Coalition Against Major Diseases (CAMD) is a public-private partnership aimed at developing creating Drug Development Tools that can be applied to increase the efficiency of the development process of new treatments for Alzheimer disease (AD) and related dementias. The annual meeting, which is open to the public, brings together members from the pharmaceutical industry, academic key opinion leaders, government and regulatory agencies, and patient advocacy groups.
Over the last year there have been a number of key developments in the field of AD and dementias highlighting the heterogenous nature of dementias that we believe warrant realigning our focus.
The objectives of the meeting are to:
- Share the prior year’s accomplishments of CAMD’s working groups;
- Identify unmet regulatory science needs related to dementias that could be addressed by CAMD;
- Prioritize which unmet regulatory science needs should be addressed by CAMD;
- Identify which Drug Development Tools (DDTs) would readily address the prioritized unmet regulatory science needs;
- Define the main aspects of a renewed consortium plan aiming at the development of the identified DDTs, including data source needs and commitments for sharing, as well as data analytics aims and resources and key-opinion-leader engagement.
- Identify the most adequate mechanisms/pathways to reach an appropriate level of regulatory acceptance for the proposed DDTs.
Annual Meeting Agenda
| 8:00 – 8:45 am | Continental Breakfast |
| 8:45 – 9:15 am |
Welcoming Remarks & CAMD Working Group Milestones Stephen Arnerić (C-Path) |
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SESSION I: Prioritizing Unmet Needs in the Field of Dementia Moderator: Samantha Budd Haeberlein (Biogen) |
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| 9:15 – 9:45 am |
Perspectives on AD and related Dementias – FDA Billy Dunn (CDER) |
| 9:45 – 10:00 am |
Digital health tools and drug development- FDA Leonard Sacks (CDER) |
| 10:00 – 10:15 am | Break |
| 10:15 – 10:40 am |
Can we detect and treat Alzheimer’s disease a decade before dementia? Reisa Sperling (Harvard) |
| 10:40 – 11:00 am |
“… and the Related Dementias” – Multiple Targets, Multiple Outcomes. Jeffrey Kaye (Oregon Health & Science University) |
| 11:00 – noon |
Panel Discussion – Aligning on Key Unmet Needs Billy Dunn (FDA-CDER) |
| 12:00 – 1:00 pm | Lunch |
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SESSION II: Moderator: Jim Hendrix (Alzheimer’s Association) The need for a global database for dementias |
|
| 1:00 – 1:15 pm |
CAP – Collaboration for Alzheimer’s Prevention Billy Dunn (FDA, CDER, Neurology Division) |
| 1:15 – 1:35 pm |
Quantitative approaches to optimize the understanding of disease progression for drug development Klaus Romero (C-Path) |
| 1:35 – 1:55 pm |
IMI Dementia Efforts – Working to share data to advance regulatory science Iracema Leroi (Manchester, UK) |
| 1:55 – 2:40 pm |
Panel Discussion: Should we integrate actionable data across dementias ? Billy Dunn (FDA-CDER) |
| 2:40 – 3:00 pm | Break |
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SESSION III: Moderator: Lisa Gold (Merck, CAMD Industry Co-Director) Prioritizing the Key Themes and Framework for 2018 and Beyond |
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| 3:00 – 4:20 pm | Open Discussion |
| 4:20 – 4:30 pm |
Summary and Next Steps Stephen P. Arnerić (C- Path) |
