Cell and Gene Therapy World Congress 2023
KEY INDUSTRY EXPERT SPEAKERS
- Doug Danison, Head of Commercial, Cell and Gene Therapy Unit, Bayer
- Eric Halioua, President & Chief Executive Officer, PDC*line Pharma
- Zhimei Du MD, VP of Process Sciences, Atara Biotherapeutics
- Wenliang Dong, Chief Operating Officer, ORCA Therapeutics
- Mohamed Oubihi, Founder and CEO, YAKUMED LIMITED
- Alberto Malerba, Lecturer in Gene Therapy, Royal Holloway University of London
- Mark Singh, Non-Clinical Manager, Cell and Gene Therapy Catapult
- Anthony Newcomb, Chief Operating Officer, VectorY
- Eugean Jiwanmall, Senior Research Analyst, Independence Blue Cross
- Cecilia Gotherstrom, Research Group leader, Associate Professor in Stem Cell Science, Karolinska Institute
- Nick Forsyth, Faculty Dean of Research, Keele University
- Vanessa Wellington, Research Scientist, University of Nottingham
- Stephen Judd, Process SME – Biologics / Cell & Gene Therapy, DPS Group
- Dr. Anand Srivastava, Chairman and Co-founder, Global Institute of Stem Cell Therapy and Research
- Amir Hefni, Global Head, Cell & Gene Therapy, Novartis
- Stefanos Theoharis, Independent Expert
- Alejandro Fernandez-Martell, former Principal Bioprocess Engineer, Achilles Therapeutics
- Stuart M Curbishley, Chief Manufacturing and Chief Development Officer, adthera bio
- Elsa Abranches, Sr Director,Head of Cell Therapy Bioprocess Development and Manufacturing, Astrazeneca*
- Ben Doak, Head of Innovative Treatments, NHS England.
- Mark Fowler, Global Head of Procurement, Autolus
- Francois Hallac, Research Associate, King's College London
- Julia Djonova, Head, Advanced Therapy Medicinal Products, Swissmedic
- Thomas Muller, Head Of Directorate General, Federal Ministry of Health Germany
- Manal Morsy, EVP, Head of Global Regulatory Affairs, Athersys, Inc
- Yue (Dina) Du, Senior Scientist, Gene Therapy R&D, AstraZeneca
- Reagan Jarvis, Chief Executive Officer and Co-founder, Anocca
- Matthias Bozza, Director, Vector BioPharma
- Chris Williams, SVP Corporate Development, Autolus Ltd.
- Dr Lilian Hook, Director Cell, Apheresis & Gene Therapies, NHS Blood and Transplant

ZHIMEI DU, MD/PHD
VP of Process Sciences
Zhimei Du, MD/PhD, VP of Process Sciences at Atara Biotherapeutics. Zhimei graduated from Cornell University Medical College – Memorial Sloan Kettering Cancer Center Joint Immunology Program. After graduation, she joined Robert G. Roeder’s laboratory at The Rockefeller University, exploring the genetic/epigenetic regulation mechanisms during leukemia genesis. She started her industrial career at Regeneron as protein engineer for bi-specific antibodies. Later, she joined Amgen followed by Teva Pharmaceuticals focusing on bioprocess development of biotherapeutics manufacturing. Zhimei had extensive experience in cell/gene therapy. She led cell/gene therapy clinical programs for type I diabetes at Diabetes Research Institute, U. of Miami. Zhimei joined Merck & Co. where she served as the Executive Director & Global Head of Process Cell Sciences, leading Process Cell Sciences Department, including allogeneic CAR-T and CAR-NK cell therapy process development, cell line development, cell banking, genetic/cytogenetic characterization, biomarker and predictive modeling. Currently, Zhimei is the VP of Process Sciences at Atara Bio, a leading Allogeneic Cell/gene therapy company. Zhimei is also the sponsor and core member of multiple Industrial-wide Consortium teams, setting up road map and establishing industrial common practices in various biotherapeutics development areas, including ISPE ATMP, Allogeneic Accelerated Development Network, BioPhorum Cell/Gene therapy, ADC/Bispeicifics Roadmap team co-lead at BPOD/NIMBLE, IQ comparability team, IQ sequence variant consortium team, IQ Design Space team.

