Agenda

London, 24 - 25 May 2022

Schedule

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May 2408:45
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Opening remarks

Keynote Plenary
Jessica Robinson, Project Director, Advanced Therapies, Terrapinn Holdings Ltd
May 2408:55
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Introduction from chair

Keynote Plenary
May 2409:00
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Keynote panel discussion: State of the industry

Keynote Plenary
  • Learnings from the last 2 years and how we can apply them in the next 5 years
  • How has the pandemic impacted the industry and how is the impact of future situations likely to differ?
  • What are the macro elements of this environment and their impact on the advanced therapies sector?
  • What can we do to improve clinical outcomes?
May 2409:30
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Keynote panel discussion: mRNA Therapeutics

Keynote Plenary
  • Where do we go from here?
  • Learning from transitioning from pandemic to endemic
  • What have we learned from the booster era and vaccinating the developing world?
  • Tackling delivery technology and other challenges
May 2410:00
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Keynote panel discussion: Tackling key regulatory challenges in the advanced therapies space

Keynote Plenary
  • The need to show that a candidate product meets the s requirements for safety and efficacy. Additionally for advanced therapies, we increasingly tackle the questions of durability of effect, and manufacturing and analytical considerations. We have seen recent examples of all of these areas impacting advanced therapy clinical trials and approvability, including clinical holds and delays. What is the role of regulatory guidance in enabling sponsors, and how should we interpret it? How are gene therapy developers coping with the evolving science and regulatory paradigm?
  • What are the advantages and the impediments to conducting clinical trials of cell and gene therapies in Europe? EU requirements for vetting trials to meet regulations regarding genetically modified organisms (GMOs). Is this regulation consistent with the current science? Is it slowing down applications for gene therapy and genome editing trials?
May 2410:30
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Regenerative medicine in daily life: will the dream become reality?

Start-up Pitches
Deana Mohr, Chief Executive Officer & Co-Founder, MUVON Therapeutics
May 2410:45
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Removing microenvironmental barriers to cancer immunotherapy success through engineered bacteria

Start-up Pitches
Pedro Correa de Sampaio, Chief Executive Officer, Neobe Therapeutics
May 2411:00
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Functional phenomics enabling comprehensive analysis of cancer-immune cell interactions at single-cell resolutions

Start-up Pitches
Hans Kleine-Brüggeney, CTO & Co-Founder, evorion biotechnologies
May 2411:15
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Company Presentation - Title to be finalised

Start-up Pitches
Paulo Refinetti, Founder And Chief Executive Officer, Rem Analytics
May 2411:30
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Roundtable 1: Staying at the cutting edge of cell and gene therapy

Keynote Plenary
May 2411:30
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Roundtable 10: Future-Proofing Supply Chain Orchestration

Keynote Plenary
Learning from previous experiences and pre-empting upcoming challenges within the industry
May 2411:30
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Roundtable 11: Tackling digital challenges faced by cell and gene therapy companies

Keynote Plenary
May 2411:30
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Roundtable 12: How do you control the quality of your cell-based therapy?

Keynote Plenary
May 2411:30
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Roundtable 13: Applying the learnings from working on the UK vaccines taskforce to ATMP manufacturing in the future

Keynote Plenary
Jasmin Kee, Bioprocessing Consultant and Former Technical Director, UK Gov Vaccines Taskforce
May 2411:30
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Roundtable 14: Building industry /academic partnerships

Keynote Plenary
May 2411:30
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Roundtable 2: Interactions with Regulatory Authorities for SMEs and Academia

Keynote Plenary
May 2411:30
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Roundtable 3: Commercial aspects: what you need to know about running a cell therapy company in 2022 & how to stand out

Keynote Plenary
David Main, President & Chief Executive Officer, Notch Therapeutics
May 2411:30
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Roundtable 4: Business models for cell and gene therapy for ultra-rare diseases

Keynote Plenary
Mélodie Dupré, Business Development, Genethon
Imen Mestiri, business development manager, Genethon
May 2411:30
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Roundtable 6: Current state of standards for regenerative medicine and resources for industry

Keynote Plenary
May 2411:30
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Roundtable 7: Tackling large scale regulatory challenges

Keynote Plenary
Yemisi Corinaldi, Regulatory Strategy Leader, Spark Therapeutics UK Limited
May 2411:30
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Roundtable 8: What are the biggest challenges in bringing ATMPs to market?

