TRENT A. CARRIER, PH.D., M.B.A.

Trent Carrier joined the BCG team in May of 2011. Dr. Carrier is a business leader with over 17 years of experience in developing new paradigms in the life science industry.  Most recently, Trent was the Senior Director of Bioprocess Services and Cellular Medicine at Life Technologies. Dr. Carrier joined Invitrogen in 2005 to lead the launch of a new process development services business focused on cell line development and cell culture media optimization.  Receiving numerous accolades for innovation and customer focus, PD-Direct grew over 40% per year overall and >100% per year in Asian markets under Dr. Carrier’s leadership.  In 2010, Dr. Carrier completed his MBA from the University of Virginia, Darden Graduate School and assumed additional responsibility for cell therapy products and services.  At Life Technologies, Dr. Carrier led multiple licensing transactions and was recognized for his ability to build high growth businesses. 

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ALICE VARGA, M.S., M.A.

Ms. Varga comes to BCG with 20 years of industry experience in areas ranging from small molecules to stem cell therapies as has spent the last 4 ½ years at the first company to receive FDA clearance for a clinical trial using a human embryonic stem cell (hESC) product. Ms. Varga’s experience with hESC products includes the preclinical, CMC and clinical areas of planning for these types of products and includes close interaction with the FDA review team in the Office of Cell Therapy and Gene Therapy (OCTGT).

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On May 19, 2011, at the invitation of the Center for Drug Evaluation (CDE), China State FDA (SFDA), a delegation from the FDAAA held two 3-hour roundtables, first with the Office of Biological Product Pharmaceutical Science (OBPPS) and then with the office of New Drug Pharmaceutical Science (ONDPS) and Office of Generic Drug Pharmaceutical Science (OGDPS). The purpose of these roundtables was to discuss the regulatory and scientific issues on chemistry, manufacturing, and controls (CMC) for biological products and new and generic chemical drugs that were of mutual interest or concern to both organizations.

The FDAAA delegation was composed of 5 former FDAers who are currently active in the pharmaceutical industry. They are:

• Chi-wan Chen (lead of delegation), Executive Director, GCMC, Pfizer; formerly Deputy Director, ONDQA, FDA; represented FDA on ICH Q1A(R2)/Q1D/Q1E EWG, Q3A(R2)/Q3B(R2) EWG, and Q8(R2) EWG
• Chuck Hoiberg, Executive Director, Pfizer, GCMC, formerly Deputy Director, ONDQA, FDA; served as CDER Quality Lead at ICH and CTD-Q; FDAAA Board member
• David Lin, Senior Consultant, Biologics Consulting Group; formerly reviewer in CBER and Team Leader and Acting Division director, ONDQA, FDA
• Duu-gong Wu, Executive Director, Consulting Division, PharmaNet; formerly Deputy Director, Division II, ONDQA; represented FDA on ICH Q5E EWG
• Mark Tucker, Senior Director, GMP Compliance, Genentech; formerly Director, Investigations Branch, Los Angeles District, FDA

Photo: Front row, second from left, Chen Zhen, Head and Vice Chief, ONDPS; fourth from left going to right, Yang Jianhong, Head and Vice Chief, OGDPS; Chi-wan Chen, FDAAA, currently Pfizer; Huang Xiaolong, Vice Chief, OGDPS; Duu-Gong Wu, FDAAA, currently PharmaNet, Inc. Second row, fourth from left going to right, Mark Tucker, FDAAA, currently Genentech; Chuck Hoiberg, FDAAA, currently Pfizer; David Lin, FDAAA, currently Biologics Consulting Group.

Article reprinted with permission of FDAAA at www.fdaaa.org

On June 1st, 2011, Ruth Wolff and John Humphries (BCG Sr. Consultants) participated in a workshop in Seoul, South Korea sponsored by the Korean FDA. Dr. Ruth Wolff gave a presentation titled "CMC Requirements for Biological Products" and Dr.  John Humphries presented 4 cases to illustrate challenges in drug development in the clinical phase ("Clinical-Regulatory Cases"). The presentations were simultaneously translated into Korean.

The workshop included 160 attendees representing 110 pharmaceutical companies and research institutes.  Most of the participating pharmaceutical companies have plans to export or develop drugs outside of South Korea.

Contact Dr. Humphries or Dr. Wolff...

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.