Agenda

 

 

London, 5 - 6 October 2021

Schedule

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Oct 510:00
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Welcome Address

Keynotes
Jessica Robinson, Project director, Terrapinn Ltd
Oct 510:05
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Cell-based COVID-19 vaccine and cancer vaccine update

Keynotes
Oct 510:25
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Panel discussion: Learnings from the COVID outbreak and how to move forward into a brighter 2022

Keynotes
Consequences of COVID19 on the advanced therapies industry·Short term, reactive:oclinical trials and supply chainoImpact on businesses: need to resolve impact on finances and stock·Learnings, long term positive effects:oTechnology advancesoRegulatoryoEventsoGM organisations & legislation regulators lifted·What can we implement as a positive consequence?·Culture/evolutions of companies, how is working from home effecting how we work?
Miguel Forte, Chief Executive Officer, Bone Therapeutics
Amir Hefni, VP, Global Commercial Head, Cell & Gene, Novartis
Oct 511:00
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Tackling large-scale, commercial regulatory challenges

Track 1: Commercialisation
Yemisi Corinaldi, Regulatory Strategy Leader, Spark Therapeutics UK Limited
Janet Glassford, Senior Quality Assessor, Medicines & Healthcare Products Regulatory Agency
Oct 514:00
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Panel discussion: Evidence, pricing & market access

Track 1: Commercialisation
Amir Hefni, VP, Global Commercial Head, Cell & Gene, Novartis
Mike Fraser, Head of EMEA Region, Novartis Gene Therapies
Tamir Singer, Head of Commercial Development, NHS England
Oct 514:00
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Precision medicine informed immuno-oncology

Track 2: Developing therapeutic modalities
Oct 514:30
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Base editing – An innovative and safer gene editing solution for advanced C&GT

Track 2: Developing therapeutic modalities
- Gene editing technologies have successfully been used to improve the next generation of C&GT.- However, standard gene editing platforms such as TALEN and CRISPR-Cas9 trigger concerning off target effects that could hinder wider clinical application.- Pin-point™ base editing offers more precise, efficacious and safer gene editing for innovative development of more potent and cost-effective C&GT.
Oct 514:30
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Effective process development and keeping costs low

Track 3: Manufacture & bioprocess
Frank Barry, Scientific Director, Regenerative Medicine Institute
Paul S Carter, Director, Head Vector Processing, Quell Therapeutics
Oct 515:00
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Regulatory session for academic and early-stage companies

Track 1: Commercialisation
·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)
Victoria English, Victoria English, Co-Founder And Editor, Evernow Publications
Margareth Jorvid, Head of Regulatory Affairs, Ilya Pharma
Nneka Onwudiwe, Former PRO/PE Regulatory Review Officer, Food and Drug Administration (FDA)
Didier Caizergues, Head of International Regulatory Affairs, Genethon
Vicki Coutinho, VP Regulatory Affairs, GammaDelta Therapeutics
Tim Bertram, Chief Executive Officer, ProKidney
Oct 515:00
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Scaling up manufacture to a commercial level

Track 3: Manufacture & bioprocess
Sponsored by Oxford Biomedica
Volker Huppert, Chief Development Officer, Glycostem Therapeutics BV
Oct 515:30
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Autologous vs Allogeneic: What’s next?

Track 2: Developing therapeutic modalities
  • Will autologous therapies diminish in importance as genome editing gathers pace, making way for more allogeneic treatments?
Stefanos Theoharis, Chief Business Officer, Bone Therapeutics
Stewart Abbot, Chief Scientific Officer, Adicet Bio
Sven Kili, CEO, Antion Biosciences
Oct 515:30
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A decade of experience in commercial cell therapy manufacturing, and lessons learned

Track 3: Manufacture & bioprocess
·Development of potency assay·Sharing insights to establish robust, reliable supply chain infrastructure for commercial scale·Optimizing manufacturing, supply chain, and logistics
Oct 516:30
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Real world evidence

Track 1: Commercialisation
Paolo Morgese, EU Director Market Access & Member Relations, Alliance for Regenerative Medicine
Oct 516:30
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Harnessing cell death for regenerative medicine

