EDUCATION:
| Ph.D. |
|
Cellular
Biology and Immunology, Dept. Of Cellular Biology,
University of Georgia, Athens, Georgia (1997) |
| M.S. |
|
Immunology,
Dept. Of Immunology of Malaria, First Army Medical College,
Guangzhou, People's Republic of China (1987) |
| M.D. |
|
Hengyang
Medical College, People's Republic of China (1984) |
|
EXPERIENCE:
|
CURRENT
POSITION
(Apr. 2007 - present) |
|
Head,
China Office Biologics Consulting Group Inc.
Beijing, China |
| |
|
|
| Oct.
2005 - Mar 2007 |
|
Reviewer,
FDA/CDER/Office of Oncology Drug Product
Rockville, MD |
| |
|
|
| Oct.
2000 - Oct. 2005 |
|
Reviewer,
FDA/CBER/Division of Monoclonal Antibodies
Rockville, MD |
| |
|
|
| Jan.
1998 - Sep. 2000 |
|
Visiting
Associate, Center for Disease Control (NIOSH) |
| |
|
|
| Jan.
1993 - Dec. 1997 |
|
Graduate
Research Assistant, University of Georgia, Dept. Of
Cellular Biology |
| |
|
|
| Sep.
1987 - Sep. 1992 |
|
Resident
Doctor in Dept. Of Medicine, General Hospital of Guangzhou
Guangzhou, People's Republic of China |
HONORS
AND AWARDS
| FDA
Group Recognition Award for exceptional performance
in reviewing and approval of the first new class of
agent (Tysabri) for the treatment of multiple sclerosis.
2005 |
| Award
for Excellence in research on T cell activation by Division
of Monoclonal Antibodies. 2004 |
REGULATORY
RESPONSIBILITIES
Submission
Review
The BINDs that I have reviewed are generally antibody-based therapeutic proteins for treatment of varieties of diseases including tumors, autoimmune diseases. I have good understanding of regulatory issues as well as scientific and technical issues related to development and manufacturing of therapeutic protein. Because of proprietary issues related to BIND, I can not give specific details on my review activities.
Inspection
- Pre-approval inspection and cGMP inspection on US biotechnology pharmaceuticals
REGULATORY TRAINING (Partial list)
- Reviewer Training Program: Introduction to the Regulatory Process, CBER, FDA
- CDER’s Review Training Program.
- CMC Strategy Workshop offered by CDER.
- Symposium on Quality Control and Manufacturing and Inspection of Biomolecules. CDER, FDA
- Workshop on Analytical Method Validation and Qualification. CDER, FDA
- OBP Training Program for Reviewer (Consisted series of courses), CDER, FDA
- Clinical Trials: Design, Conduct and Analysis, CBER, FDA
- IND Regulations, CDER, FDA
- Drug Law, CDER, FDA
- Technical Writing for Reviewers, CDER, FDA
- Well Characterized Biologicals: Managing Pre- and Post- Approval Manufacturing Changes, Special Symposium: Evaluating Immunogenicity of Recombinant Proteins, CDER, FDA
- PDA/FDA Viral Clearance Forum.
- Reviewing INDs and BLA.
- Series of FDA training on issues of clinical trials.
- Series of FDA training on Pharmacology and Toxicology
- Series of FDA inspection trainings.
- Series of cGMP and GLP trainings.
| PRESENTATIONS |
| NIH
Immunology Retreat 10/29/02: Peptide immunization excludes
antigen specific T cells from splenic lymphoid compartments. |
|
PUBLICATIONS |
| 1. |
Lei Zhang, Elaine F. Lizzio, Trina Chen, and Steven Kozlowski. Peptide immunization excludes antigen specific T cells from splenic lymphoid compartments. European Journal of Immunology 35:776-85. 2006 |
| 2. |
Lei
Zhang, Elaine Lizzio, Elena Gubina, Steven Kozlowski.
Organ specific cytokine polarization induced by adoptive
transfer of transgenic T cells. Journal of Immunology
2002, 169:5514-21. |
| 3. |
Hill
DM, Kasliwal T, Schwarz E, Hebert AM, Chen T, Gubina E,
Zhang L, Kozlowski S. A dominant negative mutant beta
2-microglobulin blocks the extracellular folding of a
major histocompatibility complex class I heavy chain.
J Biol Chem. 2003 Feb 21;278(8):5630-8. |
| 4. |
Elena
Gubina, Trina Chen, Lei Zhang, Elaine Lizzio and Steven
Kozlowski. CD43 polarization in unprimed T cell is associated
with raft coalescence and requires an intact cholesterol
synthesis pathway. Blood 2002 99:2518-25
|
| 5. |
Rick
Tarleton, Grusby M and Lei Zhang (2000). Increased susceptibility
of STAT4 Deficient and enhanced resistance in STAT6 deficient
mice to infection with Trypanosoma Cruzi. Journal of Immunology
165 (3):1520-5. |
| 6. |
Lei
Zhang and Sally Tinkle (2000). Chemical activation of
innate and specific immunity in contact dermatitis. Journal
of Investigative Dermatology. 115(2):168-76. |
| 7. |
Lei
Zhang and Rick L. Tarleton. (1999) Parasite persistence
correlated with disease severity and localization in chronic
Chagas' disease. Journal of Infectious Diseases 180:480-6. |
| 8. |
Rick
L. Tarleton and Lei Zhang (1999). Chagas' Disease Etiology:
Autoimmunity or parasite persistence? Parasitology Today
15:94-99. |
| 9. |
Rick
L. Tarleton, Lei Zhang and M.O. Downs (1997) Autoimmune
rejection of neonatal heart transplants in experimental
Chagas' disease is a parasite-specific response to infected
host tissue. Proceedings of the National Academy of Science
of the USA 94:3932-3937. |
| 10. |
Lei
Zhang and Rick L. Tarleton (1996) Characterization of
cytokine production in murine Trypanosoma cruzi infection
by in situ immunocytochemistry: Lack of association between
susceptibility and T helper type 2 cytokine production.
European Journal of Immunology 26:102-109. |
| 11. |
Lei
Zhang and Rick L. Tarleton (1996) Persistent production
of inflammatory and anti-inflammatory cytokines and associated
MHC and adhesion molecule expression at the site of infection
and disease in experimental Trypanosoma cruzi infections.
Experimental Parasitology 84:203-213. |
| 12. |
Rick
L. Tarleton, Jianren Sun, Lei Zhang and Mirian Postan
(1994) Depletion of T-cell subpopulations results in exacerbation
of myocarditis and parasitism in experimental Chagas'
disease. Infection and Immunity 62:1820-1829. |
| 13. |
Lei
Zhang, Ouyang Minghui, Chao Sui and Yingjie Li (1988)
Study on affinity of monoclonal antibodies against Plasmodium
Inui. Journal of Medical College of PLA. 3:315-321. |
Page
Updated
August 25, 2009
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