Experienced team lead with in-depth understanding of drug development processes; minimum 5 years of experience (5-10 years) in each of the following areas: Research, Biologic Development (antibody development and protein science), Early Development (CMC and other IND enabling activities).
R&D project team lead for autoimmune/inflammatory diseases and CMC/Development project team lead for immuno-oncology and high concentration ocular projects
Responsible for evaluating new target proposals and candidate nominations at Proteologix and NGMbio
Senior management team member at Proteologix responsible for strategic planning
Strong knowledge and expertise in multi-specific molecules targeting autoimmune, inflammatory diseases, and IO (including NK and T cell engager platforms)
Recipient of Roche Pharma “NEXT” award in the “Pipeline” category from Roche Headquarter, Basel
Strong communication and organization skills, effectively participated in multifunctional teams and IND fillings
Funder of Proteologix, a Lily Asia and Orbimed ventures funded startup
Key member in series A and A+ fundraising and responsible for presenting company projects and investor Q/A
Well connected with MBC Biolab (biotech startup) networks
Overview
19
19
years of professional experience
Work History
Head, Early Development
Proteologix
Redwood Shore, CA
01.2022 - Current
Decision maker and responsible for all early development activities at Proteologix
Strategic planning for cyno PK, GLP Tox and CMC activities
Design Ph1/2 clinical trials with clinical advisors, and development Target Product Profile for lead projects
Proposed and executed top priority autoimmune / inflammatory project for Asthma and COPD
R&D project team lead for two autoimmune/inflammatory projects (#1 and 2 projects at Proteologix)
Evaluate all new project proposals (target nomination and cell engager platforms)
Evaluate all candidate nominations for CMC/clinical development
Executive Director, Biologics
Proteologix
Located in MBC Biolabs, San Carlos, CA
06.2021 - 12.2021
Funder, team of 6 members
Proposed and advanced top priority project at Proteologix
R&D project team lead for two autoimmune/inflammatory projects (#1 and 2 priority projects)
Evaluated all project proposals including cell engager platforms and multi-specifics for autoimmune/inflammatory diseases
Provided competitive landscape and market opportunity evaluations for autoimmune and immune-oncology projects
Protein Science functional head, interacted with biology and antibody development to advance Proteologix's proprietary engager platforms and lead molecule development
Director, Biologics
NGM Biopharmaceuticals
South San Francisco, CA
01.2021 - 06.2021
Project team lead for NGM831 (immune-oncology project), and managed diverse cross functional team members
Project team lead for first Fast-Track CMC project at NGM for NGM621, a high concentration ocular project
Member of NGM Clinical Development team for multiple projects
Biologic team strategic committee for new proposal evaluation
Associate Director, Biologics
NGM Biopharmaceuticals
South San Francisco, CA
01.2019 - 12.2020
Developed NGM’s proprietary expression system, which increased productivity by >100%, and reduced cost by ~80%
Managed NGM’s CMC CDMO outsourcing for pipeline products
Supported all NGM development molecules during development period & significantly shortened development time
Protein science team lead supporting molecule manufacturability assessment, and cyno dose range and pk studies
Lead a team of Scientist and Research Associates for cell line development and cell engineering
Designed and executed vector and cell engineering platform development
Principal Scientist, Biologics
NGM Biopharmaceuticals
South San Francisco, CA
10.2016 - 12.2019
Responsible for all NGM’s clinical candidates cell line development
Managed NGM’s CDMO outsourcing activities for pipeline products,
Protein Science functional head, managed a team of scientists and research associates.
