8:45 am Chair’s Opening Remarks

  • John Maher Immunology Consultant, King’s College London / CSO , Leucid Bio

9:00 am CAR T Therapies: Process Development and Manufacturing Readiness

  • Gary Pigeau Director, Centre for Advanced Therapeutic Cell Technologies, GE Healthcare Life Sciences

9:30 am Determinants of Durable Response Upon Treatment with Axi-cel

  • Adrian Bot Vice President of Translational Medicine, Kite, a Gilead Company

9:45 am Contextual Regulation of CAR T Function In Vivo

10:00 am CAR-TCR Landscape Review

10:30 am Morning Refreshments

Translation
Track

Manufacturing
Track

Development & Commercialisation Track

Translating Effective Allogeneic Therapies

Cell Characterization

 

Market Access Innovations for CAR-T Therapies

Chair: Blake Aftab, VP, Head of Preclinical & Market Access Innovations for CAR-T Therapies Translational Sciences, Atara Biotherapeutics

Chair: Eric Alonzo, Senior Scientist, Cell Analytics, bluebird bio

Chair: Annie Hubert, Senior Director, Section & Public Policy, Alliance for Regenerative Medicine

11.30 Human Vd1+ T Cells; an Allogeneic ‘Off-the-Shelf’ T Cell Therapy Platform

Alice Brown, VP, Research and Gene Engineering, GammaDelta Therapeutics

11:30 Leveraging High-Dimensional '-omics' Technologies for Comprehensive Profiling of CAR-T Cells to Resolve Drug Product Complexity

Eric Alonzo, Senior Scientist, Cell Analytics, bluebird bio

11.30 Development and Execution of Clinical Trials in Europe

Jen Renwick, VP, R&D Operations, Adaptimmune

12:00 Development of Universal Off-the shelf γδ T Cell-based Therapies

Anil Singhal, President & CEO, Adicet Bio

 

12:30 Exploiting NK Cell Receptors for Autologous and Allogeneic CAR T Cell Therapy

Peggy Sotiropoulou, Director, Research & Development, Celyad

 

12:00 Streamlining CAR-T Discovery and Lentiviral Manufacture for Cell and Gene Therapies

Ryan Cawood, CEO, Oxgene

 

12:30 Process Intensification and Technology Development for CAR-T therapies

Qasim Rafiq, Associate Professor, Cell & Gene Therapy Bioprocessing, University College London

12:00 Crossing borders: Supply Chain Strategies That Foster Sustainability in a Rapidly Advancing International Environment

Mark Flower, VP, Business Development, Be The Match BioTherapies®

 

12:30 Overcoming Cross-border Restrictions for Access

Annie Hubert, Senior Director, Section & Public Policy, Alliance for Regenerative Medicine

 

Translation Track

Translating Effective Allogeneic Therapies

11.30 Human Vd1+ T Cells; an Allogeneic ‘Off-the-Shelf’ T Cell Therapy Platform
• Exploring strategies to use the unique properties of Vd1 gd T cells to:
• Generate an allogeneic platform for the treatment of solid tumours and hematologic malignancies
• Improve the tumour targeting and safety profile of engineered cell therapies

Alice Brown, VP, Research and Gene Engineering, GammaDelta Therapeutics


12:00 Exploiting NK Cell Receptors for Autologous and Allogeneic CAR T Cell Therapy
• Targeting hematopoietic and solid malignancies with NKG2D-based CAR T cells

• Development of non-gene edited allogeneic CAR T cells

• Efficacy and safety of autologous and allogeneic CAR T cells targeting solid tumours

Peggy Sotiropoulou, Director, Research & Development, Celyad

Manufacturing Track

Technology Transfer

11.30 Challenges Carrying Out Tech Transfer for Manufacturing Sites
• Experience managing different raw materials which require different supply agreements and approval status

• Introduction to the GMP requirements for the EU region to avoid challenges moving cross-country

• Managing process changes without impacting the product quality and different product

Therese Solstad Saunders, Senior Adviser, Norwegian Medicines Agency


12:00 Round Table Discussion: Logistical Challenges Transporting CAR-TCR Products to Sites Internationall

• How to maintain starting material quality in a timely manner?

• Challenges in customer screening in transportation

• Outline pros and cons of coaching containers and preference for shipping materials

• Should companies compromise own practice to find a way that works with transport service providers?

