Contact

Zhimei Du
www.linkedin.com/in/zhimei- VP, Biologics & Cell/Gene Therapy | Strategic Leadership | R&D to
du-23960a9 (LinkedIn) Commercialization
Los Angeles Metropolitan Area
Top Skills
Drug Development Summary
Cell Therapy
More than 15 years of experience combining extensive business
Gene Therapy
strategy and scientific capabilities across biotherapeutics
development areas including cell therapy, gene therapy, stem cell
Honors-Awards
transplantation, monoclonal antibodies, Fc-fusion, Bi/Tri-specific Abs,
The Best BIOT 2012
nanobodies, and peptides.
Amgen 2012 Innovation Award
Amgen 2013 Innovation Award
✓ Championed innovation and operational excellence by influencing
Merck 2019 Pipeline Award
strategic vision and long-range planning and continually redefining
and optimizing organizational structure and capabilities to create a
Publications
competitive edge for the business.
Enhancer-specific modulation of E
protein activity.
Efficient ex vivo inhibition of perforin ✓ Steered multiple global cross-organizational committee to
and Fas ligand expression by improve product/process design efficiency through dynamic effort
chimeric tRNA-hammerhead
ribozymes.
from Research, Discovery, CMC, PKDM, Pre-clinical, Clinical
High throughput, efficacious gene Development, Quality, Supply Chain, and GMP manufacturing.
editing & genome surveillance in
Chinese hamster ovary cells
✓ Envisioned and instituted new agile cross-functional drug
Use of a small molecule cell cycle
development roadmap and business strategy from target ID
inhibitor to control cell growth and
improve specific productivity and through pivotal clinical trials to accelerate speed to clinic and
product quality of recombinant commercialization.
proteins in CHO cell cultures
Investigation of the Impact from IL-2,
IL-7, and IL-15 on the Growth and ✓ Provided strategic and investment direction in emerging
Signaling of Activated CD4 + T Cells. therapeutic areas and modality/platform technologies.

Patents ✓ Key member of due diligence team for cell/gene therapy pipelines,
EXPRESSION VECTORS FOR identifying, evaluating, and negotiating external partnerships that
EUKARYOTIC EXPRESSION
SYSTEMS (BI-SPECIFICS), added value to the company.
PATENT APPLICATION
MULTIPLY AUXOTROPHIC CELL ✓ Built various business units/functions from scratch, implementing
LINE FOR THE PRODUCTION OF
RECOMBINANT PROTEINS AND
new facilities infrastructure, state-of-art technologies/platform, and
METHODS THEREOF operational/industrial guidelines.
EXPRESSION VECTORS FOR
EUKARYOTIC EXPRESSION

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SYSTEMS (HIGH EXPRESSION), ✓ Hired, mentored, and managed global multidisciplinary teams of
PATENT APPLICATION
scientists and engineers; contributed to the development of the next
Fc-containing molecules exhibiting
predictable, consistent, and generation of leaders and SMEs.
reproducible glycoform profiles
METHODS OF USING CELL- ✓ Led regulatory filings at the clinical and commercial stages,
CYCLE INHIBITORS TO
MODULATE ONE OR MORE including IND, BLA/MAA and leveraged in-depth knowledge of FDA,
PROPERTIES OF A CELL EMA, ICH guidelines, risk management, product changeover, and
CULTURE
product/technology transfer processes.

Experience
Landmark Bio
Vice President, Cell & Gene Therapy, Product Development &
Operation
2022 - Present (1 year)
In vivo & ex vivo CAR-T
Cell/Gene Therapy development & manufacturing
Business and technical strategies to accelerate speed and improve success
rate at early and late stage development
Transform groundbreaking biological discoveries to preclinical/clinical studies
Develop highly favorable external partnerships
Establish state-of-art infrastructure and intellectual properties with academic
and industry collaborators

Chief
Member
March 2023 - Present (8 months)
I'm excited to be part of a community of outstanding women who are driving
change in their organizations and making a significant impact in their
respective fields. #IAmAChief

ISPE
Steering Committee, ATMP CoP
2021 - Present (2 years)

Atara Biotherapeutics
Vice President, Allogeneic Cell Therapy
2021 - 2022 (1 year)

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Envisioned and led the establishment of a new effective early development
roadmap and business strategy to improve development success rate and
accelerate speed to clinic.
Provided strategic and tactical leadership to develop early- and late-stage
allogeneic T cell therapy pipeline programs.

