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Understanding and Exploring Elements of a Patient-Focused Product Launch
Session Chair(s)
Jennifer Helfer, PHD
Senior Director, Patient Advocacy and Engagement, Corporate Affairs
Viridian Therapeutics, Inc., United States
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 Objective : 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.
Speaker(s)
Panelist
Michele Rhee, MBA, MPH
X4 Pharmaceuticals, United States
Vice President, Patient Affairs and Advocacy
Panelist
Nicole Boice
Global Genes Project , United States
Founder
Panelist
Kari Luther Rosbeck
Tuberous Sclerosis Alliance, United States
President and Chief Executive Officer