REAGAN JARVIS
CEO and Co-founder
Reagan Jarvis is CEO and co-founder at Anocca. Previously holding the CSO post from the company’s founding in 2014 until 2018, Jarvis guided the in-house development of technological and manufacturing capabilities at the company and is co-inventor for all Anocca’s proprietary technologies. Jarvis was educated in his native New Zealand and holds a BSc(hons) and PhD from Department of Biochemistry, University of Otago. Jarvis conducted post-doctoral research in then Department of Surgical Sciences at University of Otago, and subsequently the German Cancer Research Center (DKFZ), Heidelberg.

MANAL MORSY
Executive Vice President, Head of Global Regulatory Affairs
“Manal Morsy’s extensive experience in drug development with particular focus on strategic regulatory aspects taking into account early research, clinical, commercial, & post marketing development have made her a global leader in pharmaceutical regulatory affairs. Her highly successful experience in technically & managerially leading teams to successful biologics (vaccines & cell therapy) & new chemical entities key regulatory designations (RMAT, SPA, Fast Track, Priority review) as well as global marketing traditional and conditional authorization approvals have made her an asset to Athersys Inc., where she currently serves as the Executive Vice President, Head of Global Regulatory Affairs.”

STUART M CURBISHLEY
Chief Manufacturing and Chief Development Officer
Stuart was awarded his PhD by the University of Birmingham in 2005 after which his group developed a programme of immune based therapies for liver disease and liver cancer. Forging a successful academic career, he undertook a variety of first-in-man, early phase clinical trials. Whilst at the University of Birmingham, Stuart led the development of cell therapy based around dendritic cell vaccination for primary liver cancer. Following this success, the University invested in the building and licensing of an ATMP manufacturing facility which he directed until leaving academia at the end of 2022. Since then, Stuart has been operating as Chief Manufacturing Officer and Chief Development Officer of adthera bio, a newly formed commercial CDMO. adthera is positioning itself as the partner of choice for innovative, optimised-quality, high-technology, cell & gene therapy-focussed development and manufacturing. adthera bio develops clients cell therapy ideas and makes them into workable medical interventions for patients, all in a regulatory compliant and quality managed system, to get it right first time. Based on brilliant ideas and curious capable minds, they partner with biotech and academic centres to bring novel ATMP therapies to market and thus to patients who urgently need them.

THOMAS MUELLER
Head of Directorate General “Drugs, Medical Devices, Biotechnology”
Federal Ministry of Health, Germany

THOMAS MUELLER
Head of Directorate General “Drugs, Medical Devices, Biotechnology”
Thomas Mueller is a Medical Doctor and Pharmacist. He completed his studies in Berlin and London, and then worked as medical doctor in the Dermatology Department of the University Hospital Charité Berlin. He completed postgraduate studies in business administration. Subsequently, he worked for several years in the Hospital Pharmacy Departments of the University Hospitals of Erlangen and Rostock. He became director of the hospital pharmacy and the medical purchase of the University Hospital of Rostock. From 2007 to 2018, Thomas Mueller was head of the Pharmaceuticals Department of the Federal Joint Committee (GBA) in Berlin. As part of his work at the GBA, Thomas Mueller has played a key role in successfully designing, planning, and implementing the early benefit assessment and pricing of new pharmaceuticals (AMNOG) in Germany. Since 2018, he is head of Directorate General ”Drugs, Medical Devices, Biotechnology” at the Federal Ministry of Health in Germany. He is Assistant Professor at the University of Bonn (Regulatory Drug Affairs) and Paris-Sorbonne (International Market Access).

MATTHIAS BOZZA
Director
Matthias Bozza, Ph.D., holds the position of Director at Vector BioPharma. A molecular biologist by training, he joined Vector Biopharma from the German Cancer Research Centre (DKFZ) in Heidelberg. Matthias focuses on developing the next generation of medicines with unprecedented efficacy and safety by implementing cutting-edge synthetic biology and developing cost-effective and scalable bioprocesses. Matthias has successfully translated novel ATMPs from the bench to the bedside at the University of Heidelberg, and he is now focusing on generating efficient and cost-effective novel gene therapy vectors.