Development & Commercialisation Track

Market Access Innovations for CAR-T Therapies

11.30 Development and Execution of Clinical Trials in Europe


12:00 Overcoming Cross-border Restrictions for Access
• Describe cross-border challenges for patients without central funding, creating an untimely process

• Expanding centres across Europe to overcome the geographical access challenges

Annie Hubert, Senior Director, Section & Public Policy, Alliance for Regenerative Medicine

Helen-Tayton Martin, CBO, Adaptimmune

 

1:00 pm Lunch & Networking

14:00 Development of an Allogeneic, Off-the-Shelf
T-cell Immunotherapy Cell Therapies and Derivation of
a Next-Generation CAR-T Platform

Blake Aftab, VP, Head of Preclinical & Translational Sciences, Atara Biotherapeutics

 

14:00 Quality by Design to Accelerate T-cell Based Process Development

Gisèle Deblandre, CSO, MaSThercell

 

14:00 Legal Challenges for Next Generation Therapies

Lisa Kinsella, Head of Legal NTO, Biologics, Cell and Gene, Novartis

Stefan Ibing, Attorney at Law, Head of Legal CEE Pharma,
Novartis

 

14:30 Panel Discussion: Review Cell Sources to Optimise Cell Functionality and Persistence

Cedrik Britten, VP, Oncology Cell Therapy Research Unit, GlaxoSmithKline

Peggy Sotiropoulou, Director, Research & Development, Celyad

Blake Aftab, VP, Head of Preclinical & Translational Sciences, Atara Biotherapeutics

Michael Koslowski CMO, GammaDelta Therapeutics

 

14.30 Panel Discussion: How to Improve Process Development for CAR-TCR Cell Manufacturing

Michal Besser, Head of Laboratory, Director, Sheba Medical Center

Michael Lehmicke, Director, Science & Industry Affairs, Alliance for Regenerative Medicine

Cindy Jung, Director, Vector Process Development, GlaxoSmithKline

Ali Mohamed, Vice President CMC, Immatics

 

14:30 Panel Discussion: How Does the Lack of a Centralised Process in Europe Impact Clinical Development?

Annie Hubert, Senior Director, Section & Public Policy, Alliance for Regenerative Medicine

Vicki Coutinho, Regulatory Affairs & Quality, GammaDelta Therapeutics

Oezlem Anak, VP, Global Program Head CAR-T, Novartis

Kai Pinkernell, CMO & CDO, Medigene

 

Translation Track

Translating Effective Allogeneic Therapies

14:00 Panel Discussion: Review Cell Sources to Optimise Cell Functionality and Persistence

  • Discuss the strengths and weaknesses of TILs, nonengineered T cells and iPSC cells
  • What is the best cell source for sustainability in autologous and allogeneic therapies?

Cedrik Britten, VP, Oncology Cell Therapy Research Unit, GlaxoSmithKline

David Gilham, VP, Research & Development, Celyad

Blake Aftab, VP, Head of Preclinical & Translational Sciences, Atara Biotherapeutics


15:00 Development of an Allogeneic, Off-the-Shelf T-cell Immunotherapy Cell Therapies and Derivation of a Next-Generation CAR-T Platform

  • Clinical development of allogeneic off-the-shelf T cell immunotherapies in oncology and autoimmune disease
  • Clinical and translational studies provide insight into functional biomarkers correlating to efficacy and in vivo expansion
  • Applying clinical and translational findings to the development of next gen allogeneic off-the-shelf CAR-T cell therapies

Blake Aftab, VP, Head of Preclinical & Translational Sciences, Atara Biotherapeutics

Manufacturing Track

Technology Transfer

14:00 Process Intensification and Technology Development for CAR-T therapies

  • Establishing a process control strategy facilitates process intensification, increasing yield and efficiency
  •  Automated strategies for process and product development enables increased consistency
  • Improved control allows for the potential of patient-specific adaptive manufacturing

Qasim Rafiq, Associate Professor, Cell & Gene Therapy Bioprocessing, University College London


Cell Characterisation


15.00 CAR-T Product Characterisation & Function • Gain clarity on product composition, stability and characterisation

  •  Define what makes a cell sample not possible to manufacture for CAR-T • Discuss key biomarkers to predict patient response • Identify cellular functions which categorise subpopulations as less beneficial
  • Explore cell recovery post cryopreservation, review techniques and buffers which maintain cell function

Development & Commercialisation Track

Market Access Innovations for CAR-T Therapies

14:00 Panel Discussion: How Does the Lack of a Cantralised Process in Europe Impact Clinical Development?

  • Compare how the EMA regulatory requirements compare to the FDA
  • Discuss the need for a harmonised approach in Europe to improve patient access

Annie Hubert, Senior Director, Section & Public Policy, Alliance for Regenerative Medicine


15:00 IP and Legal Implications for CAR-TCR Therapies 

  • Clarifying IP requirements for novel therapies
  • Considerations for developing CAR-TCR therapies in a crowded market

3:30 pm Close of the Summit