Executive Management
Ken Newport, CA, MAcc, Director and Acting Chief Executive Officer
Ken Newport was appointed to Jennerex's board in 2007 and to the position of acting CEO in September 2011. A chartered accountant, entrepreneur and life sciences business executive, Mr. Newport served as senior vice president and executive committee member at PRA International Inc. for three years until his retirement in 2005. In the mid-nineties he was co-founder and president of CroMedica Inc., a clinical trials contract research organization which was sold to PRA International in 2002. Mr. Newport was also a founding member of Global Biomedical Capital Corporation, Zelos Therapeutics Inc., Prime Trials Inc. and other life science organizations. He is a member of the Institute of Corporate Directors and also serves on the corporate boards of The Opmedic Group and Medgenesis Therapeutics Inc. Mr. Newport earned Honours B.A. and Masters of Accounting degrees from the University of Waterloo.
David H. Kirn, MD, Founder, President and Chief Medical Officer
Dr. Kirn is the global leader in the clinical research and development of oncolytic viruses for cancer. He designed and led clinical development programs and trials with over 10 different agents, and with over 10 different companies and leading academic programs, involving hundreds of patients (Phase 1-3). He held academic and/or faculty positions at Harvard Medical School; the University of California, San Francisco (UCSF); and the University of Oxford. In addition, Dr. Kirn was vice president of clinical research at Onyx Pharmaceuticals. After joining Onyx as the first oncology development employee, he created and initiated clinical development plans in partnership with Bayer for Nexavar, now a marketed product for kidney and liver cancers. He also led the development of a first-in-class oncolytic virus therapeutic through to Phase 3, a corporate partnership with Warner-Lambert and an initial public offering during his tenure. He has been a consultant in cancer biotherapeutics for Pfizer, Novartis, BiogenIdec, Schering AG and other leading oncology companies. He has been an invited advisor on cancer therapy to the National Institutes of Health (U.S.), the Gene Therapy Advisory Committee (U.K.) and the European Agency for the Evaluation of Medicinal Products (E.U.). He has authored over 100 publications in peer-reviewed journals and textbooks. He completed his oncology fellowship at UCSF, his internal medicine residency at Brigham and Women's Hospital, a teaching affiliate of Harvard and was chief medical resident (WR-VA) at Harvard Medical School. He received his MD from UCSF (AOA Honors) and his BS in physiology from the University of California, Berkeley, with departmental citation, Phi Beta Kappa.
John Bell, Ph.D., Chief Scientific Officer
Dr. Bell is internationally-renowned for his leading-edge research using oncolytic viruses to treat cancer. In addition to his leadership role at Jennerex, he is the director of the Ontario Institute for Cancer Research in Biotherapeutics, a program comprised of scientists and clinicians across Ontario whose common objective is to develop viral and immunotherapeutics that improve the quality and length of cancer patients lives. He formed, and continues to lead, the Canadian Oncolytic Virus Consortium, a peer-reviewed, multi-disciplinary group developing virus-based cancer therapeutics. He serves as a senior scientist at the Ottawa Health Research Institute (OHRI), a research institution affiliated with the University of Ottawa and the research arm of The Ottawa Hospital. Prior to his tenure at Jennerex and OHRI, Dr. Bell was a senior scientist at the National Cancer Institute of Canada after launching his independent research career in the biochemistry department of McGill University. Dr. Bell serves on the board of directors for the Canadian Cancer Society and is an executive member of the National Cancer Institute of Canada Clinical Trials Group. His research program has been continuously funded by peer-reviewed grants for over 20 years and he has authored over 90 publications and presentations. He completed his post-doctoral studies at the Medical Research Council in London, England and received his PhD in virology and immunology at McMaster University in Ontario, Canada.
