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

Ronald A. Salerno, Ph.D., joined Biologics Consulting Group, Inc. (BCG) as Senior Consultant in February 2008.

Dr. Salerno has eighteen years of experience in Regulatory Affairs. Since June 2006, Dr. Salerno was the Global Regulatory Therapeutic Area Head for Wyeth Vaccines leading a regulatory group responsible for bacterial and viral vaccines in early development as well as licensed bacterial vaccines. From June 2001 to June 2006, he was the Regulatory Liaison for Wyeth's Translational Medicine Research using pharmacogenomic biomarkers that are predictive of drug response and/or are new targets for discovery research. He lead the submission of three voluntary genomic data submissions (VGDS) and agency meetings, which included the first submission of a VGDS to the FDA and the first joint FDA/EMEA VGDS briefing meeting.

Dr. Salerno organized and co-chaired three FDA/Industry Workshops on Pharmacogenomics in Drug Development and Regulatory Decision-Making held in 2002, 2003 and 2005; and he was a speaker and panelist at the fourth workshop on biomarkers and pharmacogenomics December 2007. Dr. Salerno was also past chairman for the Pharmacogenetics Working Group organization with membership consisting of 23 companies activity involved in pharmacogenomics. Since 2002, he has 11 published articles and 16 presentations on the topic of Pharmacogenomics in drug development and regulatory decision-making.

Prior to joining Wyeth, Dr. Salerno was employed by Merck & Co. for 28 years and contributed significantly to Merck's vaccine products while holding various research and manufacturing positions. Before leaving Merck in June 2001, he directed a group of 30 responsible for the preparation, submission and filing strategy for CMC for new and marketed vaccines. In 1995, he completed a two-year assignment in Germany managing regulatory affairs in Europe for Merck Research vaccines in development. While working in Europe, he directed the successful registration of the first Hepatitis A vaccine in Europe by the mutual recognition procedure. He also had a significant liaison role in supporting the Merck Vaccine Joint Venture in Lyon, France. Prior to this assignment, he submitted numerous INDs and supplements in a regulatory liaison role for biologics, vaccines, antibiotics and antivirals.

Prior to Merck, Dr. Salerno worked in the field of viral-chemical oncology for NCI-sponsored contracts. He earned a. B.A. from St. Vincent College, an M.S. from Villanova University and an M.S. and Ph.D. from the University of Maryland in the Biological Sciences.

At Biologics Consulting Group, Inc. Ron will use his experience and knowledge to assist clients in:

• Regulatory strategy, assessment and competitive analysis for successful drug development and licensure
  
• Regulatory Liaison with FDA, EMEA regulations, guidance and meetings for vaccines, biologics, drugs
  
• Use of pharmacogenomics and biomarkers for clinical and regulatory decision making
  
• IND, BLA, NDA, VGDS reviews, and due diligence
  
• Management of regulatory workshops, stakeholder communications and partnerships

View Dr. Salerno's Curriculum Vitae...

Page Updated April 13, 2010