Mechanism of action characterization, receptor pharmacology, in vitro and in vivo efficacy models, dose-response analysis, and target engagement assessment.
PK/PD modeling, metabolic stability, protein binding, bioavailability assessment, and species scaling to inform clinical dosing strategies.
Toxicology study design and interpretation, safety pharmacology, non-GLP and GLP study oversight, and risk characterization for regulatory submission.
First-in-human study design, dose escalation strategies, biomarker integration, DDI assessment, and clinical PK/PD modeling.
Protocol development, endpoint selection, statistical considerations, adaptive trial designs, and CRO oversight for Phase I and II programs.
GxP Audits, Batch Release, Quality Management System, Health Authority Inspection Readiness
Patent landscape analysis, freedom-to-operate assessments, IP strategy and coordination in the context of development milestones.
Budgeting for early development and clinical programs, vendor contract review, grant structuring, and coordination with legal counsel on contracts/agreements.
Program strategy, development scenario planning, indication selection, competitive landscape analysis, and board-level scientific and development input.
Scientific due diligence for partnerships, licensing negotiations support, data room preparation, and investor-facing scientific narrative.
SBIR/STTR grant strategy, scientific writing support, reviewer engagement considerations, and milestone alignment for BARDA, NIH, and foundation funding.
Develop scientific and medical communication plans, publications and presentations
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