Speakers

Alex Hamilton

Partner • Syncona Ltd

Alex is a partner at Syncona. He is a Director on the Boards of SwanBio Therapeutics and Anaveon. Previously, he was a member of the Healthcare Investment Banking team at Jefferies, where he worked on a range of financings and mergers and acquisitions across the biotechnology, pharmaceutical and healthcare sectors. Alex has a PhD in Immunology from the University of Cambridge

Also speaking

Julia Sable

Director CMC Project Management • Tmunity Therapeutics

Mustafa Munye

Director R&D Operations • Complement Therapeutics

Mark Trusheim

Strategic Director, NEWDIGS and Visiting Scientist, • Massachusetts Institute of Technology (MIT)

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Speakers

Ian Rees

Inspectorate Strategy and Innovation • MHRA

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Ben Mosley

Director of Skills Growth • Cell and Gene Therapy Catapult

David Horna

Co-Founder & Chief Operating Officer • Aglaris

David Wolton

Engineering Technology Lead • Takeda

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Speakers

Niloofar Davoodi

Director Cell Therapy CMC • Takeda

Dr Niloofar Davoodi holds dual degrees of PharmD in Pharmaceutical Biotechnology and PhD in Molecular Cell Biology.  She has 20 years of experience in research, development, manufacturing, and supply of bio-pharmaceutical products.

Currently, Niloofar is the Director of Cell Therapy CMC at Takeda (Switzerland) and a member of Global Manufacturing Sciences Leadership Team.  In her current role she has overall responsibility for defining and execution of global CMC strategy throughout all lifecycle stages of Cell Therapy products.

Prior to Takeda, Niloofar was 14 years at Novartis (Switzerland) where she held various positions of increasing responsibilities in different global functions in Research, Quality, Analytical Science & Technology, Manufacturing Science & Technology as well as Regulatory CMC.  She was the Regulatory Science & Project Lead for the Technology Transfer of Novartis CAR-T therapy product to the first commercial CGT manufacturing facility of Novartis in Europe

Also speaking

Bastian Nießing

Group Manager, Automation in Life Sciences • Fraunhofer IPT

Michael Delahaye

Director, Team Leader, Cell Therapy Bioprocessing • AstraZeneca

Mimoun Azzouz

Director of GTIMC • University of Sheffield

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Speakers

Jonathan Appleby

Chief Scientific Officer • Cell and Gene Therapy Catapult

Dr Jonathan Appleby is currently Chief Scientific Officer at the UK’s Cell and Gene Therapy Catapult (CGT Catapult).  The CGT Catapult employs over 400 full time staff, spread across four sites.  Dr Appleby leads the London based 1200m2 development laboratories which are focused on the creation of analytical and process development solutions for ATMPs. Prior to joining the CGT Catapult Jonathan was Chief Scientific Officer for cell and gene therapy in GSK’s Rare Diseases Unit where he was accountable for the EU Submission of StrimvelisTM, the first paediatric CD34 Stem Cell Gene Therapy to be licensed anywhere in the world. He was also project leader for a similar asset focused on Metachromatic Leukodystrophy which was licenced to Orchard Therapeutics in 2018 and later approved in Europe.

Jonathan has 20 years’ experience of R&D and has worked in all phases of drug development across a broad range of therapeutic areas.

Also speaking

John Campbell

Director, Tissues Cells & Advanced Therapeutics • Scottish National Blood Transfusion Service

Laura Herbst

Research Fellow • Fraunhofer IPT

Lee Aiyegbusi

Deputy Director Centre for Patient-Reported Outcomes Research (CPROR) • University of Birmingham CPROR

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Speakers

John Spoors

Head of Commercial Medicines Policy Analysis • NHS England

John works in the Medicines Analysis Team (MAT) at NHS England and supports a number of commercial policy areas including horizon scanning, Advanced Therapy Medicinal Products (ATMPs) and managed access. John and his team work closely with commercial colleagues, the DHSC and NICE to ensure activity is based on a robust and analytical policy platform. John has degrees in politics, economics and natural sciences from the University of Manchester and Open University respectively. He has an MSc in Public Health from the London School of Hygiene and Tropical Medicine, and is currently undertaking a part-time PhD there,  looking at patient preferences in relation to ATMPs. Prior to joining NHS England in 2018, John directed and delivered global pricing and market access projects in a wide range of therapy areas across the drug development cycle

Also speaking

Michela Gabaldo

Head Alliance Management & Regulatory Affairs • Fondazione Telethon

Andrea Zobel

Senior Director, Personalized Supply Chain • World Courier Management Ltd

Silvio Weber

Director Industrial Workflow Development, Cellular Therapy • Miltenyi Biotec

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Speakers

Katherine Donigan

Senior Director of Science and Regulatory • BIO

Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory at BIO where she leads BIO’s regulatory policy efforts for cell and gene therapies and diagnostics, as well as BIO’s international regulatory work.  Prior to joining BIO, Dr. Donigan held various positions at the US Food and Drug Administration in the Center for Devices and Radiological Health and in the Center for Drug Evaluation and Research.  At US FDA, Dr. Donigan worked on developing regulatory policies to address challenges posed by emerging technologies in personalized medicine.  Dr. Donigan holds a PhD in Genetics from Yale University with a focus on DNA repair and oncology.  She completed postdoctoral training at the National Institute of Child Health and Human Development with a focus on DNA damage bypass mechanisms.

