Advanced Therapy Medicinal Products (ATMPs): How they will be affected by the General Pharmaceutical Legislation
Description
SOUNDS OF SCIENCE - EPISODE 9
On today’s episode, we will be exploring the topic of Advanced Therapy Medical Products, or ATMPs. This covers a wide range of therapies, but we’ll be using it as shorthand for gene and cell therapies for today’s conversation.
ATMPs have been receiving significantly more attention in recent years as a growing number of them come to market. As a potentially one-off, transformative treatment, these therapies are different from many therapies currently available or in development. However, much like all other therapies, ATMPs will be impacted by the ongoing review of the General Pharmaceutical Legislation, and many cases, the review of the OMP regulation as well. Beyond the legislative and regulatory framework, interesting developments are also taking place with regard to HTA and P&R. This combination of commercial and legislative developments will have long-term implications on ATMPs and the competitiveness of the EU.
Suffice to say, there is a lot happening when it comes to ATMPs, and with the help of today’s guests, we hope we can start to unpack a few of these discussions, and possibly look into the future as well.
Today's guests are:
- Dr Lutz Bonacker, Senior Vice President and General Manager, Commercial Operations Europe, CSL Behring
- Dr Alexander Natz, Secretary General, EUCOPE
------------------
For more information about our work on ATMPs or how to join our Cell & Gene Therapy Working Group, simply visit our website or send an email to maertens@eucope.org.
United States
