Partnering with Biotechnology Companies
Team Approach
Expertise
Consulting
Need
- Well established pharma company required both a TQT and Multiple-Ascending Dose (MAD) protocol for a narcotic compound to advance their NDA commitments
- Drug has potential safety concerns and establishing the upper safe dose and dosing interval is complicated by ensuring subject safety
Approach
- Quickly enlisted a team of internal experts (cardiologist, cardiac central labs personnel, statistician, pharmacokineticist, director of cardiac safety services, protocol development team) to determine the appropriate recommendations for these two complex studies
- Recommendations collected by the protocol development team sent to the client within 2 days
- Detailed discussions immediately ensued as a result of the initial input enabling client to meet the FDA requested timelines
- Involvement of the team continued throughout the protocol development process enabling both protocols to be finalized within 3 weeks
Benefits
- The client was able to provide the FDA with the protocols for review and obtain approval to proceed with their Phase I program thus advancing their timelines for approval
- Comprehensive input from multi-disciplinary team facilitated quality protocol development
- Expeditious timelines for protocol development enabled a faster turnaround for regulatory approval of the protocol and thus trial initiation