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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.

Chair

Pujita Vaidya, MPH

Speaker

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

Panelist
Theresa Mullin, PhD

Panelist
Anindita Saha

Panelist
Telba Irony, PhD



Speakers
EF

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 →
AF

Andrea Furia-Helms

Director, Patient Affairs Staff, OMPT, FDA
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba Irony 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 at CDRH including Bayesian statistics, benefit-risk determinations... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... 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 →
PV

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