Merck
Executive Director, Merck Research Lab
2015 - 2021 (6 years)
2019 Merck Global Pipeline Award winner.
Built a multi-site global team with various core functional areas, including
Cell therapy development, Biologics Early development, Cell engineering,
Vector engineering, Cell Line Development, Cell Banking, HT screening team,
Systems biology & genetic characterization, and predictive modeling.
Responsible for product & process design and development activities in
Biologics & Cell/Gene Therapy. Responsible for milestone deliverables at
various development stages, including TIDV, LIDV, pre-IND, IND, BLA, & Life
Cycle Management.

- Cell & Gene Therapy Process Development & Manufacturing

- Early development strategy to accelerate speed to clinic
- Molecule & Manufacturability Assessment
- Biologics Platform Process Development
- Cell Line Development
- Cell Banking & Characterization
- Systems Biology & Predictive Modeling
- Vector Engineering & Development
- Cell Engineering & Gene editing

Teva Pharmaceuticals
Principal Scientist
2014 - 2015 (1 year)
Pennsylvania Area

Global Program lead

Head of Upstream Process Development
Head of High Throughput Analytical Core Facility

Amgen
Senior Scientist
2008 - 2014 (6 years)

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•Global project team leader in pipeline projects. Coordinated and managed
cross functional activities. Responsible for drug candidate selection during
pre-clinical/clinical development including assessment of bioactivity and
manufacturability in expression, purification, and solution properties and
stability. Responsible for setting up technique guidelines.
•Cell line development team leader in both FIH and biosimilar projects.
Responsible for developing multiple production stable cell lines for lead
development molecules within timelines, fulfilling titer, product quality and
stability criteria (novel and biosimilar). Supported GLP cell banking, technical
transfer, biosafety assessment, and regulatory filing.
•Scientific leader in cross-site cell line development technology/advancement
working group in upstream tech forum of P&PD department. Established
and coordinated novel technology development projects. Supported the
implementation of new techniques to improve productivity, control product
quality, improve process efficiency and accelerate timeline. Development of
protocol, data analysis plan and oversight of study conduct.
•Established and lead multiple cross-functional area collaboration teams
focusing on 1) Glyco-engineering to control mAb glycan profile; 2)½
mAb characterization; 3) Process development team to increase specific
productivity; 4) Multi-layer OMICS to identify intracellular signaling targets
to improve productivity and product quality; 5) HM and drug product stability;
6) Developing UPR monitoring system and the application during mAb
development; 7) Anti-cell death team to improve productivity, product quality
and purification efficiency.
Multiple innovation awards, publications and invited speaker of conferences.

Regeneron Pharmaceuticals
Scientist
2008 - 2008 (less than a year)
Protein engineering
Bi-specific antibody design & engineering

Diabetes Research Institute, University of Miami

Clinical Development Program Lead, Cell & Gene Therapy for Type I
Diabetes
1995 - 1998 (3 years)
Miami, FL

• Cell Therapy program lead - Human bone marrow transplantation.

• Cell Therapy program lead - Pancreatic Islet product development and
treatment.

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• Gene therapy development for type I diabetes and GVHD.

Education
Cornell University
Ph.D., Immunology · (1998 - 2005)

Saïd Business School, University of Oxford

Executive Leadership · (2021 - 2021)

The Rockefeller University

Postdoctor , Robert G. Roeder Laboratory, Protein Chemistry and Molecular
Biology · (2005 - 2008)

Memorial Sloan-Kettering Cancer Center

Doctor of Philosophy - PhD, Cancer Immunology · (1998 - 2005)

Beijing Medical University

Doctor of Medicine - MD

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