Zeb Khan is a strategic leader supporting product quality within the cell therapies division for Takeda, oncology, responsible for supporting the development of cell therapy products from clinical to commercialisation.

She has over 25 years of experience in supporting development projects in the CMC space from pre-clinical to commercialisation with varying degrees of responsibility in product development, analytical laboratory, and quality assurance. In her tenure, she has contributed to developing phase appropriate quality systems for clinical development for CGT products. Zeb has coached multiple teams in the application of quality by design principles and delivered successful results-oriented strategies. She holds a master's in organic chemistry and a master’s degree in regulatory science and health safety.

Dr. Rajiv Gangurde is chief technology officer at SparingVision, leading technical operation activities including process and analytical development, manufacturing, and quality assurance.

Rajiv has over 14 years of industry experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Before joining SparingVision, Rajiv served as senior director and head of chemistry, manufacturing, and controls (CMC) at Voyager Therapeutics, a gene therapy company based in Cambridge, MA. In this role, he was responsible for CMC strategy and management of the company’s entire gene therapy portfolio. Prior to Voyager, Rajiv was director of bioprocess development and manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as head of protein sciences at LakePharma (now part of Curia), leading therapeutic protein production efforts for pre-clinical studies.

Rajiv obtained his PhD in life sciences from Mumbai University in India and did postdoctoral research at the department of biochemistry at the New Jersey Medical School, and at the department of molecular and cellular biology at Harvard University.

Rajiv is based in Massachusetts, USA.

Roberto Nitsch graduated in medical biotechnology from the University of Naples (Italy), where he also obtained his PhD in molecular genetics. He later moved to Vienna, where he focussed on mouse genetics and cancer biology, and then recessive genetics. In 2014 he shifted his research topic to genome engineering with CRISPR/Cas9 and joined AstraZeneca, where he was responsible for the CRISPR mouse models for drug discovery and oncology. Since 2017, he has been associate director in the clinical pharmacology and safety sciences pioneering CRISPR safety assessments. Today, Roberto is the director of the gene therapy at AstraZeneca, and he is working towards the generation of safer CRISPR medicines.

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

Until recently, Matthias Bozza was serving as senior member of the staff and had worked for the last seven years on the development of an autonomously replicating non-integrating DNA vector platform in Richard Harbottle’s division at the German Cancer Research Centre in Heidelberg. The aim of this research was to genetically modify cells while avoiding the risk of insertional mutagenesis or vector-mediated toxicity. For this work, he has received multiple awards from the American Society for Gene and Cell Therapy and was awarded in 2020 with the Scholar-In-Training Award from the American Association for Cancer Research. The DNA Vector Lab at the DKFZ are now implementing their vector platform into clinical pipelines.

Dr. Rahul Kaushik is an experienced biochemist, molecular biologist, and cell biologist with 12+ years of preclinical research experience in neuroscience. He has a long-standing interest and experience in using viral vectors and their use in gene manipulation, editing, and potential therapies. As molecular biology unit and project leader at German Center for Neurodegenerative Diseases (DZNE), he designed several novel and innovative AAV and LV vectors and established a small-scale AAV production. Later he was working as a senior scientist at ViGeneron, with an aim to develop innovative gene therapy solutions for retinal disorders.

Jeremy is currently serving as the director of analytical development at Asklepios Biopharmaceuticals, Inc., in Chapel Hill, North Carolina (USA). He has more than 25 years of experience in the development and manufacturing of therapeutic proteins and has overseen analytical biopharmaceutical development for recombinant proteins at all stages of development and commercialisation. His group is working to update analytical methodology utilised in structural characterisation and GMP release of AAV vectors by developing HPLC, CE-SDS, ddPCR, and LC/MS assays for identity, purity, and potency of AAV products.

Matthew Li is a biomedical scientist and engineer with over 12 years of experience across an array of areas in the biotech field including CGT R&D and manufacturing, translational medical device development, and clinical research. As an associate director at Vor Biopharma, he currently heads the cell therapy manufacturing innovation team that engages across the CGT value chain interfacing with research, development, manufacturing, quality, regulatory, clinical, business development, and commercial to holistically address and solve challenges across numerous stages across the life cycle of a therapy. Matthew holds a PhD in medical engineering and medical physics from the Massachusetts Institute of Technology.

Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia.  Since that time he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT.  Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T. Now he serves as Director of Operation and BD for Anemocyte 

Dr. Sullivan is program manager and international liaison officer for the Global Alliance for iPSC Therapies (GAiT).

GAiT works to establish an HLA-homozygous haplobank network for clinical-grade-induced pluripotent stem cell (iPSC) lines [Barry et al. 2015, Sullivan et al. 2018]. Such cells would represent an appropriate starting material for allogeneic therapeutic development worldwide.

GAiT activity is funded by an international consortium of organisations: the French Institute of Health and Medical Research, INSERM (Paris, France), the University of Hong Kong (Hong Kong, Hong Kong), the Cell and Gene Therapy Catapult (London, UK), the Centre for Commercialisation of Regenerative Medicine (Toronto, Canada), the Korea HLA-Typed iPSC Banking Initiative (Seoul, Korea), and the New York Stem Cell Foundation (New York, USA). More information on GAiT and its sponsors is available at www.gait.global.

Stephen initially earned his PhD at the Roslin Institute (Edinburgh) under Professor Ian Wilmut and Dr. Jim McWhir, becoming one of the first researchers in Europe to culture human embryonic stem cells. His work focussed on pluripotency induction in human somatic cells.

Thereafter, Stephen worked as a research fellow at the University of Cambridge, Harvard University, and UCSD, deepening his expertise of other human stem-cell types (including induced pluripotent stem cells) and their medical applications.

While at Harvard, he read Dr. Paula Stefan's "How Economics Shapes Science", which stimulated his interest in the financial, as well as the scientific and clinical, hurdles that must be surmounted to bring stem-cell therapies to the clinic. Thereafter, he also worked for Novartis, dealing with clinical trial management and compliance, to better understand manufacturing, logistic, and regulatory challenges to bringing new therapeutics to market and earned an MBA at Trinity College Dublin focussing on risk mitigation during AMTP development.

Prior to his current position, Stephen was the chief scientific officer of the Irish Stem Cell Foundation, where, working with others, he facilitated the introduction of stem-cell legislation into the Irish Program for Government. He was also a project support officer for the Scottish National Blood Transfusion Service (2017-21). In March 2021, he founded Lindville Bio, an ATMP consultancy service specialising in scalable manufacture of pluripotent stem cells (PSC) and therapeutic development therefrom.

He is also a member of the steering committee for the International Stem Cell Banking Initiative (ISCBI), the Autologous iPSC Therapy Consortium, the Human Pluripotent Stem Cell Advisory Committee at University College Cork, Ireland, and is chief editor of "Human Embryonic Stem Cells – The Practical Handbook" published by Wiley & Sons.

Nick is an experienced cell and gene therapy executive, innovator, and people leader. He has over 15 years' experience developing an assortment cell and gene therapies and associated technologies. Currently chief development officer at Artisan Bio, he previously held leadership roles at BlueRock Therapeutics, the Center for Commercialization of Regenerative Medicine (CCRM), and the Center for Advanced Therapeutic Cell Technologies. Nick's global experience includes time living and working in Canada, Switzerland, Australia, and New Zealand, engaging with a diverse assortment of partners, colleagues, and clients from industry and academia.

Abhishek Srivastava is vice president of cell therapy development at Athenex, overseeing early development, manufacturing, and technical operations of the autologous and allogeneic cell therapy programs. He has extensive clinical and translational research experience in the field of adoptive cell therapies serving both academia and industry. Most recently, he was an assistant professor (research) at the division of surgical oncology at the University of Pittsburgh, where he led the process development and manufacturing of tumor infiltrating lymphocytes (TIL) to support the multiple adoptive cell therapy Phase II clinical trials. He received his postdoctoral training from surgery branch at the National Cancer Institute and earned his PhD in immunology. He has authored numerous papers including research articles, abstracts, book chapter, and expert opinions.     

Isabelle Gennart is a biologist by training. She earned her PhD in 2018 at the University of Namur (Belgium), where she focussed on cancer development mechanisms using viral-induced lymphoma models in avian species. Since then, she has had experience with various CAR-T development and clinical manufacturing projects working as a QC specialist at Catalent. She joined Celyad Oncology in 2020 within the R&D team to setup new analytical tools to support innovative CAR-T cells product development and characterisation.