WARREN, N.J., June 17 /PRNewswire/ -- MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced the appointment of Mary Ellen Norvitch, Ph.D. to the newly created position of Vice President, Regulatory Affairs/Clinical Affairs/Quality Assurance. Effective immediately, Dr. Norvitch will report to A. Mark Schobel, President and Chief Executive Officer.
Mr. Schobel said, "We are pleased to welcome Mary Ellen to MonoSol Rx as we prepare for the FDA approvals of our first two prescription film products and aggressively continue to develop our PharmFilm-based pipeline candidates. Her leadership will be of great value as we expand our regulatory, clinical and quality assurance functions to support our upcoming marketing applications and product approval processes. As we continue both self-funded and partnered initiatives in targeted therapeutic areas and patient populations, Mary Ellen will make a significant contribution in guiding our regulatory affairs and clinical efforts."
Prior to joining MonoSol Rx, Dr. Norvitch held numerous executive level positions in major pharmaceutical and specialty pharmaceutical organizations. Most recently, she built the U.S. regulatory function for ProStrakan, Inc., a specialty pharmaceutical company. As Vice President, US Regulatory Affairs, Dr. Norvitch led her team through the successful U.S. new drug application (NDA) review and Food and Drug Administration (FDA) approval of SANCUSO® Transdermal System.
Prior to ProStrakan, Dr. Norvitch held positions of increasing responsibility and complexity within Bristol Myers Squibb, Schering Plough, Watson Pharmaceuticals, Pfizer, Inc and Barrier Therapeutics. She started her industry career with American Cyanamid in the Clinical Research - Oncology field, serving as clinical team leader for a Phase I program.
Dr. Norvitch earned her B.S. in Chemistry and a PhD. in Pathobiology from the University of Minnesota. She completed postdoctoral training at the Mayo Clinic in Molecular Biology.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver unique proprietary pharmaceutical drug films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm® technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programs that will generate long-term value.
The Company's commercialization strategy for all PharmFilm® products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).
SOURCE MonoSol Rx