David Kirn is a biotechnology entrepreneur, physician-scientist and leader in therapeutic viral vector R&D. He is co-Founder, CEO & Chairman of 4D Molecular Therapeutics, and adjunct Professor of Bioengineering at UC Berkeley. He has co-founded and led four companies in the field. He is currently also Executive Chairman of Ignite Immunotherapy Inc, an oncolytic virus cancer vaccine company that he co-founded with Pfizer. In 2013 he was awarded the Johnson & Johnson Entrepreneur Innovator Award from the J&J Innovation Center.
Over the last 20 years, Dr. Kirn has been a leader in therapeutic viral vector and oncolytic virus cancer vaccine R&D. He led the design and development of over 10 therapeutic virus products for cancer oncolysis and/or immunotherapy, involving over 750 patients, including leading clinical trials from first-in-human studies to Phase 3 randomized trials. He was Founder & CEO of Jennerex, a pioneer in oncolytic immunotherapy for cancer, where he led the development of JX-594 (Pexa-Vec; engineered vaccinia virus) from concept into Phase 3. Pexa-Vec was the first armed oncolytic virus to demonstrate 1) intravenous (IV) tumor targeting and efficacy (Nature, 2011), and 2) a significant overall survival benefit in a randomized clinical trial (Nature Medicine 2013).
Through the consulting business that he founded, he led clinical development programs on therapeutic virus cancer immunotherapy products for Biogen and Novartis/Cell Genesys, and consulted in the field for Bayer, Novartis and Pfizer. At Onyx Pharmaceuticals, he was on the founding R&D team and he led the Onyx-015 oncolytic adenovirus program from concept to Phase 3. He co-authored papers reporting firsts for oncolytic viruses including 1) targeting of tumor suppressor-deficient cells (Science 1996, Nature Medicine 1997 and Nature Medicine 2000), 2) the first Phase 1-3 clinical trials with an engineered oncolytic virus, and 3) the first clinical trial demonstrating combination therapy efficacy (Nature Medicine 2000).
Dr. Kirn has held faculty positions at UCSF Medical School, the University of Oxford & UC Berkeley. He has co-authored over 100 publications, including publications in Nature, Nature Medicine, Nature Biotechnology, Science, Science Translational Medicine and others. He earned degrees from the University of California, Berkeley (BA; Departmental Citation as top graduate within the major; Phi Beta Kappa honor society); UCSF Medical School (Alpha Omega Alpha medical honor society); Harvard Medical School (Internal Medicine resident at Brigham & Women’s Hospital, Chief Medical Resident at WR-VA Hospital). He completed hematology-oncology and clinical research fellowships at UCSF, and a degree from Haas Business School at UC Berkeley.
David Schaffer is a Professor of Chemical and Biomolecular Engineering, Bioengineering, and Neuroscience at University of California, Berkeley, where he also serves as the Director of the Berkeley Stem Cell Center. He graduated from Stanford University with a B.S. degree in Chemical Engineering, and from Massachusetts Institute of Technology with a Ph.D. in Chemical Engineering. He did a postdoctoral fellowship in the laboratory of Fred Gage at the Salk Institute for Biological Studies in La Jolla, CA. At UC Berkeley, Dr. Schaffer applies engineering principles to enhance stem cell and gene therapy approaches for neuroregeneration, work that includes novel approaches for molecular engineering and evolution of new viral vectors as well as new technologies to investigate and control stem cell fate decisions.
After training as a biochemist, chemical engineer and molecular biologist, Anthony Davies has worked in the cell and gene therapy field for some 20 years. At Onyx Pharmaceuticals, he was involved in the development of the kinase inhibitor BAY 43-9006, now better known as Nexavar, a cancer drug approved worldwide which reached >$1B sales in 2012. He also led process development of multiple live-virus gene therapy products, at scales reaching from bench through multi-thousand litre in pre-commercial mode. At Geron Corporation, Dr. Davies served as Vice President, Product Development and was responsible for all cell therapies’ process and analytical science and manufacturing, including both autologous and allogeneic products. During his tenure, the world’s first IND for a human embryonic stem cell-derived product was successfully filed with the FDA and tested in a human clinical trial.
