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Tuesday, June 26 • 8:00am - 9:15am
#206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

This will discuss the FDA's history of including patient's voice in the regulatory process and current or new efforts that may be more advanced. How has their view of patient engagement changed? Evolution of the Patient Representative Program and Patient Engagement Advisory Council, for example. Engage in dialogue with the FDA and provide considerations for next steps, including from sponsor and patient.

Learning Objectives

Describe current and upcoming FDA efforts to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Discuss regulatory and methodological considerations that must be addressed in order to realize the full potential for patient input to support medical product development and evaluation.


Pujita Vaidya, MPH


How FDA Involves Patients and Advocates
Andrea Furia-Helms, MPH

Partnering for Patients: A Regulatory Framework to Advance Patient-Focused Drug Development
Eleonora Ford, PhD

Theresa Mullin, PhD

Anindita Saha

Telba Irony, PhD


Eleonora Ford

Global Regulatory Affairs and R&D Policy, Amgen Inc.
Dr. Eleonora Ford currently serves as a Director, Global Regulatory and R&D Policy at Amgen, with a focus on Patient Focused Drug Development and Innovative Clinical Trial Design. She received her Ph.D. in Chemistry from King’s College London, UK and served as a postdoctoral researcher... Read More →
avatar for Andrea Furia-Helms

Andrea Furia-Helms

Director, Patient Affairs Staff, OC, FDA
Andrea Furia-Helms is the Director of the Patient Affairs Staff in the Office of the Commissioner at FDA. She works closely with the medical product centers and other offices to coordinate cross-cutting patient engagement activities and ensure patients, caregivers, and advocates have... Read More →
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →
avatar for Anindita Saha

Anindita Saha

Director, External Expertise and Partnerships, OCD, CDRH, FDA
Anindita Saha is the Director of External Expertise and Partnerships (EEP) in FDA/CDRH. Ms. Saha leads CDRH’s Patient Preference Initiative and helps coordinate MDUFA IV efforts in patient engagement and science. Ms. Saha is leading research projects in patient preferences and patient-reported... Read More →

Pujita Vaidya

Senior Advisor, Patient-Focused Drug Development Program,OCD, CDER, FDA
Pujita Vaidya serves as the Senior Advisor on the Patient-Focused Drug Development Program in the Office of the Center Director, in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She has been with the FDA since 2012 and leads the... Read More →

Tuesday June 26, 2018 8:00am - 9:15am
Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA