Development Clinical

Lan Zhu, M.S

732-***-**** *********@*****.***

Summary of Qualifications:

20+ years’ pharmaceutical R & D experience working in a regulated bioanalytical environment with progressively

advanced duties. Experienced in multi platforms assay development/validation, sample testing, external assay

transfer, and data reporting. Experience with cell culture, antibody production and purification and antibody

conjugation. Experienced in the preparation and the review of bioanalytical sections of regulatory documents to

health authorities. Effective cross-functional collaboration with other groups such as Safety Assessment,

Analytical, Clinical, and Regulatory to deliver results. Excellent interpersonal, teamwork and communication

skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems

simultaneously.

Experience:

Merck April 2012- Current Associate Principle Scientist

Dept. Dept. Clinical Biomarker & Diagnostics (GLP Lab)

• Serve as a group leader for designs and performs of biomarker & diagnostics immunoassay

development, validation and implementation from discovery through Clinical phase.

• Responsible for the oversight of outsourcing efforts, including CRO selection and initiation,

monitoring of externalized projects, and providing a scientific liaison role.

• Participate in prepare standard operation protocols and reports, including quantitative

analysis, summaries, and protocols. Participate in scientific meetings and presents technical

findings.

• Serve as the Principal Investigator for multiple pre-Clinical and Clinical projects, overseeing

the execution of various study component activities from initiation, tests, analyzes, and

interprets data and events requiring evaluation in response to product support requests and non-

conformances through final report submission

• In charge of Maintenance for lab equipment and follows lab quality and safety requirements.

Merck Jul 2005- Mar 2012 Sr. Research Biochemist

Dept. Metabolic Disorders-Diabetes & Obesity

• In charged for polyclonal and monoclonal antibody production and purification, conjugation

and assay development.

• Maintained of cell culture reagents and cell lines. Cell-based assay development and

performance.

• Served as a project lead for first Diabetes drug in a new class called DPP4 inhibitor-

Januvia(sitaglptin), approved in 1996. Activities including interaction with multiple cross-

functional groups (chemistry, DMPK, Biostatistics, Clinical Pharmacology, Regulatory Affairs

and Marketing ) to drive project within highly compressed time lines for fast and early entry

into different stages of preclinical developments, safety assessments, and clinical studies.

• Gave Suggestions for improvement to methodologies, processes, products, and systems

related to projects.

• Served as a Principal Investigator for multiple projects, overseeing the execution of pre-clinical and clinical

studies for novel drug candidates.

• Trained and mentored colleagues for multi-technology and assays skills (antibody production, immunoassay,

cell-based assay, enzymatic assay, gene and protein profiling).

• Participated as the Bioanalytical representative on multiple Due Diligence efforts, evaluating the prospect of

external scientific therapeutic integration into the Diabetes pipeline.

Merck Aug 2000- June 2005 Research Biochemist

Dept. Metabolic Disorders-Diabetes & Obesity

• Executed multiple pre-clinical and clinical studies for the first in-class diabetes drug DPP4

inhibitor. Responsible for the development and validation of immunoassays (PK/PD, ADA,

serum biomarker).

• Oversaw in-vitro and in-vivo studies for new diabetes drug target identification, validation &

optimization.

• Facilitated the collaboration with internal as well as external partners for evaluate of potential

new diabetes drug candidates.

Lan Zhu, M.S

732-***-**** *********@*****.***

Experience: (Cont. )

Merck Oct 1996- July 2000 Staff Biochemist

Dept. Virus & Vaccine Clinical lab (GLP lab)

• Developed and validated immunoassays for HIV Vaccine and authored their respective

reports.

• Completed HIV vaccine clinical studies consisting of sample analysis, data submission and

report writing.

• Executed INF-r ELISpot immunoassay and Cell Flow Cytometry to evaluate the cellular

immune-response of HIV Vaccine

• Participated the pre-clinical and clinical development of DNA Vaccines for Influenza Virus

and Tuberculosis

Univ. of Medicine & Dentistry of New Jersey Aug1993-Feb 1996 Research Assistant

Dept. Microbiology & Molecular Genetics

• Trained on immunology and Molecular biology techniques.

• Identified and purified a novel ulcerative colitis related protein.

• Constructed a colon tissue specific cDNA library. Screened this cDNA library using

antibody-based immunoassay.

• Finished the projects and defended for Master thesis.

Institute of Shanghai Biological Product, China Sept.1988- Dec 1992 Sr. Research Associate

Dept. Immunology & Diagnostics

• Generated monoclonal antibodies to HIV gp24, gp41 using hybridoma technique.

• Conducted immunoassay screenings for antibody expression.

• Responsible for culturing and maintenance of various cell lines and hybridomas.

• Screened the anti-HIV drugs from traditional Chinese medicine

Chinese CDC Beijing China Aug.1983- July1988 Research Associate & Graduate Stude

Institute of Microbiology & Epidemiology Dept. Immunology

• Generated hybridoma cll lines and produced monoclonal antibody against Vibrio cholera.

• Immunized small animals. Detected the antibody titer using immunoassays.

• Evaluated the preventive antigen for Vibrio cholera with monoclonal antibodies

• Preformatted the in vitro and in vivo assays

Education:

School Date Major/Minor Courses Degree

University of Medicine & Dentistry of 1993-1996 Molecular Genetics & M.S.

New Jersey Microbiology

Chinese Disease Control Center 1983-1988 Immunology & Microbiology M.S.

Sichuan University 1979-1983 Public Health Science M.D

Medical School

Reference:

Joel Berger: Director, New Frontier Science at Takeda Pharmaceuticals International, Inc

(***********@*****.***)

Paul Carrington: Principle Scientist Merck (***************@*****.***)

Ranabir Siharoy: Senior Director and Diabetes Strategic Support Leader at Janssen, Pharmaceutical

Companies of Johnson and Johnson (*******.********@*****.***)

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