Keynote Plenary
May 2411:30
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Roundtable 9: Collaboration between patient groups and industry

Keynote Plenary
Ron Jortner, Managing Director, Masthead Biosciences
May 2412:30
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Combining magnetic cell seperation with DispenCell for gentle and simple T cell cloning

Start-up Pitches
Alessia Baldo, business development manager, SEED Biosciences
May 2412:45
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Complete single-cell sequencing services

Start-up Pitches
Bastiaan Bijl, Business Development Director, Single Cell Discoveries
May 2413:00
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Enhanced safety of gene-editing pipelines through tissue-specific gRNAs that enable better control of gene-editing

Start-up Pitches
Poulami Chaudhuri, Co-Founder & Chief Executive Officer, Helex Bio
May 2413:15
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New insights into the role of metals in disease

Start-up Pitches
IVO TIMMERMANS, Chief Executive Officer, Pleco Therapeutics
May 2413:29
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Chair: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Track 1: Evidence, Pricing & Access
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
May 2413:29
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Chair: Lawrence Lamb: Executive Vice President / Chief Scientific Officer, In8bio

Track 2: Gene Modified Cell Therapy
May 2413:29
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Chair: Stefanos Theoharis, CBO Bone Therapeutics

Track 3: Cell Therapy
May 2413:29
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Chair: Magali Taiel, SMO GenSight Biologics

Track 4: Gene Therapy
May 2413:29
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Chair: Patrick J. Hanley, Chief and Director, Cellular Therapy Prgram, Childrens National Health System

Track 5: Manufacture
May 2413:29
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Chair: Albert Ribickas, Bone Marrow Transplant Laboratory Manager, Moffitt Cancer Center

Track 6: Patient Delivery
Albert Ribickas, BMT Manager, Moffitt Cancer Center
May 2413:29
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Chair: Sven Kili, CEO, Antion Biosciences; Principle, Sven Kili Consulting

Track 7: Innovation
Sven Kili, Chief Executive Officer, Antion Biosciences
May 2413:30
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Dos and don'ts of launching an ATMP in a European country

Track 1: Evidence, Pricing & Access
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
May 2413:30
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CAR T-cell immunotherapy of solid tumours: parallel learning from the clinic and lab

Track 2: Gene Modified Cell Therapy
  • Summary of a dose escalation phase 1 clinical trial of panErbB CAR T-cells in patients with head and neck cancer
  • Summary of a novel CAR platform dubbed a parallel (p)CAR, which consist of a CD28-containing second generation CAR and a 4-1BB containing chimeric co-stimulatory receptor
  • pCAR engineered T-cells demonstrate superior restimulation potential in vitro, and exert superior efficacy in 2D and 3D tumour/stroma model systems
  • Superior in vivo activity has been demonstrated in a range of cell line- and patient derived-tumour xenograft models, when compared to traditional linear CAR designs
May 2413:30
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Harnessing cell death for regenerative medicine

Track 3: Cell Therapy
May 2413:30
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Shifting gene therapy paradigm with novel capsids and manufacturing processes

Track 4: Gene Therapy
May 2413:30
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Manufacturing challenges of allogeneic cell medicines – understanding batch-to-batch variation on the way to MAA/BLA

Track 5: Manufacture
  • What are the different basic types of allogeneic cell medicines and what are the individual challenges in manufacture?
  • Allogeneic cell medicines aren’t the same as recombinant proteins and batch sizes will often be limited by replication senescence. How do you manage the transition from batch to batch?
  • How do you design your manufacturing strategy from MCB-WCB-DS and DP efficiently and with a view to providing reproducibility data to a regulatory agency at the time of MAA/BLA?
May 2413:30
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Unleashing the Allogeneic Potential by building solutions for cryologistics

Track 6: Patient Delivery
May 2413:30
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Multiplex gene engineering, moving beyond editing

Track 7: Innovation
Sven Kili, Chief Executive Officer, Antion Biosciences
May 2413:50
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Gene Therapies in Germany - landscape, aspects and current updates

Track 1: Evidence, Pricing & Access
May 2413:50
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CAR-Macrophages - a novel approach to treating solid tumours

Track 2: Gene Modified Cell Therapy
May 2413:50
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Generating a patient specific thymus

Track 3: Cell Therapy
May 2413:50
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Panel discussion: Gene therapy 2.0

Track 4: Gene Therapy
  • Delivery: exosomes, viral vs non-viral
  • Stability
  • Improving safety
Paul S Carter, Director, Head Vector Processing, Quell therapeutics
Pedro Cejas, Discovery Lead, Spark Therapeutics
May 2413:50
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Shaping the future of Viral Vector Manufacturing using a platform approach