Lara Longpre, MSc, MBA, Chief Operating Officer
Ms. Longpre has over 16 years of clinical research and operations experience in leadership and senior roles in biotechnology and contract research organizations (CROs) and biotech. She has experience in all stages of clinical development and has directly managed several pivotal Phase 3 clinical trials. Her areas of specific expertise include project management, clinical operations, and quality management systems, including achieving ISO 9001:2000 registration and ensuring Sarbanes-Oxley compliance. Prior to Jennerex, she held senior management positions at PRA International, a global CRO, including vice president of proposals and contracts, vice president of quality and process management, director of global regulatory affairs, and director of operations. Ms. Longpre holds an MSc in medical science from Harvard Medical School, an MBA from Queens University, and a BA from Cornell University.
Gregory Schafer, MBA, Chief Financial Officer
Mr. Schafer has more than 20 years of broad functional and strategic leadership as well as senior management expertise including more than 10 years as a chief financial officer (CFO) of public companies in the biopharmaceutical industry. Prior to Jennerex, he served as the CFO of Onyx Pharmaceuticals (approximately $2 billion market capitalization during his tenure) and served as CFO of Cerus Corporation prior to that. While at public biotechnology organizations, he successfully raised over $600 million in capital through a variety of financial instruments, including public offerings, private investment in public equities (PIPEs), equity line and strategic loan facilities. He brings relevant financial knowledge for companies in all stages of drug development including asset acquisition, preclinical development, clinical development and commercialization, and has been an integral member of corporate development review teams. Mr. Schafer serves on the board of directors for Nile Therapeutics. He received his MBA from the Anderson Graduate School of Management at the University of California, Los Angeles and his BSE in mechanical engineering from the University of Pennsylvania.
Mark P. Backer, Ph.D., Senior Vice President of Technical Operations
Dr. Backer has over 20 years of biologics manufacturing and technical operations experience within emerging and established biotechnology companies. Prior to Jennerex, Dr. Backer served as founding chairman and then board member of Molecular Medicine BioServices (now SAFC Biopharma), a viral-based contract manufacturing firm. Previously, he served as CEO and board member for Vaxart, Inc., a private company focused on developing vector-based oral vaccines. Dr. Backer also held management positions of increasing responsibility within Protein Design Labs (vice president), Aviron (now MedImmune Vaccines), Coulter Pharmaceuticals, Systemix, IDEC, Eli Lilly and Genentech. Prior to his tenure in biopharmaceutical companies, he was principal of Biologics Technical Consulting where he provided strategic and technical consulting services supporting developers of biological products. Dr. Backer received his PhD in chemical engineering from the University of Washington and his BS in chemistry from Stanford University.
Helena Chaye, Ph.D., LL.B., VP Corporate Affairs & Intellectual Property
Dr. Chaye has over 15 years of experience in law, intellectual property management, technology transfer and licensing, legal affairs and business development. During her tenure in her legal practice, she represented venture capital funds participating in biotechnology and high tech company financing activities. She provided counsel to her clients regarding general corporate commercial matters, mergers and acquisitions, and corporate finance. Subsequent to practicing law, she was the director of business development at MediGene, Inc., a public biopharmaceutical company. At MediGene, she led in-licensing and out-licensing of technologies for the oncolytic virus product programs and developed intellectual property strategies for multiple programs. She received her PhD in genetics from the University of British Columbia and her law degree from Dalhousie University in Nova Scotia.
Ursula Fritsch, PharmD, Vice President, Regulatory Affairs
Dr. Fritsch has more than 20 years of biopharmaceutical regulatory and quality affairs experience. Prior to Jennerex, she served as vice president of global regulatory affairs and compliance for Anthera Pharmaceuticals, where she was responsible for the strategy and implementation of all U.S. and international regulatory activities for the company's late-stage product portfolio. Previously‚ Dr. Fritsch served as senior director of regulatory affairs at Peninsula Pharmaceuticals‚ where she oversaw the late-stage regulatory strategy and operations for two key compounds, spearheading all regulatory filings including Investigational New Drug (IND) applications, fast-track designation and orphan drug applications. Prior to Peninsula, she served as the head of regulatory affairs at Onyx Pharmaceuticals, providing global leadership for the development of Nexavar® for its original gene therapy program. In addition‚ Dr. Fritsch held various management positions and oversaw several New Drug Application (NDA) approvals at Genentech‚ Inc. and Oclassen Pharmaceuticals. In addition to her tenure in biotechnology companies, Dr. Fritsch also acted as President of East Bay Bio‚ Inc.‚ a regulatory consulting company focusing on strategic drug development and submission work in all phases of development from pre–IND to NDA filing and post approval/marketing issues. Dr. Fritsch received her Doctor of Pharmacy degree from Creighton University and her BA from the University of Nebraska.
