Grant Applications: Identify funding opportunities, draft and edit grant applications, respond to critiques.
Review and edit grant applications
Regulatory Filings: Draft and edit IND, annual update to IND, Clinical Study Reports; FDA meeting request strategy.
Help writing grant applications, manuscripts or regulatory documents.
Program Development: Advise on preclinical validation, mechanism of action studies, pharm/tox screens, early clinical trial design, biomarker strategy.
Program development guidance from preclinical to clinical proof-of-concept