Katy Barglow Email and Phone Number
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CMC leader in the gene therapy space, leading process development, clinical manufacturing, analytical development, and QC functions. I am currently Sr Vice President, Technical Operations, for 4D Molecular Therapeutics, a novel AAV gene therapy company. I am responsible for driving our "IND engine" and CMC strategy (process, analytical, and CMC-quality/regulatory) for pre-clinical and clinical AAV products.Skills: Process development (Biologics and gene therapy vectors), process transfers and CMO management, assay development/qualification/validation, IND-enabling characterization strategy, real-time and accelerated stability studies, QC assay transfers, IND Module 3 and CMC regulatory strategy, OOS and DR investigations.
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Senior Vice President4D Molecular Therapeutics Jan 2022 - PresentEmeryville, California, Us
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Vice President Technical Operations4D Molecular Therapeutics Jan 2021 - Mar 2022Emeryville, California, UsFunctions:-Clinical Manufacturing and Supply Chain-Process Development-Analytical Development-Clinical QC-CMC Project Management
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Vice President, Process And Analytical Developmen4D Molecular Therapeutics Jan 2019 - Jan 2021Emeryville, California, Us
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Director, Process Sciences And Analytical Development4D Molecular Therapeutics Jun 2017 - Jan 2019Emeryville, California, UsDirector of Process Development (upstream, downstream, and analytical) for gene therapy (AAV) products. Responsible for team engaged in key IND-enabling process development studies, including DOE-based optimization of upstream and downstream unit operations (cell expansion, transfection, harvest, clarification, column chromatography, TFF) and development, qualification, and transfer of IND-enabling assays (purity, potency, safety, identity)
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Analytical Group LeaderGrifols Diagnostic Solutions Aug 2014 - Jun 2017Sant Cugat Del Vallès, Barcelona, EsAnalytical Group LeaderSubject Matter Expert in Analytical Methods Duties include:-Management of group of 6-8 associates performing analytical testing in support of small scale work-Directing assay development/improvement projects-Support QC validation/re-validation, assay improvements, and new assay implementations. -Lead and assist in investigations relating to Manufacturing or QC deviations and Out of Specifications (OOSs) and develop studies to determine their root causes. Identify and implement appropriate CAPAs. -Support process and product characterization, validation, and continuous verification, and cleaning validation studies. Support assay and process transfers.-Author technical documents including reports, protocols, product impact investigations, risk assessments, change controls, and deviation reports. -
Research Scientist IiBaxter International Inc. Aug 2012 - Aug 2014Deerfield, Illinois, UsResearch scientist II in the Process Analytical Development group, (Promoted from Research Scientist I Sept 2013. Interim Acting Manager of Analytical Group from March-July, 2014). -Assay development, qualification, and QC transfer for protein therapeutics -HPLC, UPLC, ELISA, Mass Spec, Glycan assays -degradation and stability studies -protein analytics and micro-heterogeneity assays-Analytical SME for multiple projects-OOS and OOT investigations-Worked in a GLP/GMP environment -Led a team of 3 research associates-Worked closely with quality, validation, regulatory, and QC groups-Authored sections of IND and BLA submissions (3.2.S. sections, including Elucididation of Structure and Other Characteristics, Impurities, Analytical Procedures, Specifications, and Control of Materials Sections). -Led and participated in FMEAs and risk assessments. Authored multiple technical documents (Memos, Technical Reports, Assay Qualification Reports, Comparability and Stability protocols and reports) -
Temporary Research ScientistDophen Biomedical Jun 2012 - Aug 2012Developed bioanalytical assays for modified recombinant proteins-Generated and characterized protein conjugation products-Developed MALDI and LC-MALDI assays to determine the selectivity of PEG-modified proteins-Provided mass spec and analytical support for protein purification-Trained others in the use of MALDI for protein characterization
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Staff Scientist ICatalyst Biosciences Aug 2011 - May 2012South San Francisco, Ca, UsProvided bioanalytical and mass spectrometry support for Protein Science and Assay Development groups. Designed and implemented analytical assays for recombinant proteins. Developed novel degradomics capabilities.-Implemented new N-glycan assays which reduced turnaround time from one week to three hours while increasing sensitivity and reproducibility and reducing sample requirements. Allowed protein quality to be quickly assessed prior to in vivo studies, leading to an increase in screening efficiency.-Designed novel isotope and chemical labeling techniques for monitoring protease selectivity (degradomics). Improved characterization of therapeutic protease candidates in purified and complex systems, giving essential information for future design rounds.-Analyzed recombinant protein quality (sequence, N- and O-glycan identity, site occupancy and sialic acid content, proteolytic processing, and post-translational modification) and correlated this information with plasmid design, allowing optimization of therapeutic candidates. -
Postdoctoral FellowUniversity Of California, Berkeley Jul 2008 - Aug 2011Berkeley, Ca, UsPostdoctoral Fellow of the American Cancer Society, in the laboratory of Michael A. Marletta. Working on elucidating mechanisms of specificity of S-nitrosation.-Developed a mass-spec based method allowing the first kinetic measurements of nitrosation on whole proteins, leading to rate data for nitrosation of specific cysteines on a protein involved in cellular nitrosation.-Performed proteomics experiments that provided strong evidence for cellular signaling via transnitrosation.-Coordinated a two-lab, bicoastal collaboration (Steve Tannenbaum lab, MIT) leading to peer-reviewed publications. -
Graduate StudentThe Scripps Research Institute Sep 2002 - Jun 2008La Jolla, California, UsGraduate student in the laboratory of Benjamin Cravatt, department of Chemical Physiology, working to expand proteome coverage of activity-based protein profiling technologies and their application to enzyme annotation.-Designed, synthesized, and utilized new classes of activity-based chemical probes for proteomics, and used these probes to discover novel biomarkers for obesity and diabetes.-Utilized chemical proteomics for substrate discovery in uncharacterized enzymes. Used molecular docking studies and mutagenesis for confirmation.-Produced protein crystals leading to the first structure of a mammalian nitrilase enzyme (1.4 Å resolution).
Katy Barglow Skills
Katy Barglow Education Details
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Scripps ResearchBiochemistry -
University Of California, BerkeleyPostdoctoral Fellow
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Stanford UniversityChemistry
Frequently Asked Questions about Katy Barglow
What company does Katy Barglow work for?
Katy Barglow works for 4d Molecular Therapeutics
What is Katy Barglow's role at the current company?
Katy Barglow's current role is SVP Technical Operations at 4D Molecular Therapeutics.
What is Katy Barglow's email address?
Katy Barglow's email address is ka****@****ols.com
What is Katy Barglow's direct phone number?
Katy Barglow's direct phone number is +151067*****
What schools did Katy Barglow attend?
Katy Barglow attended Scripps Research, University Of California, Berkeley, Stanford University.
What are some of Katy Barglow's interests?
Katy Barglow has interest in Biochemistry, Protein Analytics, Mass Spectrometry, Cell Biology, Enzymology, Cancer Biology.
What skills is Katy Barglow known for?
Katy Barglow has skills like Protein Chemistry, Protein Purification, Biochemistry, Proteomics, Hplc, Mass Spectrometry, Molecular Biology, Cell Culture, Assay Development, Cell, Cell Signaling, Western Blotting.
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