Dr. Rajesh Thangapazham is a regulatory affair professional with over 10 years of experience and specialisation in regenerative medicine and cell and gene therapies. He is currently the head of regulatory strategy and innovation at the cell and gene technologies unit of Lonza Pharma Biotech & Nutrition.

Raj has a bachelor’s in pharmacy, a Master of Engineering, and a PhD in biotechnology. His training includes postdoctoral fellowship, staff scientist tenure, and research assistant professorship at the US Department of Defence, where he advanced regenerative medicine and was actively involved in the preclinical development of cell and gene therapies. 

With a background in biotechnology commercialisation, intellectual property creation and considerable experience in orphan drug development, Raj joined and has supported sponsor’s CMC sections of regulatory filing, regulatory briefing documents, registration/licenses for Lonza’s establishments as well as lifecycle management of drug master files for facilities, cell banks, and donor programs. 

Raj has also provided regulatory support to Lonza’s innovative technologies, such as induced pluripotent stem cell technology, automated and closed-cell processing systems, and single-use disposables.  

Highly experienced CMC Leader, with 14 years experience in CMC biological assets and 6 years in Cell & Gene therapies, ensuring the smooth flow of programs from Lead candidate through to commercialisation. Currently leads the Analytical innovation capability projects for CGT (Cell and Gene Therapies) at GSK to address the current testing issues to releasing autologous therapies for indications with high patient numbers.

Alex Klarer is Head of Cell Therapy Development in Biocentriq. He was a senior engineer in Hitachi Chemical Advanced Therapeutic Solutions’ (HCATS) innovation and engineering group. The mission of the I&E group is to investigate new technologies and capabilities across the bioscience landscape with the goal of increasing patient access to cell and gene therapies. Since joining HCATS in 2017, Alex has worked on a wide array of projects including T-Cell culture platforms with a focus on dynamic 3D methods, novel transfection methods, label-free selection methods, supply chain security, and GMP assay qualification. Prior to joining the team at HCATS, Alex worked at Genentech on their tocilizumab and rituximab products.

Since 2018, Dr. James Wang has been the global quality auditor in cell and gene therapy at Novartis. From 2011-18, he worked in QA and GMP manufacturing operation management of CAR-T cell therapy at Memorial Sloan Kettering Cancer Center MSKCC. James received his PhD from the Hebrew University of Jerusalem.

Peter has a biology background and has been active in R&D for thirty years. His aca­demic career started as a Virologist at the Wageningen University in The Netherlands, where he obtained his PhD in 1991. In 1991 he joined Novartis Seeds where he held several research management positions in the field of plant biotechnology. He is a co-founder of Phytovation B.V., formerly active in biopharmaceuticals and vaccine production, and of its subsidiary Viruvation B.V., which was active in developing a therapeutic AIDS vaccine. Peter is founder and CSO of Amarna Therapeutics a gene and immunotherapy company based in Leiden, the Netherlands. He developed Ama­rna’s SVac viral gene delivery vector platform derived from the macaque polyomavirus SV40. Because of its non-immunogenicity in humans the SVac platform is unique in its capacity to develop effective treatment for genetic disorders and degenerative/in­flammatory/autoimmune diseases. Throughout his career Peter has worked on appli­cations of virus-associated technologies. He has a long-standing expertise in virology, molecular biology, immunology, cell biology and is highly experienced in molecular cloning activities, tissue culture of mammalian cells and production of (recombinant) virus particles in mammalian cell systems. Peter has an H-index of 35, wrote more than fifty peer reviewed scientific articles and is (co-) inventor of more than fourteen different awarded patents and patent applications.

Sarah Thomas is the VP of quality at REGENXBIO, responsible for the quality as­surance and analytical development/quality control organisations. She has over 30 years’ experience in pharmaceutical and biotech quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led quality teams through the transition from clinical to commer­cial operations, and multiple product approvals. Sarah received an MBA from George Washington University and a BSc in chemistry from Butler University.

