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Wednesday, June 19 • 1:15pm - 2:15pm
#350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

Learning Objectives

Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

Chair

Amanda Marie Roache, MS

Speaker

Moderator
Theresa Mullin, PhD

ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA

ICH Patient Engagement
Francesco Pignatti, MD

Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA


Speakers
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
BH

Brett Hauber

Senior Director, Patient Preference Elicitation, Pfizer Inc, United States
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, 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 →
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   05: Patient-Focused Drug Dev, Session