Advaxis Taps Former "Big Pharma" FDA Specialist.New Position Created - Executive Clinical Officer Dr. Christine Chansky Brings Seasoned Expertise In FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Procedures and Drug Development NORTH BRUNSWICK, N.J. -- Advaxis Inc., (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ADXS, http://www.advaxis.com.), a developmental biotechnology company, has hired Christine Chansky, MD, JD, FCLM, a veteran clinician, pharmaceutical industry Medical Director, and Food & Drug Administration ("FDA") procedural specialist, to serve in the capacity of Executive Clinical Officer. Dr. Chansky comes to the company with 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 The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S. Congress in 1996. According to the Centers for Medicare and Medicaid Services (CMS) website, Title I of HIPAA protects health insurance coverage for workers and their families when ("HIPAA (Health Insurance Portability & Accountability Act of 1996, Public Law 104-191) Also known as the "Kennedy-Kassebaum Act," this U.S. law protects employees' health insurance coverage when they change or lose their jobs (Title I) and provides standards for patient health, "). 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 NYSE See: New York Stock Exchange : 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 Policies and Procedures are a set of documents that describe an organization's policies for operation and the procedures necessary to fulfill the policies. They are often initiated because of some external requirement, such as environmental compliance or other governmental 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 NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : 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 human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. ("HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. "), 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 External links
1. ^ [2] 2. ^ [3] 3. and a Juris Doctor degree from Seton Hall University School of Law The Seton Hall University School of Law is part of Seton Hall University, the Catholic University of New Jersey, and is located in downtown Newark. Seton Hall Law School is one of only three Law schools in New Jersey and is the only private law school in the state. , 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. About Advaxis, Inc. Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes ("Lm") cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. and Chairperson of Advaxis' Scientific Advisory Board. Advaxis is developing therapeutic cancer vaccines that enhance the immune system's cancer-fighting abilities through its proprietary Lm based system, which utilizes multiple simultaneous immunological mechanisms to fight cancer safely. Advaxis' lead Lm vaccine candidate, Lovaxin C, targets HPV-associated cervical/head and neck cancers. Current Lm vaccines in development target prostate, breast, ovarian and lung cancers. Recently, Advaxis completed a Phase I/II clinical trial. A Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II is planned for patients with cervical intraepithelial neoplasia cervical in·tra·ep·i·the·li·al neoplasia n. Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma. (CIN CIN cervical intraepithelial neoplasia. Cervical intraepithelial neoplasia (CIN) A term used to categorize degrees of dysplasia arising in the epithelium, or outer layer, of the cervix. ). The company intends to start this study in CIN I/II patients in the summer of 2008. The Lm platform will also have applications in the fields of infectious disease and autoimmune disorders. For further information on the Company, please visit: http://www.advaxis.com. About Lovaxin C Vaccine Advaxis' Listeria technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Lm, combined with Advaxis' proprietary fusion protein, has the ability to generate a robust immune response and produce an unusually strong and effective multi-level therapeutic immune response to existing cancers and other diseases. Advaxis' Lm-based technology is mostly based on Dr. Yvonne Paterson's decade worth of work in her laboratory at the University of Pennsylvania. The Company's proprietary antigen fusion protein technology, also suppresses regulatory T cells that inhibit many vaccines in the generation of activated tumor-killing cells. Lovaxin C was designed to treat women who have already developed cervical cancer as a result of contracting a human papilloma virus human papilloma virus n. Abbr. HPV A DNA virus of the genus Papillomavirus, certain types of which cause cutaneous and genital warts in humans, including condyloma acuminatum. ("HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) ") infection, which is the most prevalent sexually transmitted disease sexually transmitted disease (STD) or venereal disease, term for infections acquired mainly through sexual contact. Five diseases were traditionally known as venereal diseases: gonorrhea, syphilis, and the less common granuloma inguinale, in the US. Current prophylactic products on the market are ineffective in treating HPV-infected women. For further information on Lovaxin C, please visit: http://www.advaxis.com/lc.htm Forward-Looking Statements Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company's current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements. |
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