How we help: example consulting projects
Small molecule for oncology
Designed and implemented IND-enabling preclinical/translational strategy for small molecule oncology therapeutic now in Phase 2. Selected and directed CROs to perform a series of in vitro/in vivo studies including screening, cytotoxicity, mechanism of action, efficacy in orthotopic and metastatic xenograft models, PK, and ADME studies.
Novel protein for orphan indication
Implemented the development strategy for pegylated enzyme therapeutic progressing from research through IND enabling PK/PD and Tox followed by clinical studies. Therapeutic was initially studied in oncology indications and is now in phase 3 evaluation for an enzyme deficiency orphan indication.
Biologic for inflammatory disease
Developed and implemented lead optimization strategy for a series of biologics; the lead was selected, taken through IND-enabling studies, and is now in Phase 1. Studies required included in vitro activity/mechanism of action, immunoassay development for biomarker assessment, in vivo efficacy in preclinical/translational models, dose optimization, PK, and toxicology.
Partnership evaluation of protein half life extension technologies
Evaluated scientific merit and intellectual property position of a variety of therapeutic agents for potential new partnership opportunities. Drafted Target Product Profile, Project Plan and Executive Summary for chosen product candidates.
In licensing opportunity in oncology
Provided scientific evaluation of new corporate venture in oncology. Assessed scientific and clinical data on compound and evaluated input from thought leaders in the field. Compound was chosen for internal development and further development strategy was proposed and undertaken