LOURDES BERMEJO, MS

Ms. Bermejo joined the group in October 2007 as a Senior Consultant. She was most recently the Senior Manager of Process Engineering at Biolex Therapeutics, a biopharmaceutical company involved in the development and production of therapeutic proteins using the aquatic plant Lemna. She played a pivotal role in the development of innovative production platforms, as well as, the improvement of processes through integration of process development, scale-up and facility design. Her expertise is in project management for technology transfers and start-ups, manufacturing for biological products, process improvements upstream development & scale-up.

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ELLEN RAAF, MT, ASCP

Ellen Raaf, MT, ASCP, joined the group in November as a Senior Consultant. Ms. Raaf is a microbiologist who brings to the firm over 22 years of government and biopharmaceutical experience with a principal focus on assay development, qualification and validation, managing stability and laboratory programs, and optimizing Quality systems. Most recently, Ms. Raaf was the Quality Assurance Manager for Biolex, Inc., a biopharmaceutical company involved in the development and production of therapeutic proteins using Lemna, an aquatic based plant. While at Biolex, she was responsible for directing the Quality Systems, Product Release and Document Control.

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PAULA M. KEITH, PH.D.

Dr. Keith is a microbiologist who brings to the firm over 25 years experience in the biopharmaceutical industry principally in the areas of process development, scale up, and manufacture of clinical supplies to support new product registration. Most recently, she served as V.P. of Development at two new start up biotech companies where she was responsible for selection of candidate contractors for GMP production of IND vaccine products and GLP toxicology studies. At AlphaVax Human Vaccines, she established a bioprocess development function for a novel viral vector vaccine including QA, QC, Manufacturing and Planning functions. In addition, she equipped and staffed a BL-3 pilot plant for manufacture of a variety of IND vaccine products. Dr.Keith authored the pre-IND brochure and the Chemistry,Manufacturing and Control sections for the company's first regulatory submissions and served as Project Manager for one of the company's virus vaccine products.

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Three practical tips to prepare for FDA inspections

Sponsors preparing to submit an application to the FDA realize they must face the inevitable. Before a BLA, NDA, or PMA is approved it will need to go through inspections that the FDA conducts through its Bioresearch Monitoring program. These inspections have two basic goals. They ensure that the rights and welfare of human subjects participating in research have been protected and they ensure the integrity of the data submitted to the agency.

Fortunately, these inspections are not open-ended. There are specific instructions given to the FDA field investigators in the Compliance Program Guidance Manuals (CPGMs) that the FDA has for each of its inspection programs. You can access the CPGMs for the Bioresearch Monitoring program at:
http://www.fda.gov/ora/cpgm/default.htm#bimo

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Immel Report, "The FDA 483." Vol. 1, No. 3 (March/April 2005)

Biologics Consulting Group, Inc (BCG) has partnered with AVOS Life Sciences (see www.avoslifesciences.com) to create the Proof-of-Principle Alliance (POP Alliance) to provide fast track product development and commercialization/valuation consulting services to early phase biopharmaceutical companies seeking to accelerate the advancement of their products from the research and development phase through a proof-of-principle clinical trial. See www.POPAllianceUSA.com for additional information.

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.

5th Annual Formulation & Forced Degradation

"Implementation of a flexible yet cGMP complaint Stability Program for Phase I, II and III Studies"