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Monday, June 28 • 4:00pm - 5:00pm
#147 SL: Advancing the Science of Patient Input: How are WE doing? Multi-Stakeholder Perspective

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present current efforts and future opportunities to advance the incorporation of patient input into the medical product lifecycle. A panel of experts will discuss examples of how patient input have informed medical product decisions.

Learning Objectives

Discuss current progress by key stakeholders in incorporating patient input into medical product development and regulatory decision-making; Discuss approaches and best practices to collect, analyze, assess quality, and present patient input; Identify opportunities for further enhancing the incorporation of patient input across the medical product lifecycle.

Chair

Pujita Vaidya, MPH

Speaker

Panelist
Michelle Tarver, MD, PhD

Panelist
David S. Reasner, PhD

Panelist
Annie Kennedy

Panelist
Jessica S. Scott, JD, MD

Panelist
Robyn T. Carson, MPH



Speakers
avatar for Jessica Scott

Jessica Scott

Head of R&D Patient Engagement Office, Takeda Pharmaceutical Company, United States
Dr. Jessica Scott is the Head of R&D Patient Engagement at Takeda. Prior to Takeda, she was with Global Medical Organization, leading efforts related to clinical trial transparency, patient centricity initiatives, bioethical issues and the development of GSK’s approach to sharing... Read More →
avatar for Annie Kennedy

Annie Kennedy

Chief of Policy and Advocacy, EveryLife Foundation for Rare Diseases, United States
Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Director, Global Regulatory and R&D Policy, Patient Centricity, Pediatrics, ROD, Amgen, United States
Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →
avatar for Robyn Carson

Robyn Carson

Vice President, Patient-Centered Outcomes Research, AbbVie, United States
Robyn Carson has worked in the pharmaceutical industry for 15 years and leads the Patient-Centered Outcomes Research (PCOR) function at AbbVie. In this role, Robyn is responsible for leading a team responsible for the development of innovative strategies to evaluate meaningful outcomes... Read More →
avatar for David Reasner

David Reasner

Division Director, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product... Read More →
avatar for Michelle Tarver

Michelle Tarver

Deputy Director, Office of Strategic Partnerships & Technology Innovation, CDRH, FDA, United States
As the Deputy Director of the Office of Strategic Partnerships and Technology Innovation (OST), Dr. Tarver helps provide leadership for all scientific collaborative and emerging technology-related activities at the Center for Devices and Radiological Health (CDRH). The Patient Science... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Global Regulatory and R&D Policy Director, Amgen, United States
Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum