Jane Ambler
Director, Microbiology @MannKind Corporation
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WORK HISTORY
Director, Microbiology @MannKind Corporation
Bedford, MA, US
EDUCATION
School of Pharmacy, University of London
PhD, Antibacterial resistance mechanisms (fluoroquinolones)
SKILLS
ABOUT JANE AMBLER
Experienced clinical microbiologist (20+ years) in antimicrobial drug development at companies based in the US, Germany and UK.Extensive experience establishing: in vitro microbiology studies to define primary pharmacology, infection models (in vitro and in vivo) conducted in-house, CROs and/or with academic experts, large international antibacterial surveillance programs required for an new drug application (NDA) program.Clinical development (phase 1-3): provide microbiology expertise to the clinical team wrt protocol design, laboratory manuals, CRO selection, and oversight of the central microbiology laboratory, laboratory audits, preparation of case report forms, data collection and analyses, statistical analyses plan and tables and listings, data cleaning. Authored numerous non-clinical and clinical sections of multiple antibacterial NDAs/MAAs submission documents (eCTD format) supporting worldwide or regional submissions.Participant and presenter as subject matter expert (SME) at various Health Authority meetings (FDA, EMA, Canada, Australia, New Zealand, Latin American countries, China, EU), remote and in person to discuss scientific advice, pediatric investigation plan, pre-submission meetings, final product label, label maintenance (incl. Article 30 harmonisations), pharmacovigilance (PSURs/PBRERs), supplemental NDAs and new formulations.Familiar with operational aspects of standards development organisations (SDOs) for susceptibility testing (CLSI and EUCAST) and antibacterial device manufacturers.Scientific writing: preparation of scientific conference materials (abstracts, posters, presentations, pharma sponsored symposia materials) and publications.
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