Advanced Therapeutic Medicinal Products (ATMPs) represent a dynamic and evolving field of medical progression, with a rapid growth in product diversity. This holistic classification of drug products covers a range of cell and gene therapies and delves into the world of medical devices. Regulations, product manufacturing processes and product classification, amongst other key drug development procedures, are a real challenge in the ATMP landscape and pose a steep learning curve to all those involved, from preclinical development through to market authorisation. The development of ATMPs is far more complex than traditional drug development and therefore it is vital to have the right scientific and regulatory expertise early on, as well as a tailored development plan to increase the chances of a successful outcome.
This webinar provides a real-world analysis of where we are with ATMPs, the challenges we face and the lessons we have learned. You will gain insight into the current state of the art and associated key areas of development. We will also hear a real-life case study, from the CEO of XNK Therapeutics AB, who have successfully completed their journey from bench to bedside. They will share the challenges faced and their learnings during the translational path to clinic.
At the end of the webinar there will be a Q&A session, giving you the opportunity to ask your questions to ATMP industry experts, with extensive experience and knowledge in different lines of ATMP product development.
Join RSSL and ATMP industry experts as we share our perspectives on the market and what it takes to navigate this complex landscape to ensure a successful outcome.
Key Learning Objectives
- Understanding of the current state of the art in ATMPs
- Evaluation of the current challenges faced in ATMP development and current practices for overcoming these obstacles
- Analysing real-world applications for navigating regulations and ATMP process development for successful translation
- Application of core concepts in ATMP development to your own Company’s needs
