EUGENE B. JOHNSTON, CQE, CQA

Eugene Johnston will join BCG as the new Head of the North Carolina Office in July of 2007. Mr. Johnston has over 30 years of experience in FDA-regulated industries in Quality Assurance, Quality Control and validation. He was most recently the Vice President, Quality Assurance and Regulatory Affairs at Biolex, a biopharmaceutical company involved in the development and production of therapeutic proteins using the Lemna Expression System(LEX™) which is based on the aquatic plant, Lemna. Mr. Johnston was responsible for establishing the Quality Assurance, Quality Control and Regulatory Affairs functions and Biolex and established the Quality Systems programs for preclinical and clinical manufacturing operations. Read Announcement

See Curriculum Vitae

NANDA K. SUBBARAO, PH.D.

Dr. Subbarao joined the group as a Senior Consultant in June of 2007. She has expertise in stability and laboratory cGMP systems for both biologics and conventional drugs and can assist clients with the set up of cGMP laboratory systems, implementation of stability programs, and evaluation of analytical methods and method validation. Read Announcement

See Curriculum Vitae

"Biosafety and Nonclinical Assessments of Cell and Tissue-Based Products in the United States" in Nonclinical Drug Safety Assessment: Practical Considerations for Successful Registration, W. Siestma, Ed. FDA News, Press, Weber, D.J. and Pepperl, D. (2007) in press

This chapter highlights the biosafety concerns inherent when working with medicinal products containing living cells or tissues. It also provide a comprehensive discussion of the types of non-clinical efficacy and safety studies that are generally expected by the FDA to successfully enter Phase I clinical studies.

This chapter discusses regulatory issues for manufacturing of therapeutic cells derived from stem cells and suggests approaches for successfully addressing them

There have been dramatic changes over the last decade in the post-marketing environment and probably there are more to come. These changes and the issues arising from them were discussed in three critical areas in the perspective of increasing regulatory demands; the areas reviewed were, Regular Approval, Accelerated Approval and Pediatric Drugs.

There are often unresolved issues at the time of Regular Approval of a drug including safety concerns not fully resolved with sufficient patient sampling, individual contributions of drugs in combination therapy, extension of benefit of a drug to other study populations, assay issues. These become the subject of concern and possible resolution via ongoing post marketing trials, which may have the added benefit to a drug developer of improvement of license indication and consequently expansion of market. Accelerated Approval, first introduced in 1992, has formal requirements for post-marketing which if not complied with can lead to drug labeling changes or drug withdrawal from the market since they must strengthen and satisfy the legitimacy of the initial licensing study by supporting the surrogate endpoint used. Pediatric post marketing studies have been modified several times in congressional effort to get more pediatric drugs to the market based on experimental evidence developed in children and not second-hand dosing and safety information extrapolated from adults.

BIOTECHNOLOGY CENTER EXCHANGE GROUP ELECTS NEW CHAIRWOMAN, VICE CHAIRMAN

Leaders for Bioprocessing/Process Development Professionals

RESEARCH TRIANGLE PARK, N.C., June 12, 2007 - Tanya Scharton-Kersten, Ph.D., and Ruben Carbonell, Ph.D., have replaced Peter Kilpatrick, Ph.D., to become chair and vice-chair of the Bioprocessing/Process Development (BPD) Group, one of eight intellectual exchange organizations hosted by the North Carolina Biotechnology Center.

Kilpatrick, head of the Department of Chemical & Biomolecular Engineering at North Carolina State University, stepped down at the close of the 2006-2007 seminar series after leading the group for two years. He was preceded by Bo Arve, of Wyeth, who had also served a two-year term. The post of vice chair was added this year in response to the group's growth.

Scharton-Kersten is a senior consultant with Biologics Consulting Group in Cary. Carbonell is the Frank Hawkins Kenan Distinguished Professor at NCSU and director of the university's William R. Kenan, Jr. Institute for Engineering, Technology & Science; co-director of the National Science Foundation's Science and Technology Center for Environmentally Responsible Solvents and Processes; and director of the Kenan Center for the Utilization of CO2 in Manufacturing.

The Biotechnology Center's Science and Technology Development Program initiated the BPD Group in 2002 to provide a forum for process development scientists and engineers to discuss bioprocessing issues.

The organization, with some 500 members, meets monthly with speakers from the industry, technology vendor companies and regulatory experts. The program content for the events is planned by experts from North Carolina-based bioprocess manufacturing companies including Diosynth, Talecris, Biogen, Wyeth and others.

Events this year included Formulation Development for Biopharmaceutical Development; Grand Challenges in the Development of Mammalian Cell Culture Production of Proteins; and a Bioprocessing and Bioseparations Development forum.

The BPD Group is part of the state's robust infrastructure for supporting North Carolina's biomanufacturing and pharmaceutical-production companies. Attracting, retaining and expanding these companies is a high priority of the state's strategic plan for biotechnology development because these companies create new high-paying jobs and attract substantial capital investment.

The new Beijing China office of BCG is now staffed and open for business. Dr. Lei Zhang arrived in China on May 2 to open the new office. On June 11 & 12 Dr. Kenimer, BCG President & CEO, presented a workshop entitled "US FDA's Biologics Approval Process" in Shanghai, assisted by Dr. Zhang. The Beijing office will focus on the identification of biopharmaceutical companies and companies producing Chinese traditional medicines that would like to bring their products to the US for FDA approval. In addition, the China office will enable BCG to provide auditing and due diligence services to its clients that are interested in out-sourcing services to CROs in China. For more information about our China office services contact Dr. Zhang or Dr. Kenimer.

BioChina pre-conference masterclass presented by
BCG China Office Head, Lei Zhang, M.D., Ph.D.

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.

Target Immunotherapeutics and Vaccine Summit

"Selecting a Study Population"

Annual Conference & Exhibition

"Regulatory Considerations for Starting a Gene Therapy Trial in the US" (Miller)

Somatic Cell Therapy Symposium

“Use of Devices in Cell Therapy Manufacturing”

Annual Meeting & TXPO 2007

“New Technologies in Cellular Product Testing”

Getting it Right the First Time, Every Time

"Combination and Device Inspections"