ISCT Open Access Webinars

Webinar Description:

Investors have access to large amounts of clinical and market data, however they don’t always have visibility to the details of developing, manufacturing, and distributing autologous cell therapies.

This webinar considers a variety of perspectives, from academic clinical center manufacturing through to large scale biopharma deployment.  The speakers will discuss their cell therapy journey, areas where the industry is making real progress and areas that are lagging. The audience should come away from this webinar with a greater understanding of autologous process details and where to focus effort when executing diligence in this field.

Autologous Cell Therapy Webinar 1 of the ISCT I to I Due Diligence Roadmap Series Presented by the Business Development and Finance Committee

Co-Chaired By: 

Phil Vanek, PhD ISCT Business Development & Finance Committee Member Chief Technology Officer, GammaBio United States

Speakers:

Maria Fardis, PhD Venture Partner, Frazier Life Sciences United States

Maria Fardis, Ph.D., is a Venture Partner at Frazier Life Sciences and is the Chair of Board of Directors at Obsidian Therapeutics and a member of the Board at CRISPR Therapeutics. She has over 20 years of scientific and management experience in numerous public and private companies. Dr. Fardis previously served as President and Chief Executive Officer of Iovance Biotherapeutics, a publicly traded Biotechnology company. As CEO at Iovance, she led the transformation from an early-stage development company to a company with multiple late-stage programs for the treatment of solid tumors with TIL cell therapy. Prior to Iovance, Dr. Fardis served as the Chief Operating Officer of Acerta Pharma B.V., where she worked on the development of Calquence® until the company’s acquisition by AstraZeneca. Prior to that, she worked at Pharmacyclics, Inc., where she was a key contributor in the creation of a broad clinical program leading to global approvals for Imbruvica® in multiple hematologic malignancies, and where she served as Chief of Oncology Operations and Alliances. Before Pharmacyclics, Dr. Fardis held increasing senior positions in medicinal chemistry and the project and portfolio management at Gilead Sciences, Inc., where she was involved with multiple therapeutic areas including antivirals, oncology, and cardiovascular therapeutics and worked on the development and life cycle management of Letairis®.Maria received her Ph.D. in Organic Chemistry from the University of California, Berkeley and her B.S. summa cum laude, in chemistry from the University of Illinois, Urbana-Champaign. She also holds an M.B.A., received with highest honors, from Golden Gate University.

Jim Faulkner, PhD Venture Partner, AppleTree Partners (ATP) United Kingdom

Jim Faulkner is a venture partner at ATP. A highly experienced biopharmaceutical development leader with specialist skills in gene and cell therapy, he has been significantly involved in taking more than 25 different medicines into the clinic, including multiple CAR-T assets. Most recently, Jim headed Product Delivery for Autolus Ltd, a clinical-stage CAR-T company spun out of University College London. During his tenure, he set up and led a team of over 75 scientists and engineers in the US and UK responsible for process development, technical operations, engineering and supply chain, and he served on the leadership team that took Autolus from start-up to successful IPO in three years. Prior to that, Jim held various leadership roles at GlaxoSmithKline, including overseeing the chemistry, manufacturing and controls (CMC) development and supply of a portfolio of pioneering product types that included gene and cell therapies, oligonucleotides, therapeutic enzymes, and molecular chaperones, and playing a significant role in the successful filing of the first-ever autologous ex vivo gene/cell therapy product license (for Strimvelis™).

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Rodney L Rietze, PhD CEO, iVexSol United States

Dr. Rod Rietze is co-founder and CEO of iVexSol (intelligent Vector Solutions), Inc., a viral vector contract manufacturer founded on a transformative technology that enables the production of stable lentiviral vectors at any scale. Prior to this, Rod was the Director of Strategic Development and Innovation at Novartis Cell and Gene Therapy (Cambridge, MA), where he supported the clinical development and manufacture of a number of next generation cell and gene therapies, including Kymriah™, the first FDA-approved CAR-T cell-based gene therapy. Before joining Novartis, Rod led research and development teams of both small molecule and cell- based therapeutics at Pfizer Regenerative Medicine (Cambridge, UK) and TxCell SA (Sophia Antipolis, France). During his tenure in academia, Rod co-founded the 400-member Queensland Brain Institute (Brisbane, Australia), where his lab focused on harnessing the regenerative capacity of resident neural stem cells as a means to treat age-related cognitive decline. His work was featured on the front covers of Nature and Science, and received numerous awards including Science Magazine’s “Breakthrough of the Year”. With over two decades of technical, operational and strategic leadership experience in the development of novel therapeutics, Rod remains passionate about discovering and delivering innovative technologies and medicines to transform the treatment of disease. He holds a B.Sc. and M.Sc. from the University of Calgary, Canada and a Ph.D. from The Walter and Eliza Hall Institute of Medical Research (University of Melbourne, Australia).

Isabelle Rivière, PhD Director, Cell Therapy and Cell Engineering Facility, Memorial Sloan-Kettering Cancer Center United States

Isabelle Rivière received her Ph.D. in Cellular and Molecular Biology from the University of Paris.  She initiated her graduate studies at the Institut Curie in Paris and completed her thesis at the Whitehead Institute in Cambridge, MA.  She developed retroviral vectors (MFG/SFG) for in vivo long-term expression of transgenes in hematopoietic cells, which are widely used in clinical studies worldwide. After completing her postdoctoral work at NYU, she joined the faculty of Memorial Sloan-Kettering Cancer Center in 1999 where she focuses on developing novel strategies for cell therapies and immunotherapies.  Her laboratory investigates genetic approaches to enhance various cell types including T lymphocytes and stem cells for the treatment of cancer and genetic blood disorders.  Over the past 20 years, she has conceived and implemented multiple cell manufacturing processes for several Phase I/II clinical trials. Her lab has manufactured more than 500 cell therapy drug products and currently supports multiple CAR T cell-based clinical trials for the treatment of hematological malignancies and solid tumors. She also investigates immunological functions of CAR T cells in clinical trials and animal models. She currently serves as a member of the Board of Directors of the American Society of Gene and Cell Therapy (ASGCT) and previously served on the Board of Directors of the Alliance for Regenerative Medicine (ARM). She also serves on the Advisory Board of the Center for Commercialization of Cancer Immunotherapy C3i (Canada) and the National Science Foundation (NSF) Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT). She is Scientific Co-founder of Juno Therapeutics Inc and Mnemo Therapeutics.