Strategize nonclinical development of new pharmaceutical drug products

  • Enable first-in-man clinical studies through marketing authorization and meet post-marketing commitments
    • Develop topical and systemic drug products
    • Characterize new chemical entities and repurposed active pharmaceutical ingredients
    • Utilize 505(b)(1) or 505(b)(2) regulatory pathways
    • Optimize opportunities for streamlined programs and requirement waivers
  • Design focused nonclinical plans complete with protocol synopses, timelines, and budgets


Design scientific assessments to meet regulatory objectives

  • Repeat-dose toxicity, juvenile toxicity, immunogenicity, phototoxicity, genotoxicity, carcinogenicity, developmental and reproductive toxicity studies in accordance with FDA and ICH Guidances and Good Laboratory Practices
  • Drug-drug interaction studies in accordance with FDA Guidances

Manage wet-lab experiments at external toxicology laboratories

  • Guide CROs through critical, time-sensitive decision-making to achieve Regulatory goals
  • Coordinate multi-year scientific programs to support go/ no-go clinical and business decisions
  • Manage annual program budgets of >1 million USD

Submissions & Representation

Contextualize scientific findings in integrated toxicology assessments for Regulatory submissions to the US FDA, Health Canada, and the EMA

  • Compose nonclinical sections of IND/CTA/IMPDs, NDA/NDS/MAAs, IBs, CAC communications, safety informational amendments, waiver requests, meeting requests, briefing books, and package inserts
  • Define margins of safety to enable risk/benefit analysis

Position Nonclinical in meetings with Regulatory Agencies

  • Achieve pre-IND/CTA, EOP2, pre-NDA/NDS, and Type A and C Guidance meeting goals

Due Diligence

Conduct nonclinical due diligence for product acquisitions

  • Identify program gaps
  • Project budgets and timelines for advancement