The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives
James E. Valentine, JD, MHS
Hyman, Phelps & McNamara, PC, United States
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 Objective : 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.
FDA Perspective on the Value and Potential of PFDD
Theresa Mullin, PhD
Associate Director for Strategic Initiatives, CDER
FDA, United States
Experience From an FDA-Led PFDD Meeting - NTM Case Study
Amy Leitman, JD
Director of Policy & Advocacy
NTM Info & Research, United States
Experience From an Externally-Led PFDD Meeting; TSC Case Study
Steven L. Roberds, PhD
Chief Scientific Officer
Tuberous Sclerosis Alliance, United States