Phacilitate Leaders Forum

Phacilitate Leaders Europe Agenda 2018

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If, when, why and what in Automation, how wonderful being a BMO

12-Sep-2018
Manufacturing Scalability - Cell & Gene Therapy Europe

If, when, why and what in Automation, how wonderful being a BMO
Dr Stefano Baila, Director of Operations & Business Development, Anemocyte

 

Roundtable host

Dr Dominic Clarke, Global Head of Cell Therapy, HemaCare

Session leader
Dr Elizabeth Read, Chief Technology Officer, Adicet Bio

How characteristics of donor starting material impact the final product
  • Demonstrating lot-to-lot consistency in-lieu of donor variability
  • Retention of donor samples for possible future testing
  • Lack of harmonized screening/testing requirements between US/EU and ROW

Dr Sven Kili, Principle, Sven Kili Consulting Ltd

 

Risks and considerations when implementing process changes for rAAV therapeutics with accelerated clinical timelines
Sybil Danby, Director Business Development, Paragon Bioservices

 

The importance of cell therapy standardization to mitigating clinical and business risk
Dr Stephen Sullivan, International Liaison Officer, GAiT

 

Managing and meeting the demands of donor starting materials for autologous and allogeneic cell therapies.

The discussion will focus on critical aspects including:

How to alleviate logistics challenges and risks of clinical material
  • Centralized cGMP processing site
  • Stability of the leukapheresis collection and processing
  • Standardizing collection parameters
How might we monitor the planning and execution? What key activities should be completed to facilitate a timely and successful launch? What are the key areas for discussion and decision? Who should be involved in Launch planning? When should actual launch planning start?

 

Moderator
Nicolas Danzenbacher, Senior Product Manager MACS GMP Cytokines and Cell Culture Reagents, Miltenyi Biotec GmbH

Speaker
Dr Patrick Ginty, Head of Regulatory Affairs, Cell and Gene Therapy Catapult

 

Assuming a planned European launch for a transformative Cell or Gene Therapy

When should you start to think about a launch?
  • What aspects should be thought of and how should they be actioned?
  • What will help you formalise this?
     
Regulatory round table: The regulatory implications of automation
Speakers
Dominic Clarke, Global Head of Cell Therapy - HemaCare
Elizabeth Read, Chief Technology Officer - Adicet Bio
Nicolas Danzenbächer, Senior Product Manager MACS GMP Cytokines and Cell Culture Reagents - Miltenyi Biotech GmbH
Patrick Ginty, Head of Regulatory Affairs - Cell & Gene Therapy Catapult
Stefano Baila, Director of Operations & Business Development - Anemocyte
Stephen Sullivan, International Liaison Officer - GAiT
Sven Kili, Principle - Sven Kili Consulting Ltd
Sybil Danby, Director Business Development - Paragon Bioservices
Testimonials
  • Real thinking forward combining experts in the field from manufacturing, regulatory and value vision” – “great network with strong experience and sharing risks & opportunities
    Jean-Philippe Combal
    GenSight Biologics
  • The conference consistently proves to be a great forum for networking with industry leaders in the development of cellular and gene therapies as well as vendors for important technologies and services.
    Michael Covington
    Juno Therapeutics, Inc
  • It was a very interesting event as all participants, including speakers were ready to exchange, even on the most challenging subjects such as reimbursement, GMP guidance
    Bertrand Alexandre
    Celyad
  • Phacilitate EU delivered it's promise and more, the topics discussed were highly relevant, with very good and professional speakers and panelists. You will see me next year in Berlin.
    Dr Ohad Karnieli
    Karnieli Ltd