Track 5: Manufacture
    nt needs in the ultra-rare, rare, and beyond rare clinical indications. To serve these unmet needs, cell and gene therapy companies are developing multiple products that are expected to rapidly advance from pre-clinical stages to clinical trials.In order to successfully get from the lab to the clinic in a timely, predictable way, and with the highest quality and safety, companies must begin by developing robust, scalable and reproducible manufacturing processes. Leveraging a manufacturing platform can help expedite the critical path for clinical development and commercialization.This presentation will provide an overview of FUJIFILM Diosynth gene therapy capabilities andillustrate how the FUJIFILM Diosynth Biotechnologies AAV manufacturing platform is helping clients achieve their clinical goals, including:
  • Access to an AAV manufacturing platform which includes a fully characterized, suspension adapted, clonal HEK293 cGMP cell line together with research and cGMP-grade Rep/Cap, Helper, and GOI (backbone) plasmids to accelerate early process development
  • Comprehensive analytical methods to support phase-appropriate product characterization and batch release testing.
  • Access to a comprehensive, end-to-end service offering for drug substance and drug product manufacture and an integrated manufacturing network which can support process scale up, with the flexibility to meet clinical and commercial product demand.
May 2413:50
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Ten years of evolution, a multifaceted look at modern ATMP orchestration

Track 6: Patient Delivery
  • The original need for orchestration, review of the Dendreon approval
  • The developing profile of ATMP over ten years. What has changed, what the future holds
  • The enhanced capability of software solutions and how they can be leveraged to address industry issues.
  • Responding to a supply chain eco-system that is under growing pressure of demand.
  • The united approach – solving challenges through knowledge sharing, integration and collaboration
May 2413:50
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May 2414:10
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What are the impacts of ATMPs on health services?

Track 1: Evidence, Pricing & Access
  • What are the responsibilities of the different players, commissioners, companies in the set-up of the new services?
  • What is the risk that each player should take when planning to launch a new ATMP?
May 2414:10
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New Directions in the treatment of solid tumours with gdT Cells

Track 2: Gene Modified Cell Therapy
May 2414:10
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Providing a novel off-the-shelf implant to repair damaged organs

Track 3: Cell Therapy
May 2414:10
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Manufacturing genetically modified NK cells

Track 5: Manufacture
May 2414:10
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The quality chain for receipt, processing/manufacturing and distribution of cellular products

Track 6: Patient Delivery
May 2414:10
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Generic mRNA vaccine - scientific, regulatory and legal resolutions - advice to developing nations

Track 7: Innovation
Sarfaraz Niazi, Professor, University of Illinois
May 2414:30
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English market presentation/panel: What the future of the ATMP landscape might look like

Track 1: Evidence, Pricing & Access
  • What does the funnel of the ATMP pipeline looks like (# under development vs. # launches)
  • How current challenges might be replaced with new challenges.
May 2414:30
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Gene Modified iPSC cells to tackle solid tumours

Track 2: Gene Modified Cell Therapy
May 2414:30
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Phase 3 clinical updates from a personalized vaccine platform technology for cancer and COVID-19

Track 3: Cell Therapy
  • A pan-antigenic approach, protecting against mutation-associated loss of function
  • A personalized medicine, which minimizes adverse events and maximizes efficacy
  • A point-of-care production approach, enabling distributed scaled manufacturing for COVID-19 vaccines
May 2414:30
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Panel discussion: Immunogenicity for gene therapy

Track 4: Gene Therapy
  • Addressing key unresolved issues in gene therapy: immunosuppression, re-dosing, and in-utero dosing
  • Evading neutralising antibodies
May 2414:30
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Phase dependent approaches to the supply and testing of materials for advanced therapies

Track 5: Manufacture
May 2414:30
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Mastering the orchestration of Cell & Gene Therapy Supply

Track 6: Patient Delivery
oWhy “traditional” pharma models fails and new supply chains are requiredoOrchestration of Therapy Supplies to ensure seamless processes and upscale potentialoNeed and Power of collaboration via a strong partner network
May 2414:50
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Panel: Innovative approaches to accelerate access and reimbursement in ATMPs

Track 1: Evidence, Pricing & Access
  • What make a transformative ATMP vs “marginally better” ATMP?
  • What makes it worthwhile? How can we tell which ones are the right treatments?
  • Does it really need special commercial arrangement?
  • Does it really need to be complicated? Can we make it simpler?
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
Detlev Parow, Previous Head Pharmaceutical Department, DAK-Gesundheit
Thomas Mueller, Head Of Directorate General 1 - Drugs, Medical Devices, Biotechnology, Federal Ministry of Health Germany
May 2414:50
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Oncolytic viral immunotherapy as a new modality to treat solid tumor

