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Navigating Complex Biological and Regulatory Pathways to Bring Novel Gene and Cell Therapies to the Clinic
Session Chair(s)
Lois M Hinman, PhD
, United States
An overview of the global status of regulatory guidance for cell and gene therapy will be presented. Early development and regulatory challenges for moving these novel therapies from the bench to the clinic will be discussed through case studies.
Learning Objective : Discuss the current guidance and regulatory initiatives available to expedite development of cell and gene therapies around the globe; Explain how sponsors are navigating regulatory and scientific challenges to reach the clinic with novel cell and gene therapeutics; Discuss the industry and regulatory perspectives on the critical regulatory and development challenges in this field.
Speaker(s)
Development Challenges for Cell and Gene Therapies: A Case for Integrated Development
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics, Voisin Consulting Life Sciences, United Kingdom
Strategies to Accelerate the Development of Cell and Gene Therapies from Preclinical to Clinical and Beyond
Anne-Virginie L. Eggimann, MS
Chief Regulatory Offcer, bluebird bio, Inc., United States
Hear Ye, Hear Ye: Preclinical Challenges in Bringing a Novel Gene Therapy for Hearing Loss to the Clinic
Timothy Maclachlan, PhD
Executive Director, Preclinical Safety, Novartis, United States
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