BLAIR A. FRASER, PH.D.

Dr. Fraser is a biochemist (Ph.D., The Pennsylvania State University) who brings 30 years of experience with the U.S. Food and Drug Administration (FDA) in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Until recently Director, Division of Pre-Marketing Assessment I, Dr. Fraser joined CDER, in 2004, as Deputy Director, Division of New Drug Chemistry II. In 2005, Dr. Fraser served as Chief, Branch 2, Office of New Drug Quality Assessment, prior to becoming Director in 2006. During this tenure, he engaged in the full range of CMC scientific and regulatory endeavors from review to policy. With BCG, Dr. Fraser will utilize his professional and regulatory experience in development of drugs, biologics, and vaccines.

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MIRIAM PROVOST, PHD

Miriam comes to BCG with over 13 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Most recently, she was the Deputy Director for Science and Engineering Review in the Office of Device Evaluation. The Office of Device Evaluation is responsible for the review and approval of all medical devices in the U.S., with the exception of in vitro diagnostic devices. Miriam previously worked for M Squared Associates as a Senior Project Manager, advising medical device and combination product manufacturers on regulatory strategy, FDA submissions and product development issues.

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TIMOTHY SCHOFIELD, MA

Tim comes to BCG with over 30 years of experience in the Merck Research Laboratories. He joined Merck Sharp & Dohme Research Labs in 1976 as a statistician in Virus & Cell Biology where he was responsible for statistical support of non-clinical and clinical research with vaccines. In 1981 he moved into Biometrics Research where he provided statistical support to preclinical and nonclinical research with pharmaceuticals and vaccines. In correspondence to Merck's development efforts on 6-new major vaccines, the department of Vaccine Biometrics Research was established under Tim's leadership in 1993. His department grew over time, and was instrumental in the development and launches of VARIVAX for chickenpox in children, VAQTA for hepatitis A in children and adults, ProQuad a quadravalent pediatric vaccine for measles, mumps, rubella, and chickenpox, RotaTeq a live oral pediatric vaccine for rotavirus disease, ZOSTAVAX for herpes zoster in the elderly, and GARDASIL for cervical cancer. Tim will utilize his broad technical and collaborative expertise to assist clients in nonclinical statistical support of development and manufacturing of vaccines and biologics.

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If one takes a close look at the type of Warning Letters issued by FDA over the past twelve months, you may be surprised to learn that approximately 90 letters cited failures of quality systems. Although most of the letters were issued by  CDRH citing violations of Quality Systems requirements for medical devices (21 CFR Part 820),  CDER and CBER compliance letters notably cited similar concerns regarding quality systems failures from cGMPs specified in 21 CFR Part 211  for drugs and biologics. 

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Each year, the media covering the pharmaceutical industry reports on FDA’s performance statistics for approving new drugs and biopharmaceuticals.  Most of the attention is given to the approval of new molecular entities (NMEs) since these drugs, have not been previously approved by FDA. Occasionally, approval of a NME can provide a new treatment option for patients especially when there are few approved drugs available to address a serious disease or condition (often referred to as an unmet medical need).  These drugs are generally assigned priority review by FDA (≤ 6 months) whereas all other NME applications are assigned a standard review (≤ 12 months).  

Several news sources have recently reported that FDA approved twenty-four new molecular entities in 2008 as compared to eighteen NME approvals in 2007.  Although most reported that the number of NME approvals in 2008 increased by one-third as compared to approvals in 2007, there are several other interesting and important observations that should be noted.  This analysis provides a high-level review of the applications approved.  In a subsequent analysis, we will report on Phase IV commitments for approval.

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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.

WCBP 2009

Cell and Gene Therapy Forum 2009

"Designing cell and gene therapy clinical trials"

ComplianceOnline.com

Webinar

"Off-Label Promotion of Medical Devices:   Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices"

Regulatory Affairs Professional Society (RAPS)

2009 RAPS Horizons Conference & Exhibition

"The Challenges of Nanotechnology:
Navigating the Field and the Regulatory Pathways"

Clinical Trial Planning and Management

"Trial Design for Efficient Drug Development "

Wilson W. Bryan, MD
(co-director)

Seton Hall Law School

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

AAPS 2009 National Biotechnology Conference

"Phase I INDs for Biologics: How Much Data is Adequate"

Ron Marchesani
(speaker)

National Non-Clinical Careers For Physicians

"Networking Your Way Into a Non-Clinical Career: Industry, Government & Consulting"