Eric Halioua
President & Chief Executive Officer
Serial entrepreneur that combines strong strategic, technological and managerial experience with proven track record of deal-making and fund-raising. During his career he achieved together with his different teams to bring four drug candidates from research to the clinics (up to phase IIb). Overall, Eric has raised as of now a total of more than €160 million from VCs and strategic partners in Europe, USA, Japan and Korea and have had numerous successes in the sale and initial public offering of biotechnology companies. He is CEO of the biotechnology company PDC*line Pharma and board member of Essenscia (Bio.be). Eric is co-founder of four biotechnology companies called Myosix (bought by Genzyme mid-2002), Murigenetics, HairClone and Digital Orthopaedics. He is co-Inventor of the first GMP approved mobile manufacturing unit for cell therapy. Eric worked for 12 years in the Healthcare and Life Sciences Practice of Arthur D. Little. Eric holds two master’s degrees in pharmacology and Molecular Biology and a MBA from ESSEC business school (Paris, France), with an advanced degree from the Health Care ESSEC chair.

Stephen Judd
Process SME – Biologics / Cell & Gene Therapy
Stephen Judd is a Chartered Chemical Engineer and Fellow of Engineers Ireland. He is an experienced Technical Manager and Principal Process Engineer with more than 15 years’ experience in process engineering and facility design, mainly in Biotech projects. He has extensive experience with process technology selection for hard-piped and single-use systems and his focus area is Cell and Gene Therapy (C>). Stephen has also authored or co-authored a number of technical papers including a paper on Multi-Modal Facility Design published in the ISPE PE Magazine. He is actively involved in the development of a number of ISPE guides currently in development relating to C> topics. He also supports a number of universities which include running the DPS Design Challenge with UCC and giving a lecture as part of one of the MBI modules offered by UCL Department of Biochemical Engineering.

Amir Hefni
Global Head for Cell & Gene Therapy
Amir Hefni is the Global Head for Cell & Gene Therapy at Novartis. He currently leads the development and implementation of the Global C&G strategy across indications and disease areas.
Amir joined Novartis from Ipsen, where he was Global Asset Head, Oncology and led the launch of multiple indications across the globe as well as drove a rich Life Cycle Management program.
Previously, he was with Bristol-Myers Squibb (BMS) for 11 years, roles included Leading Thoracic indications for US Oncology (NSCLC, SCLC, and SCCHN). Furthermore, Amir brings a wealth of experience working across different countries including US, UK/Ireland and Sweden. He held various leadership positions at BMS: from Business Unit Head in the UK/Ireland to roles within the Worldwide Commercial group, General Manager in Sweden and International Markets Strategy & Operations.
Amir holds a BSc and PhD in Immuno-Pharmacology from King’s College London, University of London (UK) and a MBA from Warwick Business School, University of Warwick (UK). He also completed the General Management Program at INSEAD in 2017.

Alejandro Fernandez-Martell
former Principal Bioprocess Engineer
Alejandro Fernandez Martell, PhD, Process Development Engineer & Process automation and Digitalization Lead. Alejandro received his degree in Biotechnological Engineering from the National Polytechnic Institute, Mexico and his PhD in Chemical and Biological Engineering from the University of Sheffield, United Kingdom. Alejandro has worked with world-leading biotech and research organisation as a Principal Bioprocess Engineer, where he worked on a wide range of Process Improvement, Manufacturing Operations, Process Digitalisation and Automation projects across large molecules (AAV, MABs, Bispecific) and cell-based products. These activities have combined both wet lab, automation and modelling-driven projects.
His expertise includes a variety of sophisticated areas such as specialist knowledge for developing manufacturing process for Cell and Gene Therapy, leverage technology to build efficient operations and enhance decision making, and turning complex biology, engineering and digital concepts into decisions and actions. He has developed bespoke software solutions for biopharmaceutical companies to collect, streamline and analyse data, and implement control strategies. Alejandro is committed to building innovative approaches to enable Cell and Gene Therapy Products to be manufactured smarter, more efficient and affordable.

Stefanos Theoharis
Senior Executive
Stefanos is a senior executive and consultant with more than 15 years of BD and R&D experience in pharma and biotech, with a focus on cell and gene therapy. This includes his roles as CBO at Bone Therapeutics and SVP at Cell Medica, both clinical-stage biotech companies. Prior to Cell Medica, Stefanos was Chief Business Officer at apceth GmbH, a company developing genetically engineered mesenchymal stromal (MSC) cell products and also acting as a contract manufacturer in the ATMP space, Head of BD at Antisense Pharma (now Isarna), and BD Director at Roche, focused on emerging technologies. Stefanos also worked at Lazard, the global investment bank. Stefanos received his PhD in Pathology and Immunology from Imperial College London.

