ANGELA BLACKWELL

For the past 13 years, Ms. Blackwell was a Scientific Reviewer in the Division of Anesthesiology, Infection Control, General Hospital, and Dental Devices (DAGID), Center for Device Evaluation and Radiological Health (CDRH), FDA. As a Senior Consultant at BCG Ms. Blackwell will utilize her broad engineering, clinical, and regulatory expertise to continue to assist clients in the following areas related to gaining FDA approval of medical devices.

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CARL ANDERSON

Mr. Anderson has come to BCG after 23 years and varying positions at the FDA. He started his career with FDA in 1987 as a biologist, transferred in 2000 to the Seattle District where he conducted inspections of clinical investigators, institutional review boards (IRBs), GLP laboratories, and sponsors of clinical research. In 2001 Carl became a member of the FDA international inspection cadre, conducting inspections in Canada, Switzerland, and the European Union. He also broadened his expertise to include conducting "PADE" inspections for reporting adverse events by drug and biologic company pharmacovigilance departments. In 2004 Carl was assigned to the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health. As a Senior Consultant with Biologics Consulting Group, Inc. Carl will utilize his private sector and FDA regulatory compliance experience to assist sponsors and clinical sites conduct research that meets FDA standards.

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As defined in 21 CFR § 3.2(e), the term combination product includes:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

With the addition of Angela Blackwell, BCG has enhanced its ability to provide expert regulatory consulting services for most combination products. Please contact Dr. Jim Kenimer in the BCG main office for additional information about our services as related to combination products.

FDA Office of Combination Products

Link to Important Information on Medical Device User Fees for FY 2008

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's West Coast Operations are now based in San Mateo, CA in the heart of the Biotech Bay area. The office is conveniently located close to San Francisco International Airport and is within easy driving distance to both the Oakland and San Jose airports. These headquarters make an ideal place for meeting with client companies.

Biologics Consulting Group, Inc.-
West Coast Office
1840 Gateway Drive
Suite 200
San Mateo, California 94404
P (650) 378-1303
F (650) 378-1399

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 & TXPO 2007

“New Technologies in Cellular Product Testing”

Getting it Right the First Time, Every Time

"Combination and Device Inspections" Godshalk

"Essential Documents: Auditing Trial Master Files" Anderson

John R. Godshalk, MSE, MBA
(speaker)

Carl Anderson
(speaker)

Medical Device Regulations: Essential Training in Present and Pending Medical Device Regulations

"Introduction to US FDA Regulations"

AAPS Annual Meeting

“Critical Stability Evaluation of Biopharmaceuticals During Clinical Development”