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Monday, June 20 • 1:30pm - 2:30pm
#116: Incorporating Patient Experience Data in Global R&D

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-517-L04-P ; CME 1.00; RN 1.00

This session will bring together experiences and lessons learned from sponsors, regulators, payors, and patients on realizing the potential of patient experience data through the R&D, regulatory, and market access lifecycle.

Learning Objectives

Describe new and upcoming regulatory guidance and programs enabling incorporation of patient experience data in medical product development, regulatory, and market access decision-making; Compare, contrast, and integrate lessons learned from sponsor, regulator, payor, and patient perspectives on leveraging patient experience data across the development, regulatory, and market access life cycle.

Chair

K. Kimberly McCleary
Samantha Roberts, PhD

Speaker

Patient Input: Lessons Learned and Future Plans
Yolanda Barbachano, PhD

FDA Update
Robyn Bent, MS, RN

EMA Update
Francesco Pignatti, MD



Speakers
avatar for Yolanda Barbachano

Yolanda Barbachano

Leading Senior Statistical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Yolanda is a lead statistical assessor at the MHRA where she has been working for the last 10 years. In her role she advises pharmaceutical companies on the design of their clinical trials and assesses the data supporting licensing applications to make a decision on the benefit/risk... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was... Read More →
avatar for K. Kimberly McCleary

K. Kimberly McCleary

Founder and Chief Executive Officer, The Kith Collective, LLC, United States
Kim McCleary has been at the forefront of patient engagement for more than 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Head of Oncology and Hematology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
SR

Samantha Roberts

Group Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Samantha Roberts is a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Her portfolio includes patient-focused drug development... Read More →


Monday June 20, 2022 1:30pm - 2:30pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum |   12: Value-Access, Forum