Track 2: Gene Modified Cell Therapy
May 2414:50
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Regenerative Medicine: Challenges in clinical translation & the RegmedXB Platform

Track 3: Cell Therapy
May 2414:50
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The re-dosing challenge: re-dosing strategies

Track 4: Gene Therapy
May 2414:50
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Assessing the time course of the cellular expansion and transfection and what we can learn from it for saving experiments and accelerating commercialization

Track 5: Manufacture
May 2414:50
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Panel Discussion: Impact of the pandemic on ATMP supply chains and future strategies for improvement

Track 6: Patient Delivery
Jasmin Kee, Bioprocessing Consultant and Former Technical Director, UK Gov Vaccines Taskforce
Albert Ribickas, BMT Manager, Moffitt Cancer Center
May 2415:10
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Precise and Efficient Non-viral CRISPR Gene Editing Solutions for T Cell Engineering

Track 2: Gene Modified Cell Therapy
May 2415:10
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Improving the digital landscape at Quell therapeutics

Track 3: Cell Therapy
Julien Browne, Head of Analytical Development, Quell therapeutics
Lylia Ouboussad, Senior Scientist, Quell therapeutics
May 2415:10
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Fetal gene therapy

Track 4: Gene Therapy
·Numerous studies have now demonstrated preclinical efficacy·Human fetal gene therapy is technologically feasible·In which cases is fetal intervention superior to postnatal therapy?
May 2415:10
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Panel discussion: Standardisation of cell therapy manufacturing

Track 5: Manufacture
May 2415:59
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Chair: Lawrence Lamb, Executive Vice President / Chief Scientific Officer, In8Bio

Track 2: Gene Modified Cell Therapy
May 2415:59
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Chair: Stefanos Theoharis, CBO Bone Therapeutics

Track 3: Cell Therapy
May 2415:59
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Chair: Albert Ribickas, Bone Marrow Transplant Laboratory Manager, Moffitt Cancer Center

Track 6: Patient Delivery
Albert Ribickas, BMT Manager, Moffitt Cancer Center
May 2416:00
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Tissue Engineering – Lessons learnt from the last 15 years

Track 1: Evidence, Pricing & Access
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
Andre Roeder, Head Global Market Access, TETEC AG
May 2416:00
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Logistical implications of global cell-based therapies for diabetic kidney disease: early phase III lessons learned

Track 3: Cell Therapy
May 2416:00
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New Adverse Event terminology for in utero advanced prenatal therapies

Track 4: Gene Therapy
I will be presenting new data on safety considerations for advanced prenatal therapies including the first Maternal Fetal Adverse Event Terminology, published recently. There has been lots of interest from international regulators (EMA, FDA, MHRA) plus MedDRA about the terminology. The terminology is available here:https://www.ucl.ac.uk/womens-health/research/maternal-and-fetal-medicine/prenatal-therapy/current-projects-professor-anna-david-0
Anna David, Professor and Consultant in Obstetrics and Maternal Fetal Medicine; Director, EGA Institute for Women's Health,, University College London
May 2416:00
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Evolving choices for cell and gene therapy process development

Track 5: Manufacture
Manuel Carrondo, Professor, iBET: Instituto de Biologia Experimental e Tecnológica
May 2416:00
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Developing an ideal CAR-T cell therapy patient experience through human centred design and innovation

Track 6: Patient Delivery
Nancy Pick, Implementation Coordinator, Mayo Clinic
Allison Matthews, Design Lead, Mayo Clinic Center for Innovation
May 2416:20
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Panel: Early detection and screening for genetic diseases and genetic risk factors

Track 1: Evidence, Pricing & Access
What does it take (frameworks, barriers & benefits) for policy awareness and reimbursement for genetic testing and newborn screening?
Diane Kleinermans, President of the Commission of Drugs Reimbursement, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV)
May 2416:20
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Engineering NK Cell Resistance to the Tumour Microenvironment

Track 2: Gene Modified Cell Therapy
Conrad Russell Y Cruz, Assistant Professor, Children's National Medical Center; Co-Founder, Children's National Medical Center
May 2416:20
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Conjugated AAV platfom with current applications in CNS/Ocular

Track 4: Gene Therapy
May 2416:20
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GMP-compliant Manufacturing of MSCs with a Xeno-free Cell culture medium in a closed-system automated bioreactor

Track 5: Manufacture
Sponsored by VivaBioCell
May 2416:40
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Myeloid programming, the next generation of immune therapies for oncology

