Ana Hidalgo-Simon – VJRegenMed

Challenges with ATMP clinical trials in Europe

admin_vjr_user — Fri, 30 Apr 2021 10:09:54 +0000

Ana Hidalgo-Simon, MD, PhD, European Medicines Agency, Amsterdam, Netherlands, discusses some of the key challenges associated with clinical trials for advanced therapies in Europe, including current genetically modified organisms (GMO) legislation for gene therapies, issues with heterogenicity, as well as communication difficulties across European Union member states. Dr Hidalgo-Simon highlights the importance of improving international harmonization and collaboration between developers, regulators and patients in order to speed up the clinical trial process and subsequent approval of advanced therapies in Europe. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.

Improving patient access to advanced therapies

admin_vjr_user — Wed, 14 Apr 2021 16:52:04 +0000

Ana Hidalgo-Simon, MD, PhD, European Medicines Agency, Amsterdam, Netherlands, discusses some of the key challenges associated with enabling patient access to advanced therapies and how these could be addressed in the future. Complications remain around the pricing and reimbursement of advanced therapies, the curative potential of advanced therapies makes patient follow up difficult and post-authorization processes need to be streamlined. Dr Hidalgo-Simon highlights the importance of considering these aspects during the early stages of product development, as well as the benefit of communication been developers and health technology assessment bodies. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.

Driving the ATMP sector forward: a regulatory perspective

admin_vjr_user — Tue, 13 Apr 2021 10:29:32 +0000

Ana Hidalgo-Simon, MD, PhD, European Medicines Agency (EMA), Amsterdam, Netherlands, discusses ongoing trends in the field of advanced therapy medicinal products (ATMPs) and the perception that the rate of ATMP approvals has not met expectations in recent years. Compliance with chemistry, manufacturing, and controls (CMC) standards set out by regulatory agencies remains a key challenge currently facing the sector and it is advised that ATMP manufacturers focus on CMC from the early stages of development. Dr Hidalgo-Simon also describes the role regulatory agencies can play in assisting the development of ATMPs, including the Priority Medicines (PRIME) scheme launched by the EMA. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.