Program evaluation

Program evaluation converts evidence into a defined decision: advance, redesign, pause or stop.

Every stage has a specific decision and an evidence threshold. At the computational stage, the decision is which hypotheses are ready for synthesis and direct testing. Later decisions rely on measured pharmacology, chemistry, exposure, safety and efficacy.

Evidence considered

Aeviant separates published biology, company interpretation, computational results, experimental results and program objectives. Evidence is assessed for source quality, method fitness, reproducibility, controls and relevance to the decision being made.

Advancement

Advancement requires evidence appropriate to the stage. Early gates address the biological rationale and feasibility of the therapeutic design. Later gates address reproducible pharmacology, chemical tractability, exposure, safety, efficacy and a credible path to further development. Criteria are defined before results are interpreted wherever practicable.

Redirection or termination

A result can reveal a useful pharmacology outside the original design, require a new molecular strategy or end the program. Redirection and termination decisions are recorded with the evidence that caused them, including negative and contradictory findings.