THE EUROPEAN CGT LANDSCAPE

31 Aug 2022
09:00
SPONSORED BY
Dark Horse Consulting
Oxford BioMedica (UK) Ltd
Cell and Gene Therapy Catapult
MHRA

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 HorseConsulting 

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 HorseConsulting 

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

Speakers

Anthony Davies
Founder & CEO
Dark Horse Consulting
Tom Whitehead
Co Founder & President
Emily Whitehead Foundation
Stephan Grupp
Medical Director Cell & Gene Therapy Lab
Children’s Hospital of Philadelphia
Amir Hefni
Worldwide Commercial and Region Europe Head for Cell & Gene
Novartis
James Miskin
Chief Technical Officer
Oxford BioMedica (UK) Ltd
Kinnari Patel
Chief Operating Officer
Rocket Pharma
Michael von Forstner
Global Head of Clinical Safety and Pharmacovigilance
Biogen
Jacqueline Barry
Chief Clinical Officer
Cell and Gene Therapy Catapult
Ian Rees
Inspectorate Strategy and Innovation
MHRA
Niloofar Davoodi
Director Cell Therapy CMC
Takeda