Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Lei Zhang, M.D., Ph.D., joined Biologics Consulting Group, Inc., as the Head of a newly China office on April 1, 2007.

Trained as an immunologist (PhD in Immunology, University of Georgia) and medical doctor and have been working for 7 years as a reviewer in monoclonal antibody division and in division of biological oncology product in Center for Drug Evaluation and Research, US FDA, Dr. Lei Zhang has accumulated lots of expertise in development of biological therapeutic protein drug and knowledge, and experience in regulatory issues associated with biological therapeutic protein drug development.  Dr. Lei Zhang reviewed antibody-based therapeutic proteins for treatment of varieties of diseases including tumors, autoimmune diseases.  In the Division of Monoclonal Antibodies, Lei Zhang was responsible for reviewing pre-BIND, BIND and BLA and performed facility audit for BLA pre-approval inspections and cGMP inspections, therefore,  gained expertise in regulatory issues as well as scientific and technical issues related to development and manufacturing of therapeutic protein, including characterization of the therapeutic protein, establishment of rational specification for lot release, process validation and process modification, assay validation, virus/pathogen clearance, comparability and stability study.  As an excellent immunologist with strong research ability, Dr. Lei Zhang is particularly good at assay development for therapeutic protein that is extremely critical for biologic drug development since every steps of the biologic drug development in pharmacology, toxicology, CMC or clinical study involve development of rational assays that meet the scientific and regulatory requirements. 

As a pharmacology and toxicology reviewer in the division of biologic oncology product, Lei Zhang reviewed preclinical section of INDs that are antibody-based therapeutic proteins for treatment of cancer, and gained expertise in assessing whether submitted preclinical studies are scientifically acceptable and compliant to FDA requirements and adequate for safe clinical trial.  As an excellent immunologist with medical background, the instructor has good understanding of mechanism of action of biologic drugs under development in the context of pathology and physiology of the targeted disease, and therefore, has rich experience in rational design of pharmacology and toxicology studies and development of assay and potential biomarker for pharmacokinetic and pharmacodynamic studies for biologic drugs. 

Since 2007, Dr. Lei Zhang has been hired by the respectful US consulting firm, the Biologics Consulting Group, Inc., in charge of China operation.  For last two years, Lei Zhang has been helping numerous foreign and Chinese pharmaceuticals, Chinese investors and Wall Street Investment banks with regards to pharmaceutical development, technology transfer, regulatory compliance (cGMP and biological product specific regulation), prior investment/prior technology transfer audits and mock US FDA comprehensive cGMP inspections and GLP inspections.

View Dr. Zhang's Curriculum Vitae...

Page Updated August 25, 2009