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.
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.
Shailendra Singh (Shelly) is a member of MarketsandMarket's board. He focuses on global sales and client services functions, as well as commercial optimization at MarketsandMarkets. He has years of expe¬rience in global delivery and outsourcing sector in the IT/ Consulting/Analytics/Big Data sectors. Prior to MnM, he was leading the global sales, client services and commercial ef¬fectiveness functions for Mu Sigma, a unicorn company and a leading global provider of Decision Sciences and Big Data analytics solutions.
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.
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.
Dr. Jan Joseph (Jos) Melenhorst obtained his PhD at the LUMC (Department of Hematology) on the pathogenesis of Aplastic Anemia. In 1998 he moved to Bethesda, Maryland, where he did his research ‐ first as a postdoc, later as a staff scientist ‐ in the laboratory of Dr. John Barrett at the National Institutes of Health, on the immunobiology of marrow failure syndromes, leukemic disorders, and allogeneic stem cell transplantation. In 2012 he was recruited by Dr. Bruce Levine and Dr. Carl June to the University of Pennsylvania, first as Deputy Director of their clinical manufacturing (cGMP) facility. After a year he was promoted to Director of Product Development & Correlative Sciences. In this role, he was at the cusp of the first ever CAR T cell therapy approved by FDA: Kymriah. Dr. Melenhorst is interested in understanding and improving the anti-tumor efficacy and safety of adoptively transferred chimeric antigen receptor-modified T cells through correlative, mechanistic, and functional genomics approaches.
John M Rossi is Vice President of Translational Medicine at Syncopation Life Sciences. John is an experienced Cell Therapy and Biotechnology leader with over 22 years of experience building robust clinical pharmacology, predictive biomarker, and correlative science processes to support oncology drug development. Most recently John was Senior Vice President of Research and Head of Translational Medicine at CERo Therapeutics. At CERo, John helped to guide Research, Process Development and Vector Sciences teams to advance preclinical initiatives. Prior to CERo, John was Senior Director and Head of Clinical Pharmacology at Kite, a Gilead Company. At Kite, John played an instrumental role in supporting global approvals of both Yescarta® and Tecartus® as well as IND approvals to advance investigational autologous T cell therapy products (KITE-363 and KITE-222). Among John’s notable achievements at Kite, he has represented the organization through numerous external scientific presentations and collaborative manuscripts with leading academic researchers in the cell therapy field. Significant scientific accomplishments include the discovery of novel metrics to characterize CAR T cells based on functionality and fitness, novel biomarker knowledge helping to elucidate CAR T-cell mechanism of action in humans, mechanistic information on CAR-related toxicities, novel insights into the biology of the tumor immune microenvironment, and the pivotal role of IL-15 in the context of CAR T-cell function. John began his tenure in clinical pharmacology and biomarker development at Amgen in 2002, leading global biomarker development for Phase III registrational trials in oncology (trebananib, AMG386), and preclinical, first-in-human and Phase II clinical trials (AMG780, AMG224 and AMG176). John has co-authored over 35 publications in the field of cell therapy and is co-inventor on 9 issued or submitted patents. John earned his Master of Science degree in Molecular Biology at Portland State University and his B.S. degree in Biology at Pitzer College in Claremont CA.
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.
Don has over 30 years experience in cellular immunology and immune regulation in both academic and biotech environments. Prior to joining KBI Biopharma, Don was Chief Scientific Officer at Opexa Therapeutics, developing autologous T-cell immunotherapies for the treatment of autoimmune disease. Previously, he held the position of Director of Immunology at Argos Therapeutics, and was responsible for the development of novel autologous dendritic cell therapies for the treatment of renal carcinoma and HIV. He is a former lecturer in immunology at the University of Leicester, UK, and held post-doctoral positions in the Department of Pathology, Cambridge University, UK. Dr. Healey obtained his Ph.D. at the Hunterian Institute at the University of London, UK, and obtained his BSc in the Department of Pathology, Bristol University, UK.
