Katherine Shaw Email & Phone Number

Washington, Dc, Us

Planegg, Bayern, De

• Assisted US regulatory leads with planning, preparing, and tracking lifecycle submissions including briefing packages, annual reports, IND safety reports.• Supported US Ad Promo by preparing and submitting promotional, medical, and scientific materials and labeling updates.• Responsible for document management, including uploading/tracking regulatory files, archiving submissions and agency communications in Veeva Vault RIM & SharePoint, maintaining submission logs, and revising cover letter and form templates.• Submitted 300+ SUSAR reports, collaborating with Global Patient Safety (GPS) and Quality Assurance (QA) to reduce non-compliance risks via root cause analysis and CAPA documentation.• Contributed to Veeva Vault RIMS implementation, working with IT to migrate legacy system data.• Performed searches of FDA guidance documents, FDALabel Database, and OPDP Warning Letters.

Planegg, Bayern, De

Cambridge, Massachusetts, Us

• Developed and executed assays to evaluate small-molecule compounds, contributing to lead optimization in drug development.• Analyzed and presented data to cross-functional project teams and executive stakeholders, driving strategic decision-making.• Optimized protein production processes, upscaling output to meet program demands.

• Proofread and quality-checked hyperlinks in regulatory documents for Fast Track Designation.• Generated and analyzed biotoxicity data, contributing to Apic Bio's SOD1-ALS AAV gene therapy safety profile and successful IND filing. • Quantified CNS SOD1 silencing by ddPCR and characterized AAV immunogenicity by ELISpot / NAbs assays.• Authored and updated training SOPs for major assays.• Analyzed and summarized data for weekly preclinical R&D and executive-level meetings.• Interfaced with CROs to manage off-site sample storage.• Led patient engagement initiatives, fostering partnerships with ALS Association and organizing community events.

Boston, Ma, Us

• Performed routine cell culture to maintain 30+ patient-derived cell lines (PDCs) modeling TKI- resistant non-small cell lung cancer (NSCLC).• Assisted in performing an shRNA screen of 1,000 genes in ALK-resistant PDCs, screening compounds against PDCs and identifying SHP2 as a key driver of resistance.• Maintained stocks of lab consumables and performed lab housekeeping functions.• Generated and summarized assay data influencing clinical decisions by MGH Thoracic Oncology.

Düsseldorf, Nordrhein-Westfalen, De

Selected from applicant pool of North American, British, and Irish undergraduates. Studied the role of the Aryl Hydrocarbon Receptor (AhR) transcription factor in aging.• Quantified expression of AHR-1 target genes identified by microarray in C. elegans under thermal stress to understand how AhR promotes aging phenotypes.• Maintained transgenic GFP reporter strains of C. elegans.• Analyzed and presented experimental data in lab meetings.

South Hadley, Massachusetts, Us

Guided undergraduate Cell Biology students through experimental design, cell-imaging microscopy, and poster presentation.

Bethesda, Maryland, Us

Worked on a protein engineering project with the goal of optimizing NMR applications of the bacterial transpeptidase Sortase A (SrtA).• Optimized SrtA activity for in vitro ligation of large, segmental isotopically labeled, multi-domain proteins to enable higher-resolution analysis by NMR.• Expressed and purified peptides for ligation by fast protein liquid chromatography (FPLC).• Presented poster summarizing the data and implications of the research at the NIH Summer Intern Poster Day.