Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Dominique Y. Pifat joined Biologics Consulting Group, Inc, as a Senior Consultant on August 31^st, 2011.

Dominique comes to BCG with over 25 years of experience in both government and the pharmaceutical industry. Most recently, she was Senior Director for marketing and training for the International Division of Talecris Biotherapeutics. As such she was responsible for training product distributors worldwide on the science behind the company’s entire product portfolio. She was also responsible for developing science driven marketing plans in 48 countries, remaining cognizant of applicable regulatory requirements. 

Prior to this commercial role, Dominique was head of the pathogen safety department for Talecris Biotherapeutics Inc, and Bayer Biologicals. In that role Dominique’s responsibility included the development of pathogen reduction steps for the manufacture of plasma derived and recombinant proteins, the validation of pathogen reduction steps in compliance with GLPs (including the down scale of manufacturing processes), the writing of the portions of all regulatory submissions related to pathogen safety. Also included were risk assessments for manufacturing processes and zoning strategies for new and existing products and risk assessments for any purported infectious disease transmissions. Dominique also actively participated in the development strategies for all new products and new indications. Prior to joining the pharmaceutical Industry, Dominique held positions of increasing responsibility at the United States Institute for Infectious Diseases (USAMRIID). Her work centered on the development of vaccines (both viral and bacterial), non clinical studies, and animal models for infectious diseases. Dominique has extensive experience developing GLP programs both in government and industry. Dominique holds a Ph.D from the University of Maryland and an MBA from the University of North Carolina, Chapel Hill. 

As a Senior Consultant at Biologics Consulting Group, Inc. Dominique will utilize her scientific experience and her business knowledge to assist clients in: 

• Identifying scientifically based, but commercially viable, product target profiles for new biological products
• Devising development strategies that take into account regulatory requirements and business needs
• Developing and reviewing non-clinical studies that support regulatory submissions
• Developing GLP-compliant testing programs to include potentially non-conventional areas of safety testing.
• Developing practical and effective GLP training programs
• Registering plasma-derived, recombinant and other biological products.

View Ms. Pifat's Curriculum Vitae...

Page Updated September 14, 2011