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Tuesday, June 26 • 10:30am - 11:45am
#233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will review lessons learned from the Patient-Focused Drug Development meetings held to date, including externally-led meetings, and provide patient perspectives on their experiences and what has changed in their field as a result. Representation will include both rare, life threatening and chronic disease communities, as well as FDA.

Learning Objectives

Appraise recent examples of FDA’s current efforts to incorporate the patient perspective into regulatory decision-making; Discuss implementation of patient engagement provisions in 21st Century Cures Act and PDUFA VI; Evaluate current proposals of methods collecting patient experience data.


James E. Valentine


FDA Perspective on the Value and Potential of PFDD
Theresa Mullin, PhD

Experience From an FDA-Led PFDD Meeting - NTM Case Study
Amy Leitman, JD

Experience From an Externally-Led PFDD Meeting; TSC Case Study
Steven L. Roberds, PhD

avatar for Amy Leitman

Amy Leitman

Director of Policy & Advocacy, NTM Info & Research
A native of Canada, Amy moved to Miami, Florida to pursue her undergraduate studies and law degree at the University of Miami. She has more than 17 years’ experience in both the private and nonprofit sectors. Amy handles policy and legislative issues impacting NTMir, patients, or... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Steven Roberds

Steven Roberds

Chief Scientific Officer, Tuberous Sclerosis Alliance, United States
Steve leads the development and execution of the TS Alliance's scientific strategy through partnerships and conversations with stakeholders including individuals and families affected by TSC, basic and clinical researchers, healthcare providers, government agencies, and other non-profit... Read More →
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum