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

Michael A. Trapani, MS, MBA joined Biologics Consulting Group, Inc. as Senior Consultant in January 2007.

Mr. Trapani has extensive experience in regulatory affairs, new product registration and approval, regulatory compliance and quality assurance. He has held management positions in a broad selection of the industry including large pharmaceutical companies, biopharmaceutical groups, clinical research organizations (CRO) and diversified medical products companies. Mr. Trapani started his career as an Investigator with the U.S. Food & Drug Administration.

Mr. Trapani most recently was Vice President, Worldwide Regulatory Affairs for Ethicon Inc. (a Johnson & Johnson company) where he was responsible for regulatory activities related to the development and approval of device/biologic and device/drug combination products. Prior to joining Ethicon, Mr. Trapani was Vice President, Regulatory Policy & Quality Assurance for Covance, Inc. where he was responsible for global regulatory affairs and clinical quality assurance for Phase II to Phase IV clinical trials. In addition, while at Covance, he directed a global regulatory consulting practice providing guidance, strategy and support to clients needing these services.

Mr. Trapani has a proven record of success in gaining new product approvals. While at Pharmacia and Cytogen, he secured several important drug approvals in the areas of ulcerative colitis, rheumatoid arthritis, nicotine dependency, various types of cancers and growth hormone deficiency. Mr. Trapani also has extensive experience in pharmaceutical quality assurance. At Covance, he was responsible for global clinical quality assurance including SOP development and administration, audits of clinical investigators and clinical research sites (GCPs) and oversight of the conduct of clinical research activities. At Cytogen and ImClone, Mr. Trapani was responsible for GMP quality assurance activities for marketed products and clinical research supplies including monoclonal antibodies and other drug and biologic products.

Mr. Trapani continues to be active member of the Regulatory Affairs Professional Society (RAPS). He was Chairman of the Ethics Committee in 2006 and is on the Editorial Board of the RAPS monthly regulatory affairs publication (FOCUS). Currently he is assisting to update the RAPS publication, Fundamentals for US Regulatory Affairs.

Mr. Trapani received his MS degree in Quality Assurance & Regulatory Affairs from Temple University and his MBA from Seton Hall University.

At the Biologics Consulting Group, Mr. Trapani will use his extensive experience and knowledge to assist clients in addressing regulatory challenges in product and clinical development, regulatory submissions, liaising with FDA and other regulatory bodies and assessing quality systems and procedures.

View Mr. Trapani's Curriculum Vitae...

Page Updated April 13, 2010