European Biotechnology Company Seeking First-in-Human U.S. Clinical Study
Regulatory Strategy with Scientific Input
Regulatory Operations
Need
European biotechnology company with lead recombinant biotechnology product intended to treat inflammatory diseases seeking First-In-Human (FIH) US clinical study required assistance in communicating with FDA
Required experienced regulatory affairs team to better understand FDA perspective and requirements
Required meaningful interaction with FDA to enable on-time clinical start-up for drug development program
Approach
Reviewed non-clinical data and non-clinical development program
Reviewed manufacturing data from third-party contract manufacturers
Prepared preIND debriefing package
Authored all non-clinical and manufacturing sections of the IND with continuous input and collaboration from initial client, subsequent major pharmaceutical licensee, toxicology experts, and contract manufacturers
Published complete IND with protocol provided by new Investigational New Drug (IND) client, a major pharmaceutical company
Benefits
Obtained on-time and effective FDA input during and throughout the IND pre-filing phase even with unexpected non-clinical results subsequent to filing of pre-IND meeting debriefing package
On-time and effective clearance of IND allowed clinical trial start-up as per client’s requirements
