October 23-24, 2018, Bethesda, MD
Michael Blackton is responsible for the global quality organization at Adaptimmune inclusive of Quality Control, Analytical Development, Quality Assurance, and Quality Lifecycle Management spanning sites in the Philadelphia Navy Yard and Oxford, UK. Michael's career spans over 25 years in biotechnology, medical device and pharmaceuticals where he has held leadership positions in manufacturing, quality, operations, and engineering. Prior to joining Adaptimmune, he spent 11 years with Eli Lilly and Company and ImClone in roles of increasing responsibility directing facilities maintenance operations, qualification, cleaning validation, multi-product strategies, regulatory documentation, and technology transfer initiatives supporting a portfolio of products and approvals, including CYRAMZA® (ramucirumab). Prior to joining Lilly, Mr. Blackton served in various quality management roles at Millennium Pharmaceuticals and Inhale Therapeutics. He earned his Master of Business Administration degree from New York University.
Currently Senior Vice President of Process Development - Cell Theray at Kite Pharma, a Gilead Sciences company. Vijay has 25 years of biotech industry experience with companies like Scios, Avigen, Hoffmann-La Roche, Johnson & Johnson, Amgen and Kite Pharma.
E.J. has over 35 years in life sciences including small molecules, devices and pivotal biotechnology products, and is currently the Sr. Vice President of Quality for Inovio Pharmaceuticals, where he has quality oversight of a combination Medical Device and DNA therapeutic platform. He was previously Sr. Vice President of Quality and Regulatory Affairs at Ajinomoto Althea Technologies, specializing in CMO biotech processing and aseptic filling. He was the Sr. 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 the past Chairman of the PDA Biotech Advisory Board, author of several PDA Technical Reports, and is the past President of ISPE, San Diego. He holds an MBA from UOP and a BA in Biology from UCSD.
Kim Carnes has 19 years of work experience in the biotechnology field with 16 of those years spent in Quality Assurance operational and compliance roles. She has worked at Celera Genomics, Human Genome Sciences (HGS), and GlaxoSmithKline (GSK) supporting both clinical and commercial biotechnology products. In her current role at REGENXBIO, a gene therapy company, she has responsibility for implementing Quality Systems and overseeing compliance for GXP activities.
Mr. Caudle is Associate Director of Emerging BioPharma R&D Solutions at IQVIA, the Human Data Science Company™ that mobilizes unparalleled data, analytics, technology, and expertise through solutions connecting stakeholders to improve health. He has business experience across pharmaceuticals, biotech, and medical devices helping clients to proactively interpret regulations, understand processes and product technologies, make sound decisions, facilitate change, and drive business benefit. He assists Emerging BioPharma companies plan and implement highly targeted, data-driven clinical trials to advance an asset from first-in-man through global Phase III studies. Mr. Caudle currently serves as President-Elect on the Board of Directors for the Parenteral Drug Association in the Southeast U.S. and on several conference planning committees. He holds an MS in Food Science and a BS in Nutrition Science from Auburn University.
Ms. Riley is Associate Director, Quality Systems at Merck. Previously she worked for NewLink Genetics Corporation, a biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology products to improve the lives of patients with cancer with oversight of external quality management. Her career includes over 23 years in engineering, quality assurance, validation, and project management at companies such as NewLink Genetics, GlaxoSmithKline, Johnson and Johnson, and Fluor Daniel. She is currently a member of the PDA Cell and Gene Therapy Task Force.
Dr. Gregory Block is the Vice President of Corporate Development for Universal Cells, a Seattle-based cell therapy company founded in 2013. As the first hire at the company, Dr. Block helped the founding team build and grow the company to establish an R&D and manufacturing enterprise focused on producing clinical-grade gene edited stem cell products. The company was acquired for $102 million by Astellas Pharmaceuticals in February 2018, where he continues to support advancement of innovative therapies.
Dr. Block holds a doctorate in Molecular Biology from Tulane University in New Orleans and a Masters of Biochemistry from the University of Toronto, where he studied the mechanisms of stem cell tissue regeneration and chromatin organization [under Dr. Darwin Prockop and Dr. David Bazett-Jones respectively]. He completed his postdoctoral fellowship at the University of Washington where he discovered mechanistic insights and established the first cellular assays for measuring the underlying genetic defect for Facioscapulohumeral Muscular Dystrophy (FSHD). Dr. Block has since served on the board of directors and scientific advisory board of Friends of FSH Research, an organization devoted to finding a cure for FSHD.
Mrs. Francis joined Kite in 2016 to provide leadership and quality oversight for key startup activities at the commercial manufacturing site and is currently responsible for the commercial Quality Systems and Compliance organization. Mrs. Francis has a Master’s degree in Chemical Engineering and has spent 15 years in various roles in development, validation, quality systems build and oversight, and clinical and commercial operations within both established and start-up organizations.
