Summary
Overview
Work History
Education
Skills
Publications
Selected Poster Presentations
Timeline
Generic

Lily Wong

Alameda

Summary

Dynamic Senior Scientist with extensive experience in analytical development at Pfizer, specializing in cell-based assays and method validation. Proven track record in enhancing drug product characterization and regulatory compliance. Adept at data analysis and leading cross-functional teams to achieve project milestones, driving innovation in CAR-T therapies.

Overview

25
25
years of professional experience

Work History

Senior Scientist, Scientist (Conveyed with Pfizer CART team to Allogene Therapeutics)

Allogene Therapeutics
South San Francisco
05.2018 - Current
  • Company Overview: Analytical Development, Process & Product Development. Website: [Allogene Therapeutics](https://www.allogene.com)
  • Contribute to development of allogeneic CART analytical methods to support manufacturing operations.
  • Develop and implement cell-based assays using ELISA and Luminex multiplex to examine cytokine secretion for CART drug product release and characterization, determine cytokine dataset correlation to phenotype/cytotoxicity/clinical response via Spotfire, PCA, and JMP data analysis.
  • Characterize drug product using flow cytometry to measure intracellular markers in cell proliferation assay; experience Seahorse technology to evaluate ATP production rate/metabolism profile of drug product.
  • Lead SME of method transfer and release testing to external CRO include hands-on training onsite, Test Methods writing and data verification/review.
  • Analytical Development, Process & Product Development. Website: [Allogene Therapeutics](https://www.allogene.com)

Scientist

Pfizer
South San Francisco
09.2016 - 04.2018
  • Company Overview: Cell and Gene Therapy, Analytical Development. Website: [Pfizer](https://www.pfizer.com)
  • Developed and optimized allogeneic CART analytical methods to support manufacturing operations.
  • Designed and implemented cell-based and molecular assays to assess potency and phenotype of CART products.
  • Drafted and reviewed Test Methods, SOPs, and protocols.
  • Cell and Gene Therapy, Analytical Development. Website: [Pfizer](https://www.pfizer.com)

Cell Analyst III (Conveyed with XOMA Bioanalytical team to Nanotherapeutics)

Ology Bioservices
Berkeley
03.2016 - 09.2016
  • Company Overview: Antibody Development (formerly Nanotherapeutics). Website: [Ology Bioservices](https://www.ologybioservices.com)
  • Developed and validated MSD ECLA immunoassays (PK and immunogenicity) to generate compatible antitoxins for treatment and prevention of botulinum neurotoxin serotypes C and D.
  • Antibody Development (formerly Nanotherapeutics). Website: [Ology Bioservices](https://www.ologybioservices.com)

Senior Development Associate II, Senior QC Specialist

XOMA Corporation
Berkeley
04.2008 - 03.2016
  • Company Overview: Bioanalytical Development. Website: [XOMA](https://www.xoma.com)
  • Developed and validated methods using MSD ECLA, ELISA immunoassays (PK and immunogenicity) and cell-based neutralizing anti-drug antibodies assays for GLP preclinical and clinical studies for advancement of 3 humanized monoclonal antibodies and antitoxins of botulinum neurotoxin serotypes A, B, and E.
  • Led and managed GLP preclinical and clinical studies. Coordinated with CROs for sample discrepancies. Conducted sample analysis, monitored stability studies, authored study reports, released final data to internal PK/Clinical Operation teams and interacted with QA for final closures.
  • Spearheaded and enhanced all phases of SQL LIMS for bioanalytical operations in replacement of existing sample management database system.
  • Received “Award” for successfully implemented Watson LIMS for bioanalytical operations including sample management, PK and immunogenicity data analysis.
  • Authored SOPs, Test Methods, protocols, GLP study reports and audited data packages to ensure data integrity.
  • Bioanalytical Development. Website: [XOMA](https://www.xoma.com)

Preclinical Associate III

AbbVie Inc.
Redwood City
05.2005 - 03.2008
  • Company Overview: Preclinical & Clinical Development Sciences (formerly Facet Biotech, PDL BioPharma). Website: [AbbVie](https://www.abbvie.com)
  • Designed and validated methods using biomarker multiplex and immunogenicity assays to monitor efficacies of 2 therapeutic proteins in support for GLP preclinical PK/PD and clinical studies.
  • Drafted and reviewed SOPs, protocols, technical reports. Accomplished technical review of GLP bioanalytical assays and method validation reports for data integrity.
  • Preclinical & Clinical Development Sciences (formerly Facet Biotech, PDL BioPharma). Website: [AbbVie](https://www.abbvie.com)

