Arron S.L. Xu, Ph.D. Email and Phone Number
Strategic scientific/technical expert and a very passionate scientist and leader in bioanalytical sciences. Being a collaborative leader with a strategic vision and operational expertise in bioanalysis to achieve the goals of drug and vaccine development and to improve the lives of patients. Demonstrated progressive achievements in bioanalytical sciences for biotherapeutics, biomarker and vaccine development for inflammation/ immuno oncology and infectious disease clinical studies. Strong organizational and laboratory development rack with collaborative successes. Technical leadership track in developing novel platform analytical technologies for drug and biomarker discovery and development.***Selected Areas of Expertise***Collaborative Leadership / Executive Leadership.Bioanalysis for translational sciences.Bioanalytical sciences for biotherapeutics and vaccine development.Assay development and operations for pharmacokinetics, pharmacodynamics, immunogenicity, biomarker and vaccine immune monitoring bioanalysis.Analytical immunology and biochemistry.Biologics analytical development for CMC.Immunochemistry and cell-based functional assay strategy and development.High throughput screening for drug discovery.Laboratory development strategy, execution and continuous process improvement.GxP (GLP, GCLP, cGMP) Laboratory operations, compliance & business management.
Kiniksa Pharmaceuticals
View- Website:
- kiniksa.com
- Employees:
- 344
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Executive Director, BioanalyticsKiniksa PharmaceuticalsSan Diego, Ca, Us
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Sr. Director, BioanalyticsKiniksa Pharmaceuticals Nov 2023 - PresentSan Diego Metropolitan AreaBioanalytical sciences functional lead for Kiniksa preclinical and clinical biologics development programs across multiple immune therapeutic areas.
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Sr. Director, Analytical SciencesInovio Pharmaceuticals, Inc. Sep 2020 - Sep 2023San Diego, California, United States• Led both clinical immunology bioanalysis and CMC analytical development teams supporting INOVIO DNA vaccine portfolio, leading to the completion of bioanalysis of clinical immune biomarkers for several INOVIO DNA vaccine candidates across immuno oncology and infectious disease programs in phase-1 to phase-3 clinical studies. • Led collaboration with external CRO partners on various bioanalytical projects.• Led the GCLP laboratory operation with a team of immunologist, biologist and bioanalytical scientists of associated management responsibilities. -
Vice President, Pharmaceutical Services, IntertekIntertek 2017 - Sep 2020Greater San Diego Area• Led and stabilized Intertek Bioanalytical laboratories in San Diego upon organizational leadership changes.• Led the strategy and launch of new services in GxP bioanalysis of PD biomarker, critical reagent analytical characterization, hybrid-HRMS for bioanalysis of biologics in complement to the core DMPK, and immunogenicity bioanalytical services across early development to late phase clinical studies of small molecule to biological drugs.• Led the teams for delivery of several sponsored bioanalytical studies included in the BLA submissions.• Delivered the overall business strategy/development, P&L, operations and regulatory compliance.• Built and led a cross-functional leadership team consisting at two Intertek sites. -
Site Director, Intertek Champaign LaboratoriesIntertek 2014 - 2017Urbana-Champaign, Illinois Area• Led all aspects of the site, including P&L, organization, business development, operations, and regulatory compliance for the Intertek’s CoE of GMP analytical services for OTC pharmaceutical and nutraceuticals.• Integrated site into global Intertek pharmaceutical services strategy and operation upon site acquisition by Intertek.• Led the continuing growth of expert GMP analytical services for botanical nutraceutical, medicinal and pharmaceutical ingredients, and products and achieving the site being the global primary CoE on botanical nutraceutical and OTC pharmaceutical analytical center.• Improved ISO process and GMP compliance, leading to successful regulatory audits.
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Associate Scientific Director, Biopharmaceutical ServicesIntertek 2012 - 2014Greater San Diego Area• Provided scientific/technical leadership in delivering PK, immunogenicity assessment, PD, and safety biomarker bioanalysis services for sponsored biological drug and vaccine development.• Directed scientific and technical strategies for difficult biomarker and biologics assay development, method validation and bioanalysis.• Represented the scientific and technical leadership in interfacing with client scientific teams from project design, assay development, validation to bioanalysis, and successful data delivery.• An SME member of Intertek Global Pharmaceutical Services business line leadership team.
