Track Record

Development Programs

  • Multiple INDs and regulatory interactions
  • 3 NDAs and 1 MAA approved
  • Regulatory  strategies, FDA interactions and meetings (CDER, CBER, CVM Divisions)
  • 3 Product Launches
  • Several Phase 1 - 3 clinical trials - designs, planning, and execution
  • Alliance and project management for 8 partnerships
  • Refined clinical trial processes and selection of safety database systems 
  • Managed multi-year federal DoD and NIH awards totaling over $40 million

Human Resources

Executive compensation analyses and implementation for recruitment and retention for pre- and post-IPO biotechnology companies

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