BRUNO GAGNON, BPharm, MSc
Mr. Gagnon joined the Biologics Consulting Group, Inc., as a Senior Consultant in December 2006. Bruno is a respected opinion leader in the field of Clinical Operations and has previously held various clinical positions at Chiron, PAREXEL International and Hoechst Marion Roussel. He is often invited as a speaker or facilitator at professional meetings, his favorite topics being Outsourcing, Clinical Supplies Management, Study Start-up and Training. He has been an instructor for various Clinical Trials certificates at Laval University (Quebec), the University of San Diego, UCSD Extension, and is currently on the faculty for the Clinical Trial Design and Management program at San Francisco State University, College of Extended Learning.

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WILSON W. BRYAN, M.D.
Dr. Bryan will join Biologics Consulting Group, Inc., as a Clinical Consultant in February 2007. As a medical officer and team leader at FDA's CBER and CDER, Dr. Bryan was responsible for the clinical review of Investigational New Drug (IND) applications for drugs and biologics, including monoclonal antibody, cell, and gene therapies, for a wide range of neurologic indications, including cerebrovascular disease, multiple sclerosis, Alzheimer's disease, Parkinson's disease, other movement disorders (e.g., cervical dystonia), headache, amyotrophic lateral sclerosis and other neuromuscular disorders, insomnia and other sleep disorders, and a variety of other neurologic indications. As team leader, Dr. Bryan also ensured the quality and consistency of clinical reviews, actively participated in sponsor meetings, and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products, primarily for neurology indications.

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Have you ever wondered if companies that are under an FDA consent decree got warning letters from the FDA first? The answer is YES. FDA uses warning letters as one of the many methods to bring firms into compliance with regulations. FDA's pattern in the past shows that multiple warning letters are issued before a consent decree is sought. Thus the warning letter is just that - it means that the firm is at risk for further regulatory action by FDA.

What does FDA issue warning letters for? As 2006 comes to a close, FDA has issued about 230 warning letters between CBER, CDER, and CDRH. Most of the warning letters were issued due to deficiencies in a firm's cGMP or Quality Systems Regulation. A quick analysis of the total number of warning letters issued for the three centers that regulate human drugs, biologics, and devices (excluding foods and vet products) shows that about 100 warning letters were issued by mid Dec 2006 for cGMP and QSR non-compliance. The second major category was labeling/misbranding/false and/or misleading claims, at about 68 warning letters through mid DEC 2006. These warning letters are often written by FDA in an attempt to reel in overzealous promotion or marketing materials that may promote a drug/biologic/device with a claim that go beyond what FDA approved, or what is supported by a clinical trials. The balance of the warning letters written by FDA is smaller in number, from only one (1) for HCTCPs to 22 for clinical investigators.

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The demand for biologics including therapeutic proteins, monoclonal antibodies, vaccines and cell-based therapies is on the increase worldwide and the US remains the largest and one of the most lucrative markets for these therapeutic products.

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BCG has supplemented its advisory committee preparation services by teaming with the regulatory communication group Pharmapprove to assist companies in the preparation of high impact FDA advisory committee presentations. If you have an advisory committee appearance in your future, and would like to maximize the impact of your presentation, please contact Jim Kenimer.

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.

4th Annual Forced Degradation Studies

David T. Lin, Ph.D.
(speaker)

2nd Annual Commercial Implications of Stem Cell Research

Track 6 at Molecular Medicine Tri-Conference; Panel Expert on Regulatory Issues for Neural Regeneration

World Vaccine Congress 2007

Agenda

Spring Cell Therapy Conference

Moderating session on Novel Cell Therapies