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!


 

Speakers

Dr Paula Salmikangas

Advisory Board Director

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Claes Buxfeldt

HTA Director

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