Scott Burger is the principal of Advanced Cell & Gene Therapy, a consulting firm specializing in development and commercialization of cell and gene therapy products, providing expert guidance on development strategy, manufacturing, quality, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 80 industry and academic clients in North America, Europe, Asia, and Australia. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. Dr. Burger serves on the scientific advisory boards of multiple organizations and companies, including BioLife Solutions, BioCision, HemaCare, Longevity Therapeutics, and the Regenerative Medicine Foundation, as well as the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development.
William E. Janssen, Ph.D. has worked for the past 30+ years at translating lab bench models into cell and gene therapy products for patients. In the course of these efforts he has developed and refined methodologies for all phases of cell therapy from collection, through administration. He has also been engaged in the regulatory process, preparing and managing numerous applications for INDs and IDEs. Dr. Janssen has also been responsible for facility design, drug master file creation, development of staff training programs, process engineering, SOP development, process validation, and integration of processses, equipment and raw materials. He has held leadership positions in the International Society for Cell and Gene Therapy and the Foundation for Accreditation of Cellular Therapy. Most recently Dr. Janssen has transitioned from the academic sphere and currently works as an industry consultant.
Tiffany D Rau, Ph.D., Owner and Principal Consultant of Rau Consulting and is an expert in bioprocessing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing. Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems Previously, Dr. Rau has held leadership positions at Evonik-Degussa, Eli Lilly, Pall and GlaxoSmithKline all focused in process development, tech transfer, commercial manufacturing, and CMC strategy. Dr. Rau has over 75 invited speaking engagements focused on delivering current and next-generation products from R and D to commercialization/post-commercialization. Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.
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. Prasun Mishra is an investor, co-founder, advisor, and board member of a few US-based corporations; he has numerous publications/patents, several drugs in clinical trials, and has over 40 prestigious awards honors to his credit. He is the founder and CEO of Agility Pharmaceuticals, a technology-driven pharmaceutical company committed to revolutionizing drug discovery & development. Dr. Mishra is also the founding president and chair of the American Association for Precision Medicine and the AAPM Innovation Center, where he is leading research efforts focused on preventing & curing chronic diseases, treating the sick, and providing knowledge/tools to individuals to live longer, healthier lives.
He is a serial entrepreneur who founded his first company after graduating high school and his second company during his Ph.D. Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies. He is also a General Partner in the Global Health Impact Network and Fund, a healthcare-focused investment fund based in Silicon Valley, CA. He is also a founding chair of WISE: World Investors and Entrepreneurs Society, an investment collective with a global investment footprint. He is a founding investor and advisor to Barcelona Ventures and an advisor to a $100M private equity fund.
He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche. Where he participated in several drug discovery project teams; moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic.
Dr. Maria Germana Sanna is currently a Field Application Scientist at Gyros Protein Technologies.
She has been with the company since 2018 and prior to joining the company she was a Staff Scientist/ Senior Staff Scientist in the departments of Immunology, Chemical Physiology and Molecular Medicine at The Scripps Research Institute (TSRI).
Germana received her Ph.D. in Microbiology and Epidemiology from the University of La Sapienza in Rome and completed a postdoctoral fellowship at the California Institute of Technology before joining TSRI. During her scientific career she has worked on several major scientific fields including Infectious Diseases, Signal Transduction, Immunology, Autoimmune Diseases and Pharmacology making the transition to exploring the ways immunoassay technologies can be applied to problems in bioanalysis and biotherapeutic drug development an easy progression of her interest and career.
A well-known international expert in cell therapy with extensive knowledge of the industry. Dr Karnieli is the founder and CEO of Adva Biotechnology, a leading automation platform for cell and gene therapy. Dr Karnieli was the founder and former President of Atvio Biotech, a specialized cell and gene therapy innovation center which was sold to Orgenesis Inc. 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, 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 developing companies. Dr Karnieli earned his PhD 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.
He worked on early stage product development of AAV mediated gene therapy for diseases such hemophilia, neuronal and eye disorders. He successfully developed the pilot scale manufacturing platforms using suspension cell lines in upstream and chromatography in downstream process. He also contributed for assay development. He served as Research Scientist from 2015 to 2017 and as Senior Research Scientist from 2017 to 2019. He also developed early stage designs and assays for CAR-T research. In 2018 to 2019, he completed Diploma in International Business Management from Ahmedabad Management Association in affiliation with California State University. In 2019, he joined Immuneel Therapeutics as Head of Vector & CAR-T Manufacturing. His work encompasses the process development and GMP grade manufacturing of autologous CAR-T cells for clinical trials. The disease areas mainly include the leukemias and lymphomas. He has 7 peer reviewed publications in the field of gene therapy and functional genomics.
Jayanthi Grebin has 20+ years as an Application and Technical Engineer in several different industries with the last 10 years focusing in product and business development for single use technology in Bioprocessing and Cell and Gene market.
Ejvind holds a PhD degree from University of Southern Denmark in Protein Chemistry & Molecular Biology. He has more than 20 years of experience in development of protein analyses and mass spectrometry methods in research & development of protein biologics; vaccines, monoclonal antibodies, therapeutic proteins as well as cell and gene therapies. He is experienced in project management and outsourcing collaboration projects with pharma/biotech, CMO/CROs as well as university research groups.
PhD in Biology/Biochemistry from Gothenburg University. 50 + publications in peer reviewed journals, several book chapters and patents. Ten years within AstraZeneca R&D in Cardiovascular Diseases, twelve years at Cellartis/Cellectis as VP Regenerative Medicine, responsible for e.g. the major collaboration with Novo Nordisk on development of a human embryonic stem cell derived beta cell treatment for diabetes. Also, responsible for development of human pluripotent stem cell derived cardiomyocytes and hepatocytes. As of February 2014, CEO of VERIGRAFT AB, a pioneering company within tissue engineering and advanced regenerative medicine for use in treatment of cardiovascular, neuronal and other diseases.
15 years spent in ALS R&D and Technical dept. He holds a Master of Science degree in Engineering from the University of Perugia, Italy in 2002. In the last 3 years he has been appointed as Sr. Product Manager & Application Specialist.
Audrey Chang Ph.D. earned her PhD in Biology at The Johns Hopkins University; Baltimore Maryland and has over 25 years of government and industry experience in conducting biological products testing and in managing laboratories. In her current role as Vice President of QC and Analytical Development at Vigene Biosciences, she is responsible for managing and developing a team scientific expert that provides greater focus to the development of new services and technologies while providing technical solutions and support to clients and operating laboratories.
