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

Dr. Zhang earned his M.D. degree from Medical College of South China University in 1984 and was employed as a resident in the Department of Internal Medicine at Guangzhou General Hospital from 1987 to 1992. Dr. Zhang then earned his PhD in Immunology from the University of Georgia in 1997. Dr. Zhang worked as a research scientist at the Center for Disease Control from 1998-2000. His research was focused on autoimmunity and inflammatory diseases.

In 2000, Dr. Zhang joined the Division of Monoclonal antibody, Center for Biologics Research and Review, FDA where he was primarily responsible for the review of antibody-based therapeutic proteins for the treatment of various diseases including cancer and autoimmune diseases. He was responsible for reviewing pre-IND, IND and BLA submissions and gained expertise in regulatory issues as well as scientific and technical issues related to development and manufacturing of therapeutic proteins, including product characterization, establishment of specifications 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. Zhang is also experienced in the critical area of assay development for therapeutic proteins.

In 2005, Dr. Zhang joined the Division of Biologic Oncology Product, Office of Oncology Product, CDER, FDA as a pharmacology and toxicology reviewer where he reviewed the preclinical sectione of new drug applications including products of antibody-based therapeutic proteins, growth factors, cytokines, toxins, enzymes, and tumor vaccines for treatment of cancer. Dr. Zhang has gained expertise in assessing whether submitted preclinical studies are compliant to FDA requirements and adequate for safe clinical trial. As an immunologist with medical background, he has a good understanding of mechanism of action of biologic drugs under development in the context of pathology and physiology of the targeted diseases. This made him very good at rational design of pharmacology studies and development of assay and potential biomarker for pharmacokinetic and pharmacodynamic studies for biologic drugs.

Dr. Zhang will use his experience and knowledge to assist client in the following:

1) IND and BLA submission to US FDA and China's FDA
2) Design and strategic planning of biological drug development including drug candidate selection, molecular engineering of humanized or full human antibody-based biologic drug, pilot lots manufacturing for phase I clinical trial, process validation, virus clearance and regulation-related issues.
3) Design of assays for all stages of biologic development including assays for PK, PD, potency and immunogenecity.
4) Design and strategic planning for pharmacology and toxicology studies for biologic drug.
5) Review and audit CMC data for of biotechnology-derived products.
6) Write clinical protocols for Phase 1 and 2 clinical trials on autoimmune diseases and tumors.

View Dr. Zhang's Curriculum Vitae...

Page Updated April 24, 2007