Dr. Wei is an award-winning entrepreneur and chemistry professional in biomimetic nanoscience. She is recognized as a pioneering chemist in the field of cryobiology by her work on developing bioinspired ice-interactive molecules to advance the legacy cryopreservation technology in regenerative medicine. She founded X-Therma Inc. to pursue her 10-year passion and dedication to improve biopreservation for human health, resulting in X-Therma’s core technology based on hyper-effective ice prevention materials and a three-tier bioinspired chemical technology platform. She has led X-Therma as a selected industrial User at The Molecular Foundry, Lawrence Berkeley National Laboratory 2015-2020. She is the PI of multiple federal/state awards to develop breakthrough cryopreservation for complex tissue and organs. She is a distinguished member of the RULEBREAKER society and executive member of American Chemical Society, California section.
Dr. Hanley is an assistant research professor of pediatrics and Director of the Cellular Therapy Laboratory at Children’s National Hospital. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, and testing of novel cell therapies for patients enrolled on clinical trials. Trained as an Immunologist. He has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 13 years he has helped to translate more than 20 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic. He is on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT), is an active inspector, is chair of FACT’s education committee, serves on their accreditation committee and is also on the immune effector cell standards subcommittee. He serves on the editorial boards of the journals Cytotherapy and Molecular Therapy: Methods and Clinical Development. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys playing soccer, cooking, and traveling.
Bill obtained his bachelor’s degree in Cell Biology/Biochemistry from Bucknell University and his Master’s Degree from M.I.T. Prior to joining Tosoh Bioscience LLC, Bill worked in analytical method development at Neose Technologies, in vitro assay development and protein purification at Locus Pharmaceuticals, and in viral clearance at Charles River Laboratories. Bill joined Tosoh Bioscience LLC in March 2014 as a process technical service specialist. His research includes developing applications for the comprehensive line of process media from Tosoh. He also assists customers with a variety of process chromatography technical issues. When not working at Tosoh, Bill enjoys spending time with his family, playing piano, singing, and cooking.
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.
Margaret Temple has qualifications in genetics and business and has twenty-five years’ experience of client consultation to discuss and recommend biosafety testing strategies to clients in North America, Asia and Europe. Margaret has worked with clients developing a wide range of biologics: vaccines, cell therapies, gene therapies, recombinant proteins and monoclonal antibodies to ensure compliance with the requirements of the international regulatory authorities. Margaret started her career with Q-One Biotech in 1995 and was a co-founder of Vitrology (now SGS Glasgow since acquisition by SGS in 2012) with colleagues who remain in the senior management team of SGS Glasgow.
Dr. Stephen Lock obtained his PhD in Physical Organic Chemistry from the University College of Swansea in 1993 and is a chartered chemist and a member of the Royal Society of Chemistry. Previously a lecturer of Chemistry at the University of Hull and a senior scientist at CCFRA he has worked for SCIEX™ in various technical roles for over 20 years. He has over 25 years’ experience in Analytical Chemistry and has presented at over 80 international meetings around the world. Steve is currently the EMEA CE Marketing and Market Development of SCIEX and was also recently appointed in a volunteer role as an Adjunct Professor at the University of Pannonia to act as a Scientific Advisor for the Horváth Csaba Memorial Laboratory lead by Prof. Andras Guttman. At the Horváth Csaba Memorial Laboratory Steve provides technical advice and supports the groups fundamental research and development of new applications in the area of CE and CE-MS.
Mahendra Rao is internationally known for his research involving, IPSC (induced pluripotent stem cells) human embryonic stem cells (hESCs) and other somatic stem cells and has worked in the stem cell field for more than twenty years with stints in academia, government and regulatory affairs and industry. Dr. Rao has an extensive background teaching medical and graduate students, as well as postdoctoral fellows at institutions including Johns Hopkins University School of Medicine, The National Centre for Biological Sciences in Bangalore, India, and the University of Utah School of Medicine. Dr. Rao has published more than 350 papers on stem cell research and is the co-founder of a neural stem cell company Q therapeutics based in Salt lake City (Utah) and more recently NxCell based in California. He is currently on the Board at Q therapeutics and PanCella serves as a consultant of several companies in the regenerative medicine field. His clients include several stem cell and regenerative medicine companies such Stempeutics, Eyestsem, CBR and Megakaryon. He also contributes his expertise on regulatory affairs by serving on regulatory forums and as the CIRM and ISSCR liaison to the ISCT.Dr. Rao was recently named one of the top ten influential people in the stem cell field and was honored recently by the Federation of Biologists (FABA) India for his achievements in the stem cell field and awarded the NBRI medal (India) for his contributions to neuroscience research.
