Coalition Against Major Diseases and FDA 2015 Annual Scientific Workshop

October 15, 2015

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.

Click here for the 2015 Annual Meeting Minutes.
 

Agenda

 

 7:30-8:30 am Continental Breakfast

8:30-9:00 am

Welcoming Remarks

Martha Brumfield, CEO (Critical Path Institute)
Janet Woodcock, Director (Center for Drug Evaluation and ResearchFDA)
Diane Stephenson & Stephen Arneric, Executive Co-Directors (CAMD)

9:00-9:20 am

Keynote Address 

Manuel Haas (EMA)
Coalition Against Major Diseases and FDA 2015 Annual Scientific Workshop

9:20-9:40 am

Regulatory Perspectives

ShaAvrée Buckman-Garner (FDA)
FDA Biomarker Learnings and the Future

9:40-9:55 am BREAK

SESSION I: Exciting Developments in CAMD Working Groups
Mark Gordon, Chair

9:55-10:10 am

Meeting the Needs of the Parkinson’s Community
Steve Ford (Parkinson’s UK)

10:10-10:25 am

Computational Modeling for AD
Julie Stone (Merck) & Klaus Romero (C-Path)
Where has CAMD come and where do we need to go?
How can we achieve better understanding of disease progression and efficient clinical trial design in MCI populations?

 10:25-10:40 am

AD Hippocampal Volume Team
Derek Hill (Ixico)

10:40-10:55 am

AD CSF Biomarkers Team 
Robert Dean (Lilly)

10:55-11:40 am

Regulatory Panel Discussion: Regulatory Innovation Now and in the Future
Moderator: Richard MeibachJim Kaiser (FDA), Eric Bastings (FDA), Keiju Motohashi (PMDA), Billy Dunn (FDA), Sandra Kweder (FDA), Maria Isaac (EMA), Vikrma Sinha (FDA), Chris Leptak (FDA), Peter Como (FDA)                                                             
11:40-12:25 pm

LUNCH & AWARDS

SESSION II:
Strategies for Successful Implementation of Biomarkers in Clinical Trials
CAMD Data Sharing and Integration…Looking to the Future
Peter Loupos, Chair (Sanofi)

12:25-12:40 pm

Data Sharing…What Can Be Learned from ALS?
Melanie Leitner (Biogen)

12:40-12:55 pm

PPMI Paving the Way for Defining Prodromal PD
Ken Marek (MNI)
12:55-1:10 pm Data sharing…Success Story from Multiple Sclerosis (MSOAC)
Jesse Cedarbaum (Biogen)
1:10-1:25 pm Panel Discussion on Prospective Directions for CAMD…Focus on Data
Melanie Leitner, Jesse Cedarbaum, Ken Marek, Paul Maruff (Cogstate, AIBL)
1:25-1:35 pm BREAK
1:35-1:50 pm Transforming Alzheimer’s Disease Therapies Through Collaboration
James Hendrix (Alzheimer’s Association)

Integrated Focus Sessions

1:50-2:30 pm

 

Session III: Modeling

How can we achieve better understanding of disease progression and efficient clinical trial design in MCI populations?

Vikram Sinha (FDA Co-chair) & Klaus Romero (CAMD Co-chair)

2:30-3:10 pm

 

Session IV: Biomarkers

Chris Leptak (FDA Co-chair) & Richard Meibach (CAMD Co-chair)

3:10-3:50 pm

 

Session V: Digital Biomarker Technologies

Medical Device Regulatory Decision Points

Defining Context of Use and Challenges to Deploying Wearables and Digitial Technologies in Clinical Trials
Peter Como (FDA Co-chair) & Jesse Cedarbaum (CAMD Co-chair)

3:50-4:05 pm BREAK
4:05-4:35 pm KEY RECOMMENDATIONS: SESSIONS III-V
4:35-4:45 pm Wrap-up and Looking Ahead
Diane Stephenson & Stephen Arneric