Track 2: Gene Modified Cell Therapy
  • Myeloid cells are engaged in all diseases and disorders. The ability to program them opens a novel avenue to treat disease.
  • Autologous Myeloid cells can be engineered with novel receptors to recognize and kill cancer, with phase 1 clinical trials underway in PTCL
  • Next generation in vivo mRNA-delivery of novel receptors can program myeloid cells in situ, driving them to recognize and kill cancer
May 2416:40
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Transforming Incubator of Life into Innovative Treatments: allogeneic Amnion Epithelial Stem Cells to treat congenital and chronic disorders without immunosuppression

Track 3: Cell Therapy
May 2416:40
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Lumevoq Gene Therapy in Leber Hereditary Optic Neuropathy

Track 4: Gene Therapy
May 2416:40
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Economics of viral vector manufacture for cell and gene therapy commercialisation

Track 5: Manufacture
May 2416:40
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Nursing considerations in cellular therapy

Track 6: Patient Delivery
Sally Alexander, Clinical Nurse Specialist, Massachusetts General Hospital
May 2417:00
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Panel Discussion: Is Europe a graveyard for gene therapies?

Track 1: Evidence, Pricing & Access
Policy considerations, in particular looking at the EU policy and legislative landscape and changes which would be required to keep Europe competitive for the ATMP sector
Sven Kili, Chief Executive Officer, Antion Biosciences
Detlev Parow, Previous Head Pharmaceutical Department, DAK-Gesundheit
Seren Phillips, Senior Director, EMEA Health Economics and Outcomes Research, Real World Evidence and Market Access, Novartis Gene Therapies
May 2417:00
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Panel Discussion: Improving standards for regenerative medicine

Track 3: Cell Therapy
  • Measurement infrastructure and standards for advanced therapies
May 2417:00
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Moving from observing effects in process development to understanding them

Track 5: Manufacture
May 249:30
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Keynote panel disucssion: mRNA Therapeutics

Keynote Plenary
  • Where do we go from here?
  • Learning from transitioning from pandemic to endemic
  • What have we learned from the booster era and vaccinating the developing world?
  • Tackling delivery technology and other challenges

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May 2509:00
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May 2509:30
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Panel discussion: Addressing the skill shortage in Advanced Therapies

Keynote Plenary
Jasmin Kee, Bioprocessing Consultant and Former Technical Director, UK Gov Vaccines Taskforce
Conrad Russell Y Cruz, Assistant Professor, Children's National Medical Center; Co-Founder, Children's National Medical Center
Sven Kili, Chief Executive Officer, Antion Biosciences
May 2510:00
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Panel discussion: Deals and investments made: where are we going in 2023?

Keynote Plenary
Sven Kili, Chief Executive Officer, Antion Biosciences
Owen Smith, Investment Director, 4BIO Capital
David Greenwald, Vice President Of Business Development, Deerfield Management
May 2510:30
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Maximising vector production - targetting antiviral defence using small molecule VSEs

Start-up Pitches
Jean-Simon Diallo, Chief Executive Officer, Virica Biotech
May 2510:45
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A novel microfluidics-based platform for process development and manufacture of cell therapies

Start-up Pitches
James Kusena, Head of Bioprocessing, MicrofluidX
May 2510:59
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Chair: Snehal Naik Regulatory Policy Leader, Regulatory Strategy Leader (Ocular), Spark Therapeutics

Track 1: Evidence, Pricing & Access
May 2510:59
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Chair: Peter Olagunju, CTO, TCR2

Track 2: Gene Modified Cell Therapy
Peter Olagunju, Chief Technology Officer, TCR² Therapeutics
May 2510:59
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Chair: Miguel Forte, CEO, Bone Therapeutics

Track 3: Cell Therapy
May 2510:59
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Chair: Eric Michael David, CEO, Gene Therapy BridgeBio

Track 4: Gene Therapy
May 2510:59
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Chair: Patrick J. Hanley, Chief and Director, Cellular Therapy Program, Children's National Health System

Track 5: Manufacture
May 2510:59
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Chair: Moshe Israeli, Medical Director, Rabin Medical Center

Track 6: Cord blood and tissue
Moshe Israeli, Medical Director, Rabin Medical Center
May 2510:59
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Chair: David Morrow, Senior Scientific Programme Manager-ATMP/Vaccines, EATRIS

Track 7: Innovation
May 2511:00
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European regulatory environment: upcoming changes and remaining challenges

Track 1: Evidence, Pricing & Access
  • New centralized procedure for clinical trials submission
  • GMO national requirements: status
  • National advice versus EMA centralised procedure
  • Still plan early!
Severine Marconi, Senior Director for EU Regulatory Affairs, AskBio
May 2511:00
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Current approaches to advanced cell and gene therapies and adverse events; the Risk - Benefit balance

