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Monday, June 26 • 10:45am - 11:45am
#105: What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-514-L04-P; CME 1.00; RN 1.00

The forum will present a multi-stakeholder discussion on the future of patient-focused medical product development. Experts will discuss existing barriers, upcoming efforts, and where they see the field going in the next five to 10 years.

Learning Objectives

Discuss how patient-focused medical product development should advance in the coming years; Identify existing barriers to advancing patient engagement and patient-focused medical product development; Describe upcoming patient-focused efforts.

Chair

Patrick Frey

Speaker

FDA Update
Theresa Mullin, PhD

EMA Update
Francesco Pignatti, MD

Industry Perspective
Marc M. Boutin, JD

Patient Perspective
David L. Feldman, PhD

PMDA Update
Shinobu Uzu, PhD


Speakers
avatar for Patrick Frey

Patrick Frey

Director, Global Regulatory and R&D Policy, Amgen, United States
Patrick Frey is a Director of Regulatory Policy at Amgen. He leads a small team focused on US regulatory issues within the Global Regulatory and R&D Policy organization. He specific focus areas are accelerated regulatory pathways, decentralized trials, and innovative trial designs... Read More →
avatar for Marc Boutin

Marc Boutin

Global Head of Patient Engagement and Advocacy, Novartis , Switzerland
Marc Boutin is the Global Head of Patient Engagement at Novartis where he leads a global team implementing an enterprise-wide patient engagement strategy. Before joining Novartis, he was the CEO of the National Health Council where he was deeply involved in health advocacy, policy... Read More →
avatar for David Feldman

David Feldman

Senior Medical Project Director, National Kidney Foundation, United States
David Feldman has a PhD in biology with an emphasis in experimental pathology. During his over 30-year career in Pharma, he led pre-clinical research laboratories supporting drug discovery projects in kidney disease, thrombosis, atherosclerosis, and hypertension. David joined the... Read More →
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 Shinobu Uzu

Shinobu Uzu

Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu... Read More →

Monday June 26, 2023 10:45am - 11:45am EDT
Room 205 A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Forum