Services provided by the Massachusetts based BCG staff include:

• Regulatory advice and support
  
• Quality Systems development and assessment
  
• Biologics manufacturing operations advice and support
  
• Identifying, qualifying, and managing contract manufacturing and testing organizations
  
• Quality Auditing and Management Planning for Regulated Data and Computer Systems
  
• 21CFR Part 11 risk assessment and compliance advice
  
• Program management of biologic products
  
• Clinical development support and advice
  
• Advice and support for process development, validation, and process analytical technology (PAT)
  
• Due diligence

The Massachusetts based BCG Staff include:

Keith H. Wells, Ph.D.- Massachusetts Office Head
Dr. Wells has 15 years of experience in the biologics industry in areas such as validation, process development, process analytical technology (PAT), and manufacturing operations ranging from the production of Master Cell Banks through the Fill and Finish of clinical and commercial vaccine and therapeutic protein products. He has additional experience in identifying, qualifying, and managing contract manufacturing and testing organizations, and in the design, validation, and operation of biologics production facilities. Dr. Wells has also served on numerous NIH Special Emphasis and Source Selection Panels in the areas of HIV, infectious disease, and biodefense.

Loriann Baranauskas - Senior Consultant
Effective September 11, 2006, Loriann Baranauskas has joined Biologics Consulting Group, Inc. as a Senior Consultant in the Massachusetts office. Lori has over 11 years of experience in the biotechnology industry. Prior to joining Biologics Consulting Group, Lori spent the past 11 years in Quality and Regulatory leadership roles at Antigenics, Inc. and Aquila Biopharmaceuticals, Inc. (acquired by Antigenics in 2000).Prior to Antigenics, Lori has over 10 years of experience in the diagnostic and medical device industries. From 1989 through 1995, Lori managed the Regulatory Affairs group at Behring Diagnostics, Inc. (formerly PB Diagnostic Systems) where she and her staff were responsible for strategic planning and preparation of 510(k), PMA and international regulatory filings for the company's in vitro diagnostic and auto-analyzer product pipeline.

Jim McIver, Ph.D. - Senior Consultant
Dr. McIver has more than 25 years of experience in biologics product research, development, manufacturing, and quality systems as the Assistant Director at the Massachusetts Biologic Laboratories (MBL). His experience at MBL included 4 years as the Director of Quality, and 20 years as the Director of Therapeutic Immunoglobulin and Plasma Fractionation Research, Development, and Production. He has experience in all phases of cGMP and GLP compliance, technology transfer, and validation. He has experience in the development of Quality Systems, preparation of manufacturing documents, process validation, viral clearance validation, and preparation of CMC sections for INDs and BLAs. In addition, he has experience in the development and implementation of process technology for the production of intravenous immune globulin, hyperimmune globulin, and monoclonal antibody products.

Nanda K. Subbarao, Ph.D. - Senior Consultant.
Dr. Subbarao joined the group in June of 2007. She has expertise in stability and laboratory cGMP systems for both biologics and conventional drugs and can assist clients with the set up of cGMP laboratory systems, implementation of stability programs, and evaluation of analytical methods and method validation.

Michael A. Trapani, MS, MBA - Senior Consultant
Mr. Trapani joined the group in January of 2007. He 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 and was most recently Vice President, Worldwide Regulatory Affairs for Ethicon Inc. 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.

For further information regarding the new Massachusetts BCG office, please contact Dr. Keith Wells.

Click HERE to download a .pdf file to view the consultants' Areas of Expertise

Contact Information for the Massachusetts Office:

Tel: 508-541-8883
Contact: Dr. Keith Wells

Biologics Consulting Group, Inc.
Massachusetts Office
310 North Main Street
Unit 6
Mansfield, MA 02048

Page Updated: July 30, 2007