While Dr. Davies was Chief Technology Officer at Capricor Therapeutics, a large, randomized, placebo-controlled clinical trial for an allogeneic cardiac stem cell product was initiated. The company became publicly traded by reverse merger, and a CMC-focused collaboration agreement was executed with Janssen Biotech, Inc. worth up to $325M. Dr. Davies is founder and Executive Chairman of Dark Horse Consulting, a boutique practice focused on strategic CMC and product development issues in cell and gene therapy. He is currently Chief Operating Officer of 4DMT, where he is responsible for day-to-day operation of the company and all aspects of process development and manufacturing of a highly novel portfolio of AAV-based gene therapy vectors.
Theresa Janke has over 15 years of experience in the biopharmaceutical industry, including clinical research and operations, alliance and program management, and business operations. She’s worked in diverse fields including immunotherapy, gene therapy, oncolytic virus therapy, and medical devices. She was a founding member of the management team at 4DMT, and is co-founder and board member of IGNITE Immunotherapy.
Theresa started her career in clinical research in medical devices with Allergan and Abbott. She later expanded into oncology therapeutics R&D, serving as Clinical Project Manager and Director of Clinical Operations at Jennerex Biotherapeutics, a pioneer in intravenous oncolytic virus immunotherapy. There she directed and conducted execution of clinical trials with Pexa-Vec (JX594, an engineered oncolytic vaccinia virus), including the first randomized Phase 2 oncolytic immunotherapy trial to show a statistically significant survival benefit (published in Nature Medicine, 2013). At Jennerex, she managed all aspects of study start-up: RFP process/CRO and specialty lab selection, protocol design/development, development of trial timelines and budgets, forecasting of clinical and non-clinical supplies, and development of trial plans, site selection, clinical site team training, and management, vendor selection and management, risk assessment and mitigation, managing internal and vendor timelines and budgets, collecting and analyzing performance metrics, compilation, analyses and reporting of clinical and safety data.
Theresa has directed multiple international partner alliances and has experience as a multi-national trial leader in the US, Canada, South Korea, Taiwan, China, Germany and France.
At Celgene, as Director of Clinical R&D Strategy and Alliances, Theresa worked closely with the SVP of Clinical R&D for hematology-oncology; she led the development of Clinical Research and Development (CR&D)-Regulatory 5-year integrated Clinical Development Plans (CDP) for each disease area within the hematology-oncology group.
Theresa graduated from the University of California, Santa Barbara in 1996 with a Bachelor of Science in Biopsychology. She also holds professional certificates from UC Berkeley in the area of clinical project management.
Dr. Johnson has roughly 18 years of experience in cutting edge biological sciences and biotherapeutics R&D, and with 10 years of leadership experience at Genentech, the world leader in biologics R&D and commercialization. As an experienced biologist, geneticist and preclinical researcher and therapeutics developer, Dr. Johnson has worked on antibodies, oncolytic virus gene therapy vectors, viral vector gene transfer and production, and small molecule kinase inhibitors. She completed her PhD in Biology at MIT in the lab of Tyler Jacks, a world-class in vivo animal disease modeling group. Her industry experience started at Onyx, a pioneering cancer therapeutics company that went public and eventually was sold for roughly $10B. At Onyx she started as a post-doc and rose quickly to take leadership of a new viral vector gene therapy product development program. She subsequently held a leadership role at Exelixis, a scientifically- and genetically-driven biotherapeutics company that is now public. Most recently, at Genentech she ran scientific and preclinical development teams with a focus on in vivo animal models (including genetically-engineered mouse models of disease), pharmacodynamics, lentivirus-based gene delivery and production and therapeutics research and development.
Working closely with 4DMT partnered R&D and CMC organizations, Dr. Johnson drives the process of identifying novel vectors, characterizing them, designing and engineering new therapeutic candidates, progressing them through preclinical pharmacology-toxicology and biodistribution studies, and ultimately leading to the initiation of testing in human clinical trials.
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