Coalition Against Major Diseases 2016 Annual Regulatory Science Workshop
October 12, 2016
College Park Marriott Hotel and Conference Center, Hyattsville, Maryland
SPONSORED BY: Critical Path Institute
MEETING MINUTES [PDF]
(Presentations are linked in the agenda, below.)
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’s 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, NIA, FDA, EMA and advocacy groups. The objectives of the meeting are:
- To understand accomplishments of CAMD’s scientific project teams;
- To discuss how these tools are currently, or will be applied in drug development;
- To obtain commitment for sharing information/data to begin quantifying benefits of these tools;
- To facilitate robust and open discussion among all parties of drug development for the treatment of dementias.
Experts in the fields of Alzheimer’s disease and other neurodegenerative diseases and leaders of the patient stakeholder community will deliver keynote presentations and regulatory science will be prominently featured throughout the meeting.
Annual Meeting Agenda
| Continental Breakfast | |
|
8:15 – 8:30 am |
Martha Brumfield (Critical Path Institute) |
|
8:30 – 9:00 am |
The Voice of the Alzheimer’s Disease Patient Brian Van Buren (National Early-Stage Advisor) |
|
9:00 – 9:30 am |
Informed Consent – Making Patient Data Count! Penny Dacks (Alzheimer’s Drug Discovery Foundation) |
| 9:30 – 10:00 am | FDA Priorities and Initiatives ShaAvhrée Buckman-Garner (FDA) – 30 minutes |
| 10:00 – 10:15 am | Break |
| SESSION I: Johan Luthman (Eisai, Chair) Smart Standardized Data: Objective Measures of Patient ‘Signs’ |
|
|
10:15 – 10:35 am |
Integration of Models in Biomarker Qualifications Klaus Romero (Critical Path Institute) |
|
10:35 – 10:55 am |
Digital Drug Development Tools Team – Building a Regulatory Roadmap Dan Karlin (Pfizer) |
|
10:55 – 11:10 am |
Data Standards for Mobile Devices Sam Hume (Clinical Data Interchange Standards Consortium) |
|
11:10 – 12:00 am |
Gaps & Opportunities for Mobile Devices in Clinical Trials FDA Participants: Eric Bastings, Billy Dunn, Sean Khozin |
|
12:00-1:00 pm |
Lunch |
| SESSION II: Richard Meibach (Novartis, Chair) Progress in the Qualification of Biomarkers |
|
| 1:00 – 1:20 pm |
AD Hippocampal Volume Team – Steps Enabling a Qualification Package Derek Hill (IXICO) |
|
1:20 – 1:40 pm |
The IDEAS Study – PET Imaging Update James Hendrix (Alzheimer’s Association) |
|
1:40 – 2:00 pm |
CSF Biomarker Team – Refocusing on Low Hanging Fruit Mary Savage (Merck) |
| 2:00 – 2:30 pm |
Panel Discussion: Biomarker Qualifications – Where should AD focus? Shashi Amur (FDA) |
| 2:30 – 3:00 pm | Break |
| SESSION III: Dan Karlin (Pfizer, Chair) Working Across Eco-Systems: Lessons Learned |
|
| 3:00 – 3:20 pm |
Wearable Devices in Parkinson’s Disease Research Lauren Bataille (Michael J. Fox Foundation) |
| 3:20 – 3:40 pm |
Challenges to GCP Compliant Deployment of Biosensors in Cognitively Impaired Populations Derek Hill (IXICO) |
| 3:40 – 4:00 pm |
Deep Phenotyping of AD patients – Modeling Real World Evidence John Gallacher (Oxford-ROADMAP) |
| 4:00 – 4:20 pm |
Jennifer Goldsack (CTTI) |
| 4:20 – 4:45 pm |
Panel Discussion on Global Synergies Lauren Bataille (Michael J. Fox Foundation) |
| 4:45 – 5:00 pm |
Wrap Up, Looking Ahead & Adjournment Stephen P. Arnerić (Critical Path Institute) |
