Dr. Chansky has over fifteen years of professional expertise in health care compliance and FDA regulations with comprehensive experience in drug development, pharmaceutical promotional regulations, and patient compliance within the guidelines provided by the Health Insurance Portability and Accountability Act (“HIPAA”). She has been integrally involved in every stage of FDA clinical protocols from pre-IND submission through drug commercialization in the global arena and has been involved with blockbuster drugs such as Johnson & Johnson’s (NYSE: JNJ) Procrit/Eprex and Sanofi-Aventis SA’s (NYSE: SNY), formerly Aventis Pharmaceuticals, Lovenox.
“We welcome Dr. Chansky to the company with open arms,” commented Advaxis Chairman and CEO Tom Moore. “Her expertise and impressive background in the execution of clinical trials and her deep knowledge of FDA procedures will be a key addition to our team in the furtherance of our flagship drug candidate, Lovaxin C, and the future development of our drug pipeline. With her knowledge, we are confident in being able to successfully navigate the FDA’s procedural landscape in short order and avoid the common pitfalls facing biotechnology companies.”
About Dr. Christine Chansky, MD, JD, FCLM
Before coming to Advaxis, Dr. Chansky was a Senior Director and Medical Monitor for Bayer HealthCare Pharmaceuticals. In that capacity, she was the Global Clinical Project Director of six (6) separate Women’s Health Care protocols. The focus of her responsibilities was the medical review of patient profile listings, adverse event reviews, comprehensive FDA communications, and safety reports. Contemporaneously, she was the clinical lead of various project managers, study monitors, clinical research associates (“CRAs”) and statisticians; oversaw data management, clinical operations, and medical writings; and was involved in pharmacovigilance and strategic collaboration with the regulatory and marketing departments.
Prior to that, Dr. Chansky was the Global Lead and Director of Medical Operations for Cordis Corporation, a Johnson & Johnson Company (NYSE: JNJ). In this capacity, she was responsible for establishing and leading the Global Protocol Review Committee for all Cordis marketed products involving the cross-functional creation of internal relationships to document spending of departmental funds. Her managerial influence and leadership catalyzed and provided medical leadership to the internal and external CROs for all clinical studies and registries. Similarly, she oversaw the Healthcare Compliance teams with respect to writing and maintaining policies and procedures as required by U.S. and ex-U.S. regulatory health authorities.
As part of her earlier accomplishments and roles, Dr. Chansky held senior positions orchestrating regulatory affairs, global development, medical affairs, medical marketing, and clinical research for The Medicines Company (NASDAQ: MDCO), Sanofi-Aventis (NYSE: SNY), formerly Aventis Pharmaceuticals, Johnson & Johnson Company (NYSE: JNJ), GlaxoSmithKline (NYSE:GSK), formerly Glaxo Wellcome, and Roche Pharmaceuticals (PINK: RHHBF). Her U.S. and ex-U.S. regulatory affairs experience includes the submissions of Investigational New Drug Applications (“INDs”), New Drug Applications (“NDAs”), Supplemental New Drug Applications (“sNDAs”), CTDs, and Marketing Authorization Applications (“MAAs”). She has worked as an industry expert in a variety of therapeutic areas that include oncology, the human immunodeficiency virus (“HIV”), anemia, pain management, women’s health care, and interventional cardiology.
Dr. Chansky holds a Doctor of Medicine degree from The Georgetown University School of Medicine and a Juris Doctor degree from Seton Hall University School of Law, with a concentration in pharmaceutical, regulatory, and health law. She trained as a surgeon in New York and Delaware, and currently maintains her Delaware medical license.
