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Panel discussion - Advanced Therapy Collaboration and Integrated Development: The challenges and opportunities
When: Wednedsay 13th November, 12.00-13.00
Location: Level 1, Hall B1, Rm 6
In the 10 years since the first Advanced Therapy Medicinal Product (ATMP) was approved in Europe, a total of 14 have been approved, 4 of which were later withdrawn from the market. However, the interest in these types of medicines continues to accelerate. Indeed, FDA commissioner Scott Gottlieb recently said “… by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.” ATMPs bring many challenges and opportunities for patients, physicians, payers, developers, regulatory agencies and the investment community alike. They are forcing stakeholders to think, behave and work in a different way and in doing so change the paradigm of drug development. The importance of collaboration and integration of activities for these therapies is becoming more evident. This session aims to discuss the further development of new ways of working, new collaboration models among the stakeholder groups and the opportunities for ATMPs in the next 5 years.
Moderator: Morrie Ruffin - Co-founder, Alliance for Regenerative Medicine
Paul Baldrick - Executive Director, Non-clinical Regulatory Strategy, Covance Laboratories
Alexander Fink - Managing Partner Europe, TRINITY Life Sciences
Keith Thompson - CEO, Cell and Gene Therapy Catapult
Chris Williams - VP Business Development, Autolus Therapeutics