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Friday, June 18 • 12:00pm - 1:00pm
#525 OD: Gene Therapy: Getting Back on Track After COVID-19

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Component Type: Session
Level: Intermediate

This session will explore the effect of the COVID-19 pandemic on the development of gene therapies across the spectrum from discovery through clinical trials on to approvals. Although work on gene therapy has continued to advance during the pandemic, initiating clinical trials during the pandemic has been challenging, and continuing trials has not always been easy. Particularly, those trials that required medical procedures, such as biopsies, have been adversely affected, since elective medical procedures were curtailed during periods of lockdown and otherwise sometimes difficult to schedule. As we come out of the pandemic period, careful assessment of individual studies will be needed in order to salvage the maximum amount of patient data from clinical trials. Additionally, new policy initiatives may be considered to help expedite the development of gene therapy both in the United States and globally. These initiatives include resumption of efforts to achieve better international harmonization regarding the regulation of gene therapies.

Learning Objectives

Discuss the effect of the COVID-19 pandemic on the development of gene therapies; Identify the need for new policy iniatives to help expedite the gene therapies both in the US and globally.

Chair

Janet Lynch Lambert

Speaker

FDA Update
Peter W. Marks, MD, PhD

Update from EMA Committee on Advanced Therapies
Martina Schüssler-Lenz, DrMed

Industry Update
Adora Ndu, JD, PharmD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Adora Ndu

Adora Ndu

Chief Regulatory Affairs Officer, BridgeBio Pharma, United States
Adora Ndu, PharmD, JD, is Chief Regulatory Affairs Officer at Bridgebio Pharma. Prior to joining Bridgebio, Adora spent several years at BioMarin Pharmaceutical in various roles including as Group Vice President, and Head of Worldwide Research and Development Strategy, Scientific... Read More →
avatar for Janet Lynch Lambert

Janet Lynch Lambert

Chief Executive Officer, Alliance for Regenerative Medicine, United States
Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served... Read More →
avatar for Martina Schüssler-Lenz

Martina Schüssler-Lenz

Deputy Head of ATMT; Chair, EMA Committee for Advanced Therapies, Paul-Erhlich-Institut
In January 2020, Dr. Martina Schüssler-Lenz was elected on her second mandate as the Chair of the Committee for Advanced Therapies (CAT) of the European Medicines Agency's (EMA). The CAT is the committee responsible for evaluating the quality, safety and efficacy of marketing authorisations... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   09: Regulatory, Session |   20: Early Access Content, Session