Xin Zhang md, ms

* ********* *** . **********, ** 01701 . Cell: 858-***-**** .

aboh5d@r.postjobfree.com

Summary

10+ years of drug discovery and development experience in biotech and

pharmaceutical industry . 3+ years of successful clinical trial managing

experience . Experience in leading international (APAC) teams . Strong

ability to effectively apply technical principles, theories and concepts to

clinical drug development . Experience in communicating and negotiating

with investigators and CROs . Expertise in GCP, FDA and ICH requirements .

Global clinical trial and BLA experience . Strong presentation and

interpersonal skills . Proficient computer skills

EXPERIENCE

Senior Clinical Trial Manager, Biogen Idec, Weston, MA,

October 2009 - Present

. Responsible for clinical operations within Asian Pacific countries

. Lead CTM for 2 Phase I Neurology clinical studies

. Lead Phase I clinical study protocol concept and full protocol

development

. Manage 6 phase III global clinical studies for Hemophilia within 37

different sites in 6 APAC countries

. Manage the APAC clinical operation team of 11 employees

. Oversee CRO to insure quality of the studies as well as timeline and

budget on targets

. Study sites co-monitoring as sponsor

. Provide input into strategies for country selection, CRO/vendor

selection and budget planning

. Establish and maintain effective working relationships with study

investigators and coordinators

. Comply with company SOPs and ICH/GCP guidelines

. Manage clinical operation elements with an emphasis on identification,

resolution and/or escalation of discrepancies

Research Scientist, Bayer Healthcare LLC, Berkeley, CA, June 2006-

October 2009

. Responsible for PK/PD and efficacy studies in diseased animal models

for preclinical evaluation of coagulation factors

. Projects management for research collaborations in China

Staff Scientist, Merck, San Diego, CA,

September 1999 - May 2004

. Responsible for development of monoclonal and polyclonal

antibodies

. Responsible for drug screening, assay development, gene cloning

and expression

Research Biologist, Stratagene Genomics Inc, San Diego, CA,

July 1997 - September 1999

. Led in-house RNA production and quality control

. Managed RNA out-sourcing manufacture and trained technical support

and sales personnel

Research Fellow, La Jolla Cancer Research Foundation, San Diego, CA,

July 1996 - July 1997

. Evaluated the function of Fap-1 protein in the Fas induced

apoptosis pathway

. Developed two monoclonal antibodies against Bad and Bclx

Senior Research Associate, University of Texas Anderson Cancer Center,

Houston, TX, September 1994 - July 1996

. Conducted research on gene function validation and gene therapy

vector evaluation

. Evaluated apoptosis gene expression in leukemia patient and

chemotherapy outcome

Research Assistant, University of Texas, Houston, TX, September 1992 -

September 1994

. Studied the functional role of IHF in the nitrate reductase gene

expression in E. coli.

Post-doctor, University of Texas, M.D. Anderson Cancer Center, Houston,

TX, July 1987 - September 1992

. Studied erb-2 neu-oncogen amplification in human ovary cancer

Attending Surgeon, Normal Bethune University of Medical Sciences,

Changchun, China, July 1984- July 1987

EDUCATION

. Masters Degree in Molecular Biology and Biochemistry

- University of Texas in Houston, Graduate school of Biomedical

Sciences

. MD Degree in Medicine

- Normal Bethune University of Medical Sciences, China

PROFESSIONAL TRAINING

. Clinical Project Management: Advanced, Boston, MA 2013

. Clinical Research Monitoring Workshop, Society of clinical

research associates, San Diego, CA, 2010

. Clinical Science Course, Society of clinical research

associates, San Diego, CA, 2010

. Introductory Workshop in PK/PD modeling Using WinNonlin,

Mountain View, CA,

AWARD

2008: Special Recognition Award for Innovation, Bayer HealthCare

PUBLICATIONS

. Dumont JA, Liu T, Low S C, Zhang X, Kamphaus G, Sakorafas P, Fraley C,

Drager D, Reidy T, McCue J, Franck HW, Merricks EP, Nichols TC, Bitonti

AJ, Pierce GF, Jiang H. "Prolonged activity of a recombinant factor

VIII-Fc fusion protein in hemophilia A mice and dogs." Blood. 2012 Mar

29;119(13):3024-30. Epub 2012 Jan 13.

. Powell JS, Josephson NC, Quon D, Ragni MV, Cheng G, Li E, Jiang H, Li

L, Dumont JA, Goyal J, Zhang X, Sommer J, McCue J, Barbetti M, Luk A,

Pierce GF." Safety and prolonged activity of recombinant factor VIII Fc

fusion protein in hemophilia A patients." Blood. 2012 Mar

29;119(13):3031-7. Epub 2012 Jan 5.

