戻る Agenda
Session 3: Lessons learned from the COVID-19 pandemic in the ATMP space
Session Chair(s)
Martin Telko, PHD, MS
Global Public Affairs Director for Biomedical Innovation
Novartis, Switzerland
The COVID-19 pandemic has exposed vulnerabilities in healthcare systems around the world. It has also spurred unprecedented innovation, adaption of new solutions, and collaboration among regulators, sponsors, and researchers. The COVID-19 pandemic and our collective response to it, holds many lessons for healthcare, including the development of ATMPs. In this session we explore those lessons, which include collaboration between sponsors and regulators, reliance on real world evidence, and regulatory flexibility to accelerate development and approval of new products.
Topics explored in this Session:
- Platform approaches for Cell & Gene therapies to aid accelerated approvals.
- Rolling reviews for COVID-19 vaccines & treatment and what can we learn for C&G.
- Application of RWE in the rollout of the vaccines.
Speaker(s)
Conducting clinical trials during the COVID pandemic – an Early Development perspective
Constance Adriane Berghs-Clairmont, PHD
Novartis Pharmaceuticals, United States
Global Head of Early Development Regulatory Affairs
Accelerating interactions between Sponsors and Regulators
Nick Sykes, MS
EFPIA, Belgium
Policy Advisor, Regulatory Strategy
Application of RWE in the Rollout of the COVID-19 Vaccines
Jesper Kjær, MS
Danish Medicines Agency DKMA, Denmark
Director of DKMA Data Analytics Centre