David McDonald serves as SillaJen’s Chief Business Officer, with responsibility for strategic planning, corporate development, partnering and licensing initiatives. Prior to joining SillaJen, McDonald served as Executive Vice President, Business Development and Chief Financial Officer of Delcath Systems, Inc. from September 2009 to April 2013. He was formerly the Senior Vice President of Business Development at AngioDynamics, Inc., where he led the company’s strategy, licensing and acquisition activities. Mr. McDonald founded Minneapolis-based Cornerstone Healthcare Advisors LLC in April 2005, which he led until joining AngioDynamics in July 2008. At Cornerstone, he provided advisory and consulting services to emerging medical technology companies and their financial sponsors. Prior to 2005, Mr. McDonald was a Managing Director and leader of Medical Technology Investment Banking at RBC Capital Markets. Before his involvement with these companies, Mr. McDonald was a Senior Vice President and Equity Portfolio Manager at Investment Advisers, Inc. as well as a research analyst covering the healthcare industry for more than a dozen years. He received a Bachelor of Arts Degree in Economics from St. Olaf College in Northfield, Minnesota in 1982.
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.
Ms. Longpre joined the Company in April 2008 as a clinical consultant and became chief operating officer in June 2010. She has over 19 years of drug development and operations experience in leadership and senior roles in biotechnology and contract research organizations (CROs). She has wide-ranging experience in strategic planning, project management and all phases of clinical development including direct management of several global pivotal trials. Prior to Jennerex, she was senior vice-president, clinical and corporate development at MedGenesis Therapeutix. Ms. Longpre has also held senior management positions of increasing responsibility 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 during which time she was responsible for global clinical programs in several therapeutic areas. Ms. Longpre holds an MSc in medical science from Harvard Medical School, an MBA from Queens University Executive Program, and a BA from Cornell University.
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.
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.
Dr. Roth has over 20 years of experience in the biopharmaceutical industry. He is the founder of Roth Bioprocessing Consulting (RBC), an international consulting firm advising clients on all aspects of product development and manufacturing. RBC has worked with clients in the US, EU and China and is also a member of a German consultants network group.
Prior to the founding of RBC Dr. Roth was director of Technical Affairs at Dynavax Technologies, responsible for process development and manufacturing of protein therapeutics and vaccines.
Previously Dr. Roth worked in positions of increasing responsibility at Berlex Laboratories on the development of mammalian, microbial and gene therapy products. Dr. Roth started his career in Germany with Schering AG, an international pharmaceutical company recently acquired by Bayer AG.
Dr. Roth holds a Ph.D. and a masters degree in chemical engineering from Technical University Berlin, Germany.
Dr. Moon has over 15 years of experience in oncology drug development and is a founding team member of Jennerex, overseeing development sciences including clinical bioanalytics, preclinical development and next-generation research. Prior to Jennerex, she was part of the start-up team at Cytokinetics, establishing the cell-based screening program and managing intellectual property filings on the high-content screening platform. At Onyx Pharmaceuticals, she served as project manager of the oncolytic virus program and worked on scientific projects within the small molecule therapeutics partnership with Bayer. She received her Ph.D. in Molecular & Cell Biology from the University of California, Berkeley and an AB in Biology from Harvard University.
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.