2013 CAMD Annual Face-to-Face Meeting

Tuesday, November 12, 2013
8:30 am to 2:30 pm

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road – North Bethesda, MD 20852

SPONSORED BY:
Critical Path Institute

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 following Annual Meeting Agenda provides an overview of the meeting as well as links to the slide sets presented.

Registration & Breakfast 7:30-8:30 am
Introduction
Diane Stephenson (CAMD Executive Director, C-Path)
Richard Moscicki (Deputy Director, CDER, FDA)
Mark Gordon (New, CAMD Industry Co-Director, Boehringer Ingelheim)
8:30-9:00 am
Session I: Disease Modeling-Quantiative Tools

Vikram Sinha, Director Pharmacometrics, FDA:
Model-based drug development in neurodegenerative diseases:
regulatory perspectives
9:00-9:30 am
Session II: Outcome Measures
Robert Stern, Professor of Neurology and Neurosurgery, Boston University:
Unmet needs in Neurodegeneration: focus on endpoints
9:35-10:00 am
Break 10:00-10:10 am
Breakout Session III: Biomarkers
(Moderators: Adam Schwarz, Lilly; Gerald Podskalny, FDA)
AD and PD Biomarkers – integrating modeling to enable success
Key topics for breakout: data standardization, harmonization and cutpoints,
evidentiary standards, precompetitive data sharing
10:15 am-12:05 pm
Breakout Session IV: Outcome Measures
(Moderators: Johan Luthman, Merck; Ashley Slagle, FDA)
AD pre-dementia outcome measures-what does success look like?
Key topics for breakout: Evidentiary standards, consensus on strategies
to enable path forward, clinical meaningfulness, de novo vs existing scales,

learnings from PD endpoints.
10:15 am-12:05 pm
Lunch and Awards
(Mid-Day Remarks: Martha Brumfield, CEO, C-Path)
Awards Presentations, Diane Stephenson
12:10-12:40 pm
Session V: Biomarkers
Robert Temple, Deputy Center Director for Clinical Science, CDER, FDA
The Role of Enrichment Biomarkers in AD and PD
12:45-1:10 pm
Reconvene and Report on Breakouts (all) 1:15-2:10 pm
Closing Comments
Mark Gordon
2:15-2:30 pm