Heather Taylor, Bs, Dabt Email & Phone Number

Responsible for the overall planning and conduct of non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice

Responsible for the overall planning and conduct of non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice

• Provided toxicology support for 20+ large and small molecule oncology, immunology and infectious disease programs from late stage research through phase III trials
• Authored and peer reviewed high quality non-GLP/GLP toxicology study reports, regulatorydocumentation (including INDs, PMPs, NIH RAC submission, carcinogenicity risk assessment andIND Annual Reports), target safety.
• Represented Safety Assessment on (global) project teams for early and late stage drug candidates and collaborated with pathologists, pharmacokinetic, pharmacodynamic scientists and clinicians to provide an integrated.
• Collaborated with investigative toxicologist as well as clinical, drug safety and biomarker scientists to evaluate safety signals that arise during the course of clinical trials to ensure continued patient safety
• Active contributor to departmental Cancer Immunotherapy and Immunology Expert Working Groups
• Served as the Business Process Owner for the literature review process for IND Annual Reports

• Designed, executed and generated study reports for IND-enabling murine toxicology and efficacy studies for two infectious disease indications
• Authored and reviewed non-GLP/GLP protocols for non-/rodent studies at selected Contract Research Labs (CROs)
• Interfaced with academic and clinical collaborators on various preclinical projects to ID new clinical targets
• Optimized clinical immune monitoring assays for Phase I clinical trials in oncology and infectious disease
• Analyzed clinical PBMC samples for Phase I clinical trials to characterize platform-specific responses
• Qualified clinical site labs to purify PBMCs from patient whole blood samples

• Coordinated IND-enabling non-human primate studies and Chemistry, Manufacturing and Controls (CMC) release testing with CROs
• Participated in IND-related FDA teleconferences
• Led project team meetings
• Maintained timelines, minutes and agendas communicated to executive staff
• Provided essential equipment and lab design specifications to architects, engineers and project managers during design phase of the new Anza facility.

• Designed, optimized and executed in vivo experiments to assess efficacy, tolerability and bio-distribution of Listeria-base vaccine platforms to support two IND filings
• Cloned, isolated and characterized new Ag expressing tumor cell lines to test potential antibody-dependant cell-mediated cytotoxicity (ADCC) and Toll-Like Receptor (TLR) vaccine targets
• Developed new animal models with established cells lines to test new ADCC and TLR targets
• Conducted in vivo studies to ensure GMP product potency and stability

• Evaluated chemokine and bacterial adjuvant vaccine therapies for metastatic colorectal cancer in a murine model
• Optimized protocol for autologous hepatic cancer vaccine preparation above approved clinical trial standards

• Evaluated a bioremediative technique for detoxifying PCBs in various harbor sediments.
• Created an intact and functional E.coli plasmid containing RAD genes from M. thermophila to better understand DNA Excision Repair mechanisms – prokaryotic-like or eukaryotic-like – in archea.

Biotechnology

Bachelor Of Science, Biology

Activities and Societies: Phi Sigma Pi, Environment Studies Scholars Graduate