Track 2: Developing therapeutic modalities
Francesco Dazzi, Professor Of Regenerative And Hematological Medicine, King's College London
Oct 516:45
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Cell-based Therapies and the Treatment of Chronic Kidney Disease: Phase II Interim Analysis of Autologous Cell Therapy for Diabetic Kidney Disease

Track 2: Developing therapeutic modalities
Oct 517:00
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The science and business strategies surrounding our gamma/delta T cell programs

Track 1: Commercialisation
Oct 517:00
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Stem cells and the secretome

Track 2: Developing therapeutic modalities
Nada Alaaeddine, Head Of The Regenerative And Inflammation Lab In The Faculty Of Medicine, Lebanese university
Oct 517:00
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Application of a novel bioreactor system for automated expansion of adipose-derived mesenchymal stem cells under GMP-compliant conditions

Track 3: Manufacture & bioprocess
  • The current implementation and deployment of autologous cell therapies remains a true challenge, mainly because of therapy manufacturing and cost-related issues
  • The utilization of automated technologies for cell therapy manufacturing can make these processes more consistent, scalable and cost-effective
  • This validation study shows how the NANT 001 System has demonstrated to be a useful tool for the automated GMP-compliant production of autologous adipose-derived MSCs
Frank Barry, Scientific Director, Regenerative Medicine Institute
Oct 517:15
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Safety and proof of Concept data of a new allogenic cell therapy for treatment of orthopaedic disorders

Track 2: Developing therapeutic modalities
Oct 517:30
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Caladrius Biosciences; Progress, challenges and learnings during the COVID-19 pandemic

Track 1: Commercialisation
Oct 517:30
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Panel dicussion: Stem cells and regenerative medicine

Track 2: Developing therapeutic modalities
Sven Kili, CEO, Antion Biosciences
Derek Dashti, Founder And Chief Executive Officer, D and P Bioinnovations
Francesco Dazzi, Professor Of Regenerative And Hematological Medicine, King's College London
Oct 517:30
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Learning from the evolution of the mAbs industry: a solution to impact and facilitate gene therapy manufacturing

Track 3: Manufacture & bioprocess
·Integration of an intensified and continuous process within an automated platform·Experimental results demonstrating the benefits of fixed-bed technology for gene therapy manufacturing
Martina Sebastian, Sales Manager, Univercells Technologies

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Oct 609:00
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Panel discussion: Deals and investments made: what have we learnt and where are we going in 2022?

Keynotes
Vivienne Parry, Head Of Engagement, Genomics England
Dominic Schmidt, Partner, Syncona Investment Management Ltd
David Greenwald, Vice President Of Business Development, Deerfield Management
Owen Smith, Investment Director, 4BIO Capital
Oct 609:45
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Keynote panel discussion: Broadening the scope of gene therapies, expanding towards less rare conditions

Keynotes
Janneke Meulenberg, Managing Director, MeiraGTx Netherlands B.V.
Paul Gissen, Professor of Metabolic Medicine, Head of Genetics and Genomic Medicine Department, UCL Great Ormond Street Institute of Child Health
Birgitte Volck, Non Executive Director, Soleno Therapeutics
Bobby Gaspar, CEO, Orchard Therapeutics
Oct 611:30
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Workshop 2: New Data from the Cell and Gene Therapy Catapult shows Improved Yield & Quality for AAV Manufacturing Using Osmolality

Keynotes
  • The importance of including osmolality as a critical process parameter within cell and gene therapy processes.
  • Insight into new data looking at improved yield, quality and efficiency of AAVs using osmolality.
  • A hands-on demonstration of Advanced Instrument’s latest osmometer
Oct 613:30
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Panel discussion: Ask the investors

Track 1: Commercialisation
Sven Kili, CEO, Antion Biosciences
David Greenwald, Vice President Of Business Development, Deerfield Management
Owen Smith, Investment Director, 4BIO Capital
Oct 613:30
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Lumevoq Gene Therapy in Leber Hereditary Optic Neuropathy (LHON)

Track 2: Developing therapeutic modalities
Oct 613:30
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What’s next for patient delivery in 2022?