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Technical Manager (Sr. Manager), Biomarker Center Of ExcellenceCovance Laboratories, Inc. 2010 - 2012Technical and laboratory leader of the Covance Biomarker Center of Excellence (BCOE). Directed a broad range of bioanalytical laboratory capabilities (immunochemistry, mass spec, flow cytometry, clinical chemistry) in support of biomarker strategies in multiple therapeutic areas for preclinical and early clinical drug development sponsored by clients and collaborators. -
Manager, Assay/Applications CenterCorning Incorporated, Corning Life Sciences 2006 - 2009Manager of an assay/application team with expertise encompassing biochemistry, cell biology & pharmacology for the development a novel label-free detection technology for drug discovery & development of various drug targets. Established the Epic® Application Center for assay development and operation of the HTS for drug discovery. -
Scientific Program ManagerCiphergen Biosystems 2005 - 2006Manager of Ciphergen’s regional technical interests through technology transfer/adaptation and research collaboration with academic institutions to advance the ProteinChip proteomics technology for biomarker discovery and development.
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Sr. Field Research ScientistCiphergen Biosystems 2001 - 2005Research scientist established and operated a field application lab of the ProteinChip system for collaborative proteomics biomarker discovery with academic peers of diverse clinical biomarker projects including alcoholism, autism, LPS toxicology, Lou Gehrig’s disease, colon cancer, HIV-associated dementia.
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Research ScientistUniversity Of North Carolina-Chapel Hill (Dept Of Cell & Molecular Physiology) 1998 - 2001Research Scientist led the development of a multi-disciplinary project for design & fabrication of the novel biocompatible and biodegradable microcarriers for cryopreservation of hepatic progenitor cells and tissue engineering programs in Dr. Lola Reid’s hepatic stem cell laboratory. -
Visiting FellowNational Institute Of Environmental Health Sciences (Niehs, Laboratory Of Structural Biology), Nih 1995 - 1998Visiting Fellow of Dr. Robert E. London’s molecular biophysics laboratory as a primary project scientist and postdoctoral fellow conducting NMR research on protein adducts from chemical modification by agents such as aspirin and other potential anti sickle cell agents. Conducted mechanistic research on the transmembrane uptake of new potential anti-viral agents. -
Research OfficerCo-Operative Research Centre For Molecular Engineering & Technology, University Of Sydney 1993 - 1995Research Scientist in Prof. Philip W. Kuchel and Dr. B.A. Cornel’s laboratories of the CRC center for biophysical study and analytical characterization of a novel ion-channel-synthetic membrane biosensor technology for pathogen detection and diagnostics applications.
Arron S.L. Xu, Ph.D. Education Details
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Biochemistry/Physical Biochemistry/Analytical Biochemistry (Prof. Philip W. Kuchel'S Laboratory)
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National Institute Of Environmental Health Sciences, NihAnalytical, Physical Biochemistry & Structural Biology
Frequently Asked Questions about Arron S.L. Xu, Ph.D.
What company does Arron S.L. Xu, Ph.D. work for?
Arron S.L. Xu, Ph.D. works for Kiniksa Pharmaceuticals
What is Arron S.L. Xu, Ph.D.'s role at the current company?
Arron S.L. Xu, Ph.D.'s current role is Executive Director, Bioanalytics.
What schools did Arron S.L. Xu, Ph.D. attend?
Arron S.L. Xu, Ph.D. attended University Of Sydney, National Institute Of Environmental Health Sciences, Nih.
Who are Arron S.L. Xu, Ph.D.'s colleagues?
Arron S.L. Xu, Ph.D.'s colleagues are Yvette Stroehlein, Marguerite Grossenbacher, Reid Cranmer, Carlos Ruiz, Paul Bischoff, Vonda Colvin, Laura Winter.
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