. Mei B, Pan C, Jiang H, Tjandra H, Strauss J, Chen Y, Liu T, Zhang X,

Severs J, Newgren J, Chen J, Gu JM, Subramanyam B, Fournel MA, Pierce

GF, Murphy JE. "Rational design of a fully active, long-acting

PEGylated factor VIII for hemophilia A treatment." Blood. 2010 Jul

15;116(2):270-9. Epub 2010 Mar 1.

. Pan J, Liu T, Kim JY, Zhu D, Patel C, Cui ZH, Zhang X, Newgren JO,

Reames A, Canivel D, Jesmok G, Pierce GF, Sommer JM, Jiang H. "Enhanced

efficacy of recombinant FVIII in noncovalent complex with PEGylated

liposome in hemophilia A mice." Blood. 2009 Sep 24;114(13):2802-11.

Epub 2009 Aug 4

. Zhang, X, T. Liu, J. Pan, D. Sim, K. McLean, Z. Cui, J. M. Sommer, J.

Haaning, X. Zhao, J. E. Murphy, G. F. Pierce, and H. Jiang (2009)

"Enhanced and prolonged efficacy of a novel recombinant FVIIa variant

(BAY86-6150) for acute and prophylactic treatments in Hemophilia A

mice." Submitted

. Liu, T., D. Lillicrap, X. Zhang, A. Labelle, S. Powell, B. Mei, J. E.

Murphy, G. F. Pierce, and H. Jiang (2009). "Site-specific PEGylation

of FVIII preserves full clotting activity and extends therapeutic

efficacy in hemophilic dogs." Submitted

. Gu G, Lorrain D, Wei H, Cole R, Zhang X, Daggett L, Schaffhauser H,

Bristow L, and Lechner S. "Distribution of Metabotropic Glutamate

Receptor 2 in the Rat Forebrain Supports Its Target Candidacy for

Anxiety." Brain Research. Volume 1197, 4 March 2008, Pages 47-62

. Bain, G., Daggett, L. P., Massari, M. E., and Zhang, X. "Matrix

Analysis of Gene Expression in Cells (MAGEC)". PCT application, 15

April 2002

. Kitada S, Krajewska M, Zhang X, Scudiero D, Zapata JM, Wang HG, Shabaik

A Tudor G, Krajewski S, Myers TG, Johnson GS, Sausvill EA and Reed JC.

"Expression and location of pro-apoptotic Bcl-2 family protein BAD in

normal human tissue and tumor cell lines," Am L Pathol 1998

Jan;152(1):51-61

. Younes A, Zhao S, Zhang X, Snell V, Clodi K, Kliche KO, Thomas E,

Cabnillas F and Andreeff M. "CD30-ligand expression in lymph nodes

involved with Hodgkin's disease," Ann Oncol 1997;8 Suppl 2:97-100

. M. Lisovsky, Z. Estrov, X. Zhang, U. Consoli, G. Sanchez-Williams, V.

Snell, R. Munker, A. Goodacre, V. Savchenko and M. Andreeff. "Flt3

Ligand Stimulates Proliferation and Inhibits Apoptosis of Acute

Myeloid Leukemia Cells: Regulation of Bcl-2 and Bax," Blood. 1996.

Vol 88, No 10, p3987-3997

. Zhang, X., and DeMoss, J. A. "Structure modifications induced in the

narG promoter by binding of IHF and NARL-P", J. of Bacteriology. 1996

July, 178. 13. p3971-3973

. Hung, M. C., Zhang, X., Yan, D. H., Zhang, H. Z., He, G. P., Zhang, T.

Q., and Shi, D. R. "Aberrant expression of c-erbB-2/neu proto-oncogene

in ovarian cancer", Cancer-lett. 1992 Jan 10. 61 (2). p 95-103

. Yung, W. K., Zhang, X., Steck, P. A., and Hung, M. C. "Differential

amplification of the TGF-alpha gene in human gliomas", Cancer-

Commun., 1990 2 (6).P201-5

. Zhau, H. E., Zhang, X., Eschenbach, A. C., Scorsone, K., Babaian, R.

J., Ro, J. Y., and Hung, M. C. "Amplification and expression of the c-

erb B-2/neu proto-oncogene in human bladder cancer", Mol-Carcinog.,

1990 3 (5). P 254-7

. Zhang, X., Silva, E., Gershenson, D., and Hung, M. C. "Amplification

and rearrangement of c-erb B proto-oncogenes in cancer of human female

genital tract", Oncogene, 1989 Aug. 4 (8). P 985-9

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