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Translational support to successfully move your assets from IND-enabling stage to Phase 1:

Early Development Support
 

Review of pharmacology and toxicology studies to identify gaps and provide recommendations to complete the package for a successful IND submission

Pre-IND meeting support including preparation of the Clin Pharm/Clinical portions of the pre-IND meeting package and developing the company's position

Developing the Phase 1A (dose escalation) study including first in human dose and dose escalation strategy

Developing Phase 1B (dose expansion-optimization) study, including selection of doses, number of patients per dose group, schedule of events etc.

We perform all pharmacometrics analysis such as NCA, POPPK and Exposure-Response analysis needed to identify the Recommended Phase 2 Dose (RP2D)

Developing the Briefing Document for the FDA End of Phase 1 (EOP1) meeting including the company's position

Attendance in the FDA Type B meeting to defend your RP2D

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