Monique Zangarini

I lead translational and regulatory-oriented strategies to progress inhaled therapies from discovery into first-in-human and early clinical development. I am responsible for translational pharmacology and PK/PD activities supporting human dose rationale, exposure justification and IND/CTA readiness. I work cross-functionally across nonclinical, regulatory and CMC teams to ensure programs enter the clinic with a strong scientific and regulatory foundation.

I led nonclinical and translational development for monoclonal antibody programs, bridging nonclinical data with first-in-human and early clinical development. I defined toxicology, PK and PK/PD strategies supporting candidate selection, human dose justification and therapeutic window definition, building translational packages to support IND/CTA submissions. I directly supported early clinical development through clinical dose strategy, contribution to protocols and SAPs, definition and review of CP, PK and PK/PD TLFs, interpretation of emerging clinical data, and preparation of key clinical and regulatory documents (IB, IMPD/IND-CTA, reports, briefing materials) and responses to regulatory questions. I worked cross-functionally with clinical, regulatory and CMC teams and provided scientific leadership to external CROs.

Lead nonclinical development and GLP toxicology activities for biologics to enable clinical translation. Oversee in vitro and in vivo PK/PD and toxicology studies, managing CRO collaborations for robust nonclinical packages. Author critical regulatory documentation, including IMPDs and Investigator Brochures (IBs). Drive collaboration across internal and external teams to meet key R&D milestones. Manage intellectual property development and contribute to patent filings.

Supported the R&D of biologics from discovery through toxicology, ensuring seamless project progression. Oversaw and managed preclinical studies with CROs, including protocol development, study monitoring, and data interpretation. Communicated study findings, including relevance and insights, to cross-functional teams and key stakeholders. Built strong collaborative relationships across functions and with key opinion leaders (KOLs). Managed intellectual property, contributed to patent filings, and participated in preparing regulatory dossiers.

Served as the DMPK representative in integrated project teams, ensuring alignment of pharmacokinetics strategy with project goals. Conducted in vivo PK and PK/PD studies, providing both practical and strategic insights to support discovery and lead optimization. Performed PBPK modeling using GastroPlus™ to to support discovery, lead optimisation and pre-clinical development projects. Developed bioanalytical mass spectrometry methods.

Conducted and interpreted in vivo PK studies to support exploratory and discovery projects. Developed and applied LC/MS/MS methods to evaluate the in vivo ADME of new compounds and calculation of PK parameters by Phoenix software. Managed in-house and CROs studies appropriately to deliver quality DMPK data. Collaborated closely with Medical Chemists and Biologists, attendance of project meetings providing interpretation of DMPK data. Prepared DMPK study reports. Mentored junior members of staff. Developing skills on PK/PD and PBPK.

Participated in PK studies during early phase clinical trials sponsored by of Cancer Research UK. Designed, developed and validated bioanalytical methods (LC/MS/MS, AAS, ELISA) under GcLP, to quantify new drugs in complex matrices. Responsible for doing background research on the compounds, planning the assay development work and carrying out all the experiments. Writing method validation plans, reports, SOPs and manuscripts for publications. Collection of documentation for Trial Master File.

Designed, conducted and interpreted PK studies to support discovery and development projects. Evaluated the results of in vivo ADME of drug candidates from Drug Discovery by Phoenix and Kinetica software. Oversaw CROs in bioanalytical method validation and sample analyses to support pre-clinical and clinical PK studies. Collaborated closely with PD and Biostatistics scientists by attendance of project meetings. Prepared DMPK study reports and regulatory documents: Protocols, Reports, Investigator’s Brochure and manuscript for publications.

Developed and Validated bioanalytical methods (LC/MS/MS) under GcLP to quantify drugs in complex matrices during PK studies of clinical trials. Calculation of PK parameters by WinNonLin. Completed all the projects providing bioanalytical validation plans, reports and writing manuscripts for publications. Collaborated with internal and external pre-clinical and clinical PK studies; PK/PD studies; Supervised students.

Developed and validated an LC/Fluorimeter method under GcLP for the quantification of a drug and its metabolite in plasma during PK study of clinical trial; Prepared bioanalytical protocols, report and SOPs.