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8:00 am Registration and Coffee

8:30 am Industry Leader’s Fireside Chat

Synopsis

•Business insights to tackle the unmet need in solid tumours
•Experience and advice on navigating the European regulatory boards
•Future plans for CAR-TCR development

9:30 am Cell Therapy Manufacturing and Commercialisation: Challenges and Opportunities

Synopsis

Terumo BCT

10:00 am Speed Networking & Morning Refreshments

Translation
Track

Manufacturing
Track

Development & Commercialisation Track

Selecting & Expanding Optimal T Cell Products

Disrupting Current Processes to Shorten
Manufacturing Times

Clinical Development Decision Making

11.00 FasT CAR Technology: New Practice from Lab to Clinic
• FasT CAR technology enables overnight cell manufacturing, setting up new industry standards
• Preclinical study reveals superior CAR-T cell characteristics in contrast to conventional CAR-T cells
• Beyond CD19, FasT CAR technology is broadly applicable to CAR-Ts against other targets
• Safety profile and efficacy of FasT CAR-19 investigational study
William Cao, CEO, Gracell

11.00 Strategies to Improve Manufacturing Turnaround Time
• Discuss the risk of disrupting regulatory norms to revolutionise timescale to 1-5 days
• Review data to decipher whether it is possible to carry out release testing before material is placed into manufacturing machinery
• Outline QA test or electronic test records to speed up the availability of drugs
Ali Mohamed, VP, CMC, Immatics

11.00 Strategies for Acceleration of Cell Therapies into the Clinic
• Discuss science and risk-based approaches to getting cell therapy ready for the clinic
• Outline the importance of multidisciplinary collaborations which are critical to finding efficiencies
• Provide commentary on development pathway for next generation of a lead asset
Delfi Krishna, Director, Strategy, Portfolio, Operations, Cell & Gene Therapy Platform, GlaxoSmithKline

11:30

isoplexis-logo@2x

11:30

Miltenyi logo

11:30 Panel Discussion: What Infrastructures Need to Be in Place to Ensure Successful Commercial Delivery of CAR-TCR Therapies?
• Building centers of excellence
• Transport and logistics of commercial delivery of a CAR-TCR product
• Patient case management and scheduling
• Educating and training to drive CAR-T and TCR adoption
• Dealing with the huge patient demand

12.00 Empowering T Cell Therapies through Pharmacologic
Regulation of Engineered Immunomodulatory Factors

• CAR-T therapy has lacked significant efficacy in treating
solid tumors due to multiple factors, including inadequate
CAR-T cell expansion, the immunosuppressive TME, and
tumor escape
• Engineering CAR-T cells to produce factors such as IL15, IL12,
or CD40L has been shown to enhance functional activity,
however clinical utility is limited by systemic toxicities
• We are using cytoDRiVETM technology to couple titratable
regulation of immunomodulatory factors with clinically
approved drugs to enable safe and efficacious CAR-T therapies

Steven Shamah, SVP, Scientific Affairs & Technology, Obsidian Therapeutics

12.00 Towards Proof of Concept of TEGs Based on a Point-of-care Manufacturing Model
• Analyse the recoveries of cells in different patient populations, alongside the levels of viable cell production, after infusion to understand how culture conditions can affect expansion
• Automating manufacture to reduce cost and time of production

12.00 Translating Academia to Industry - Multi-tumourassociated Antigen-specific (MultiTAA) T Cells
• MultiTAA recognize multiple antigens via native TCR without genetic engineering due to selection process during manufacturing
• Since lymphodepletion is not required for MultiTAA T cell approach, not only is tumor eliminated via direct killing by infused T cells, but also through recruitment of the endogenous immunity
• Clinical data for both hematological malignancies and solid tumors shows both the safety and efficacy of MultiTAA approach
Mythili Koneru, Senior Vice President, Clinical Development, Marker Therapeutics

Translation Track

Selecting & Expanding Optimal T Cell Products

11.00 FasT CAR Technology: New Practice from Lab to Clinic
• FasT CAR technology enables overnight cell manufacturing, setting up new industry standards
• Preclinical study reveals superior CAR-T cell characteristics in contrast to conventional CAR-T cells
• Beyond CD19, FasT CAR technology is broadly applicable to CAR-Ts against other targets
• Safety profile and efficacy of FasT CAR-19 investigational study
William Cao, CEO, Gracell


11.30


12.00 Hurdles for Off-the-Shelf CAR-T Therapies Using Invariant NKT Cells
• Development of the CARNKT platform against haematological and solid tumour malignancies
• Engineered products to secrete cytokines that further enhance persistence and solid tumour activity
• Explore strategies to overcome immunogenicity and enhance persistence and potency
Stefanos Theoharis, SVP, Corporate Development & Partnering, Cell Medica

