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DIA 2021 Global Annual Meeting


Gene Therapy: Getting Back on Track After COVID-19

Session Chair(s)

Janet  Lynch Lambert

Janet Lynch Lambert

  • Chief Executive Officer
  • Alliance for Regenerative Medicine, United States
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 Objective : 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.

Speaker(s)

Peter W. Marks, MD, PhD

FDA Update

Peter W. Marks, MD, PhD

  • Director, Center for Biologics Evaluation and Research
  • FDA, United States
Martina  Schüssler-Lenz, DrMed

Update from EMA Committee on Advanced Therapies

Martina Schüssler-Lenz, DrMed

  • Deputy Head of ATMT; Chair, EMA Committee for Advanced Therapies
  • Paul-Erhlich-Institut, Germany
Adora  Ndu, JD, PharmD

Industry Update

Adora Ndu, JD, PharmD

  • Group Vice President, Head of WWRD Strategy, Scientific Collaborations & Policy
  • Biomarin, United States