Early Development Support

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

What we do

Translational support to Phase 1

IND through Phase 1 design

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

Pre-IND meeting support: Clin Pharm/Clinical portions of the meeting package and company position

Phase 1A (dose escalation) study design, including first-in-human dose and dose escalation strategy

Phase 1B (dose expansion/optimization) study: dose selection, patients per dose group, schedule of events

Pharmacometrics and EOP1

We perform NCA, POPPK and Exposure-Response analysis to identify the Recommended Phase 2 Dose (RP2D). We develop the Briefing Document for the FDA End of Phase 1 (EOP1) meeting and attend the Type B meeting to defend your RP2D.