Dr. Ian Gaudet studied Bioengineering at the University of California, San Diego, and received his doctorate in Biomedical Engineering jointly from Rutgers University and the University of Medicine and Dentistry of New Jersey. Following his Ph.D., Dr. Gaudet worked for Progenitor Cell Therapy (PCT) where he was the Sr. Engineer and then Director of Innovation and Engineering, leading a scientific and engineering team in support of design, development, and implementation of clinical cell therapy manufacturing processes, as well as cell therapy commercialization strategy consulting. Dr. Gaudet led multiple new client projects from tech transfer, development, and into clinical manufacturing, including multiple hematopoietic stem cell therapies. He also led the development efforts for the first CliniMACS Prodigy-based commercial cell therapy into FDA-approved clinical trials. He joined Miltenyi Biotec, Inc. (MBI) in 2016 and is currently the Director of Process Development at MBI’s Sunnyvale, CA, cell therapy CDMO facility, working to bring new therapies into the clinic while ensuring long term commercial feasibility.
Heidi is a Co-founder and Chief Strategy Officer for Vineti Inc., a company that is scaling and digitizing cell and gene therapies through an advanced software platform and data analytics. Heidi is also an advisor for a variety of cell therapy companies and currently sits on the Board of Directors for Vericel Corporation, a commercial cell therapy company that markets and produces MACI and Epicel for orthopedic and wound healing indications. In her career, she has overseen operations that have produced more than 100,000 doses of cell therapy.
Heidi has a proven track record in leading operations and commercializing innovative technologies worldwide. She is the former Global COO for SOTIO a.s. in Prague, CZ Republic. Before joining SOTIO she worked at Dendreon for ten years as Senior Vice President of Operations, where she was responsible for Technical Operations, among other duties. She built the commercial U.S. Provenge facilities and operations (the first active cellular immunotherapy approved in both the US and EU) and led all operations for the U.S. and the EU. Before Dendreon, she spent ten years with Immunex Corporation. Heidi has a B.S. in Cell and Molecular Biology, M.S. in Bioengineering, and M.B.A. from the University of Washington.
Peter L. Hoang brings over twenty years of investment banking, venture capital, immuno-oncology and public company executive management experience to Marker Therapeutics, Inc., serving most recently as President & CEO of TapImmune Inc. (Nasdaq: TPIV), one of the predecessor companies that merged to form Marker Therapeutics. He has also served as Senior Vice President of Business Development & Strategy at Bellicum Pharmaceuticals (Nasdaq: BLCM). Previously, as the Managing Director of Innovations at The University of Texas MD Anderson Cancer Center, he headed the new venture formation and development effort for the institution. There, he led the commercialization of MD Anderson’s Sleeping Beauty transposon-based CAR-T program, resulting in the largest public company-to-academic research institution upfront deal in history. Before joining MD Anderson, Mr. Hoang was a Managing Director and head of healthcare mergers & acquisitions advisory for CIT Group (NYSE: CIT). He also served as a senior investment banker in the M&A departments at Oppenheimer, J.P. Morgan, Merrill Lynch, and Deutsche Bank. He earned an M.B.A. with high honors distinction from the Anderson School of Management at UCLA and a B.A. from Yale University.
Dr. Kwilas received her B.S. in Animal Science from West Virginia University in 2002.
She then received her Ph.D. in Biomedical Science from The Ohio State University in 2010 with an emphasis in Molecular Virology & Gene Therapy and Translational Science. Graduate research was performed at The Research Institute at Nationwide Children’s Hospital under the direction of Dr. Mark Peeples examining the potential application of respiratory syncytial virus (RSV) as a gene therapy vector for the treatment of cystic fibrosis.
Performed post-doctoral research at the National Cancer Institute in the laboratory of Dr. Jeffrey Schlom investigating the efficacy of modified vaccinia virus Ankara (MVA) and adenovirus-based cancer vaccines alone and in combination with approved and investigational cancer therapeutics. Designed and conducted proof of concept studies of MVA-TWIST-TRICOM supporting the clinical development of MVA-Brachyury-TRICOM.
Received Interagency Oncology Task Force Fellowship in 2015. Began conducting research at the FDA involving the generation of safer vector producing cells with the use of CRISPR/Cas9 genome editing technology and participating in the regulatory review of gene therapy product chemistry, manufacturing and control (CMC). In May 2016, accepted a full-time gene therapy CMC reviewer position at the FDA.
Dr. Sheng Lin-Gibson is the Chief of the Biosystems and Biomaterials Division (BBD) at the National Institute of Standard and Technology (NIST). BBD has a multidisciplinary technical portfolio that includes genomic measurements, synthetic biology, regenerative medicine and advanced therapies, biomaterials, diagnostics, and complex microbial systems. BBD carries out its mission through fundamental research in measurement science, the development of new technologies, and the deployment of new measurement solutions, including reference materials and data. She serves as the Chairperson of the U.S. Technical Advisory Group (TAG) to ISO/TC 276: Biotechnology as well as the Convenor of ISO/TC 276 Working Group 3: Analytical Methods. She leads or contributes to the development of several international standards particularly relevant to cell and gene therapy manufacturing and characterization. Dr. Lin-Gibson is the NIST lead of various joint NIST/SCB efforts to coordinate the development of standards for regenerative medicine. She co-chairs the Multi-Agency Tissue Engineering Science (MATES) Working Group, an ad hoc interagency group that ensures communication and coordination of US Federal Agencies. She has coauthored over 80 peer-reviewed publications, served on numerous NSF, NIH, and NIST expert review panels, and is a recipient of three US Department of Commerce Bronze Medals.