Track 2: Gene Modified Cell Therapy
  • Gene-therapy / editing (GT/GE) solutions are emerging advanced therapies for life-threatening monogenetic disorders!
  • Early outcomes of GT/GE solutions look very promising: effective and low toxic
  • Recently ‘possibly’ IND related adverse events of MDS/AML are reported in a couple clinical trials.
May 2511:00
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ISCT: Trends in CGT Translation

Track 3: Cell Therapy
May 2511:00
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Process intensification and manufacturing strategies for ATMPs

Track 5: Manufacture
May 2511:00
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Optimising gene therapy translation from academia to industry

Track 7: Innovation
May 2511:20
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Panel discussion: Getting first in class therapies into the clinic

Track 1: Evidence, Pricing & Access
  • Engaging with the regulators
  • When during planning do you apply for approval?
  • Surprises along the way, what would you do differently?
  • Any advice for emerging companies?
  • Differences in EU & US
May 2511:20
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3D cultivation of mesenchymal stem cells

Track 3: Cell Therapy
May 2511:20
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Leveraging Moderna’s mRNA platform in the context of rare diseases

Track 4: Gene Therapy
May 2511:20
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Workforce education as advanced as ATMP's: Navigating the talent shortage

Track 5: Manufacture
May 2511:20
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Use of cord blood as starting material for cell therapy

Track 6: Cord blood and tissue
Marcie Finney, Executive Director, Cleveland Cord Blood Center
May 2511:20
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UK Gene Therapy Innovation Hub: Optimising translation from academia to industry

Track 7: Innovation
Sven Kili, Chief Executive Officer, Antion Biosciences
May 2511:40
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Mesenchymal stromal cells - an unlimited source of cell therapies

Track 3: Cell Therapy
May 2511:40
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Genethon: late preclinical and clinical updates

Track 4: Gene Therapy
Mélodie Dupré, Business Development, Genethon
Imen Mestiri, business development manager, Genethon
May 2511:40
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Scalable Purification of Recombinant Adeno-Associated Viral Vectors

Track 5: Manufacture
May 2511:40
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Experimental approaches to improve umbilical cord blood transplant outcomes

Track 6: Cord blood and tissue
May 2511:40
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The role of Research Infrastructures in supporting Innovative Vaccine and ATMP development to tackle infectious diseases and cancer

Track 7: Innovation
May 2512:00
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Commercialisation of ATMPs (including customer model)

Track 1: Evidence, Pricing & Access
May 2512:00
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Expanding CAR T cell profiling to accelerate therapeutic insights

Track 2: Gene Modified Cell Therapy
  • Understanding biomarkers in CAR T therapy requires looking at different points in the manufacturing process
  • "-Omic" technologies such as CyTOF are ideal for looking at these parts of the CAR T manufacturing process
  • Clinical trial data show that memory subsets and long-term memory markers are associate with better patient response
  • conversely more effector like and senescent phenotypes inversely associated with patient response
  • Mass cytometry identified potentially predictive biomarkers for further exploration
May 2512:00
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Measuring biodistribution of cell therapies in humans and other species

Track 3: Cell Therapy
May 2512:00
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A single platform for Cell Therapy manufacturing from research to commercial. Dream or reality?

Track 5: Manufacture
May 2512:00
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Promoting best practice in cord blood utilisation through collaboration

Track 6: Cord blood and tissue
May 2512:00
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New approaches for identification of potential off-target mutations associated with genome editing in cell therapies – a collaborative initiative

Track 7: Innovation
May 2512:20
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Panel discussion: Ask the investors

Track 1: Evidence, Pricing & Access
Sven Kili, Chief Executive Officer, Antion Biosciences
David Greenwald, Vice President Of Business Development, Deerfield Management
May 2512:20
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May 2512:20
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Treating cancer and covid with allogenic gamma delta T cells, update on phase 2/3 clinical programs

Track 3: Cell Therapy
May 2512:20
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Panel discussion: Rare diseases & orphan drugs, patient perspectives

Track 4: Gene Therapy
Ron Jortner, Managing Director, Masthead Biosciences
David Edward Rose, Business Development And Sales Associate, Rare Revolution
May 2512:20
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Metabolic and Environmental Control-Based Automation, Machine Learning and AI with the Adva X3 Platform

Track 5: Manufacture
May 2512:20
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Allogeneic UC-MSC drug product for treatment of type 1 diabetes

Track 6: Cord blood and tissue
May 2512:20
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The development of new T-cell based concepts for cancer immunotherapy

