RUTH E. WAGER, Ph.D

Dr. Wager joined BCG in April of 2008. While at the FDA from 2002-2005, she was a CMC reviewer for biologics, small molecules, and combination products. Her industrial employment experience includes participation at all stages of product development for protein and small molecule therapeutics, as well as in vivo diagnostics. Her expertise is in product development and characterization, release and stability testing, and cGMP. Her most recent position was at Amgen where she held the position of Director of Corporate Product Quality, overseeing the quality of Amgen's products throughout their lifecycle.

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GILBERT T. SALUD

Mr. Salud joined BCG in April of 2008. Gil has over 14 years of industry experience in the technical, quality and regulatory requirements of biologic, small molecule, and medical device product manufacturing and commercialization. Gil's most recent position was at the FDA with CDER at the Office of Compliance where he held the position of Team Leader of the Biotech Manufacturing Team, overseeing the manufacturing regulatory review of BLA and sBLA (PAS, CBE, and AR) applications and conducting pre and post approval inspections.

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SUSAN M. BOWLEY, PH.D.

Dr. Bowley joined the BCG group mid-April 2008. Susan spent four years as a reviewer at the FDA working predominately on balloon catheters, arthrectomy devices, stents, and drug eluting stents. Susan has over twenty years of diverse experience as a Mechanical and Biomedical engineer. She spent four years as a reviewer at the FDA working predominately on balloon catheters, arthrectomy devices, stents, and drug eluting stents. Most of her time was spent on reviews for the unique and dynamic area of development in drug eluting stents, being involved in all of the submissions for these novel products.

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Sign up soon for May 8-10 courses below
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FDA REGULATION OF BIOTECHNOLOGY AND BIOLOGICS PRODUCTS: FROM IND TO BLA
presented by:

Jim Kenimer, Ph.D. - President & CEO, BCG
Ron Marchesani - Head, West Coast Operations, BCG
Janice Wilson, Ph.D. - Senior Consultant, BCG

Click here to sign up for FDA Regulation course #21339

Day one provides a detailed look at the IND process as it applies to biologic products, including the timing, structure and content of pre-IND meetings, and reviews currently acceptable IND formats. The content, format, and post-approval considerations of INDs are covered in depth.

Day two conducts a thorough review of the Biologics License Application (BLA) process including the information necessary for successful BLA planning and filing. GMP, GCP, and GLP requirements are reviewed including validation issues, bioresearch monitoring inspections, and preapproval inspections.

General Information
Location: UCSC Extension, 10420 Bubb Rd., Cupertino.
Dates: 2 meetings: Thursday-Friday, 8:30am-5pm, May 8-9.
Fee: $700
Course #: 21339-001 (use course-section number to enroll)

For more information, visit www.ucsc-extension.edu/bcgbio.

MEDICAL DEVICES AND THE FDA: AN INSIDER’S PERSPECTIVE
presented by:

Carl Anderson - Senior Consultant, BCG
Susan Bowley, Ph.D. - Senior Consultant, Medical Devices, BCG
Stuart Portnoy, M.D. - Senior Consultant, Medical Devices, BCG

Click here to sign up for Medical Devices course #21340

Understanding when and how to communicate directly with the FDA is crucial in speeding a medical device application to market. This special workshop takes you step-by-step through the maze of the medical device pre-approval process and highlights how to effectively communicate with FDA decision makers throughout. Explore important features of a high quality pre-IDE submission, the most common reasons for IDE disapproval, and determine when a panel meeting is necessary. Through the use of real-world case studies, the course discusses what really matters to FDA in determining 510(k) versus a PMA, clinical study considerations, and the unique focus of FDA medical device Bioresearch Monitoring Inspections. This workshop will include a discussion of combination products including jurisdictional issues and common problems to avoid.

General Information
Location: UCSC Extension, 10420 Bubb Rd., Cupertino.
Dates: Saturday, 8:30am–5pm, May 10.
Fee: $435
Course #: 21340-001 (use course-section number to enroll)

For more information, visit www.ucsc-extension.edu/bcgdevices.

BCG-Japan is open for business

Pharmacogenetic diagnostic tests that are laboratory-developed tests (LDTs) are currently regulated by the Center for Medicare and Medicaid Services by authority of the Clinical Laboratory Improvement Amendments of 1988. LDTs are not marketed outside the single laboratory that developed the test service and are not required to submit data for FDA review. The FDA has generally exercised enforcement discretion over standard LDTs that use primarily analyte specific reagents, general purpose reagents, laboratory equipment, instrumentation and controls and fall under the regulation of CMS CLIA requirements.

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Contact Dr. Salerno....

Reproduced with permission from Medical Devices Law & Industry Report, Vol. 2, No. 4, 02/27/2008. Copyright ©2008 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

Medical device sponsors received a wake-up call early in 2008 when Michael Marcarelli, director of the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year (Oct. 1, 2006 through Sept. 30, 2007).1 CDRH reported that the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Inspections resulting in an Official Action Indicated (OAI) inspection classification had grown to an all-time high of 33 percent.

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Contact Carl Anderson....

Reproduced with permission from BioProcess International, originally this article appeared in the February 2008 issue of BioProcess International.

Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. manufacturing change scenarios. Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability (e.g., trending analysis, additional characterization studies, accelerated stability data).

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http://www.bioprocessintl.com/

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 PEGS (Protein Engineering Summit)

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

Lab Compliance

“Stability Testing Fundamentals and Considerations in the Current Regulatory Environment”

ISCT 14th Annual Meeting

speakers

Ellen M. Areman, MS, SBB
David J. Pepperl, Ph.D.
Darin Weber, Ph.D.

Study Directing: Principles and Practices

"Your "other boss": How an FDA reviewer reads your reports"

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"