As CSO and Co-Founder of EpiBone, Sarindr leads the R&D team in innovating Tissue Engineered Medical Product to advance skeletal repair from product concept to clinical use. With >15 years of experience in tissue engineering and bioreactor design, he currently leads the development of EpiBone’s three product lines; one of which, a tissue engineered anatomical bone graft, has received IND clearance from the FDA and is currently in Phase I/II clinical trial. Sarindr received a PhD in Biomedical Engineering from Columbia University as well as, BS and MS from Northwestern University and University of Michigan-Ann Arbor, respectively. He has more than 20 peer-reviewed publications and more than 7 patents family that are the core technology of EpiBone.
Dr. Philip Ramsey is a Senior Data Scientist and Statistical Consultant at Predictum. He provides data science consulting services for our software products and several custom projects of integrated analytical systems, specializing in modern experimental design and analysis strategies and application of machine learning to science and engineering. In addition, Dr. Ramsey is a Professor in the Department of Mathematics and Statistics at the University of New Hampshire (UNH) where he teaches courses at the undergraduate and graduate level in design of experiments, machine learning, and statistical methods for quality improvement. He has held the following relevant industrial positions: Senior Engineer for Materials and Processes Development, McDonnell Douglas, St. Louis, MO; Staff Scientist/Statistician, Alcoa Technical Center, Pittsburgh, PA; and Statistician/Senior Engineer, Rohm & Haas Electronic Materials (now Dow), Marlboro, MA. Dr. Ramsey has a Ph.D. in statistics from Virginia Polytechnic Institute and State University.
Janet Rothberg is a Development Manager with the Center for Commercialization of Regenerative Medicine (CCRM) in Toronto and has been with the group since 2016. She received her PhD from the University of Ottawa in Cellular and Molecular Medicine. At CCRM, her work has focused on early scale-up of iPS-derived cell therapies. Her projects have included the translation of cardiac and hepatocyte differentiation protocols from 2D to suspension culture.
Dr. Jaishankar is the Associate Director of the MD Stem Cell Research Fund (MSCRF). In this role, she is responsible for MSCRF business development, scientific management and oversight of portfolio. She interacts with stem cell scientists across Maryland to develop a collaborative research program and promote commercialization of stem cell technologies. MSCRF has thus far invested over $157million in identifying, supporting and accelerating cutting-edge research, innovation, clinical trials and commercialization of human stem cell-based technologies in Maryland. Amritha brings over 10 years of experience in stem cell research in federal, university, and industry settings. Prior to joining the stem cell program, she was a founding member of the Lieber Institute for Brain Development at Johns Hopkins School of Medicine, developing cures for schizophrenia and other neurodevelopmental disorders in partnership with AstraZeneca. She has an MS in molecular genetics from the University of Leicester, UK; a PhD in genetics from Penn State University, and commenced her postdoctoral training as a visiting scientist at the National Institute of Health’s National Institute of Neurological Disorders and Stroke. She has more than 10 years of expertise in human pluripotent and adult stem cell biology and their use in exploratory research, patient-specific disease modeling and assay development for pharmaceutical applications, and is passionate about using stem cell technologies to accelerate cures for patients in need.
On the completion of her studies at Glasgow University in 2000, Fiona began her career working in the laboratories of the MRC Centre for Reproductive Biology in Edinburgh, primarily in the Clinical Andrology Unit. From there, she moved into more commercial roles as a technical specialist and account manager within the biological sciences and healthcare fields. Fiona developed her up to date knowledge of ATMP processes, clinical trials, and GMP requirements as a business development manager at a leading cell and gene therapy contract manufacturing organization prior to joining Proteintech. She became part of the Proteintech team in 2020 to lead the Humankine business in Europe following the completion of the new GMP manufacturing facility in Chicago
Dr Gavin Allsop is the Senior Business Development Manager at OXGENE. He has a degree from the University of Warwick, a PhD from the University of Leeds, post-doctoral experience in cardiovascular antibody production at Badrilla Ltd, and synthetic biology / CRISPR technical experience with Life Technologies. Gavin currently provides technical and consultative support through OXGENE to clients embarking upon the manufacture of AAV, LV and Adenovirus for cell and gene therapy and oncolytic vaccine clinical trials.
