Early Phase BAE: Screening All Technologies Under One Roof

As drug candidates become more complex and development timelines tighten, selecting a bioavailability enhancement strategy early has consequences well beyond Phase 1. A formulation that meets an immediate clinical milestone may later create challenges with exposure, dose burden, manufacturing, or scale-up.
This presentation examines why amorphous solid dispersion (ASD) technologies should be evaluated against the needs of each molecule and the full development program. Spray drying, hot-melt extrusion, KinetiSol™, and solvent precipitation offer different formulation and manufacturing options. Early screening across these technologies, supported by biorelevant dissolution, stability testing, pharmacokinetic assessment, and manufacturing evaluation, can help teams select and optimize a strategy before clinical commitments make a change more costly.
A client case study illustrates the stakes: a later switch from a spray-dried dispersion to KinetiSol improved exposure and reduced dose burden, but required two human pharmacokinetic bridging studies. The presentation makes the case for comprehensive early screening as a way to meet near-term milestones while protecting long-term clinical and commercial options.