Coalition Against Major Diseases and FDA 2014 Annual Scientific Workshop
October 20, 2014
FDA White Oak Campus
CO-SPONSORED BY:
Critical Path Institute
U.S. Food and Drug Administration
Overview and Objectives
The Coalition Against Major Diseases (CAMD) is a public-private-partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer’s disease (AD) and Parkinson’s disease (PD). The annual meeting brings together members from the pharmaceutical industry, academic key opinion leaders, NIA, FDA, EMA and advocacy groups. The objectives of the meeting are: understand accomplishments of CAMD scientific projects, discuss how these tools are currently or will be applied in drug development, obtain commitment for sharing information/data to begin quantifying benefits of these tools, and facilitate robust and open discussion among all parties of drug development in Alzheimer’s and Parkinson’s diseases. Experts in the fields of Alzheimer’s disease and Parkinson’s disease, and leaders of the patient stakeholder community will deliver keynote presentations and regulatory science will be prominently featured throughout the meeting.
Agenda
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7:30-8:30 am |
Continental Breakfast |
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8:30-8:50 am |
Welcome Remarks |
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8:50-9:40 am |
Keynote Address Speakers |
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9:40-10:00 am |
Carl Ames: Vision and Views from a Patient’s Perspective Walter Koroshetz, NINDS: NINDS PD Recommendations: Filling Gaps for PD Drug Development |
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SESSION I: Mark Gordon (Chair) Exciting Developments in CAMD Working Groups |
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10:00-10:15 am |
Klaus Romero and Tim Nicholas: Modeling and Simulation for Parkinson’s Disease |
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10:15-10:30 am |
Les Shaw: AD CSF Biomarkers Team |
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10:30-10:45 am |
Derek Hill: AD HV MRI Biomarkers Team |
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10:45-11:00 am |
Johan Luthman/Michael Ropacki: Predementia Clinical Outcome Assessment Team |
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11:00-11:15 am |
BREAK |
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SESSION II: Richard Meibach (Chair) |
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11:15-11:30 am |
Peter Loupos (Sanofi): Why Data Standards? |
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11:30-11:50 am |
Issam Zineh (FDA): A Regulatory Perspective on Strategies for Implementation of Biomarkers in Clinical Trials |
| 11:50-12:10 pm | Ken Marek (Institute of Neurodegenerative Diseases): Learnings from Parkinson’s disease: Critical role of Biomarkers In successful drug development |
| 12:10-12:20 pm |
Jim Hendrix (Alzheimer’s Association): Progress and Needs in Biomarker Standardization and Harmonization in AD |
| 12:20-12:40 pm |
Billy Dunn (FDA) and Dave G. Podskalny (FDA): Panel Discussion on Prospective Directions Beyond Qualification of Biomarkers by CAMD |
| 12:40-1:10 pm | LUNCH & AWARDS |
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SESSION III: Eric Reiman (Chair); Eric Karran (Co-chair) |
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| 1:10-1:30 pm |
Eric Karran (Alzheimer’s Research UK): Clinical Data Sharing Today: Where Are We and Where Do We Need to Be? Learnings from amyloid trials to date |
| 1:30-1:45 pm |
George Vradenburg (USAgainstAlzheimer’s): Overcoming Challenges |
| 1:45-2:50 pm |
PANEL Discussion: Current Therapeutic Trials in Pre-dementia AD: Focus on Biomarkers and Outcome Measures |
| 2:50-3:05 pm | BREAK |
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SESSION IV: Jesse Cedarbaum (Chair) |
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| 3:05-3:20 pm | Billy Dunn (FDA): Delivering on the FDA’s Draft Guidance: Drug Development for Early Alzheimer’s Disease |
| 3:20-3:40 pm |
Keiju Motohashi (Expert advisor, PMDA office of new drugs): PMDA Considerations for Outcome Assessments |
| 3:40-4:00 pm |
PANEL Discussion on COA Qualification |
| 4:15-4:30 pm |
Diane Stephenson and Mark Gordon: Wrap Up and Looking Ahead |
