THE EUROPEAN CGT LANDSCAPE
08:55 – Welcome Address & Opening Remarks
Becky Johnson, Vice President – Europe, Phacilitate
09:00 – PANEL: A CELEBRATION OF SCIENCE – HOW CAR-T BECAME SYNONYMOUS WITH COMMERCIAL SUCCESS
In August 2012, as the last hope to cure her of leukemia, Emily Whitehead became the first child in the world to receive a revolutionary cell therapy treatment named CAR-T. 10 years on and Emily remains in remission. To those within the cell and gene community Emily’s story and the scientific and commercial success of CAR-T are well known. But as 2022 marks a significant milestone, so too grows the wider public awareness and implications of CAR-T. Join us as those involved in this end-to-end success story look back on the journey so far and discuss what the possibilities hold for the future
Chair: Anthony Davies, Founder & CEO, Dark Horse Consulting
Speakers:
Tom Whitehead, Co-Founder & President, Emily Whitehead Foundation
Dr. Stephan Grupp, Medical Director Cell & Gene Therapy Lab, Children’s Hospital of Philadelphia
Amir Hefni, Worldwide Commercial & Region Europe Head Cell & Gene, Novartis
James Miskin, Chief Technical Officer, Oxford Biomedica
09:25 – FIRESIDE CHAT: TRAVERSING THE CHALLENGES & OPPORTUNITIES WITHIN THE CURRENT UK & EUROPEAN CGT LANDSCAPE
No one could have predicted the events of the last two years or the implications of a pandemic and UK’s exit from the EU, many of which are still making themselves known. Join our panel of experts as they navigate the systemic changes that have occurred and unravel what this really means for the coming months and years
- Understanding the impact and changes as a result of Covid-19 and Brexit
- Where is Europe now focused?
- How can we demonstrate end-to-end value along the therapy supply chain and ensure consistent patient access and centricity?
- Establishing and maintaining a treatment network for your product across varying and changing regions
- Global risk-benefit and evaluation
Chair: Anthony Davies, Founder & CEO, Dark Horse Consulting
Speakers:
Miguel Forte, CEO, Bone Therapeutics & President-Elect, ISCT
Kinnari Patel, Chief Operating Officer, Rocket Pharma
09:50 – PANEL: NAVIGATING THE SHIFTING REGULATORY PATHWAYS TO DEVELOP A STRONGER CGT GROWTH STRATEGY
When the UK voted to exit the EU in 2016, there were fears about what this would mean for the UK life science sector and the relationship that had developed within Europe. Now, post-Brexit the long-term impact is still unclear, but with this uncertainty also comes opportunity. In this panel, we debate the possibilities and outcomes of a post-Brexit landscape
- What do the ever increasing regulatory changes mean in real-world terms and what is the impact on ATMP?
- As a third country with respect to the EU, how is the UK remaining competitive in bioscience post-Brexit and Covid?
- How do you set up clinical trials following the impact of therapeutic approval and move to other jurisdiction routes
- What are the opportunities within Europe for growth and innovation compared to the competitive landscape within the US?
Chair: Jacqueline Barry, Chief Clinical Officer, Cell and Gene Therapy Catapult
Speakers:
Michael von Forstner, Global Head of Clinical Safety and Pharmacovigilance, Biogen
Niloofar Davoodi, Director Cell Therapy CMC, Takeda
Ian Rees, Inspectorate Strategy and Innovation, MHRA