Wen has been working in the field of oncology and virus research and development for over 15 years. He has a PhD from the University of Leiden in the Netherlands and an Executive MBA degree from Erasmus University. He has worked at the German Cancer Research Center in Heidelberg, Germany, and at the International Agency for Research on Cancer in Lyon, France.  Wen has worked at Sanquin Plasma Products BV as project leader at the CMO division and as member of the management team of pharmaceutical services. Currently, he is the Chief Operational Officer at ORCA Therapeutics BV, where he has been managing operational activities related to the development of ORCA’s technology from R&D to the clinic.

Christiane Niederlaender has spent more than 12 years in medicines tissue, cell and gene therapy regulation. She spent eight years with the MHRA, where she worked until August 2019, assessing all groups of biological medicines and managing the biologicals unit.  

Christiane was the UK representative at the EMA committee for advanced therapies (CAT) and the rapporteur/co-rapporteur/CMC assessor for several ATMPs. She acted as the rapporteur for the EMA gene therapy guideline and was drafting group member for many other CAT guidelines.   

Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European tissues and cells directive as an assessor and inspector. She has a PhD and research background in cell-signalling, cancer, and stem cells and obtained a law degree in 2005. 

Karsten Hendriks obtained his Diploma in Chemistry and Biotechnology at the Niederrhein University of Applied Sciences in Germany in 1994. He has worked for Beckman Coulter™ in various customer supporting roles for over 19 years. In 2014 he started to work for SCIEX as a Sales Support Specialist for Capillary Electrophoresis. He has over 24 years’ experience in supporting analytical solution.

Karsten is currently the EMEA CE Business Development Manager of SCIEX. He provides technical advice and supports the development of new applications in the area of CE and CE-MS.

Dr. Simon Briggs is currently Head of Gene Therapy Technical Product Development at Biogen in the UK. Until recently he was Bioprocess and Manufacturing Senior Manager supporting process development activities in preparation for commercialization of AAV vector-based therapeutics. Until recently, he was a senior technical product steward for Kymriah at Novartis, supporting the successful launch of Kymriah for pALL and DLBCL patients in Europe and Asia. Simon entered the world of cell and gene therapy 20 years ago through a PhD and postdoctoral research at the University of Oxford. He moved from academic research to industry to develop the skills in order to realize the commercial potential of cell and gene therapies and make these life-changing medicines available to patients. Simon has been responsible for bringing OPV data and analytics platforms online in a number of roles supporting a global network of manufacturing partners.

Dr. Monica Nelson is the Director of Quality Control at Century Therapeutics, which is focused on developing novel allogeneic, genetically-engineered iPSC-derived immune effector cell products to specifically target hematologic and solid tumor cancers.  At Century Therapeutics, Monica leads the establishment of the quality control (QC) strategy and manages all related QC activities across the internal and external network. Previously, Monica held several leadership roles within Biologics Analytical Development and Quality Control at Bristol Myers Squibb (BMS), including oversight of Analytical Matrix Teams, Bio-separations Quality Control, the Biologics Specification Committee, and Biologics Analytical CRO Operations. Prior to BMS, Monica was a downstream process scientist and matrix leader in the Biologics Process and Product Development group at GlaxoSmithKline. Monica holds a Bachelor's degree in Chemical Engineering from Villanova University and a Ph.D. in Chemical Engineering from the University of Delaware. Monica also held a Research Fellow position in the Chemical Biology Laboratory at the National Cancer Institute at the NIH.

Jørn Henriksen has more than 15 years of experience in Life Science. Since 2011 he has worked at ArcticZymes Technologies both as a scientist and leading internal teams when developing methods for enzymatic purification of various biological materials. He also has extensive experience in guiding external partners in implementing enzymatic purification methods in their processes and platforms. Over the last year he has focused on how enzymes with novel features can be used to simplify purification of protein-based products in bioprocessing, e.g. viral vectors, vaccines and other biomolecules.

