E.J. Brandreth has over 30 years in life sciences including small molecules, devices and pivotal biotechnology products, and is currently the head of quality for Inovio Pharma­ceuticals, where he oversees QA for a combination medical device and DNA therapeutic platform. He was previously senior VP of quality and regulatory affairs at Ajinomoto Althea Technologies, specialising in CMO biotech processing and aseptic filling. He was the senior director of quality for BioMarin, where he helped design the commercial orphan drug facility and launched Aldurazyme® and Naglazyme®. During the startup of IDEC Pharmaceuticals, he held various management positions in QA, validation and regulatory affairs, and was a core team member for the development and launch of Rituxan® and Zevalin®. He is a past chairman of the PDA Biotech Advisory Board, author of several PDA technical reports and is a past president of ISPE, San Diego. He holds an MBA from UOP and a bachelor’s in biology from UCSD.

Stephan Reynier joined Cellectis in April 2011. He serves as chief regulatory and com­pliance officer after holding the position of head of programs at Ectycell, a former subsidiary of Cellectis, from April 2011 to 2014, with the mission of managing and coordinating internal and external collaborative programs. As chief regulatory and compliance officer, Stephan is in charge of ensuring a speedy and successful develop­ment of the UCART product family by establishing close interactions with regulatory agencies such as EMA and FDA, while securing compliance to applicable regulations, regulatory guidelines and quality assurance standards. Stephan has extensive experi­ence, from his previous positions as senior director at Voisin Consulting Life Sciences and European associate director of medical affairs at Gilead Sciences, in the design and implementation of regulatory strategies for the development of drugs and biolog­ics, with a strong focus on cell and gene therapy. He graduated as an agro-engineer in France and received a master’s of science in chemical engineering from the University of Toronto, Canada.

Christine Le Bec joined Genethon in 1997 as a scientist and currently heads the CMC analytical department. She is responsible for the analytical activities in the charac­terisation and release testing of gene therapy products at early stage development, stability studies and interface with CMO for method transfer and validation, analytical / QC testing. She also assists in the response to CMC questions from regulatory agencies query. She has a strong expertise in the development and qualification of analytical methods based on biochemical, biophysical and cell-based assays to assess identity, potency, impurity profile and safety. Before joining Genethon, she obtained her PhD in bio-organic chemistry from Université Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, US) and then at Institut Pasteur (Paris, France) in the field of synthesis, structural analysis and in vitro evaluation of antisense DNA as therapeutic agents for cancer and AIDS.

Manuela Cota is an upstream process development supervisor in MolMed. She joined MolMed in 2007 working in the research unit and then in the development unit. She gained knowledge and experience in the design of vector production processes con­tributing to the development of processes in cell and gene therapy field. She is involved in the process development and industrialisation of large-scale production of lentiviral and retroviral vectors in compliance to GMP requirements. She also has experiences in the development and industrialisation of T- and haematopietic cells transduction processes with lentiviral and retroviral vectors. She holds a degree in biological science from Università degli Studi-Milano.

Kathryn Parsley is a biological science graduate with an master of philosophy in micro­biology/immunology and a PhD in molecular immunology/gene therapy. She started her career in anthrax vaccine research, development and GMP manufacture at the Centre for Applied Microbiology and Research (CAMR), UK. Kathryn then progressed to the Great Ormond Street Institute of Child Health Hospital NHS Trust, UK, where she worked for 12 years in the research, development, translation, manufacture and management of gene and cell-based phase I/II clinical trials. During this time, Kathryn trained as a clini­cal scientist in immunology/gene therapy and was registered with the Health and Care Professions Council in the UK. In 2011, Kathryn moved to PPD and progressed to senior manager, where she was regulatory affairs lead for numerous global phase I-IV stud­ies involving chemical, biological (including vaccines) and advance therapies medicinal products (ATMP). As a subject-matter expert (SME) in gene therapy and genetically modified organism (GMO) products, Kathryn was a key member of the team providing early engagement and product development consultancy to sponsors developing ATMP and GMO products. In 2018, Kathryn joined Boyd Consultants, where she continues to support sponsors in all stages of drug development particularly in the field of ATMPs and GMOs. She is an active member of the British Society for Cell and Gene Therapy (BSGCT), presenting at the BSGCT conference in 2017 on early-stage development of GTMP. She also co-authored an article on global regulatory challenges during early-stage development of GTMP, published in the June 2017 edition of the Regulatory Rapporteur. Kathryn plays a pivotal role in ATMP education, presenting recently at TOPRA Human Medicine Symposium in Sweden.

Marian Bendik holds a master’s degree in biochemistry from the University of Chem­istry and Technology in Prague, Czech Republic. He then worked as an immunoassay research scientist in academia and later in industry. Afterwards, he occupied different process and manufacturing expert roles with increased responsibilities in the cell-based vaccines business unit at Baxter Bioscience. In 2014 he joined the gene therapy process development team to support developing of the AAV manufacturing platform in Austria. Currently, he holds accountability for gene therapy manufacturing and acts as site lead in Orth for Gene Therapy Center Austria at Takeda.

Dr. Vladimir Slepushkin is leading process development for manufacturing of lentivirus vectors in suspension cell culture, guiding assay development to support process de­velopment for lentiviral vectors, managing CMO for GMP vector production and T-cell processing, directing research vector core, providing lentiviral, retroviral and AAV vectors for Kite Pharma. Vladimir proved successful in developing novel high quality products by managing diverse technical groups and cross-functional teams, developing first-in-class clinical product from scratch, including facilities, equipment, manufacturing process, quality systems, regulatory CMC submissions and clinical trials design. He has proven expertise in technically understanding and leading the development and improvement of cell culture and purification processes, and operations and analytical methods, adhering to customer, regulatory, safety and environmental requirements and guidelines. Vladi­mir is experienced in identifying and resolving regulatory and manufacturing technical problems, intellectual property assessment and licensing (an author on 10 patents and patent applications). He has authored 59 scientific papers in peer-reviewed journals.

