Drug Development Stages

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The Drug Discovery Process

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Presentation transcript:

Drug Development Stages IRB continuing education Walter K. Kraft Fall 2018

Sage words from an olde tyme drug developer When the molecule is born, its fate is determined. It's up to us to find out what the truth is, but in the end we can't change its fate. The more skilled we are, the sooner we know the fate.

Preclinical Identifying diseases Understanding biology of the system Formulating molecules Test tube engagement Animal testing in at least 2 species

Investigational New Drug (IND) FDA approval to test in humans 30 days to place on hold Very high standards for manufacturing, stability, purity, proof of concept, animal

Phase 1 Generally healthy volunteers Characterize 50-200 volunteers Pharmacokinetics Safety Drug interactions Pharmacodynamics 50-200 volunteers In oncology, patients used

Phase I Oncology Trials Usually no benefit to subjects Common therapeutic misconception among patients More recently, in healthy volunteers for non- cytotoxic drugs

Simvastatin Phase II dose range study in 43 individuals Phase III 4444 patient 4S trial linked simvastatin to reductions in CV in events.

As IRB reviewer FDA approval does not mean everything is known about a drug We assess risk and ensure it is conveyed to subjects We do not seek the fool’s errand of eliminating risk What stage is a drug trial? What is the specific question being asked by the study? What is the uncertainty around drug safety and efficacy?