Welcome - Overview of FDA’s Patient-Focused Drug Development Initiative

RADM Sandra Kweder, M.D., Deputy Director, Office of New Drugs, CDER, FDA
Theresa Mullin, Ph.D., Director, Office of Planning and Informatics, CDER, FDA
Sara Eggers, Ph.D., Office of Planning and Analysis, Office of Planning and Informatics, CDER, FDA

Discussion Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

Moderators: Sara Eggers, Ph.D. and Theresa Toigo, R.Ph., M.B.A., Associate Director for Drug Safety Operations, CDER, FDA

Discussion Topic 2: Patient perspective on treating CFS and ME

Moderators: Sara Eggers, Ph.D. and Theresa Toigo, R.Ph., M.B.A.

Welcome

RADM Sandra Kweder, M.D., Deputy Director, Office of New Drugs, CDER, FDA

Panel 1: Drug Development: Innovation, Expedited Pathways, Regulatory Considerations

Sandra Kweder, M.D.
Bernard Munos, MS, MBA Founder, InnoThink Center for Research in Biomedical Innovation
Suzanne D. Vernon, Ph.D., Scientific Director, The CFIDS Association of America
Melissa Robb, Associate Director for Regulatory Affairs, Office of Medical Policy Initiatives, Office of Medical Policy, CDER, FDA

Panel 2: Symptoms and Treatments: A View from Clinicians and Patients

Moderator: Nancy Klimas, M.D., FACP, FIDSA, Chair, Department of Clinical Immunology, Director, Institute for Neuro-Immune Medicine, Nova Southeastern University
Moderator: Theresa Michele, M.D., Clinical Team Leader, Division of Pulmonary, Allergy, and Rheumatology Products (DPARP), Office of Drug Evaluation II (ODE II), Office of New Drugs, CDER, FDA
Panelists: Lucinda Bateman, M.D., Fatigue Consultation Clinic, Salt Lake City, Utah
Lisa W. Corbin, M.D., FACP, Associate Professor, Division of General Internal Medicine University of Colorado Denver School of Medicine
Lily Chu, M.D., MSPH, International Association for CFS/ME, Patient
Jose G. Montoya, M.D., FACP, FIDSA, Professor of Medicine, Division of Infectious Diseases and Geographic Medicine Stanford University School of Medicine
Jennifer Spotila, JD, Patient
Christine Williams, MEd, Patient

Panel 3: CFS and ME Clinical Trial Endpoints and Design

Moderator: Jordan Dimitrakoff, M.D., Ph.D., Assistant Professor, Tufts University, Boston, MA
Moderator: Edward M. Cox, M.D., M.P.H., Director, Office of Antimicrobial Products, OND, CDER, FDA
Peter C. Rowe, M.D., Professor of Pediatrics, Johns Hopkins University School of Medicine, Director, Chronic Fatigue Clinic, Johns Hopkins Children’s Center
Christopher R. Snell, Ph.D., Professor, Health, Exercise and Sport Sciences, University of the Pacific
Elizabeth R. Unger, Ph.D., M.D., Chief, Chronic Viral Diseases Branch, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention
Ashley F. Slagle, MS, PhD, Oak Ridge Institute for Science and Education (ORISE) Fellow, Study Endpoints and Labeling Development Staff, ONDIO, CDER, FDA (contractor)

Panel 4: Roundtable Discussion -- Summary and Path Forward

Moderator: Dennis Mangan, Ph.D.
Moderator: Badrul Chowdhury, M.D., Director, Division of Pulmonary, Allergy, and Rheumatology Products, ODE II, OND, CDER, FDA
Panelists: Lily Chu, M.D., M.S.P.H.
Jordan Dimitrakoff, MD, PhD
Nancy Klimas, M.D. FACP, FIDSA
Nancy Lee, M.D., Deputy Assistant Secretary for Health;Director, Office of Women’s Health, Department of Health and Human Services (HHS)
Susan Maier, Ph.D., Deputy Director, Office of Research of Women’s Health, National Institutes of Health (NIH)
Theresa Michele, M.D.
Robert Miller, Patient
Jody L. Roth, MS, RAC, Director Regulatory Affairs, Biomedicines Eli Lilly and Company