Cell and gene therapies raise specific challenges to securing regulatory approvals. This session will look in detail at those challenges and provide insight into effective regulatory strategies.Â
A Discussion on Challenges, Opportunities and Market Access within Advanced Therapies; how do we create a robust market economy for Advanced therapies, taking into account costs of goods, manufacture and procurement. Do we need a new business model?
As manufacturing technologies continues to emerge, we must have the skills to deliver the science at scale. How can we ensure that talent tracks with emergent manufacturing trends?
What are the emerging therapeutic technologies and what will the next generation of ATMPs look like? Do we have the right capabilities and assets to manufacture them?
In an ever-changing pharmaceutical landscape, successfully bringing a concept to market — and to patients — involves many different stakeholders. How do industry leaders navigate this journey most effectively?
Evaluation and Development for ATMPs is different from the ‘norm’; do we need to rethinking the design of clinical trials for a clear path to commercialisation.
Taking learnings from Covid-19 (vaccines), i.e., efficiency in a crisis – what can we learn?
What are the emerging therapeutic technologies and what will the next generation of ATMPs look like? Do we have the right capabilities and assets to manufacture them?
Evolving the relationship between developers, regulators, payers, providers and patients to speed ATMP development through to adoption. How healthy are the Technology Assessments for ATMPs, are they revealing the full value?
What are the current challenges and future opportunities for opening up the ATMP markets? MHRA, NICE and NHS England are working together can make the UK attractive, but there are lower number of patients in UK as opposed to Europe. So how attractive is the UK for investment? How can investors get quicker and better returns? Divergence from MHRA and EMA
Making Waves: Technologies and development improvements
How good are we at making Advanced Therapies today, what should the future look like? Focusing on manufacturing technologies and analytical methods and the role of High throughput and automation.
As more ATMPs progress towards the market, there are significant emergent challenges to the supply chain. What needs to happen to ensure therapies are effectively and efficiently produced?
As manufacturing technologies continues to emerge, we must have the skills to deliver the science at scale. How can we ensure that talent tracks with emergent manufacturing trends?
Shortening upstream and downstream process is key to cost and natural resource savings and efficiencies for ATMPs. Can we share knowledge for the greater good of patients and the planet?
In an ever-changing pharmaceutical landscape, successfully bringing a concept to market — and to patients — involves many different stakeholders. How do industry leaders navigate this journey most effectively?
Cell and gene therapies raise specific challenges to securing regulatory approvals. This session will look in detail at those challenges and provide insight into effective regulatory strategies. We will also look at how regulatory systems need to adapt to keep pace with technological advancements such that ground-breaking and effective treatments are adopted quickly.
FACILITATED BY
JAMES FRY | Partner and Head of Life Sciences | Mills & Reeve
PANELLISTS INCLUDE
AHMED BOUZIDI | Vice-President Biotech | ProductLife Group AGATHE GUILLOT | Head of Regulatory Affairs | Cell and Gene Therapy Catapult MARIA REVIRIEGO | Executvie Regulatory Consultant & Co-Founder | Alladvice
Making Waves: Technologies and development improvements
How good are we at making Advanced Therapies today, what should the future look like?
Focusing on manufacturing technologies and analytical methods and the role of high throughput and automation
FACILITATED BY
JASON C. FOSTERÂ | Chief Executive Officer and Executive Director | Ori Biotech
PANELLISTS INCLUDE
DAVID BLAKEY | Senior Vice President Strategic Alliances | MiNA Therapeutics BRIAN HARRISON | Managing Director | HiTech Health JAMES KUSENA | Head of Bioprocessing | MicrofluidX KRZYSZTOF POTEMPA | Founder and CEO | BRAINCURES KEITH MUIR | Founder & Director | Cytomos
NICK STEPHENS | Executive Chairman | The RSA Group CHRIS NOWERS | Chief Executive Officer | ONK Therapeutics CHARLOTTE CASEBOURNEÂ | Chief Executive Officer and Co-founder | Theolytics STEPHEN WARD | Chief Manufacturing Officer| Cell and Gene Therapy Catapult COLIN MACKAYÂ | Founder and CEO | Symbiosis Pharmaceutical Services Ltd
Evolving the relationship between developers, regulators, payers, providers and patients to speed ATMP development through to adoption. How healthy are the Technology Assessments for ATMPs, are they revealing the full value?