Also speaking

Stephen Sullivan

Programme Manager & International Liason Officer • GAiT

Oliver Sexton

Investment Director • UK Innovation & Science Seed Fund

Edison Bicudo

Research Fellow • UCL

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Speakers

Edison Bicudo

Research Fellow • UCL

Dr Edison Bicudo is a sociologist and geographer studying the social and geographical implications of pharmaceuticals, advanced therapies, and healthcare-related technologies. His studies have covered topics such as international clinical trials, neuroimaging software, 3D bioprinting, and CAR-T cells. In 2012 he completed his PhD in International Politics at King’s College London. In 2019 he published Neuroimaging, software, and communication (Palgrave McMillan)

Also speaking

Michael Delahaye

Director, Team Leader, Cell Therapy Bioprocessing • AstraZeneca

Pamela Tranter

Head Translational Research Group, UCL Translational Research Office • UCL

Alexander Natz

Secretary General • EUCOPE

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Speakers

Ben Mosley

Director of Skills Growth • Cell and Gene Therapy Catapult

Ben is an accomplished leader in Learning & Development with over 20 years’ extensive experience operating at senior levels in large complex regulated organisations.

Working for leading brands such as easyJet, Marks & Spencer and British Airways Ben has supported significant growth and driven positive organisational change by creating and executing Skills, L&D and Talent frameworks and strategies aligned to business needs.

His retail and aviation experience means he balances low cost and high quality without compromise to high safety, customer and regulatory standards.

Ben currently works as Director of Skills Growth for the Cell & Gene Therapy Catapult applying his experience to coordinate and support the evolving skills agenda across the advanced therapy and medicines biomanufacturing sector

Also speaking

Qasim Rafiq

Associate Professor Cell & Gene Therapy • UCL

Alexandre Reeber

CEO • Core Biogenesis

Nicholas Medcalf

Deputy Challenge Director for the Medicines Manufacturing Challenge • Innovate UK

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Speakers

Dorothea Ledergerber

Chief Technical Officer • Tigen Pharma

Dorothea is a pharmacist with more than 20 years of experience in research, development, manufacturing and supply of pharmaceutical products. She received her PhD from the University of the Saarland, Saarbrücken, Germany.

While with Novartis, she was leading manufacturing sites in Switzerland, Germany and
Ireland. A highlight in her career was the build-up and operational launch of the first
commercial Cell & Gene manufacturing facility for Novartis in Europe.

In 2020, Dorothea moved on to Tigen Pharma, a Swiss biotech company in the field of cell
therapies to cure cancer. Tigen is a disruptive catalyst, combining a unique culture with a
multidisciplinary set of clinical and technical capabilities and a long-term perspective to the
benefit of patients and society.

Dorothea is a firm believer in cross-cultural and -functional teams to go beyond the beaten
industry track.

Also speaking

Ian Rees

Inspectorate Strategy and Innovation • MHRA

Michael von Forstner

Global Head of Clinical Safety and Pharmacovigilance • Biogen

Mark Lowdell

CSO/CMO • INmune Bio

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Speakers

Lee Aiyegbusi

Deputy Director Centre for Patient-Reported Outcomes Research (CPROR) • University of Birmingham CPROR

Dr Lee Aiyegbusi is a Senior Research Fellow and a Deputy Director at the Centre for Patient-Reported Outcomes Research (CPROR), University of Birmingham, UK. He is a co-Lead for the PRO theme, Medical Research Council – National Institute for Health Research (MRC-NIHR) Trial Methodology Research Partnership (TMRP) Outcomes working group. His primary research interests are focused on the optimisation of patient-reported outcome assessments for clinical trials, routine clinical practice, and regulatory purposes; and the optimisation of patient public involvement and engagement (PPIE) in research. He has led research with the Midlands and Wales Advanced Therapy Treatment Centre, exploring information provision and the use of PROs and PPIE in advanced therapy medicinal products (ATMPs). He is the PPIE lead for the NIHR Oxford-Birmingham Blood and Transplant Research Unit in Precision Cellular Therapeutics.

Also speaking

Michelle Duquette

Director, Business Development – Cell Therapy • Invetech

Rachel Yao

Associate Director Technical Operations • SOTIO Biotech Inc

Bastian Nießing

Group Manager, Automation in Life Sciences • Fraunhofer IPT

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