Manufacturing Track

Disrupting Current Processes to Shorten Manufacturing Times

11.00 Strategies to Improve Manufacturing Turnaround Time
• Discuss the risk of disrupting regulatory norms to revolutionise timescale to 1-5 days
• Review data to decipher whether it is possible to carry out release testing before material is placed into manufacturing machinery
• Outline QA test or electronic test records to speed up the availability of drugs
Ali Mohamed, VP, CMC, Immatics


11.30


12.00 Towards Proof of Concept of TEGs Based on a Point-of-care Manufacturing Model
• Analyse the recoveries of cells in different patient populations, alongside the levels of viable cell production, after infusion to understand how culture conditions can affect expansion
• Automating manufacture to reduce cost and time of production
Tol Trimborn, COO, Gadeta

Development & Commercialisation Track

Clinical Development Decision Making

11.00 Strategies for Acceleration of Cell Therapies into the Clinic
• Discuss science and risk-based approaches to getting cell therapy ready for the clinic
• Outline the importance of multidisciplinary collaborations which are critical to finding efficiencies
• Provide commentary on development pathway for next generation of a lead asset
Delfi Krishna, Director, Strategy, Portfolio, Operations, Cell & Gene Therapy Platform, GlaxoSmithKline


11:30 Panel Discussion: What Infrastructures Need to Be in Place to Ensure Successful Commercial Delivery of CAR-TCR Therapies?
• Building centers of excellence
• Transport and logistics of commercial delivery of a CAR-TCR product
• Patient case management and scheduling
• Educating and training to drive CAR-T and TCR adoption
• Dealing with the huge patient demand


12.00 Translating Academia to Industry - Multi-tumourassociated Antigen-specific (MultiTAA) T Cells
• MultiTAA recognize multiple antigens via native TCR without genetic engineering due to selection process during manufacturing
• Since lymphodepletion is not required for MultiTAA T cell approach, not only is tumor eliminated via direct killing by infused T cells, but also through recruitment of the endogenous immunity
• Clinical data for both hematological malignancies and solid tumors shows both the safety and efficacy of MultiTAA approach
Mythili Koneru, Senior Vice President, Clinical Development, Marker Therapeutics

12:30 pm Lunch & Networking

Translation

Track

Manufacturing

Track

Development & Commercialisation Track

Selecting & Expanding Optimal T Cell Products

Disrupting Current Processes to Shorten
Manufacturing Times

13.30 Clinical Use of Gamma-delta T Cells to Treat Haematological Malignancies – Translation to Phase 3
• What’s special about gamma-deltas?
• Building an allogeneic cell therapy platform – clinical and
regulatory considerations
• Overcoming logistic challenges of allogeneic approaches
Michael Leek, CEO, TCBiopharm

13.30 Two-day Manufacturing and Release of T Cells Genetically Modified with Sleeping Beauty System
• T cells under IND can be genetically modified using the nonviral Sleeping Beauty system to express chimeric antigen
receptor (CAR) to redirect specificity for hematologic malignancies
• The Sleeping Beauty system can be adapted to express cytokines in addition to immunoreceptors
• The co-expression of membrane-bound IL-15 (mbIL15) and CAR enables resting T cells from the peripheral blood to be
produced and infused within 2 days under an IND using the Sleeping Beauty system using an approach called “rapid
personalised manufacture” (RPM)
Laurence Cooper, CEO, Ziopharm Oncology

13.30 Delivery of Advanced Therapies in the UK
Landscape

• Establishing the Advanced Therapy Treatment Centre (ATTC)
Network Infrastructure
• Collaborative approach across commercial, clinical and
academic partners
• Scale-up of activities across the UK
Fiona Thistlethwaite, Medical Oncology Consultant &
Director of iMATCH

CMC Control to Develop Consistent Quality Products

Regulatory Guidance to Initiate Clinical Trials in Europe

14:00

 

bio-techne logo

14:00

KeyBiologicsLogo

14:00 Round Table Discussion: Building a Regulatory Strategy for Global Clinical Trials 

• Outline the different types of authorities that require
approval
• Experience working with various European countries
• Considerations for which country to start trials in to ensure
clinical growth and timely execution
• Review the framework in Europe for new innovations

Overcome Tumour Resistance to Improve Durability of Response

14:30 CT053, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Long-term Results from a Phase I Study
• Patients with relapsed and refractory multiple myeloma have poor prognoses despite latest treatment advance
• CT053, a fully human anti-BCMA CAR-T cell is being developed to address the following issues: (1) significant
adverse events observed in other BCMA programs; (2) lack of durable response in the high-risk population; (3) lack of persistence of CAR T cells with a non-human anti-BCMA CAR construct; and (4) patients may relapse after other anti-BCMA modalities
• CT053, BCMA CAR-T proof of concept phase I clinical trial results with long-term follow-up will be reported
Hong Ma, SVP, Clinical Development, CARsgen Therapeutics

