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.

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. 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).

Dr. Vladimir Slepushkin until recently was leading process development for manufacturing of lentivirus vectors in suspension cell culture, guiding assay development to support process de­velopment for retroviral vectors, managing CMO for GMP vector production and T-cell processing at Autolus Therapeutics. Previously, he was directing research vector core, and 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, as well as intellectual property assessment and licensing. He has authored 59 scientific papers in peer-reviewed journals and he’s an author on 10 patents and patent applications.

Matthew Fuller is the Director of Vector Platform Research at Ultragenyx Pharmaceutical within the Ultragenyx Gene Therapy Research team. He is leading the HeLa Producer Cell Line (HPCL) and Vector Engineering (VE) teams, both of which perform program and platform research to continually optimize and invest in Ultragenyx’s gene therapy platforms and programs. Specifically, the HPCL team focuses on generation, characterization, and improvement of the HeLa-based producer cell line to maximize the quality and quantity of rAAV generated. The VE team focuses on optimization of vector construct regulatory elements to modulate and maximize tissue-specific expression and efficacy. Matthew received a PhD in molecular microbiology/virology from the University of Missouri and a MSPH from Tulane University.

Gabrielle Humphrey is a CMC consultant specializing in the delivery of viral vector for ATMP. She has in-depth experience in lentiviral vector for CART19 and TCR cell therapy products. Gabby has led manufacturing sciences and technology teams at biotech organizations such as Emergent Biosolutions, Oxford BioMedica, and Adaptimmune. She has a PhD in human nutrition from Robert Gordon University, Aberdeen (UK). She founded her CMC consultancy Vectaplus in France to support the emergence of cell and gene therapy clinical trials in the European Union.

Luca Biasco, PhD, is the Founder and Director of the gene therapy and biology department at AVROBIO and an honorary senior research associate at University College of London (UCL) under the gene therapy program of the Institute of Child Health (ICH) of the Great Ormond Street Hospital (GOSH).

Dr. Biasco graduated in medical biotechnology in 2003 at Alma Mater Studiorum University of Bologna, Italy, and moved to Milan to join the San Raffaele Telethon Institute of Gene Therapy (SR-TIGET), where he obtained his PhD in 2010 and later became a group leader specializing in the study of retroviral/lentiviral vector-host interactions. In this period, he generated the safety data for the marketing authorization of Strimvelis™, the first commercially-approved ex vivo stem cell gene therapy in the world, distributed by GlaxoSmithKline (GSK), and was a consultant of GSK for the safety of lentiviral gene therapy for Wiskott Aldrich Syndrome.

In 2016 he moved to Boston, US, to be an assistant professor at Harvard Medical School where he directed the vector safety team for the gene therapy program at Boston Children's Hospital/Dana Farber Cancer Institute. His research laboratory at Harvard Medical School worked on understanding the properties of stem cell gene therapy products and their in vivo dynamics upon infusion in humans. Over the same period, he was appointed senior research associate in London at UCL, where he conducted translational research on immunodeficiencies and CAR-T cells. In 2019 he became director of R&D at AVROBIO, where he is currently applying state-of-the-art single cell molecular analyses to track the fate and activity of genetically engineered cells in humans. Luca is the author of 29 peer-reviewed manuscripts that comprise publications in high-impact scientific journals such as science, nature medicine and stem cell. He has been the recipient of five international awards in the area of gene therapy and hematology, and he is recognized worldwide as a pioneer in the field of clonal tracking of genetically engineered cells in humans.

Dr. Klaus Richter is the leader of the AUC group at Coriolis Pharma, which is dedicated to the biophysical characterization of drug products and drug substances ranging from small molecules and peptides to viral particles and liposomes. He is a biochemist by training and received a Ph.D. from the Technical University of Munich in the field of protein characterization and worked for several years in the area of structure-function and structure-activity relationships of pharmaceutically relevant proteins before joining Coriolis Pharma. Klaus obtained his Habilitation in 2012 and is the (co-) author of more than 70 publications in the field of protein characterization with diverse biophysical methods, in many cases applying analytical ultracentrifugation (AUC) as a tool to investigate protein structure, protein interaction, and stability.

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.

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.

Dr. Susan Faust is the Founder and CEO of NxGEN Vector Solutions, LLC. She has experience in scientific research, academic technology transfer, patent prosecution, and business development.

Dr. Faust received a B.S. in Microbiology from the Pennsylvania State University with Minors in Biochemistry and Molecular Biology, a Ph.D. in Cellular and Molecular Biology and a concurrent Master’s Degree in Human Genetics from the University of Michigan. She held a postdoctoral position at the University of Pennsylvania studying the immune response to viral vectors used in gene therapy.

Dr. Faust is an inventor on multiple patent applications, including the recently issued U.S. Patent, No. 11,015,210, which further strengthens the Company’s intellectual property position and coverage for the Company’s CpG-depletion AAV Vector Technology. Dr. Faust has also received numerous awards for her work, including a Young Investigator Award from the American Transplant Congress and the Sanjeev Kumar Excellence in Science Award from the University of Pennsylvania.