Active representative in both R&D and development teams
Scientist and Group/Team Lead
Genentech, A Member Of The Roche Group
South San Francisco, CA
05.2009 - 09.2016
Supported 10 Ph1/2 and 4 Ph3 products including bispecific, ADC or TDC conjugated antibody projects
Developed and implemented a robust Targeted Integration Cell Line Development Expression platform, which resulted in ~50% reduction in FTE and timeline, and >50% reduction in cost
Developed speedy expression system for research material generation at Genentech. It replaced large-scale transient expression system to supply research materials to Genentech Research organization
This system enabled multiplex expression to support multiple molecules (lead and backups) for cyno PK and dose range studies and toxicity investigations
Mammalian genome engineering using shRNA, Zinc Finger, and CRISPR Cas technologies in modulating cell metabolism pathways and assay development for accompanying cell-based assays
Managed genomic characterization project using targeted locus amplification (TLA) and next Gen sequencing
Genentech/Roche Cell Line Development & Engineering global strategy committee
Participated in multifunctional teams and IND filing to support Ph1/2 and ph3 products
Postdoctoral Fellow
Genentech, Inc
South San Francisco, CA,
01.2005 - 01.2009
Mentored by Napoleone Ferrara, MD, Distinguished Professor of Pathology and Adjunct Professor of Ophthalmology and Pharmacology UCSD, member of National Academy of Medicine, and Lasker Award winner for discovery of vascular endothelial growth factor (VEGF) and it's role in pathogenesis
Investigated role of tumor microenvironment in tumorigenesis and tumor angiogenesis
Identified stroma fibroblast-derived factor, PDGF-C, as predictive modulator for tumors’ response to anti-VEGF or other anti-angiogenic therapies
Demonstrated of MOA of PDGF-C in tumor angiogenesis via VEGF dependent and independent pathways
Developed functional and signaling assays using primary cells from tumor biopsy or blood samples, and established animal models for therapeutic resistance studies
Ophthalmologist
Nanjing First Municipal Hospital
Nanjing, China
08.1993 - 08.1994
Ophthalmology resident
Specialized in surgery
Education
Ph.D - Biomedical Sciences
University of California, San Francisco
San Francisco, CA
Postgraduate Study - Biochemistry
University of Washington
Seattle, WA
M.D. - Medicine
Nanjing Medical University
Nanjing, China
Skills
Program oversight
Consulting
Negotiation
Business Development
Staff Management
Decision-Making
Analytical and Critical Thinking
Problem-Solving
Critical Thinking
Interpersonal Communication
Business planning
Team Building
Additional Information
Roche Pharma “NEXT” Award in the Pipeline category, 2016, Roche Headquarter, Basel
Regents Fellowship, University of California, San Francisco, 2001-2004
Session chair for BioProcess International conference, 2020
Session chair for BioProcess International West, 2019
Session chair for Next Generation Protein Therapeutics & Bioconjugates Summit, 2019
Symposium chair at AACR annual meeting as a postdoctoral fellow, 2009
Languages
English
Native or Bilingual
Chinese (Mandarin)
Native or Bilingual
PUBLICATIONS
Shatz W, Hass PE, Mathieu M, Kim HS, Leach K, Zhou M, Crawford Y, Shen A, Wang K, Chang DP, Maia M, Crowell SR, Dickmann L, Scheer JM, Kelley RF.
Contributions of antibody hydrodynamic size to vitreal clearance revealed through rabbit studies using a species-matched Fab.
Mol. Pharm, 2016, Sept 6;13(9):2996-3003
Yip S, Joly J, Snedecor B, Shen A, Crawford Y.
Complete knockout of the lactate dehydrogenase A gene is lethal in pyruvate dehydrogenase kinase 1, 2, 3 downregulated CHO cells Mol. Biotechnology. 2014 Sept;56(9):833-8
Crawford Y*, Zhou M, Hu Z, Joly J, Snedecor B, Shen A, Gao A.
