DAVID KIRN, MD
Co-Founder, President & CEO, Chairman
Dr. David Kirn is a physician-scientist, experienced biotech business executive and entrepreneur, and global leader in the design and clinical R&D of viral vector genetic therapies. Dr. Kirn is an Adjunct Professor of Bioengineering at UC Berkeley. He was a founder at three successful genetic therapy-viral vector companies, led the development of three novel viral vector-based product platforms resulting in over 10 different products, and he designed and led roughly 30 clinical trials (Phase 1-3) involving over 800 patients treated with viral vector gene therapies.
ENTREPRENEURSHIP IN GENETIC THERAPY: At Onyx Pharmaceuticals he was VP, Clinical R&D and a founding management team member. During his tenure leading product development, the company executed three pharmaceutical partnerships and a successful IPO (eventually sold for ~$10 Billion to Amgen). He led over 15 clinical trials involving over 400 patients in Phase 1-3 with an ad- enovirus-based genetic therapy for cancer. He was then Founder & CEO of Jennerex, the pioneer in oncolytic immunotherapy for cancer with vaccine virus vectors. He successfully raised over $50 Million dollars and executed three biotech partnership deals, while leading over 10 clinical trials involving over 250 patients in Phase 1-2b. He sold the company for ~$150 Million dollars with earn-out payments. Finally, he co-founded 4D with David Schaffer in 2013.
In 2013 he was the inaugural recipient of the Johnson & Johnson Entrepreneur-Innovator Award.
BIOTHERAPEUTIC PRODUCT CLINICAL DEVELOPMENT: Dr. Kirn has led product translation and clinical R&D with over 10 biotherapeutic agents involving over 800 patients in Phase 1-3 trials. He served as SVP Clinical R&D at Celgene, VP Clinical R&D at Onyx Pharmaceuticals, and consulting clinical project leader for biological therapies at Biogen Idec, Novartis-Cell Genesys, and Intermune.
ACADEMIC POSITIONS: Dr. Kirn is an Adjunct Professor of Bioengineering at UC Berkeley. Dr. Kirn held academic faculty positions at the University of California, San Francisco (UCSF); Imperial College (London); and the University of Oxford. He co-authored over 100 publications in peer-reviewed journals, including Nature, Nature Medicine, Nature Biotech, Nature Reviews Cancer, Science & Science Translational Medicine. He completed oncology fellowship at UCSF, internal medicine residency at Harvard Medical School (Brigham and Women’s Hospital), and was chief medical resident at a Harvard teaching hospital. He received his MD from UCSF (AOA Honors) and BA in Physiology from UC Berkeley (Departmental Citation, Phi Beta Kappa).
DAVID SCHAFFER, PHD
Co-Founder, Acting CSO, Co-Chairman
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 In- stitute of Technology with a PhD 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.
AWARDS: David Schaffer has received an NSF CAREER Award, Office of Naval Research Young Investigator Award, Whitaker Foundation Young Investigator Award, and was named a Technology Review Top 100 Innovator. He was also awarded the Biomedical Engineering Society Rita Shaffer Young Investigator Award in 2000, the American Chemical Society BIOT Division Young Investigator Award in 2006, the American Chemical Society Marvin John- son Award in 2016, and was inducted into the College of Fellows of the American Institute of Medical and Biological Engineering in 2010.
PUBLICATIONS, EDITORIAL & SCIENTIFIC ADVISORY BOARDS: Dr. Schaffer has over 180 scientific publications, has served on 7 journal editorial boards and 7 industrial scientific advisory boards, and is currently the Secretary and a Board of Directors member of the American Society for Gene and Cell Therapy (the premiere gene therapy society). He serves on the Board of Directors for UniQure (QURE, NASDAQ).
HOYOUNG HUH, MD, PHD
Hoyoung Huh, MD, PhD brings a wealth of expertise on transformational and emerging approaches to biological therapeutics and an extensive scientific and executive leadership background within the biotechnology industry. As current Chairman of Cytomx Therapeutics (NASDAQ:CTMX) and Chairman of Geron Corporation (NASDAQ:GERN), Dr. Huh has been involved in the formation, management and financing of more than 20 successful biotechnology entities across the United States, Europe and Asia.
Dr. Huh was previously the president and CEO of BiPar Sciences Inc., which was acquired by Sanofi-aventis in 2009. He also served as the Chairman of Epizyme Inc. (NASDAQ:EPZM), chief operating officer and board member of Nektar Therapeutics (NASDAQ:NKTR), and board member of Facet Biotech (NASDAQ:FACT), which was acquired by Abbott Laboratories in 2010. Dr. Huh was formerly a partner at McKinsey & Company in the healthcare and technology practices. Dr. Huh holds a AB in biochemistry from Dartmouth College, an MD from Cornell University Medical College, and a PhD in genetics and cell biology from Cornell University/Sloan-Kettering Institute.
CHARLES P. THEUER, MD, PHD
Dr. Theuer has been CEO and President of TRACO, and a Director of TRACON Pharmaceuticals (NASDAQ: TCON) since 2006. Prior thereto, from October 2004 to July 2006, Dr. Theuer was Chief Medical Officer at TargeGen Inc., where he led the development of small molecule kinase inhibitors in oncology (including fedratinib, a jak2 inhibitor), ophthalmology and cardiovascular disease. From October 2003 to October 2004, Dr. Theuer was the Director, Clinical Oncology at Pfizer, where he led the clinical development of Sutent® (sunitinib maleate) in kidney cancer; Sutent® was approved by the U.S. Food and Drug Administration in January 2006 for treating advanced kidney cancer.
Prior thereto, Dr. Theuer held senior positions at IDEC Pharmaceuticals, from June 2002 to October 2003, and the National Cancer Institute developing other agents, including small molecules and monoclonal antibody therapies. Dr. Theuer holds a B.S. degree from the Massachusetts Institute of Technology, an MD degree from the University of California, San Francisco and a PhD degree from the University of California, Irvine. He completed a residency in general surgery at Harbor-UC- LA Medical Center and was Board Certified in general surgery in 1997. Dr. Theuer held academic positions at the National Cancer Institute (NCI) and at the University of California, Irvine, where he was a member of the Division of Surgical Oncology. His previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, as well as gastrointestinal cancer epidemiology.
MARGI MCLAUGHLIN, PHD
Margi McLoughlin is an Executive Director in Worldwide Business Development (WWBD) at Pfizer based in South San Francisco, CA. Margi currently works with Pfizer’s Worldwide R&D (WRD) organization to invest in companies working in areas aligned with the future directions of WRD. Through these investments, she works with the companies and WRD leadership to help advance products and technologies of value to the pharmaceutical industry. In addition to advancing these investments, Margi supports the WRD organization’s research portfolio through a range of deals that include collaborative research agreements, equity investments and corporate acquisitions.
Margi held a position in Discovery Research at Mallinckrodt Medical, developing diagnostic pharmaceuticals for nuclear medicine, MR and X-ray imaging. After five years in the laboratory, Margi spent two years in Technology Planning at Mallinckrodt Medical, where she supported internal R&D through outside alliances. In 1999, she moved to Yale University where she worked as Associate Director in the Office of Cooperative Research. Since joining Pfizer in 2001, she has had roles of increasing responsibility in WWBD and has had a significant role in defining Pfizer’s Centers for Thera-peutic Innovation and led transactions with Ablexis, Coley, Excalliard, Gliknik, Medarex, Scil, MorphoSys (Sloning) and Theraclone. Margi received a PhD in chemistry from the University of California, Santa Barbara and completed postdoctoral work at Washington University.