Michael Trapani, MS, MBA

Michael Trapani, MS, MBA

Group Leader
CMC Development

Mr. Trapani has extensive experience in regulatory affairs, regulatory compliance and quality assurance. He has held management positions in pharmaceutical and biotech companies, clinical research organizations (CRO) and diversified medical products companies. Mr. Trapani started his career as an Investigator with the U.S. Food & Drug Administration (FDA).

Prior to joining Biologics Consulting in 2007, Michael was Vice President, Worldwide Regulatory Affairs for Ethicon Inc. where he had overall responsibility for the regulatory activities related to the development and approval of device/biologic and device/drug combination products. From 2001 through 2005, Michael 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.

Mr. Trapani has extensive experience in quality management systems used in developing and manufacturing drugs, biologic and medical devices. Michael managed GMP quality assurance activities for marketed and investigational drug products including monoclonal antibodies and therapeutic protein products. During his career, Michael was also responsible for global clinical quality assurance functions including SOP development and administration, GCP audits and the oversight of clinical research activities performed by Sponsors and CROs. Recently as a Biologics Consulting consultant, Michael was an expert witness in an arbitration during which he provided testimony on the adequacy of clinical quality assurance oversight measures used for a global clinical research program.

At Biologics Consulting, Michael uses his experience and knowledge to assist clients in:

  • Preparing IND, NDA and BLA submissions to FDA
  • Directing and/or participating in pre-IND and FDA Type A, B and C Meetings
  • Identifying, evaluating and selecting CROs
  • Preparing for FDA bioresearch monitoring (BIMO) inspections
  • Conducting mock-FDA inspections
  • Conducting PAI readiness assessments and audits
  • Conducting GMP audits of bulk drug substance and drug product manufacturing facilities
  • Conducting Clinical QA audits for sponsors, CROs, Clinical Investigator sites
  • Reviewing advertising, labeling and promotion materials
  • Performing GXP training

Education

MS, Quality Assurance & Regulatory Affairs, Temple University, Graduate School of Pharmacy, Ambler, PA

MBA, Marketing, Seton Hall University, Graduate School of Business, South Orange, NJ

BS, Biology, Brooklyn College, Brooklyn, NY