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Tuesday, June 16 • 8:00am - 9:00am
#201 L: Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will highlight progress to date in identifying metrics to assess patient involvement in drug development and drug safety, and the current challenges to, and benefits of, achieving a more patient-centric culture within the pharmaceutical industry. Perspectives on this topic will be provided by representatives from IMI-PARADIGM, industry, the patient advocacy sector, and the US FDA. Join the DIA Patient Engagement Community for a follow up round table discussion (session #216 L-RT) on Tuesday, June 16, 10:45AM - 11:30AM.

Learning Objectives

Discuss how to use a framework to guide selection of appropriate patient-centricity metrics for use within a pharmaceutical company; Describe the types of metrics that have been developed to date to measure patient involvement in drug development, including drug safety; Identify key challenges to implementing patient-centricity metrics within a pharmaceutical company and identify specific strategies to overcome those barriers.

Chair

Mariette Boerstoel-Streefland, MD, MBA, MS

Speaker

FDA Update
Robyn Bent, MS, RN

Industry Update
Katherine Capperella

Policy Update
Elisabeth Oehrlein, PhD, MS

What Frameworks and Metrics Exist for Measuring Patient-Centricity in Drug Development and Drug Safety
Tjerk Jan Schuitmaker, PhD, MSc


Speakers
avatar for Katherine Capperella

Katherine Capperella

Global Patient Engagement Leader, Janssen Pharmaceutical Companies of Johnson & Johnson
As global head of Patient Engagement, Katherine leads a cross-functional team responsible for developing and driving patient engagement strategy and measuring progress over time. She is focused on leading Janssen to incorporate direct patient voice early and throughout the entire... Read More →
avatar for Mariette Boerstoel-Streefland

Mariette Boerstoel-Streefland

Senior Vice President Global Drug Safety, Alexion Pharmaceuticals, Inc.
Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Head of Global Safety at Alexion Pharmaceuticals, Inc, a world leader in rare diseases. Prior to her current role, Mariette was SVP, Head of Global Drug Safety at Shire, having been appointed to lead the safety organization after... 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 Elisabeth Oehrlein

Elisabeth Oehrlein

Senior Director, Research and Programs, National Health Council (NHC)
Elisabeth M. Oehrlein, Ph.D., MS is Senior Director, Research & Programs at the National Health Council (NHC), a non-profit membership organization dedicated to providing a united voice for people with chronic diseases and disabilities and their family caregivers. Dr. Oehrlein leads... Read More →
avatar for Tjerk Jan Schuitmaker

Tjerk Jan Schuitmaker

IMI-PARADIGM; Assistant Professor, Athena Institute of the Vrije University of Amsterdam
Dr. Tjerk Jan Schuitmaker is assistant professor at the Athena Institute of the VU University Amsterdam. He is interested in the system transformation to sustainable health and care and works on a variety of projects in preventive medicine, maternal care and medicine development... Read More →

Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session