14:30 Round Table Discussion: Standardising Raw Material & their Supply
• Review the availability of raw materials and variability
• Discuss the need to normalise raw materials including
patient materials and culture material

14:30 Navigating GMO & Environmental Requirements
• Insights into GMO submission processes across different countries in context of ATMP
• Overview of recent developments to streamline GMO submission and assessment process for ATMPs in Europe
• Recommendations for alignment with CTA process in context of forthcoming implementation of Clinical Trials Regulation
Jacquelyn Awigena-Cook, Associate Director, Regulatory Policy & Intelligence, EMEA Regulatory Affairs, Celgene

Translation Track

Selecting & Expanding Optimal T Cell Products

13.30 Clinical Use of Gamma-delta T Cells to Treat Haematological Malignancies – Translation to Phase 3
• What’s special about gamma-deltas?
• Building an allogeneic cell therapy platform – clinical and
regulatory considerations
• Overcoming logistic challenges of allogeneic approaches
Michael Leek, CEO, TCBiopharm


14.00


Overcome Tumour Resistance to Improve Durability of Response


14:30 CT053, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Long-term Results from a Phase I Study
• Patients with relapsed and refractory multiple myeloma have poor prognoses despite latest treatment advance
• CT053, a fully human anti-BCMA CAR-T cell is being developed to address the following issues: (1) significant
adverse events observed in other BCMA programs; (2) lack of durable response in the high-risk population; (3) lack of persistence of CAR T cells with a non-human anti-BCMA CAR construct; and (4) patients may relapse after other anti-BCMA modalities
• CT053, BCMA CAR-T proof of concept phase I clinical trial results with long-term follow-up will be reported
Hong Ma, SVP, Clinical Development, CARsgen Therapeutics

Manufacturing Track

Disrupting Current Processes to Shorten Manufacturing Times

13.30 Two-day Manufacturing and Release of T Cells Genetically Modified with Sleeping Beauty System
• T cells under IND can be genetically modified using the nonviral Sleeping Beauty system to express chimeric antigen
receptor (CAR) to redirect specificity for hematologic malignancies
• The Sleeping Beauty system can be adapted to express cytokines in addition to immunoreceptors
• The co-expression of membrane-bound IL-15 (mbIL15) and CAR enables resting T cells from the peripheral blood to be
produced and infused within 2 days under an IND using the Sleeping Beauty system using an approach called “rapid
personalised manufacture” (RPM)
Laurence Cooper, CEO, Ziopharm Oncology


CMC Control to Develop Consistent Quality Products


14.00


14:30 Round Table Discussion: Standardising Raw Material & their Supply
• Review the availability of raw materials and variability
• Discuss the need to normalise raw materials including
patient materials and culture material

Development & Commercialisation Track

Regulatory Guidance to Initiate Clinical Trials in Europe

13.30 Round Table Discussion: Building a Regulatory Strategy for Global Clinical Trials
• Outline the different types of authorities that require approval
• Experience working with various European countries
• Considerations for which country to start trials in to ensure clinical growth and timely execution
• Review the framework in Europe for new innovations


14:00 Round Table Discussion: Building a Regulatory Strategy for Global Clinical Trials - CONTINUED...


14:30 Navigating GMO & Environmental Requirements
• Insights into GMO submission processes across different countries in context of ATMP
• Overview of recent developments to streamline GMO submission and assessment process for ATMPs in Europe
• Recommendations for alignment with CTA process in context of forthcoming implementation of Clinical Trials Regulation
Jacquelyn Awigena-Cook, Associate Director, Regulatory Policy & Intelligence, EMEA Regulatory Affairs, Celgene

3:00 pm Afternoon Refreshments & Poster Session

Synopsis

Share your work with the pioneers of CAR-TCR therapeutic development! Bring a poster and gain feedback on your latest research with this
expert community. Growing through popular demand, this exciting session brings you hot new data highlighting innovating research

Translation
Track

Manufacturing
Track

Development & Commercialisation Track

Toxicity Management

CMC Control to Develop Consistent Quality Products

Regulatory Guidance to Initiate Clinical Trials in Europe

16:30 Mechanisms, Predictive Markers and Progress with Management of Axicelrelated Toxicities
• Explore the mechanism of toxicity and strategies to
manage it with early clinical biomarkers and immunemonitoring tests
• Review clinical outcomes of combination trials to manage
safety without interfering with clinical efficacy
Adrian Bot, VP, Translational Medicine, Kite, a Gilead Company

16:30 CMC for CAR-TCR Therapies – Shifting the Quality Paradigm
• Best practices for the application of Quality by Design (QbD) principles to cell and gene therapy
• Standards development in the areas of starting materials, cell collection, and supply chain logistics
• Evolving regulatory guidance for CMC - compare and contrast EMA to FDA
Michael Lehmicke, Director, Science & Industry Affairs, Alliance for Regenerative Medicine