Tae-Ho Hwang, DDS, Ph.D., Research Advisor, and Head of Pusan Research Site
Dr. Hwang has over 20 years of experience in the field cancer research, with more than 10 years focused specifically on cancer virotherapy. Prior to Jennerex, he was head of clinical pharmacology at Pusan National University in South Korea and vice president of research for liver and cholangio carcinomas at YangSan Hospital. During his tenure at Pusan National University, he gained practical and clinical knowledge of liver cancer patients and different treatment regimens available. In addition, Dr. Hwang served as a professor at Baylor School of Medicine and Dong-A University School of Medicine in South Korea. Dr. Hwang serves on the board of directors for SillaJen BT Inc. He has authored more than 50 publications in the field of cancer. He was a post-doctoral fellow at Johns Hopkins University and received both his DDS and PhD in physiology from Pusan National University in South Korea.
James M. Burke, M.D., Vice President, Clinical Research
Dr. Burke has approximately 20 years of experience in basic and applied clinical science of genetic and immunotherapy. Prior to Jennerex, Dr. Burke was the Director of Cancer Research at Billings Clinic, where he was also a clinical investigator for JX-594. His clinical research using immunotherapeutics including oncolytic viruses for the treatment of various cancers have advanced the understanding of the medical applications for oncolytic virus therapy. He had previously served as associate director of clinical research at Cell Genesys, Inc., where he was responsible for the development of the oncolytic adenovirus platform of agents and other gene therapy vaccines for the treatment of cancer and other diseases. In addition, after completing his Hematology and Oncology Fellowship at UC San Francisco (UCSF), he was an attending physician at UCSF in the department of hematology and oncology. He received his M.D. from Georgetown University and his B.S. in biochemistry and cell biology from the University of California, San Diego. He is the author of more than 10 key publications and presentations detailing the use of gene therapy and oncolytic viruses to treat cancer. He is board certified in hematology, oncology and internal medicine.
Lucy Chang, Ph.D., Vice President, Quality and Analytical Development
Dr. Chang joined the Company in May 2011 and brought more than 20 years of experience in positions with increasing responsibility in the biopharmaceutical industry, including managing a number of critical outsourced and partnered activities. In parallel with her consulting work over the last few years, Lucy has served as acting head of manufacturing with AP Pharma, and COO of BEING Pharmaceuticals. Previously, she was vice president, manufacturing with Raven Biotechnology which included responsibility for Quality and technical development. Prior positions with Operations and Quality responsibilities were with Genetrol, Coulter Pharmaceuticals, Systemix, Xoma, and Fort Dodge Laboratories. Lucy has an undergraduate degree in biochemistry from UC Berkeley and a Ph.D. in microbiology (with emphasis in virology) from UC Davis.
Samantha Miller, MBA, MSc, Vice President, Corporate Development
Ms. Miller has over 15 years of biotechnology and pharmaceutical business development experience, and has negotiated, executed and managed numerous global partnerships, as well as regional partnerships in the United States, Europe and Japan. She has been involved in executing over 30 partnerships and licenses with companies such as GlaxoSmithKline, Eli Lilly, Johnson & Johnson, AstraZeneca, and Astellas. Prior to Jennerex, Ms. Miller held business development positions of increasing responsibility in various biotechnology and pharmaceutical companies including Anesiva, Theravance, Scios Pharmaceuticals, Onyx Pharmaceuticals and Procter & Gamble Pharmaceuticals. Ms. Miller received her MBA and MS in immunology from the University of Rochester, and holds a BS in biochemistry/cell biology from the University of California, San Diego.
