Cell and Gene Therapy World Congress 2023
KEY INDUSTRY EXPERT SPEAKERS

Marianthi Psaha
Global Head Cell & Gene Therapy
Marianthi Psaha is the Global Head of Santen’s Cell & Gene Therapy business unit. She is leading the establishment of a global team dedicated to unlocking the potential of cell and gene therapies to address significant unmet needs in ophthalmology by building capabilities and creating a sustainable, scalable platform for Santen’s future therapies.Marianthi has worked for 25 years as a commercial leader, spanning the local, regional and global levels. She has over 14 years of experience in the pharma industry, primarily focusing on gene therapy, rare diseases, and primary and specialty care. Prior to joining Santen, she held roles of increasing responsibility at Novartis, where she ultimately led the launch of the first ever gene therapy in ophthalmology. She previously also held a General Management role in Slovakia where she led a business and cultural transformation focused on creating an environment where people can thrive and win as a team.Marianthi holds a Bachelor’s degree in Economics and Management from McGill University in Canada, a postgraduate degree in Leadership Capabilities from Glasgow Caledonian University, and an MBA from the Warwick Business School in the UK. She is based in Basel, Switzerland, where she lives with her husband and son.

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.

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.

Mark Singh PhD
Non-Clinical Manager
Mark joined the Cell and Gene Therapy Catapult in June 2021 as a Non-Clinical Manager. In this role, he works with external collaborators to ensure that non-clinical studies of candidate products meet the current regulatory requirements. Prior to joining Catapult, Mark has worked in both industrial and academic settings, including as Head of Flow Cytometry Standardization at the MHRA, a Research Scientist at Charles River Laboratories, in addition to a post-doctoral fellowship at the Benaroya Research Institute in Seattle, Washington. Mark has a PhD in Immunology, which was awarded by the University of Glasgow in 2013. With approximately 15 years’ experience, Mark has a broad understanding of Cellular and Molecular Immunology and can effectively apply this knowledge to various drug development platforms.

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.

Adrien Lemoine
Co-Founder & CEO
Adrien brings 20+ years of experience to Bloomsbury, which he co-founded. He was previously Chief Business Officer of Orchard Therapeutics, where he led business development activities, played a leading part in fundraising efforts, and contributed to the EU approval of one the first commercial gene therapies, Libmeldy™. He was previously at AstraZeneca and GSK in roles of increasing seniority in commercial, strategy, operations & corporate development. Adrien holds an Engineering Degree from CentraleSupélec (Paris, France) and a MSc in Engineering and Physical Science in Medicine from Imperial College (London, UK).

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.

DR. IVANA BARBARIC
Senior Lecturer
Centre for Stem Cell Biology, School of Biological Sciences, The University of Sheffiel

DR. IVANA BARBARIC
Senior Lecturer
Dr Ivana Barbaric, Centre for Stem Cell Biology, School of Biological Sciences, The University of Sheffield, UK Ivana Barbaric completed her DPhil at the University of Oxford prior to joining the Centre for Stem Cell Biology at the University of Sheffield in 2006. She established her own group in Sheffield in 2014. Her research is focused on the basic biology of human pluripotent stem cells and their applications in regenerative medicine and disease modelling. She is a Board member of the British Society for Gene and Cell therapy, a member of the Steering Committee of the International Stem Cell Initiative and the ISSCR Task Force for Standards in Stem Cell Research, a member of the MRC Molecular and Cellular Medicine Board and the lead for the genetic stability of stem cells theme within the UK Regenerative Medicine Platform.

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.