16:30 Navigating the Regulatory System for an ATMP
• Outline how different national agencies have different attitudes
• Address the need to make early contact with the regulator
• Review the perspective of the regulator, understanding that there will be on-going validation of assays and control over
processes
 John Johnston, Clinical Assessor, MHRA

Overcoming Vector Supply Bottlenecks

Early Evidence Criteria to Achieve Access & Reimbursement

17:00 Translational Strategies to Prevent Toxicity
• Discuss the need to overcome CRS and NT to enable the delivery of these therapies in an outpatient setting
• Review alternative strategies to design the next-gen T-cells with enhanced efficacy and optimised activation and regulatory pathways
• Analyze clinical results outlining reduced CRS and NT
Cheng Liu, CEO, Eureka Therapeutics

17:00 Overcoming Challenges in Obtaining High, Quality Sustainable Vector Supply
• Holistic view in terms of vector, formulation, clearance and lead
• Experience sourcing vector supply as a raw material and building up with a global supply chain
• Outline which grade of vector, and type, should make up a final product
Cindy Jung, Director, Vector Process Development, GlaxoSmithKline

17:00 Evidence Generation and Access to CAR-T Therapies: A Health Technology Assessment Approach
• Advances in precision medicine, including CAR-T therapies, mean treatments are becoming increasingly tailored to
individuals with patients being offered more personalised therapeutic options
• CAR-Ts have a disruptive impact on current health delivery processes leading to capacity issues in some therapeutic areas
• Early/limited evidence generation impacts the health technology assessment and economic evaluation of these agents necessitating novel approaches to funding and adoption
• Address how these complexities are being managed and where further work is needed
Deborah Morrison, Principal Scientific Advisor, National Institute for Health & Clinical Excellence

Translation Track

Toxicity Management

16:30 Mechanisms, Predictive Markers and Progress with Management of Axicelrelated Toxicities
• Explore the mechanism of toxicity and strategies to
manage it with early clinical biomarkers and immunemonitoring tests
• Review clinical outcomes of combination trials to manage
safety without interfering with clinical efficacy
Adrian Bot, VP, Translational Medicine, Kite, a Gilead Company

17:00 Translational Strategies to Prevent Toxicity
• Discuss the need to overcome CRS and NT to enable the delivery of these therapies in an outpatient setting
• Review alternative strategies to design the next-gen T-cells with enhanced efficacy and optimised activation and regulatory pathways
• Analyze clinical results outlining reduced CRS and NT
Cheng Liu, CEO, Eureka Therapeutics

 

Manufacturing Track

CMC Controls to Develop Consistent Quality Products

16:30 CMC for CAR-TCR Therapies – Shifting the Quality Paradigm
• Best practices for the application of Quality by Design (QbD) principles to cell and gene therapy
• Standards development in the areas of starting materials, cell collection, and supply chain logistics
• Evolving regulatory guidance for CMC - compare and contrast EMA to FDA
Michael Lehmicke, Director, Science & Industry Affairs, Alliance for Regenerative Medicine


Overcome Vector Supply Bottlenecks


17:00 Overcoming Challenges in Obtaining High, Quality Sustainable Vector Supply
• Holistic view in terms of vector, formulation, clearance and lead
• Experience sourcing vector supply as a raw material and building up with a global supply chain
• Outline which grade of vector, and type, should make up a final product
Amol Ketkar, VP, Cell & Gene Therapy & Product Development, GlaxoSmithKline

 

Development & Commercialisation Track

Regulatory Guidance to Initiate Clinical Trials in Europe

16:30 Navigating the Regulatory System for an ATMP
• Outline how different national agencies have different attitudes
• Address the need to make early contact with the regulator
• Review the perspective of the regulator, understanding that there will be on-going validation of assays and control over
processes
 John Johnston, Clinical Assessor, MHRA


Early Evidence Criteria to Achieve Access & Reimbursement


17:00 Evidence Generation and Access to CAR-T Therapies: A Health Technology Assessment Approach
• Advances in precision medicine, including CAR-T therapies, mean treatments are becoming increasingly tailored to
individuals with patients being offered more personalised therapeutic options
• CAR-Ts have a disruptive impact on current health delivery processes leading to capacity issues in some therapeutic areas
• Early/limited evidence generation impacts the health technology assessment and economic evaluation of these agents necessitating novel approaches to funding and adoption
• Address how these complexities are being managed and where further work is needed
Deborah Morrison, Principal Scientific Advisor, National Institute for Health & Clinical Excellence

6:00 pm Chair’s Closing Remarks & End of Summit Day 1

6:15 pm Drinks Reception