Track 7: Innovation
  • A pipeline to identify highly effective and specific T-cell receptors for cancer therapy
  • From therapeutic concept to first-in-human clinical trial
  • Infrastructure for effective cell therapy drug development in an academic setting
May 2512:40
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May 2512:40
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Manufacturing stem cell therapies at cord blood bank. FamiCord experience

Track 6: Cord blood and tissue
  • Changing role of perinatal tissue banks in the biopharmaceutical ecosystem
  • Regulatory framework to bring mesenchymal stem cells to clinic
  • Mesenchymal Stem (stromal) cells manufacturing and applications – FamiCord experience
  • Proven vs unproven stem cell therapies
Tomasz Baran, Executive VP, PBKM/FamiCord Group
May 2512:40
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Automating autologous and allogeneic cell therapy manufacturing

Track 7: Innovation
Integrating quality control with manufacturingDifferent modes of automation are needed for autologous (e.g. CAR-T cell therapy) and allogeneic (e.g. MSCs) cell therapy manufacturingIntegrating quality control for better process understanding and faster release of product is a key challengeTwo case studies are used to illustrate how and to what extent automated quality control is integrated with automated cell therapy manufacturing
May 2513:15
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Order of magnitude - a simple change to increase lentiviral production yields by 10 fold

Start-up Pitches
Adam Inche, Founder, Lentitek
May 2513:45
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Curing corneal blindness with stem cells

Start-up Pitches
Laura Koivusalo, Chief Executive Officer & Founder, StemSight
May 2513:59
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Chair: Snehal Naik, Regulatory Policy Leader, Regulatory Strategy Leader (Ocular), Spark Therapeutics (confirmed)

Track 1: Evidence, Pricing & Access
May 2513:59
Conference pass

Chair: Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck, Sharp and Dohme

Track 2: Immuno-oncology
May 2513:59
Conference pass

Chair: Miguel Forte, CEO, Bone Therapeutics

Track 3: Cell Therapy
May 2513:59
Conference pass

Chair: Eric Michael David, CEO, Gene Therapy BridgeBio

Track 4: Gene Therapy
May 2513:59
Conference pass

Chair: Patrick J. Hanley, Chief and Director, Cellular Therapy Program, Children's National Health System

Track 5: Manufacture
May 2513:59
Conference pass

Chair: Moshe Israeli, Medical Director, Rabin Medical Center

Track 6: Cord blood and tissue
Moshe Israeli, Medical Director, Rabin Medical Center
May 2513:59
Conference pass

Chair: Sven Kili, CEO, Antion Biosciences; Principle, Sven Kili Consulting

Track 7: Innovation
Sven Kili, Chief Executive Officer, Antion Biosciences
May 2514:00
Conference pass

Building on what we’ve seen so far: combinations

Track 2: Immuno-oncology
·IO/IO and IO/T4 updates
Jonathan Cheng, Senior Vice President, Bristol Myers Squibb
May 2514:00
Conference pass

Clinical development of iPSC-derived mesenchymal stem cells

Track 3: Cell Therapy
May 2514:00
Conference pass

Gene therapy for non-genetic neurological disorders: What is the promise? What are the challenges?

Track 4: Gene Therapy
May 2514:00
Conference pass

Addressing gene therapy commercialization bottlenecks through intensified and integrated manufacturing

Track 5: Manufacture
Novel integrated technology designs to respond to flexibility & capacity needsAchievement of drastic footprint reduction through intensification & continuous processingExperimental results demonstrating higher performance with both adherent & suspension cell lines
Thomas Robert, Product Manager, Univercells Technologies
May 2514:00
Conference pass
May 2514:00
Conference pass

Little, useful secrets on how to create and execute an effective quantum computing strategy

Track 7: Innovation
Quantum Computing is an emerging technology that could have important implications in the way we develop new advanced therapies. There are a few not very well-known but important things you need to be aware of if you want to create and execute a Quantum Computing strategy. I learned them the hard way, so let me save you time and effort so that you will be more productive and successful than I was, if you need to start to adopt and leverage Quantum Computing in your organization.
May 2514:20
Conference pass

Panel: What is the value of existing real-world databases? How reliable are health databases?

