Jeannine M. Fisher, M.S.

Senior Scientist II & Scientific Project Manager

Jeannine joined Metrum in 2006 and has more than 20 years of experience in clinical and pre-clinical research experience in academia and the pharmaceutical industry. Jeannine has supported all phases of clinical research across multiple therapeutic areas, with a particular emphasis on pediatric and rare disease patient populations. Her clinical experience has most recently focused on model-based analyses of pk, biomarker, and efficacy endpoints to support decision making in various phases of drug development.

Recent publications by this scientist

Shortening the Regulatory Submission Critical Path via MIDD Acceleration: A Multi-Trial Phase 3 Case Study

October 9, 2026

Marc R. Gastonguay, William Knebel, Timothy Waterhouse, Jeannine Fisher, Brian Corrigan

Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 12th, 2026.

Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on MIDD (model-informed drug development) analyses to support dosing, labeling, and design of post-approval trial commitments. Frequently, MIDD related activities (data cleaning/prep, analysis, summary document preparation) are on the filing critical path (CP) following completion of the final registration studies, with delays directly impacting time to file. These delays impact overall medicine value and access for patients. This case study highlights a MIDD acceleration (MIDD-A) strategy that resulted in a meaningful reduction in the NDA submission critical path (CP) for an ongoing Phase 3 drug development program.

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Scientific Project Management (SPM) to Enhance Model-Informed Drug Development.

December 6, 2024

Presented at ACoP 2024. This poster describes the scientific project management role in MIDD and it’s benefits over a traditional project management approach.

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Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia

July 22, 2021

Galluppi GR, Polhamus DG, Fisher JM, Hopkins SC, Koblan KS. CPT Pharmacometrics Syst Pharmacol. Published online July 22, 2021. doi:10.1002/psp4.12692

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