Dr. Nicolas Brauckhoff started at PPS as Team Leader for glycan analyses in 2016. Since 2020, Head of Biotherapeutical Analytics being responsible for three PhysChem-focussed Laboratory Teams performing e.g. CE, HPAEC-PAD, HILIC-MS, RP-HPLC.

From 2015 was working for CRO as Lab Head for mass spectrometry analyses. Studied Chemical Biology at the Technical University Dortmund. Received a PhD in the field of protein semi-synthesis and biomedical research in 2015 at the Chemical Genomics Centre of the Max Planck Society and the Max-Planck-Institute of Molecular Physiology.

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. Ohad Karnieli is the founder and CEO of Adva Biotechnology, a well-known international expert in cell therapy with a significant extensive and scientific knowledge of the industry. Dr. Karnieli is the former founder and President of Atvio Biotech, a leading Innovation center for cell and gene therapy. Former VP of Technology & Manufacturing at Pluristem Therapeutics, and the former VP medical device at Goji solutions. Dr. Karnieli served as the chair of several industry committees such as the process & product development committee of the International Society for Cellular Therapies, an expert member in the ISO TC276 Biotechnology standard committee, and the former chair of the science and technology committee of the Alliance for Regenerative Medicine. Furthermore, Dr. Karnieli serves as an advisor and board member to several of the lead cell therapy for developing companies. Dr. Karnieli earned his Ph.D. on Cell and Gene Therapy in the Sackler School of Medicine of the Tel Aviv University. Furthermore, he holds an MBA from the Haifa University business management school.

Dr Houria Bachtarzi is a Senior Consultant, Regulatory Affairs CMC - Gene and Cell Therapies; with 14 years of experience in the scientific and regulatory CMC aspects of advanced biological therapies including virally vectored gene therapy, in vivo and ex vivo gene editing, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based therapies. Houria started her career by first training and registering as a Pharmacist in the UK, before embarking into a unique journey in gene therapy and regenerative medicine. She completed her PhD in cancer gene therapy at the University of Oxford, Department of Oncology (previously Department of Clinical Pharmacology). She subsequently followed up with additional post-doctoral work in AAV-based gene therapy and shRNA therapeutics for degenerative neuro-muscular disorders at the Centre for Biomedical Sciences, Royal Holloway – University of London, in collaboration with Benitec Biopharma, Inc. and the Institute of Myology at the Pitié-Salpétrière Hospital in Paris, France. In 2013, Houria was appointed as a Lecturer in Biopharmaceutics and Biotechnology at the School of Pharmacy and Biomolecular Sciences, University of Brighton.  

Prior to joining Dark Horse Consulting, Houria was a Senior Consultant in Gene and Cell Therapies at other product development and regulatory consultancies: ERA Consulting (UK) Ltd. and NDA Group, where she provided CMC and regulatory/development strategic advice in relation to different complex gene and cell therapy technologies. She also provided expert advice on matters related to genetically modified organisms (GMOs).

Thomas Parker has worked as a Process Development Scientist for Merck KGaA for 4 years. He has a breadth of experience in the purification of biopharmaceuticals including viral vectors, recombinant proteins, and vaccines. Additionally, he functions as the Global Focal Point Lead for Vaccines and Viral Therapies in Merck KGaA’s Technology Management organization. He holds a B.S. in Chemical Engineering from North Carolina State University with a Biomanufacturing minor from the Golden LEAF Biomanufacturing Training and Education Center (BTEC).

Neil McGowan graduated with a First Class BSc. (Hons.) in Immunology & Pharmacology from the University of Strathclyde in 1998, after which he gained a Ph.D. in medical science (specifically bone cell biology) from the University of Aberdeen. He moved to London in 2002 to continue his work in the bone cell biology field as a Postdoctoral Research Associate at King's College London.

He joined the Scottish National Blood Transfusion Service (SNBTS) in 2005, after following a desire to enter a more clinical-based field. There he initially worked as a Tissue & Cells Scientist, covering the broad range of roles involved in the procurement, testing, manufacture, storage, and issue of a range of live and cadaveric tissue and cell products, before being promoted to Glasgow Tissue Bank Laboratory Manager in 2007.

