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The BCG Bulletin                            

The Official Newsletter of the Biologics Consulting Group, Inc.

 

Issue 30

May 2 , 2007

 

Bulletin Highlights

Office Head Position Available in California

BCG Welcomes Lei Zhang as the Head of the new Beijing Office

BCG CEO to present"Biologics Approval Process" course in China

Your chance to meet with BCG representatives

 
Featured Stories
Position Available - Head, West Coast Office

Biologics Consulting Group, Inc (BCG) is initiating a search for the position of Head of our West Coast Office to be based in San Francisco, CA. Currently BCG plans, over the next several years, to increase the staff in this area to at least ten consultants, and is searching for a person with extensive firsthand biologic product regulatory experience to lead this expansion.

The position requires both management and business development skills as well as excellent consulting skills as related to a specific area of biologic product development. Compensation will be based on billable time plus the ability to successfully grow the CA office and meet agreed revenue goals. BCG offers a comprehensive benefits package including an Employee Stock Ownership Plan (ESOP).

Interested persons should send their CV to the attention of Jim Kenimer, Ph.D., President & CEO of BCG.

BCG Welcomes:
Lei Zhang, MD, Ph.D. as the Head of our
new Beijing office

LEI ZHANG, M.D, Ph.D.

Dr. Zhang joined BCG April 1, 2007. Prior to this position, Dr. Zhang served as a pharmacology and toxicology reviewer in the Division of Biologic Oncology Product, Office of Oncology Product, CDER, FDA where he reviewed new drug applications including products of antibody-based therapeutic proteins, growth factors, cytokines, toxins, enzymes, and tumor vaccines for treatment of cancer. The China office will focus on producing regulatory and product development assistance to Asia-Pacific companies that want to submit their products to the US FDA for marketing approval, as well as assisting non-Chinese companies who wish to perform contract manufacturing or testing at Chinese companies. Read Announcement

See Curriculum Vitae

 

BCG CEO to present "Biologics Approval Process" course in China, June 11-12, 2007
This 2 day masterclass sponsored by IBC Asia Pte Ltd. and conducted by Dr James G. Kenimer will offer participants a complete overview of the regulatory requirements and processes in the US for biologic products.

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.

Learn More...

Register for the course...

Upcoming BCG Presentations
& Conference Appearances

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.

Date
Sponsoring Organization
Conference and Presentation Title
BCG Attendee(s)/ Speaker (s)
Location
Apr. 28 - May 5, 2007 American Academy of Neurology 59th Annual Meeting Wilson W. Bryan, MD Boston, MA
May 6 - 9, 2007 BIO (Biotechnology Industry Organization) BIO 2007 Jim Kenimer, Ph.D.
& Others
Boston, MA
May 7 - 9, 2007 Pharmaceutical Education Research Institute (PERI) Effective Planning and Management of Clinical Trials Wilson W. Bryan, MD
(Course Co-Director )
Arlington, VA
May 15 - 16, 2007 IBC Life Sciences Training Academy "Best Practices for Biotechnology Product Comparability and Stability Studies -
Protocols, Test Methods and Quality Practices"
Nadine Ritter, Ph.D.
(speaker)
Boston, MA
May 21 - 22, 2007 IVT Method Validation Conference "Test Method Qualification or Test Method Validation: What is the Difference?" Nadine Ritter, Ph.D.
(speaker)
Boston, MA
May 30 - Jun 3, 2007 ASGT (American Society of Gene Therapy) 10th Annual Meeting Maritza C. McIntyte, Ph.D.
(speaker)

Seattle, WA
June 12 - 13, 2007 IBC Life Sciences Training Academy "Best Practices for Biotechnology Product Comparability and Stability Studies -
Protocols, Test Methods and Quality Practices"
Nadine Ritter, Ph.D.
(speaker)
Seattle, WA
June 18-21, 2007 Drug Information Association (DIA) 43rd Annual Meeting

“The Impact of FDA's Quality-by-design Initiative on Biologics Development”

David T. Lin, Ph.D.
(speaker)
Atlanta, GA
June 19 - 20, 2007 IVT Method Validation Conference "Test Method Qualification or Test Method Validation: What is the Difference?" Nadine Ritter, Ph.D.
(speaker)
Brussels, Belgium
June 27 - 28, 2007 Pharmaceutical Training Institute “Design and Implement Effective Stability Programmes for Biotechnology Products” Nadine Ritter, Ph.D.
(speaker)
London, England
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