Matthias serves as senior member of the staff and has worked for the last 7 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 is to genetically modify cells whilst 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 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.

Tony Newcombe is a co-founder and Chief Operating Officer at VectorY, a gene therapy company based in Amsterdam developing novel AAV gene therapies for the treatment of CNS and neuromuscular diseases. Prior to joining VectorY, he was a member of the site leadership team at Samsung Biologics responsible for tech transfer and production of biologics at one of the world's largest single capacity GMP biopharmaceutical drug substance facilities in Incheon, South Korea. He previously held technical leadership positions at GSK Biologicals and Pfizer supporting process development, tech transfer, manufacturing and process validation for the late-stage development and production of biologics. Tony received a PhD from the MRC National Institute for Medical Research, London UK.

Richard Denk studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment, and eight years ago he founded the expert containment group of the ISPE DACH. The containment group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

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

Simone Biel is a Senior Regulatory Consultant and provides regulatory expertise to our customers and internal stakeholders with a focus on Single-Use Technology and filtration. Over the years, Simone has supported biopharmaceutical drug manufacturer’s implementation of Single-Use Technology in their manufacturing process and gained a deep understanding of market needs and industry trends in this field. Her objective is to ensure that product performance meets quality and regulatory requirements.

Simone holds a Ph.D. from the University of Frankfurt in Microbiology.

Walid El Azab is an industrial pharmacist, a qualified person, and a Lean Six Sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. Finally, he leads audits at manufacturer sites and workshops to improve processes and inspection readiness levels. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilization and EU GMP Annex 1 guideline revision. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions) and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is the secretary of the Belgium Qualified Person Association.

Dr. Silvia Aldi is a cell and gene therapy bioprocessing and translational research expert. Currently, she is a cell and gene product manager at SKAN AG, where she leads the product development strategies for the manufacturing of cell and gene therapies.

She has more than 10 years of expertise in R&D management in academic settings, working in the top research centre worldwide (Karolinska Institutet in Sweden and Weill Cornell Medicine in USA), where she gained extensive scientific knowledge in cell and gene processes.

Silvia worked for six years at Karolinska Institutet as assistant professor and research coordinator, where she coordinated international and interdisciplinary research programs focused on the validation of drug targets for cardiovascular diseases and medical device for the diagnosis of autoimmune disease.

She has a master's degree, a BS in cell and molecular biology, and received her PhD in molecular medicine from the University of Siena, Italy.

Emmanuelle has more than 13 years’ experience in biotechnology process development and GMP production. Highly skilled in the field of cell culture applications, Emmanuelle joined Pall Biotech almost 10 years ago, first as a bioprocess specialist (BPS) for four years. She then transitioned to the bioreactor applications team, where she was principal bioreactor specialist until February 2021 when she transitioned to her current role. Prior to Pall, Emmanuelle worked as a biotech process sciences upstream process development engineer at Merck Serono for four years. She received her biotechnology engineer diploma from the former Ecole Supérieure d’Ingénieurs de Luminy (now Polytech Marseille).

Dr. Cosmin Pocanschi is head of sales at CeGaT GmbH and in charge of establishing collaborations with research institutions and pharmaceutical/biotech companies in the DACH and BeNeLux regions.
 He received his PhD in biology from University of Konstanz and completed the business edge executive program at Rotman School of Management in Toronto, Canada. Before joining CeGaT, he gained experience in a variety of fields, including biomedical research, health services, quality assurance, process improvement, and product management.

Nicolas is a senior product manager at Miltenyi Biotec and is responsible for lentiviral vectors and MACS GMP cell culture reagents.
Nicolas has over 10 years of experience in biotech organisations. After joining Miltenyi Nicolas, he was contributing to the development of Miltenyi Biotec’s lentiviral vectors and MACS GMP cell culture reagents as an integral part of the Miltenyi Biotec cell manufacturing platform. Before joining Miltenyi Biotec, Nicolas worked in different roles in biotechnology, taking care of cytokines and cell culture reagents for research and cell therapy manufacturing use.
Nicolas holds a diploma in microbiology from the University of Kiel and a doctorate in cell biology from the University of Luebeck.

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 

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Syntegon Technology GmbH in 2009. During his first 3 years, he was a project manager for handling complex customer projects. Since 2012, he is the globally responsible product manager for barrier systems, isolator and process technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA

Ruthger van Zwieten received his PhD in gene and cell therapy from the University of Lausanne, Switzerland and developed the research plan for a pharmaceutical company before transitioning into business development roles in natural sciences companies. He has been with Picarro since November 2019 and has intimate knowledge of the Picarro H2O2 CRDS pharma analyzer which has a major role in the filling of biopharmaceuticals.

Ken Nagai works as a deputy general manager of the total design and project department for Airex, an isolator/decontamination equipment company for the pharma and ATMP industry. His responsibility includes project management, international expansion, new business creation, strategic planning, and production improvement for the organisation. Previously, he experienced new business development in a $10B organisation as a product line manager. He also worked in a consultancy, applying the Toyota production system to many different manufacturing organisations as a consultant. Ken has a bachelor’s degree from the University of Tokyo and an MBA from University of Notre Dame.