Dr. Anand Srivastava
Chairman and Co-founder
Dr. Anand Srivastava is a Chairman and Cofounder of California based Global Institute of Stem Cell Therapy and Research (GIOSTAR) headquartered in San Diego, California, (U.S.A.). Dr. Srivastava has been associated with leading universities and research institutions of USA. In affiliation with University of California San Diego Medical College (UCSD), University of California Irvine Medical College (UCI), Salk Research Institute, San Diego, Burnham Institute for Medical Research, San Diego, University of California Los Angeles Medical College (UCLA), USA has helped develop several research programs and has an extensive research experience in the field of Stem cell which is documented by more than 100 publications in revered scientific journals. Dr. Srivastava’s expertise and scientific achievements were recognized by many scientific awards/ fellowships and by two consecutive awards of highly prestigious and internationally recognized, JISTEC award from Science and Technology Agency of the government of Japan, Excellent presentation award in the “Meeting of Clinical Chemistry and Medicine, Kyoto, Japan, USA Congressional Recognition awards from USA Congressmen. Recently, He received very prestigious award from Society of American Asian Scientists in Cancer Research (SAASCR)-2020 for his contribution in the fields of cancer research and “World Shifter Award 2023” from Nation Building Institute International, Thailand.

BEN DOAK
Head of Innovative Treatments
Ben’s primary role is to fulfil NHS England’s commissioning responsibility to ensure that services are in place so that patients can benefit from licensed ATMPs recommended by NICE (the National Institute of Health and Care Excellence) in the NHS in England. Since commencing his current role in 2020, Ben has overseen the expansion of CAR-T services in the England as well supporting access to ATMPs such as Zolgensma for spinal muscular atrophy, Libmeldy for metachromatic leukodystrophy and Upstaza for AADC deficiency. He maintains an active interest in horizon scanning of ATMPs and other innovative treatments.

CECILIA GÖTHERSTRÖM
Research Group leader, Associate Professor in Stem Cell Science
Karolinska Institutet

CECILIA GÖTHERSTRÖM
Research Group leader, Associate Professor in Stem Cell Science
Cecilia Götherström is Associate Professor in Stem Cell Research at Karolinska Institutet in Sweden and her research is on translational regenerative medicine. Dr Götherström has developed the ATMP fetal mesenchymal stem cells as a treatment for Osteogenesis Imperfecta with promising results. Dr Götherström is leading an academic international multicentre trial, Boost Brittle Bones Before Birth (BOOSTB4), which is the first of its kind to evaluate the safety and the clinical effect of mesenchymal stem cell transplantation for the treatment of severe Osteogenesis Imperfecta in young and unborn children.

ALBERTO MALERBA
Lecturer in Gene Therapy
Dr Malerba was awarded a PhD in Biotechnologies, describing novel approaches to improve muscle
regeneration. He joined the Gene therapy laboratory at Royal Holloway, University of London, in
2007 and since then he contributed to the development of novel gene therapy agents and antisense therapeutics for the treatment of rare neuromuscular diseases. Initially he focused his work on developing antisense reagents for the treatment of Duchenne muscular dystrophy and his work was instrumental to optimize the dosing regimens used for the morpholino exon skipping phase II/III clinical trial for this disease. Afterwards, he worked for 2 years as independent research fellow at the
Royal Veterinary College in London, where he developed a scientific program based on new splicing-modulating molecules for the treatment of cardiovascular diseases. In 2013, he re-joined the gene therapy laboratory at Royal Holloway where he has worked as project manager on the optimization of gene therapies and antisense therapeutics for a number of muscular dystrophies. His work was
crucial in developing, in collaboration with Benitec Biopharma, a gene therapy AAV vector for Oculopharyngeal Muscular Dystrophy (OPMD), a rare muscle proteinopathy. The vector is expected
to enter a first-in-human phase I/II clinical trial in 2023. He is now the academic leading the Gene therapy laboratory at Royal Holloway.

FRANCOIS HALLAC
Research Associate
Cecilia Götherström is Associate Professor in Stem Cell Research at Karolinska Institutet in Sweden and her research is on translational regenerative medicine. Dr Götherström has developed the ATMP fetal mesenchymal stem cells as a treatment for Osteogenesis Imperfecta with promising results. Dr Götherström is leading an academic international multicentre trial, Boost Brittle Bones Before Birth (BOOSTB4), which is the first of its kind to evaluate the safety and the clinical effect of mesenchymal stem cell transplantation for the treatment of severe Osteogenesis Imperfecta in young and unborn children.