Track 3: Manufacture & bioprocess
Stefano Zancan, Head Clinical Development And Operations, Fondazione Telethon
Oct 613:45
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Update on HIV gene therapy clinical trial

Track 2: Developing therapeutic modalities
Oct 614:00
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Commercialisation: scaling up your business

Track 1: Commercialisation
Oct 614:00
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Panel: Immunogenicity for gene therapy

Track 2: Developing therapeutic modalities
Key unresolved clinical issues in gene therapy: immunosuppression, re-dosing, and in-utero dosing
Paolo Morgese, EU Director Market Access & Member Relations, Alliance for Regenerative Medicine
Paul Gissen, Professor of Metabolic Medicine, Head of Genetics and Genomic Medicine Department, UCL Great Ormond Street Institute of Child Health
Oct 614:00
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Patient delivery including logistics, transportation & distribution

Track 3: Manufacture & bioprocess
Oct 614:30
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Business Development: collaboration and competition

Track 1: Commercialisation
Oct 614:30
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Analytical tools to help the production of your gene therapy products

Track 2: Developing therapeutic modalities
Oct 614:30
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Upcoming data management transitions and their impact on advanced therapy supply chains

Track 3: Manufacture & bioprocess
·The current challenges related to data management in conjunction with supply chain distribution.·Upcoming communication technology changes that will impact critical chain of custody, chain of condition and Chain of Compliance® data collection and management.·Next generation technologies associated with more effective management of chain of custody and chain of condition in the field.
Oct 615:00
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Rare disease & orphan drugs: updates and discussion

Track 2: Developing therapeutic modalities
Paolo Morgese, EU Director Market Access & Member Relations, Alliance for Regenerative Medicine
Bobby Gaspar, CEO, Orchard Therapeutics
Frederic Chereau, Chief Executive Officer, LogicBio Therapeutics
Oct 615:00
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UCL Therapeutic Innovation Networks (TINs) - Aims and opportunities

Track 2: Developing therapeutic modalities
Oct 615:00
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Consolidated GMP Technology can help in Successful Fast Go-To-Market of New Advanced Cell Therapy Procedures

Track 3: Manufacture & bioprocess
  • Rapid evolving scenario suggests a fast, flawless go-to-market for Advanced Therapies
  • To address the above, a fast and reliable way to manage the different variables influencing Product and Process Quality, in the peculiar aspects of both, is required.
  • Current closed technologies, integrated with suitable SOPs, can offer the right level of confidence for running AT processes solving the major production issues concerned with potential manufacturing failures, thus allowing early stable results and easier market access.
Oct 616:00
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Precise and Efficient Non-viral CRISPR Gene Editing Solutions for T Cell Engineering

Track 2: Developing therapeutic modalities
  • The overall advantage of non-viral CRISPR gene-editing method on T cell engineering compares to lentivirus transduction
  • How to achieve high engineering efficiency and high cell viability via dedicated CRISPR reagents, with minimized off-target risk
  • An overview of GenScript CRISPR portfolio
Lumeng Ye, Senior Scientist, R&D department, GenScript
Oct 616:00
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Establishing the safety and efficacy of advanced therapies – the bio-distribution question

Track 3: Manufacture & bioprocess
·ATMPs bring a great opportunity for novel solutions for longstanding healthcare challenges – but with novel new therapies consideration is needed of the associated risks, which bring greater chances of newer and unique adverse events that are difficult to identify.·Current non-clinical and pre-clinical methods to understand ATMPS provide specificity to unique cell and gene therapies, but can often lack the tissue context, which is essential in understanding, delivery, bio-distribution and immune interactions.·How is RNAscope technology being used to expand understanding and answer important questions in the pre-clinical development of a range of advanced therapies
Oct 616:29
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Cord Blood

Track 2: Developing therapeutic modalities
Oct 616:30
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Phase II study results in treatment of diabetes type-1 with MSC from umbilical cord tissue

Track 2: Developing therapeutic modalities
Mathias Svahn, Chief Executive Officer, NextCell Pharma
Oct 616:30
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Viral vector analytics and safe manufacture

Track 3: Manufacture & bioprocess
Oct 617:00
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Oct 617:00
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The latest advances on a monitoring system integrated bioreactor for 3D cell culture

Track 3: Manufacture & bioprocess
last published: 18/Sep/21 11:05 GMT