Join us on Thursday 3rd October 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar where Dr Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board and Claes Buxfeldt, HTA Director NDA Advisory Board will describe an integrated product development process for ATMPs, which will take key aspects of both reviews into account from the beginning, thus ensuring a positive path from clinical trials up to pricing and reimbursement.
Advanced Therapy Medicinal Products (ATMPs, or cell and gene therapy and tissue engineering products) is an increasing group of innovative products, often targeting diseases and conditions with high unmet medical need.
The success of first CD 19 CAR T products against B-cell malignancies has raised awareness of the high potential of these new products, but also shown the several challenges relating to their manufacturing and regulatory approval. The prices of the first approved ATMPs have been high and not always supported by the national pricing and reimbursement bodies.
In such cases, the discrepancy between regulatory approval and negative result of a health technology assessment (HTA) has raised concerns and questions within the industry, as to how to ensure an approved product also gets to the market and patients. Many jurisdictions have created early access schemes and ways to communicate with regulatory and HTA bodies early on to ensure successful outcomes of both reviews. However, the ATMP industry is facing challenges in both aspects.
Why you should attend:
- See how the regulatory and HTA expectations differ
- Learn how to build an Integrated Regulatory / HTA Product Development for ATMPs
- Identify the need for interactions with regulatory and HTA authorities
Click here to book your place today!
Paula is a clinical biochemist by original training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Paula joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals.
Claes joined pharma-industry in 1992, have close to 20 years’ experience working in local and global market access and health economics positions, in a variety of disease areas. Prior to joining NDA he spent 10 years at AstraZeneca starting as a Value Demonstration Leader in Global Health Economics & Outcomes Research, and most recently as the Global Price & Reimbursement Director in Respiratory & Inflammation, in addition to CNS/Pain.
He has supported more than 30 molecules/brands in development in a global position. He has represented the payer voice in many development programs, including the development of payer evidence strategies, pricing and market access strategy, economic models, PROs, RWE and clinical program input. Claes has a MSc from University of Karlstad and more recently a postgraduate diploma in health economics from University of York.