A two part webinar series
Together with Cirio Advokatbyrå would like to invite you to our two-part interactive webinar series, Optimising the path to market for ATMPs.
ATMPs, Advanced Therapy Medicinal Products, are an increasing and diverse group of innovative products. They are complex products with unique development challenges, and several have shown very promising efficacy results in treating highly debilitating diseases and conditions. However, the prices of the first approved ATMPs have been high and not always supported by the national pricing or reimbursement bodies or other payers.
This interactive webinar series will focus on the challenges of ATMP development and market access with case examples of approved products. The option of an integrated product development to cover both regulatory and HTA expectations will be presented, together with information on regulatory, HTA and market access support available for ATMP developers.
Session 1: Integrated Product Development for ATMPs to meet Regulatory and HTA requirements
Date: 22nd September
Time: 11am – 12pm CET
Session 2: Models for realizing ATMP- value
Date: 29th September
Time: 11am – 12pm CET
Our panelists are available to answer questions at the end of each session. You can ask your questions during the webinar or send them in advance to firstname.lastname@example.org
Click here to book your place today!
Paula Salmikangas: Director of Biopharmaceuticals and ATMP, NDA Group
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.
Steffen Thirstrup: Director NDA Advisory Board, NDA Group
Steffen joined NDA in 2013 from his position as head the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority where he alos acted as Danish member of the Committee for Human Medicinal Products (CHMP) at the EMA. Steffen excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and have successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.
Anders Burén: Senior Counsel, Cirio Advokatbyrå
Anders specialises in strategic collaborations in the pharmaceutical industry and in regulatory law. He advises on Swedish and international aspects of agreements of all kinds governing research, development and commercialisation in the pharmaceutical industry and on product approvals, marketing and other regulatory considerations. Anders has previous experience as Assistant General Counsel for the AstraZeneca Group’s transaction lawyers based outside the US. Before that he was Assistant General Counsel for the Group’s lawyers based in Sweden.
Per Hedman: Partner, Cirio Advokatbyrå
Per Hedman is head of Cirio’s Life Science, Health and Food practice – the Biological team. Per advises companies in all aspects of their business and legal affairs, including regulatory advice, R&D arrangements (such as non-disclosure, material transfer, clinical trial and joint development agreements), commercial relationships (such as manufacturing, supply and distribution agreements), M&A (such as product acquisitions and spin-outs, domestic and cross border), capital-raising transactions (debt and equity), and IPO:s and other capital market transactions.
To learn more about NDA’s ATMP capabilites click here