04
Led regulatory agency scientific advice applications, contributed to the document packages, attended agency meetings and provided post-meeting input
Clinical Hybrid Team Successfully Moved Asset into the Clinic
Challenge
Weatherden was required to provide clinical development
and regulatory support for an asset with a novel mechanism of action moving into first-in-human studies
FROM PH1/2 CDP DESIGN & FEASIBILITY TO REGULATORY AGENCY APPLICATIONS & INTERACTIONS THROUGH TO CRO SELECTION
01
Weatherden provided access to a clinical lead, head of regulatory strategy, head of clinical operations and a drug development statistician
02
Reviewed the non-clinical plan from both regulatory and clinical development perspectives. Our hybrid
team designed a clinical
development plan - writing a Ph1/2 trial protocol, synopsis and investigators’ brochure
03
Clinical operations insight supported feasibility, costings & CRO selection