Research Associate II

Novartis
Emeryville
09.2003 - 05.2005
  • Company Overview: Drug Assessment & Development (formerly Chiron Corporation). Website: [Novartis](https://www.novartis.com)
  • Utilized ELISA to characterize biomarkers and IP/Western blotting to examine target modulation/mechanism of action of phosphorylated targets for targeted oncology therapies.
  • Constructed human tissue bank of tissue specimen from 70 normal donors as resource for biomarker and target discovery/validation within department.
  • Drug Assessment & Development (formerly Chiron Corporation). Website: [Novartis](https://www.novartis.com)

Research Associate II, I

Pfizer
South San Francisco
06.2000 - 07.2003
  • Company Overview: Preclinical Research and Exploratory (formerly SUGEN Incorporated). Website: [Pfizer](https://www.pfizer.com)
  • Supported biomarker identification in preclinical and clinical development projects using xenograft models and human cultured tumor cells.
  • Employed Affymetrix gene expression arrays, DNA and RNA isolation, Taqman qRT-PCR, ELISA, immunoprecipitation, and Western blot for biomarker discovery and validation.
  • Preclinical Research and Exploratory (formerly SUGEN Incorporated). Website: [Pfizer](https://www.pfizer.com)

Education

Bachelor of Arts - Molecular Cell and Biology

University of California at Berkeley
Berkeley, CA
05.2000

Skills

  • Analytical development
  • Cell-based assays
  • Data analysis
  • Flow cytometry
  • Method validation
  • Regulatory compliance

Publications

  • DePrimo, S.E., Wong, L.M., Khatry, D.B., Nicholas, S.L., Manning, W.C., Smolich, B.D., O’Farrell, A-M., Cherrington, J.M., Expression profiling of blood samples from an SU5416 Phase III metastatic colorectal cancer clinical trial: a novel strategy for biomarker identification., BMC Cancer, 2003, 3, 3, http://www.biomedcentral.com/1471-2407/3/3
  • O’Farrell, A-M., Abrams, T.J., Yuen, H.A., Ngai, T.J., Louie, S.G., Yee, K.W., Wong, L.M., Hong, W., Lee, L.B., Town, A., Smolich, B.D., Manning, W.C., Murray, L.J., Heinrich, M.C., Cherrington, J.M., SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo., Blood, 2003, 101, 9, 3597-3605, http://www.bloodjournal.org/content/101/9/3597

Selected Poster Presentations

  • Ahene, A., Cao, L., Chen, J., Espinoza, Y., Wong, L., Shimizu, R., Wong, D., Development and Validation of Immunoassays for the Detection and Confirmation of Anti-drug Antibodies of Two Co-formulated Combination Anti-botulism Drug Candidates in Rats., 2014 AAPS National Biotechnology Conference, San Diego, CA, 05/14
  • Chen, J., Wong, L., Cao, L., Gasper, C., Ma, J., Ahene, A., Toxicokinetics and Immunogenicity of Gevokizumab in Pre- and Postnatal Development in Rats., 2013 AAPS National Biotechnology Conference, San Diego, CA, 05/13

Timeline

Senior Scientist, Scientist (Conveyed with Pfizer CART team to Allogene Therapeutics)

Allogene Therapeutics
05.2018 - Current

Scientist

Pfizer
09.2016 - 04.2018

Cell Analyst III (Conveyed with XOMA Bioanalytical team to Nanotherapeutics)

Ology Bioservices
03.2016 - 09.2016

Senior Development Associate II, Senior QC Specialist

XOMA Corporation
04.2008 - 03.2016

Preclinical Associate III

AbbVie Inc.
05.2005 - 03.2008

Research Associate II

Novartis
09.2003 - 05.2005

Research Associate II, I

Pfizer
06.2000 - 07.2003

Bachelor of Arts - Molecular Cell and Biology

University of California at Berkeley
Lily Wong