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Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
Session Chair(s)
Agathe Le Lay, PhD, MSc
Global Head of Value Evidence & Patient Insights
H. Lundbeck A/S, Denmark
Addressing data gaps in drug development, especially capturing patient experiences in both rare and non-rare diseases, is crucial. From Proof of Concept to Proof of Value, integrated evidence planning and incorporating patient voices in Target Product Profile (TPP) creation drive comprehensive evidence generation.
Learning Objective : Insight into company approach for building an integrated evidence framework; Discuss the utility in global drug development context, including post-marketing efforts; Insight into strategies to create a patient informed comprehensive Target Product Profile; Strategies outlined in the interactive guide to align PAG and industry efforts in creating a comprehensive Target Product Profile.
Speaker(s)
From Proof of Concept to Proof of Value, an industry approach to integrated evidence planning throughout the product lifecycle
Martine Zimmermann, PharmD
Ipsen , France
Senior Vice President, Head of Global Regulatory Affairs
New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Patricia Roselle
Sanofi, United States
Head of Patient Stakeholder Engagement
New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Bruce E. Miller, PhD
COPD Foundation, United States
Chief Scientific Officer
What are we Missing: Potential Data Gaps in Drug Development and the Importance of Capturing Lived Experience in rare and non-rare Diseases
Kristin Hatcher
Global Liver Institute/Alpha One Patient, United States
Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate
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