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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)
Constance Adriane Berghs-Clairmont, PhD
Global Head of Early Development Regulatory Affairs, Novartis Pharmaceuticals, United States
Conducting clinical trials during the COVID pandemic – an Early Development perspective
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
Accelerating interactions between Sponsors and Regulators
Jesper Kjær, MS
Director for Public, Private Partnerships - Science, Policy & Intelligence, Novo Nordisk A/S, Denmark
Application of RWE in the Rollout of the COVID-19 Vaccines
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