* Corresponding author
Fast identification of reliable hosts for target cell line development from a limited genome screening using combined φC31 integrase and CRE-Lox technologies. Biotechnology Prog. 2013 Sept-Oct;29(5):1307-15
Zhou M, Crawford Y, Ng D, Tung J, Pynn AF, Meier A, Yuk IH
Decreasing lactate level and increasing antibody production in Chinese Hamster Ovary cells by reducing the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
J Biotechnol. 2011 April;153(1-2):27-34
Bais C, Wu X, Yao J, Yang S, Crawford Y, McCutcheon K, Tan C, Kolumam G, Vernes JM, Eastham-Anderson J, Haughney P, Kowanetz M, Hagenbeek T, Kasman I, Reslan HB, Ross J, Van Bruggen N, Carano RA, Meng YJ, Hongo JA, Stephan JP, Shibuya M, Ferrara N.
PIGF blockage does not inhibit angiogenesis during primary tumor growth. Cell, 2010 Apr; 141(1):166
Crawford Y, Kasman I, Yu L, Zhong C, Wu X, Modrusan Z, Kaminker J, Ferrara N.
PDGF-C mediates the angiogenic and tumorigenic properties of fibroblasts associated with tumor refractory to anti-VEGF treatment. Cancer Cell, 2009 Jan;15(1):21-34
Crawford Y, and Ferrara N.
Tumor and stroma pathways mediating refractoriness/resistance to anti-angiogenic therapies.
Trends Pharmacol Sci. 2009 Dec;30(12):624-30
Crawford Y, and Ferrara N.
VEGF inhition: insights from preclinical and clinical studies
Cell Tissue Res. 2009 Jan; 335(1):262-9
Dumont N, Crawford Y, Sigaroudinia M, Nagrani SS, Wilson MB, Buehring GC, Turashvili G, Aparicio S, Gauthier ML, Fordyce, C, McDermott K, Tlsty TD.
Human mammary cancer progression model recapitulates methylation events associated with breast premalignancy
Breast Cancer Res. 2009 11(6):R87
Crawford Y, and Ferrara N
Mouse models to investigate anti-cancer effects of VEGF inhibitors.
Method in Enzymology 2008;445:125-139.
Dumont N, Wilson, M, Crawford Y, Reynolds P, Sigaroudinia M, and Tlsty T.
Sustained induction of epithelial to mesenchymal transition activates DNA methylation of genes silenced in basal-like breast cancers. PNAS, 2008 Sep; 105(39):14867-72
Red-horse K, Crawford Y, Shojaei F, Ferrara N.
Endothelium-microenvironment interactions in the developing embryo and in the adult. Developmental Cell. 2007 Feb; 12(2):181-94.
Berman H, Zhang J, Crawford Y, Gauthier M, Fordyce C, McDermott K, Sigaroudinia M, Kozakiewicz K, Tlsty T
Genentic and epigenetic changes in mammary epithelial cells identify a subpopulation of cells involved in early carcinogenesis.
Cold Spring Harb Symp Quant Biol. 2005;70:317-27
Crawford Y, Gauthier M, Joubel A, Mantei K, Kozakiewicz K, Afshari C, Tlsty T
Histologically normal human mammary epithelial cells with p16INK4a promoter hypermethylation over-express COX-2, promoting pre-malignant phenotypes Cancer Cell, 2004 March;5(3):236-273
Tlsty T, Crawford Y, Holst C, Fordyce C, Zhang J, McDermott K, Kozakiewicz K, Gauthier M.
Genetic and epigenetic changes in mammary epithelial cells may mimic early events in carcinogenesis
J Mammary Gland Biol Neoplasia. 2004 Jul;9(3)263-74
Tlsty T, Romanov S, Kozakiewicz K, Holst C, Haupt L, Crawford Y
Loss of chromosomal integrity in human mammary epithelial cells subsequent to escape from senescence.
J Mammary Gland Biol Neoplasia. 2001 Apr;6(2):235
Patent
Targeted integration of nucleic acids WO2019126634A2
Head of Talent & Development and Early Careers at Group 1 Automotive/Inchcape UKHead of Talent & Development and Early Careers at Group 1 Automotive/Inchcape UK