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Wednesday, June 26 • 10:30am - 11:30am
#334: Understanding and Exploring Elements of a Patient-Focused Product Launch

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-667-L04-P; CME 1.00; IACET 1.00; RN 1.00

A true patient-focused drug development (PFDD) approach requires implementation throughout the entirety of a product’s lifecycle, including pre-clinical, development, product launch and post-market approval. While the role of patients in medicine development has been expanding and evolving within the last decade, most notably since 2012 when the U.S. FDA Safety and Innovation Act was signed into law, much of this work has been focused on incorporating the patient’s voice into research, development and clinical trial operations. With progress to date, the present day provides an opportunity to understand how sponsors develop PFDD when preparing for a launch and incorporating patient engagement principles into their commercialization plans.

Learning Objectives

Discuss how and when Patient Advocacy and Patient Engagement functions within a sponsor company partner with the Commercial and Market Access functions; Discuss the role of patient input into product-specific marketing and disease education materials; Identify communications strategies that include messaging and content for patients and caregivers; Describe regulatory and compliance considerations for regional launches; Identify opportunities for improved collaboration moving forward.


Jennifer Helfer, PhD


Michele Rhee, MBA, MPH

Nicole Boice

Kari Luther Rosbeck

avatar for Jennifer Helfer

Jennifer Helfer

Patient Advocacy, bluebird bio, Inc.
Jennifer Helfer joined bluebird bio in December of 2015. As part of the Patient Advocacy team, Jen serves as a conduit to patient organizations and advocates. Patient Advocacy is responsible for building and sustaining trusted collaborations with stakeholders to address patient and... Read More →
avatar for Michele Rhee

Michele Rhee

Head of Patient Affairs, Enzyvant
As a member of the rare disease patient community for over a decade, Michele has dedicated her career to getting treatments to the patients who need them. Michele is a founding board member of Costs of Care and volunteers as a SAMbassador for SAMFund. She received her MBA from the... Read More →
avatar for Kari Rosbeck

Kari Rosbeck

President and Chief Executive Officer, Tuberous Sclerosis Alliance
Kari joined the TS Alliance in June 2001 and became President and CEO in November 2007. Kari has been involved in nonprofit fundraising and volunteer management for nearly 30 years. During Kari’s tenure as President and CEO, the TS Alliance established a comprehensive research program... Read More →

Nicole Boice

Founder, Global Genes Project

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient Engagement, Forum