Sillajen Biotherapeutics Management
Targeting, Attacking, and Eradicating Cancers®
SillaJen Biotherapeutics, Inc. was formerly known as Jennerex, Inc.; and is a wholly owned subsidiary of SillaJen Inc. SillaJen Biotherapeutics is located in San Francisco with expertise in late stage clinical development, global regulatory affairs, CMC and business development.The two companies are operationally integrated with the teams working collaboratively across the Pacific Ocean to innovate, design and develop novel oncolytic viral immunotherapy to cure cancer.
Helena H. Chaye
Chief Business Officer
Dr. Chaye has served as a Chief Business Officer at SillaJen Biotherapeutics, Inc. since August 2016 and prior to this, as Vice President of Corporate Affairs and IP at Jennerex, Inc. during the years 2006-2012. During her tenure at Jennerex, she has held many leadership positions incorporate affairs, business development, HR and tech ops. As the CBO, Dr. Chaye is responsible for overseeing R&D, strategic corporate planning, general operations, business development and intellectual property management. Dr. Chaye has over 20 years of experience in business development, intellectual property management, corporate affairs and general operations. Dr Chaye received her B.S. Biochemisty and her Ph.D. in Genetics from the University of British Columbia and her J.D. from Dalhousie University both in Canada.
Chief Operating Officer
Dr. Roth has served as Chief Operating Officer and Senior Vice President of Technical Operations at SillaJen Biotherapeutics, Inc. since 2014, where he is responsible for managing U.S. operations and heading all technical functions for the development of oncolytic viruses. Prior to SillaJen, he worked as Vice President of Technical Operations at Jennerex, with responsibilities in process development, analytical development and manufacturing of oncolytic viruses. Dr. Roth was Director of Technical Affairs at Dynavax and in 2008 established an international consulting company specializing in bioprocess technology. He also held positions of increasing responsibility at Berlex Laboratories. Altogether Dr. Roth has over 30 years of experience in the pharmaceutical industry. Dr. Roth holds a Ph.D. in Chemical Engineering from Technical University Berlin, Germany.
James M. Burke
Chief Medical Officer
Dr Burke has served as Chief Medical Officer at Sillajen Biotherapeutics, Inc. since April 2014 and, prior to this beginning in November 2010 as Vice President of Clinical Research at Jennerex, Inc.. Dr. Burke oversees global clinical development for Sillajen including design and oversight of clinical trials of gene and immunotherapy agents for hepatocellular carcinoma (now in Phase 3), renal cell carcinoma, colorectal cancer, and various other solid tumors. Dr. Burke has over 15 years of preclinical and clinical experience in the field of gene and immunotherapy including work with various oncolytic virus platforms, tumor vaccines, and other gene therapy related agents. Prior to SillaJen, he was Associate Director of Clinical Research at Cell Genesys and, thereafter, Director of Clinical Research at a regional cancer center. Dr. Burke received his MD degree from Georgetown University School of Medicine; he completed a general internal medicine residency at the University of California, San Diego followed by a Hematology-Oncology Fellowship at the University of California, San Francisco. Dr. Burke is Board Certified in both Hematology and Oncology.
Senior Vice President of Regulatory Affairs and Quality Assurance
Dr. Fritsch has served as Senior Vice President of Regulatory Affairs and Quality Assurance at SillaJen Biotherapeutics, Inc. since April 2014 where she is responsible for managing regulatory and quality compliance. Dr. Fritsch has led Sillajen’s global regulatory strategy and worldwide agency negotiations for the company’s lead Phase 3 product (Pexa-Vec) and other projects at various stages of development. Prior to her position at SillaJen, she served as Vice President of Regulatory Affairs and Quality Assurance at Jennerex. She led the regulatory function at Onyx Pharmaceuticals, Anthera Pharmaceuticals and Peninsula Pharmaceuticals and had positions of increasing responsibility at Genentech. She has over 25 years of experience in managing regulatory affairs, compliance and quality. Dr. Fritsch received her Doctor of Pharmacy from Creighton University.
Vice President of Product and Alliance Management
Ms. Scully has served as Vice President of Product and Alliance Management at Sillajen Biotherapeutics, Inc. since December 2014. Prior to her position at SillaJen, she worked as a Clinical Operations Consultant at Jennerex, where she provided Phase 3 clinical study plans, and cross functional support for clinical studies and alliance management. Ms. Scully has over 18 years of broad clinical research, operations and leadership expertise in all stages of clinical development.Prior to SillaJen, she held positions at Teva Neuroscience, Octapharma, and has worked as a consultant for Genentech and several other bay area companies. Ms. Scully has an M.B.A. from Saint Joseph’s University in Philadelphia, and a B.S. degree in Health Care Administration from Philadelphia University.She is also a registered nurse.