Healthcare Industry News: Healthpoint
News Release - April 11, 2007
Mike Bernstein Appointed Vice President of Regulatory Affairs, DFB Branded PharmaceuticalsFort Worth, Texas, April 11, 2007 --(HSMN NewsFeed)-- Mike Bernstein, MPH, has been named Vice President of Regulatory Affairs for DFB Branded Pharmaceuticals, according to Michael E. Steadman, Group President and Chief Operating Officer.
DFB Branded Pharmaceuticals is a segment of Fort Worth-based DFB Pharmaceuticals, Inc.
"The centralized, specialized support of regulatory affairs and compliance is critical as we fulfill this next phase of DFB’s strategic plan,” said Mr. Steadman. “Mike will confidently direct these vital functions."
Mr. Bernstein was recruited by DFB in 2005 as VP of Regulatory Affairs for the holding company. The new position more closely focuses his role on DFB’s commercial branded businesses. Healthpoint, Ltd., and Coria Laboratories, Ltd. comprise the Branded Pharmaceuticals segment.
Mr. Bernstein joined DFB with a wealth of regulatory experience gained over two decades in various facets of the industry, ranging from government agencies to the private sector. Mr. Bernstein was most recently Senior Director, Regulatory Affairs and Safety for Ilex Pharmaceuticals, LP (now Genzyme Corporation), focusing on the oncology field. Prior to Ilex, he was Senior Director, Worldwide Regulatory for Sensus Drug Development Corporation, a position that required both US and international regulatory expertise for growth hormones. In the late 1990’s, Mr. Bernstein was Manager for Regulatory and Product Development of PPD-Pharmaco, Inc., a role that followed his position as Consumer Safety Officer for the Food and Drug Administration (FDA). Mr. Bernstein was a US Public Health Service Commissioned Corps Officer for 25 years, spending 12 of those years in his role with the FDA. Mr. Bernstein began his career in healthcare by serving in the US Army for three years as a dietitian and nutritionist.
Mr. Bernstein received a Bachelor of Science degree from Pratt Institute and a Master of Public Health degree from Tulane University.
DFB Pharmaceuticals, Inc.
DFB Pharmaceuticals, Inc. is a privately held Texas corporation that provides technology-driven pharmaceutical products, outsourcing services, and licensing opportunities through its affiliate partners to the healthcare industry worldwide. DFB’s business structure is organized by segments: Branded Pharmaceuticals, Biotechnology, and Pharmaceutical Services. The Branded Pharmaceuticals segment includes Healthpoint, Ltd., active in the research, development, and marketing of branded pharmaceuticals, over-the-counter drugs, and biotech drugs for tissue management and surgical indications since 1992; and Coria Laboratories, Ltd., focusing on dermatology and treatments of diseases that affect the skin, hair, and nails. Pharmaceutical Services includes DPT Laboratories, Ltd., a Contract Development and Manufacturing Organization (CDMO) and industry source for semi-solid and liquid development and manufacturing services for the world’s leading pharmaceutical, biotechnology, and healthcare companies. The Biotechnology segment encompasses Phyton Biotech, Inc., whose proprietary plant cell culture technology platform is used to develop and manufacture products with applications in the pharmaceutical and biotech industries; and Phyton’s German subsidiary, Phyton GmbH, which operates the world’s largest commercial cGMP manufacturing facility for plant cell fermentation.
Source: DFB Pharmaceuticals
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