Dr. Basel Assaf is a board certified veterinary pathologist and a senior principal scientist with training emphasis on laboratory animal and investigative pathology as well as safety assessment of novel large molecule biotherapeutics. His background spans aca­demia, regulatory agency and the pharmaceutical industry. Basel currently supports evaluating the efficacy and safety of several Pfizer therapeutic assets with emphasis on AAV-based gene therapy and gene modulation platforms. Prior to joining Pfizer, he was an investigative pathologist at the Primate Research Center of Oregon Health and Science University, where he established and led investigative pathology capabilities that supported the infectious and non-infectious research programs.

Jacek Lubelski, PhD, joined uniQure as a scientist in 2008. As a VP of global pharma­ceutical development he is overseeing uniQure’s vector, process, non-clinical and ana­lytical development teams. Prior to leading uniQure’s development organisation, he led the vector development and process development departments. Vector development is the team responsible for the molecular design, engineering and development of viral vectors, and process development provides non-GMP manufacturing capabilities and is responsible for process and manufacturing platform development. Jacek received a master’s degree in biotechnology at the University of Maria Curie-Skłodowska in Lublin, Poland, and a PhD in molecular biology from the University of Groningen, The Nether­lands. Subsequently, in his postdoctoral work he served as postdoctoral fellow at the molecular genetics department of Groningen University in The Netherlands. He has co-authored more than 20 scientific publications and is an inventor or co-inventor of multiple rAAV-related patents and patent applications.

Paul Byrne has over 20 years’ experience in the CRO business and has worked at various levels including study director and head and molecular biology. Paul currently focusses on the analytical support required for cell and gene therapy molecules within the preclinical, CMC and clinical testing areas.

Catherine Cancian is responsible for the management of the pharmaceutical develop­ment programs from preclinical to phase III clinical studies and commercialisation at GenSight Biologics. She has over 20 years’ experience in manufacturing operations and bioprocesses improvement in biotechnology companies. Prior to joining GenSight in 2017, Catherine held various positions at Sanofi Pasteur, including management level responsibilities in manufacturing, quality and CMC compliance and project man­agement, leading multifunctional project teams in the new drug application filing and marketing approval. From 2015-17, she served at Genethon Bioproduction to lead in­dustrialisation projects for gene therapy vectors. Catherine received a master’s degree in neurosciences from Pierre & Marie Curie University (Paris), an engineering degree in biotechnologies from UTC and a master’s degree in business and management of strategic units from HEC (Paris).

Lior Raviv joined Pluristem in 2011 and currently serves as vice president of develop­ment in charge of process and technology development and manufacturing sciences. Prior to that, Lior served as process development engineer, projects manager and product development team leader at Pluristem in charge of new technologies and process development. Prior to joining Pluristem, Lior spent 2010-11 in the position of R&D analytical researcher at Teva Pharmaceutical Industries. He holds a master’s in pharmacology from Ben-Gurion University and a bachelor’s in biotechnology engineer­ing from Ben-Gurion University.

Axel is a principal consultant in biologics at Propharma. Before joining in 2017, he had positions at the Swedish medical products agency for 16 years as a pharmaceutical assessor of biological products and also as a preclinical assessor. He has experience from clinical trials, scientific advice, and marketing authorisations for biological products, including recombinant products and advanced therapy products, as well as oligonucleotide-based medicines. As a long-time member of gene therapy working groups at EMA and EDQM, he has long experience from writing EU guidelines and pharmacopoeia texts. At Propharma, he is involved in drug-related development projects as an expert in biological products in particular and non-clinical issues in general.

Dr. Carmen Brenner, who received her PhD in biomedical science, joined Bone Thera­peutics eight years ago as an R&D project manager. Two years later, Carmen became head of the QC department, first as manager and now as associate director.

Rita Majithiya has been with GSK since 2010 in various roles within different R&D business units (biopharm, small molecule product development and cell and gene therapy). Her area of expertise and passion has been developing drug products for a range of modalities and different delivery routes, with improved understanding of translational and CMC aspects enabling development of improved medicines. Rita is currently scientific leader, leading the cell formulation team within cell and gene therapy product development at GSK. Her team is accountable for development of all aspects related to final cell drug product and formulation processes to support all clinical phases through to commercialisation. Her role also involves close collaboration with GSK multidisciplinary project teams for various assets and external CMO’s, col­laborators and clinical sites. She is also leading platform formulation development and automation of formulation processes for cell-based drug products. Prior to joining GSK, Rita was a postdoctoral fellow at Queen’s University Belfast. She has a degree and a master’s in pharmacy with a PhD in pharmaceutical technology, completed in India.

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. Lutz Ehrhardt lives with his family close to Munich, Germany, and holds the position of senior marketing manager centrifugation Europe, CIS, India and Africa at Beckman Coulter. Lutz is an educated physicist with a focus on biophysics throughout his degree and PhD. He’s done scientific work in the fields of membrane transport and protein structure as on application of biophysical techniques to living systems. In the life science industry, he has 14 years’ experience in selling life science products to academia and biopharma, and in application and product support. In the last eight years he has held different positions in marketing and field marketing for particle characterisation and for centrifugation and analytical ultracentrifugation.