Track 1: Evidence, Pricing & Access
May 2514:20
Conference pass

Precision medicine informed therapeutic approaches to synthetic lethality

Track 2: Immuno-oncology
May 2514:20
Conference pass

Impact of the CVOID-19 pandemic on clinical trials in advanced cell therapy

Track 3: Cell Therapy
Frances Verter, Chief Executive Officer, Parent's Guide to Cord Blood Foundation
May 2514:20
Conference pass

Panel discussion: Philanthropic VC perspective for rare diseases

Track 4: Gene Therapy
May 2514:20
Conference pass

Panel: Panel discussion: Centralized vs. distributed manufacturing: learnings from current manufacturing

Track 5: Manufacture
Farid Ighemat, Senior Director Cell and Gene Therapy, GlaxoSmithKline
Dorothea Ledergerber, CTO, Tigen
May 2514:20
Conference pass

Panel discussion: The changing landscape of Cord blood banking environment

Track 6: Cord blood and tissue
Moshe Israeli, Medical Director, Rabin Medical Center
Marcie Finney, Executive Director, Cleveland Cord Blood Center
Frances Verter, Chief Executive Officer, Parent's Guide to Cord Blood Foundation
Tomasz Baran, Executive VP, PBKM/FamiCord Group
May 2514:20
Conference pass

Advancement of Cell Replacement Therapy

Track 7: Innovation
Harald Stover, CEO, CTO & Founder, Allarta Life Science Inc.
May 2514:40
Conference pass

Next Generation Immuno-oncology

Track 2: Immuno-oncology
David Fontana, Team leader, Umoja Biopharma
May 2514:40
Conference pass

Consistency and dependability of quality testing for clinical grade induced pluripotent stem cells

Track 3: Cell Therapy
  • To maximise the full potential of human induced pluripotent stem cell (iPSC) based therapies, banks of suitable quality and demonstrable equivalence of iPSC lines are required for the use of different banks as starting materials for Advanced Therapy Medicinal Products (ATMPs) and the comparability of the ATMP thereafter.
  • This requires consistent quality control testing across iPSC manufacturers’ facilities worldwide.
  • Here we describe data from an international quality assessment round organised by the Global Alliance of iPSC Therapies (GAiT) specifically undertaken to assess iPSC quality control assays.
May 2514:40
Conference pass

Driving the advanced therapy processing revolution; a biocomputer based therapy development kit

Track 7: Innovation
May 2515:00
Conference pass

Panel discussion: Creating a collaborative ecosystem

Track 1: Evidence, Pricing & Access
May 2515:00
Conference pass

Precision medicine informed immuno-oncology

Track 2: Immuno-oncology
May 2515:00
Conference pass

Rare diseases

Track 4: Gene Therapy
May 2515:00
Conference pass
May 2515:00
Conference pass

SCTbio, your reliable CDMO partner for cell & gene therapy GMP manufacturing

Track 7: Innovation
May 2515:10
Conference pass

Multifaceted potential of Treg-based therapies in tackling neurodegeneration

Track 7: Innovation
May 2515:50
Conference pass

Start-up quality and compliance: building the foundation

Start-up Pitches
Tanya Sharma, Chief Executive Officer, Assurea LLC
Krisha Patel, partner, Assurea LLC
May 2515:59
Conference pass

Chair: Snehal Naik, Regulatory Policy Leader, Regulatory Strategy Leader (Ocular), Spark Therapeutics

Track 1: Evidence, Pricing & Access
May 2515:59
Conference pass

Chair: Roy Baynes, Senior Vice President and Head Global Clinical Development, Chief Medical Officer, Merck, Sharp and Dohme

Track 2: Immuno-oncology
May 2515:59
Conference pass

Chair: Patrick J. Hanley, Chief and Director, Cellular Therapy Program, Children's National Health System

Track 5: Manufacture
May 2516:00
Conference pass

Creating a collaborative ecosystem

Track 1: Evidence, Pricing & Access
David Venables, Chief Executive Officer, Skylark Therapeutics
May 2516:00
Conference pass

Regulatory session for academic and early-stage companies

Track 1: Evidence, Pricing & Access
  • How and when small companies should apply for the EMA’s Priority of medicines scheme (PRIME) and the FDA’s Regenerative medicine advanced therapy designation (RMAT)
May 2516:00
Conference pass

Optimising risk and benefit in immunotherapy of GU malignancies

Track 2: Immuno-oncology
May 2516:00
Conference pass

Implementation of automation & closed systems in a multi-user, multi-product facility

Track 5: Manufacture
May 2516:20
Conference pass
May 2516:40
Conference pass

Panel: Intersection of precision medicine, targeted therapies, and immune oncology

Track 2: Immuno-oncology
last published: 02/May/22 13:25 GMT


Get involved with Advanced Therapies Congress

 

To speak


Jessica Robinson
Jessica.Robinson@terrapinn.com
+44 208 164 3086

 

 

To sponsor or exhibit


Ashlea Foster
Ashlea.Foster@terrapinn.com
+44 208 164 3032