A tentative schedule of events for the M-CERSI Conference on Patient-Focused Drug Development is provided below for your convenience.
This one-day conference scheduled for Monday, March 9, 2015, will be held at the Hyatt Regency Hotel in Bethesda, Md. It is open to the public. For a printable agenda, please download the conference brochure.
|8:30–9:00 a.m.||Registration and Continental Breakfast|
James Polli, PhD
Shangraw/Noxell Endowed Chair in Industrial Pharmaceutics
Co-Principal Investigator, Center for Excellence in Regulatory Science and Innovation
University of Maryland School of Pharmacy
Introduction and Objectives
Eleanor Perfetto, PhD, MS
Professor, Department of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy (UMSOP)
Founding President and CEO
Parent Project Muscular Dystrophy (PPMD)
|9:15-11:00 a.m.||FDA Activities in Patient-Focused Drug Development
Moderator:Sara Eggers, PhD (FDA)
An Overview of FDA's Patient-Focused Drug Development Initiative
Patient Representative Program
|11:15-1:00 p.m.||Patient Engagement in Patient-Focused Drug Development
Moderator: Pat Furlong (PPMD)
Dialogue on Patient Engagement in Drug Development
Patient Organization Action Steps to Engage in New Therapy Development
Lunch with Keynote Speaker
|2:00–3:00 p.m.||How Companies Are Preparing for Patient-Focused Drug Development
Lisa Egbuonu-Davis, MD, MPH, MBA, Co-Founder and Director, ROI Squared, and Senior Advisor, Avalere Health
Pharma’s Role in Getting Patients Ready to Partner in Development
Patient-centricity: Making Stone Soup
Patient Focused Drug Development: The Time is Now
|3:15–4:45 p.m.||Panel Discussion: Future Directions and Opportunities for Collaboration
How do we create a model for Patient-Focused Drug Development that will meet the needs of Patients, Drug Regulators, Drug Developers, and Payers?
Moderator: Eleanor Perfetto, PhD, MS (UMSOP)
Participants: Murray Ross, PhD (Kaiser-Permanente), Robert Epstein, MD, MS (Epstein Health, LLC), Marc Boutin, JD (National Health Council), Kristin Van Goor, PhD (PhRMA), Theresa Mullin, PhD (FDA), Suzanne Schrandt, JD, (PCORI).
|4:45-5:00 p.m.||Closing Remarks and Adjourn
Eleanor Perfetto, PhD, MS (UMSOP) and Pat Furlong (PPMD)