| (Fort
Worth, TX) --- 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. 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. DFB is on the web
at www.dfb.com.
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