FIONA THISTLETHWAITE | Medical Oncology Consultant | The Christie NHS Foundation Trust BILL SHINGLETON | Department Director, Biology - Cell & Gene Therapy | Cytiva STEPHEN LITTLEÂ | Vice Chairman | Yourgene Health ANTHONY WILSON | Consultant in Anaesthesia and Critical Care | Manchester University NHS Foundation Trust CLARE HAGUE Therapy Area Market Access Leader for Hematology | Janssen (a Johnson & Johnson company)
As more ATMPs progress towards the market, there are significant emergent challenges to the supply chain. What needs to happen to ensure therapies are effectively and efficiently produced?
A Discussion on Challenges, Opportunities and Market Access within Advanced Therapies; how do we create a robust market economy for Advanced therapies, taking into account costs of goods, manufacture and procurement. Do we need a new business model?
What are the current challenges and future opportunities for opening up the ATMP markets? MHRA, NICE and NHS England are working together can make the UK attractive, but there are lower number of patients in UK as opposed to Europe. So how attractive is the UK for investment? How can investors get quicker and better returns? Is there a divergence from MHRA and EMA?
FACILITATED BY
NATHAN SIGWORTHÂ | Co-founder and Chief Executive Officer | PharmaCCX
PANELLISTS INCLUDE
CAROLE LONGSONÂ | Independent Senior Advisor | Life Science Policy, HTA and Market Access ROUDIE SHAFIEÂ | Director | OVID Health ALASTAIR THONGÂ | Founder | Selvedge Venture GAVIN LEWISÂ | Vice President, Global Value and Access | Amgen (Europe) GmbH
As manufacturing technologies continue to emerge, we must have the skills to deliver the science at scale. How can we ensure that talent tracks with emergent manufacturing trends?
JANE KENNEDY | Chief Business Officer | Discovery Park LUCY FOLEYÂ | Director of Biologics | CPI KEVIN BRUCE | Chief Operating Officer | Roslin Cell Therapies Ltd
DAN PEARCE | Vice President, European Manufacturing & Technical Operations | Adaptimmune WILL ROHLEDER | Director | Reef Group KASIA AVERALL | Head of Cluster Development | Cell and Gene Therapy Catapult JENNY LAIRD | Vice President, Search & Evaluation Pain & Neurodegeneration |Â Eli Lilly and Company MARY JONES | Deputy Director for Strategy, Investment and Manufacturing | Office for Life Sciences
Shortening upstream and downstream process is key to cost and natural resource savings and efficiencies for ATMPs. Can we share knowledge for the greater good of patients and the planet?
NAZNEEN RAHMAN | Founder and Chief Executive Officer | YewMaker JASON DOWD | Vice-President of Science & Technology | CCRM WILLIAM ‘BILL’ SCOTT | Scientific Director, Transplant Regenerative Medicine | Newcastle University Medical School STEVEN TAIT | Business Manager | LifeArc HARVEY BRANTON | Technology Lead | CPI Biologics
What are the emerging therapeutic technologies and what will the next generation of ATMPs look like? Do we have the right technologies & capabilities to develop and manufacture them?
FACILITATED BY
JESÚS ZURDO | Global Head Cell, Gene Therapy & Bioproduction | Horizon Discovery
PANELLISTS INCLUDE
JANE THEAKER | Chief Executive Officer | Kinomica JOE HEALY | Chief Executive Officer and Co-Founder | NanoSyrinx BAKUL GUPTA | Chief Executive Officer and Co-founder | ImmTune Therapies TIM LUKER | Vice President Emerging Technology and Innovation | Eli Lilly
How can stakeholders come together to address cell and gene therapy's global talent gap? Do we have the right skills and capabilities in place to identify and develop the next generation of ATMPs?
In an ever-changing pharmaceutical landscape, successfully bringing a concept to market — and to patients — involves many different stakeholders. How do industry leaders navigate this journey most effectively?
FACILITATED BY
KATHRYN SIMPSON | Business Consultant| Kathryn Simpson Consulting
PANELLISTS INCLUDE
MALCOLM BARRATT-JOHNSON | Managing Director | PharmaMedic Consultancy Ltd TERRI GASKELLÂ | Chief Technical Officer | Rinri Therapeutics Ltd. EMILY MERRELL | Interim Head of ATTC Network Coordination | Cell and Gene Therapy Catapult NADINE CLEMO | Drug Discovery Program Director | Apollo Therapeutics
