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

Loriann Baranauskas joined Biologics Consulting Group, Inc. as a Senior Consultant in the Massachusetts office, in September 2006.

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). Since 2005, Lori has served as the Senior Director of Quality Systems where one of her primary roles included integration of the Quality Control and Quality Assurance functions into a cohesive Quality Systems unit. Lori was responsible for management of and strategic planning for the Quality Assurance, Validation & Calibration, Training, Documentation, Auditing and Quality Control functions. For the past several years, Lori has also served as a key member of the company's product development teams. Lori's recent experience includes autologous vaccines for various cancer indications, recombinant vaccines for infectious disease and cancer programs, pharmaceutical compounds and vaccine adjuvants, ranging from pre-clinical development to late-stage clinical development. Lori also has first hand experience working with cross functional Business Development teams in the development and execution of license and supply agreements.

From 2002 to 2005, Lori served as the Director of Quality Assurance at Antigenics where she and her staff were responsible for the development and implementation of the company's quality systems, cGMP compliance programs and validation strategies, as well as providing CMC support for various regulatory programs. In this role, Lori actively participated in the design, build-out, validation and Type C review of the company's autologous manufacturing facility. Lori was also responsible for leading the company through a successful FDA inspection in 2004.

From 1995 to 2002, Lori served as the company's Director of Regulatory Affairs where she was responsible for developing and executing regulatory strategies for the company's vaccine and biologic programs. In this role, Lori was responsible for the preparation of, and regulatory agency communication related to, the company's IND, Annual Report and Master File submissions. In 1996, as part of a collaborative program between industry and area colleges, Lori served as the instructor for a three credit course in GMP/Quality Assurance for the Biotechnology Certificate Program at Becker College.

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. In this role, Lori was also responsible for managing routine and pre and post-approval related regulatory inspections, as well as the company's internal audit, recall and field correction programs. Lori also served on the cross functional product transfer teams and actively participated in the advancement of numerous diagnostic indications from research and development to commercialization and product launch.

In her early career, Lori worked in supervisory roles for Boston Scientific Corporation in regulatory compliance and customer support related functions. During her five plus years at Boston Scientific, Lori was responsible for monitoring and trending customer complaints, evaluating and reporting MDRs and coordinating and executing product recalls for the company's endoscopy and cardiology devices. Lori also served as a member of the company's GMP audit team responsible for conducting internal audits.

At the Biologics Consulting Group, Lori will use her experience and knowledge to assist clients in the:

• Generation of product development plans and related strategies
  
• Development and implementation of Quality Systems and cGMP compliance programs
  
• Auditing and Gap Analysis of existing quality programs
  
• Planning and preparation of regulatory submissions
  

View Ms. Baranauskas's Curriculum Vitae...

Page Updated June 16, 2008