L. BRUCE PEARCE

Bruce Pearce joined the BCG team in July of 2010. Bruce is a pharmacologist who brings 20 plus years of academic and industry experience encompassing many aspects of biologics development including design, development, analysis, oversight, and regulatory reporting of pharmacology, toxicology, pharmacokinetic, safety pharmacology, physiologic research and Phase I-III clinical trials. Expertise in non-clinical and clinical pharmacology/toxicology, program strategic/technical design, quantitative outcomes analysis, and benefit-risk balance assessment. Therapeutic areas include; treatment of anemia due to surgery, trauma, chemotherapy, emergency research under exception to informed consent (21 CFR 50.24) including in/pre-hospital resuscitation from hemorrhagic shock due to trauma. Treatment of cardiac, cerebral and peripheral ischemia and therapeutic use of botulinum toxin.

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DAVID ROUSE, M.S.

David comes to BCG with over 23 years experience in the research, review and regulation of biological products within FDA/CBER and the biopharmaceutical industry. Most recently, David was the head of CMC Vaccines regulatory affairs group for Pfizer Pharmaceuticals, Inc. (previously Wyeth Pharmaceuticals, Inc.) at the Sanford, NC location. David led a department of nine regulatory affairs professionals responsible for the development of global regulatory strategies to support successful domestic and international regulatory submissions for licensed and clinical vaccines. Prior to joining Wyeth, David was a biologist for over 12 years at the Food and Drug Administration's Center for Biologics Evaluation and Research, Office of Vaccines Research and Review.

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Position available: President/CEO (click for full job ad)

Biologics Consulting Group, Inc. (BCG), a nationally recognized biopharmaceutical product development and regulatory consulting firm, with offices in Alexandria, VA (head office); Cary, NC; Franklin, MA; San Francisco, CA, and Tokyo, Japan, is seeking candidates for the position of President and Chief Executive Officer (President/CEO).

Specific Role:

BCG has developed a prominent reputation in the biopharmaceutical regulatory community. The President/CEO will be expected to represent BCG in a manner which will continue to grow and enhance that reputation.

The President and CEO will assume full operational and executive responsibilities for the day-to-day activities of BCG, operating from its head office in Alexandria, VA. and will report directly to the Board of Directors.

Qualified candidates should forward their CV and statement of qualifications for the position to:

If your company is planning a submission of a BLA or NDA in the foreseeable future, you should be paying close attention to the changing regulatory environment related to FDA inspections of clinical trials. You will need to be prepared for a comprehensive FDA inspection process which may further delay the approval of your drug.  And, if you are outsourcing your clinical studies, you will need to demonstrate how you provided adequate oversight of the CRO for assuring compliance with Good Clinical Practices (GCPs) and FDA regulations.  The following paragraphs provide background for FDA’s new inspectional approach.

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Challenges of a Quality Assurance Unit at Early Product Development
article by Ellen Raaf, MT ASCP, BCG Sr. Consultant

A Quality Management System should encompass collective practices to minimize nonconformances to specifications, standards, and customer satisfaction in an efficient and cost effective manner.

Managing and overseeing theses multiple quality facets can be a daunting task for the Quality Assurance unit, especially when supporting start-up companies at very early product development. Frequently, the Quality unit is understaffed and required to wear multiple hats trying to balance the science with compliance.

The growing pains when advancing from Phase 1, 2 to Phase 3 are numerous. Ideally, all essential Quality elements should be in practice to include controls of the production system, facilities and equipment, laboratory, materials, and packaging and labeling.  Realistically, many systems may not be adequately in place. Systems currently in place should be assessed by performing gap analysis. Those systems that are deficient should be identified and prioritized based on risk assessment. Review of the Quality elements should be a joint effort with all departments involved to mitigate unnecessary deviations and to optimize the efficiency. 

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BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.