JOHN E. HUMPHRIES, MD

Dr. Humphries joined the group in February 2008. He has acquired diverse skills and competencies during his 20+ year professional career. While at the University of Virginia, he was an accomplished researcher, educator and clinician with over 40 peer-reviewed journal publications, focused in the field of hemostasis, thrombosis and fibrinolysis. While at Bayer he was involved in the clinical development and regulatory interactions with FDA and EMEA on a transgenic alpha-1-antitrypsin, was responsible for early clinical development of a plasma-derived plasmin, clinical strategy for development of intravenous immunoglobulin in neurologic disorders and clinical strategy for new indications for plasma-derived antithrombin III. Dr. Humphries will utilize his expertise in clinical strategy and clinical development of therapeutic proteins to assist clients in drug development and commercialization.

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RONALD A. SALERNO, PH.D.

Dr. Salerno joined BCG in February of 2008. Dr. Salerno has eighteen years of experience in Regulatory Affairs. Since June 2006, Dr. Salerno was the Global Regulatory Therapeutic Area Head for Wyeth Vaccines leading a regulatory group responsible for bacterial and viral vaccines in early development as well as licensed bacterial vaccines. From June 2001 to June 2006, he was the Regulatory Liaison for Wyeth's Translational Medicine Research using pharmacogenomic biomarkers that are predictive of drug response and/or are new targets for discovery research. He lead the submission of three voluntary genomic data submissions (VGDS) and agency meetings, which included the first submission of a VGDS to the FDA and the first joint FDA/EMEA VGDS briefing meeting. Ron's expertise is in global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making.

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A Brief Report on the Value of Pharmacogenomics based on the Outcomes of the Pharmacogenomics Workshop IV held 12/10-12/2007

The fourth FDA/Industry workshop in a series on Pharmacogenomics (PGx) was held December 10-12, 2007 in Bethesda, Maryland with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, PWG, PhRMA, BIO, and DIA.

Dr. Ron Salerno opened the plenary session of this fourth workshop on pharmacogenomics by noting the challenging environment the pharmaceutical industry is now facing. Interestingly enough, the Wall Street Journal published an article the week before the workshop on December 6, 2007 that painted a grim prognosis for big pharma: "Industry Fails to Find New Drugs to Replace Wonders Like Lipitor".

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Protocol Adherence and Recordkeeping
By Carl Anderson, Senior Consultant

Ann Sutton, VP, Bacterial Products at Biologics Consulting Group, Inc. recently contributed 2 articles to Clinical Infectious Diseases:

Environmental Assessment Requirements for Live Biological Drugs

Astract: Marketing approval of biological products by the US Food and Drug Administration must comply with requirements of Code of Federal Regulations title 21 part 25, “Environmental Impact Considerations.” An environmental impact statement is usually not required. Environmental assessment is required unless excluded. As naturally occurring substances, biological products qualify for categorical exclusion if manufacture and use do not significantly alter their concentration or distribution in the human environment. The manufacturing process and establishment descriptions in the license application should include enough detail to ensure that waste is controlled and inactivated. During clinical development of a live biotherapeutic product, data should be collected regarding the shedding of live organisms from treated patients. The ability of the live organism to persist in the environment should be assessed, and instructions for safe handling by health care providers and consumers should be incorporated into the package insert.

Product Development of Probiotics as Biological Drugs

Elements of product and manufacturing-process design are described for product development of live biotherapeutic biological drugs. Product design uses the history and the phenotypic and genotypic characterization of the selected strain. The quality and integrity of the selected strain can be ensured by preservation in a qualified cell-bank system. Manufacturing-process design includes step-by-step description, including the necessary process-input parameters and the expected output results. The active ingredients in the biological drug are usually manufactured using aseptic processing. The manufacture of the final dosage form of live biotherapeutics requires bioburden control or aseptic manufacture, as appropriate. Specifications for live biotherapeutics must comply with regulations for licensed biological products. Evidence of stability for the duration of the shelf life, as well as stability under the recommended conditions of use, must be provided for licensure.

Full text versions of these articles can be obtained from the University of Chicago Press website.

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With over $22 billion in partnering deals for 2007 (Current Partnering Scorecard for top 20 deals in 2007), and a larger figure expected for 2008, the changing dynamic between pharmaceutical and biotechnology companies is in full focus. Deals such as the Genzyme/Isis partnership for $1.9 billion including an upfront payment of $750 million for a phase III cardiovascular drug and Merck's partnership with Addex for a preclinical CNS drug are just two examples of activity in the market this year. Transactions such as these are expected to continue, driven by the need for established pipelines, global expansion and a selective IPO market. Strategic alliances provide a unique reduced risk/increased reward profile for all parties that is more attractive in today's market.

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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.

Annual Meeting

"Regulatory Considerations for Cell Manufacturing and Cell Delivery"

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

PharmaMedDevice Conference

"Combination Products -- Regulatory: Applications & Documentation"

Spring Conference 2008

Regulatory Considerations of Using Stem Cells for Cardiac Applications