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.

TimeActivity
8:30–9:00 a.m. Registration and Continental Breakfast
9:00–9:15 a.m. Welcome
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)

Pat Furlong
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)
  • How FDA defines PFDD
  • Current FDA activities in PFDD
  • PRO's in PFDD
  • Future Directions

An Overview of FDA's Patient-Focused Drug Development Initiative
Theresa Mullin, PhD
Director, Office of Strategic Programs
Food and Drug Administration

The Role of Patients in Health Outcomes Assessment
Ashley Slagle, PhD
Study Endpoint and Labeling Division
Food and Drug Administration

Patient Representative Program
Richard Klein
Director, Patient Liaison Program
Food and Drug Administration

11:00-11:15 a.m. Break
11:15-1:00 p.m. Patient Engagement in Patient-Focused Drug Development
Moderator: Pat Furlong (PPMD)
  • Patient and Patient Advocate definition of PFDD
  • View of Patient and Advocacy Roles within PFDD
  • Current Activities in PFDD
  • Future Directions

Dialogue on Patient Engagement in Drug Development
Marc Boutin, JD
Chief Executive Officer
National Health Council

Patient-Focused Drug Development:  Exploring from a Patient-First Perspective
Sally Okun, RN
Vice President, Advocacy, Policy & Patient Safety
PatientsLikeMe

Tom Murphy
PatientsLikeMe
Patients Advocate for ALS

Patient Organization Action Steps to  Engage in New Therapy Development
Christine Brown, MS
Executive Director
National PKU Alliance

1:00-2:00 p.m.

Lunch with Keynote Speaker

George Vradenburg
Convener
The Global CEO Initiative on Alzheimer’s Disease

2:00–3:00 p.m. How Companies Are Preparing for Patient-Focused Drug Development
Moderator:

Lisa Egbuonu-Davis, MD, MPH, MBA, Co-Founder and Director, ROI Squared, and Senior Advisor, Avalere Health

  • Industry Definition of PFDD
  • Industry Current Activities
  • Industry View of Its Role
  • Future Directions

Pharma’s Role in Getting Patients Ready to Partner in Development
Anne Beal MD, MPH
Chief Patient Officer
Sanofi

Patient-centricity: Making Stone Soup
Roslyn Schneider, MD, MSc
Global Patient Affairs
Pfizer

Patient Focused Drug Development: The Time is Now
Marjorie Gatlin, MD
VP & Head of Regulatory A&P and Risk Management
Novartis

3:00–3:15 p.m. Break
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)