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       Strategies for virtual and semi-virtual company building

  • Virtual model for protein development company
  • Semi-virtual development for small molecule and protein development

       Strategic development planning for small molecules and proteins

  • Small molecule GMP and GLP strategies
  • Oncology small molecule and antibody strategies from discovery to Phase III
  • Protein antifibrotic therapeutics strategy from preclinical to Phase II
  • CNS and stroke therapy strategies
  • Discovery project candidate selections for development

       Project Management handling multiple projects from preclinical/IND to    NDA filings

  • Oncology therapeutic antibody pre-clinical through two simultaneous Phase I trials in Europe
  • Therapeutic proteins from DNA to Phase I/II clinical trials
  • Preclinical small molecule, antibody and protein development with IND filings
  • Phase I, II, and III clinical planning and studies
  • NDA preparation and filing

       CMC small molecule and protein programs

  • Small molecule lead compound to development candidate programs
  • Small molecule and protein GMP synthesis and manufacturing
  • 6 IND filings