Agenda

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.

Time	Activity
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)