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
Thomas has over 2 decades of experience in biotechnology spanning discovery to commercialization. He has held positions of increasing authority responsible for development, technology transfer, validation, and operations. He has designed facilities for multiple companies, authored patents and presented extensively. He is active in BPOG and other organizations and serves on scientific advisory boards for developing companies. He currently serves on the FDBT leadership team and is responsible for TBF-100 manufacturing, late phase fill/finish, facilities, engineering, automation, validation and EHS.
Patrick Pezzoli is the Director of the Product Characterization group at Inovio Pharmaceuticals and has been with the company for three years. The group is responsible for the development of potency assays for the company’s pipeline of drug products as well as other product characterization efforts such as, stability, identity, and in vivo immunogenicity. The Product Characterization group is also responsible for developing pharmacokinetic and antidrug antibody analytical assays for Inovio’s clinical trials. Mr. Pezzoli has over thirty years of biotechnology experience that also includes gene expression analysis and compound screening bioassays.
Dr Qasim Rafiq is an Associate Professor at University College London in Cell and Gene Therapy Bioprocessing. He is a multidisciplinary engineer working at the life science, engineering and commercial interfaces and his research focuses on the bioprocessing, automation and biomanufacture of cell and gene-based therapies.
He currently leads a research portfolio of >£2.5m and heads up the Advanced Therapy Bioprocess Engineering group at UCL which includes 4 post-doctoral researchers, 5 PhD students and 3 MSc students.
Prior to joining UCL, he was an Assistant Professor at Aston University where he established the Bioprocess Engineering Group. He completed his PhD at Loughborough University investigating the scalable manufacture of human mesenchymal stem cells in bioreactors.
He has specific interest in addressing the large-scale manufacturing challenges and enhancing process and product understanding to enable successful translation from the laboratory to the clinic. This includes development of enabling tools and manufacturing processes for cell and extracellular vesicle production
He is both a Chartered Engineer (CEng) and Chartered Scientist (CSci) and sits on multiple scientific and engineering committees including ESACT-UK, the IChemE Biochemical Engineering Subject Interest Group and The BIA’s Cell and Gene Therapy Advisory Committee.
David Smith leads the Innovation & Engineering Center at Hitachi Chemical Advanced Therapeutics Solutions’ with the drive to develop, evaluate and provide novel technology solutions in order to realize commercial success of cell therapies. Before joining the company in 2015, David completed his PhD at Loughborough University establishing Quality by Design principles within cell therapy manufacturing with an interest in Process Analytical Control. Prior to this, David completed a Masters in Biochemical Engineering based at University of Bath, along with extensive periods at UNSW, Australia and DSM, Netherlands. This interdisciplinary background allows David to enhance the robustness and reproducibility of processes whilst analyzing costs and sustainability to supplement Hitachi Chemical Advanced Therapeutics Solutions’ Development by Design paradigm.
Mr. Stout joined Adaptimmune in 2017 as Director of Global Sourcing & Procurement. As the first sourcing professional to join the organization, his primary focus has been on ensuring the reliable supply of critical materials and services in support of the start-up of manufacturing operations. He has also initiated the process of building out the sourcing organization and implementing best in class sourcing methodologies. Prior to joining Adaptimmune, he held sourcing leadership positions at GSK supporting Vaccine Manufacturing & Clinical Operations and at Merck supporting Pre-Clinical Biologics & Vaccines. Prior to entering the pharmaceutical industry, Mr. Stout began his sourcing career supporting manufacturing operations at Schindler Elevator and Tyco Electronics.
Dr. Weiner is the Wistar Institute Professor & WW Smith Chair in Cancer Research, Director Vaccine Center & Executive Vice President of the Wistar Institute,
Professor Emeritus University of Pennsylvania School of Medicine.
Dr. Weiner directs a translational research laboratory, in the area, of Molecular Immunology. His group is one of the pioneering research teams in establishing the field of DNA Vaccines & Immune Therapies. His laboratories & collaborators accomplishments include the first clinical studies of DNA vaccines, clinically important advances in gene optimization as well as in DNA delivery. His group developed the first clinically efficacious DNA vaccine (HPV immune therapy) and has moved synthetic DNA MERS, HIV, Ebola and Zika vaccines through development into clinical studies. His laboratory has published over 400 papers/chapters & reviews. Dr. Weiner has received multiple awards/honors, including the NIH Directors Translational Research Award (2011), the WW Smith Family Chair in Cancer Research – 2016, Top 20 Translational Research Laboratories of the Year (Nature Biotechnology 2016 & 2017), Fellow of the American Association for the Advancement of Science 2011. Fellow of the International Society for Vaccines 2014, President International Society for Vaccines (2018-2020). Dr. Weiner remains an avid trainer and advisor for students/fellows and is highly committed to the development of the careers of young scientists.