He returned to Edinburgh in 2009 after being appointed Laboratory Manager of the Clinical Pancreatic Islet Cell Laboratory, overseeing the establishment of this new cellular therapy transplant service in Scotland. In 2013 he moved to a new role as Cell Therapy Project Manager for the SNBTS based at the University of Edinburgh Scottish Centre for Regenerative Medicine (SCRM) and subsequently in 2017 became the Head of Manufacturing for Tissues, Cells, and Advanced Therapeutics in SNBTS.

Within this role, he is responsible for the GMP translation, manufacture, and QC of a range of tissue, cell, and novel advanced therapeutics through to clinical trials within HTA and MHRA-licensed facilities at both the SCRM and the state of the art Jack Copland Centre. He is also currently training to become a Qualified Person that can certify the release of advanced therapeutics in accordance with EU law.

Al Ribickas is the BMT/QC Laboratories Manager in the Cell Therapies Facility at the Moffitt Cancer in Tampa Florida. Al has provided leadership for cellular therapy facilities for over eighteen years. He attended the University of South Florida receiving a degree in Clinical Laboratory Sciences. He is board certified by the American Society of Clinical Pathology as a Medical Technologist, a Specialist in Blood Banking, and as a Hemapheresis Practioner. He has been at the Moffitt Cancer Center since it’s opening in 1987. He initially worked as a blood bank technologist in the transfusion service until 2001. During his time in the transfusion service, he was trained in extracorporeal photopheresis for the treatment of Sezary syndrome, and for the treatment of graft versus host disease. This inspired him to explore, and move to the apheresis collection and processing laboratories of the blood and marrow transplant program to enhance his skills, and contribute to the emerging area of cell therapies. Al has worked on the production of various cellular therapies clinical trial products, and the implementation of commercial FDA approved products.

Martijn Kelder obtained his MSc in molecular genetics from Utrecht University, after which he further specialized in the mechanisms of genome editing using CRISPR/Cas9 during his doctoral training at the University of Edinburgh. He has co-authored in several journals including PLoS Biology and Nature Protocols. As Strategic Account Manager at Cergentis, Martijn is overseeing business development and establishing long-term partnerships with key customers.

Martha Luevano is responsible for the clinical Engineered cells portfolio, including CAR T and CAR NK cells at Miltenyi Biotec. During the past 6 years, she has been working together with R&D and the Clinical Development team in order to advance the development of tools to enable CAR T and CAR NK cell immunotherapy. Prior to joining Miltenyi Biotec, Martha Luevano did her postdoctoral research in stem cells (Miltenyi Biotec-Marie Curie fellowship) and her PhD in the Anthony Nolan (University College London) finding solutions to expand NK cells for therapeutic purposes. Her combined experience in molecular and cellular research has made her the recipient of international grants and fellowships. 

Before joining Kanglin Biotechnology (Hangzhou) Ltd, where Dr. Ying Dang is currently supervising Kanglin Bio's preclinical R & D pipelines, he was the Senior Research Associate in the Center of Excellence in Infectious Diseases, Texas Tech Health Science Center (Lab of Dr. Haoquan Wu). Earlier, he was occupying a post-doctoral research associate position in the Department of Microbiology and Molecular Genetics, Michigan State University (Lab of Dr. Yong-Hui Zheng). 

Dr. Daniela Woide joined ProJect Pharmaceutics in 2015 in her role as Director Key Account Management / Director Sales and Marketing. Based in Martinsried/Munich, Germany, ProJect Pharmaceutics CRO was founded and is managed by leading experts in formulation and pharmaceutical process development with many years of experience in bio-pharmaceutics. Deviant from prevalent trial & error approaches, ProJect Pharmaceutics focuses on the design of a quality product and its manufacturing process on a sound scientific rationale pursuant to ICH Q8 and other guidelines, thus truly supporting the establishment of a design space, specifications and manufacturing controls to ensure processability of the formulations under standard aseptic conditions.