Effective Execution of Your in vivo Pharmacology Research by using CROs.

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Effective Execution of Your in vivo Pharmacology Research by using CROs

Target identification Target validation In vitro compound screening In vivo efficacy Pharmacology Toxicology IND

Nature of in vivo pharmacology research High start up cost Facility Equipment Personnel High regulatory burden Long start up time High maintenance cost Personnel-centric Low tech Routine

Different levels of outsourcing Contract Personnel Contract Facility/incubator Contract Research (outsourcing)

Example : contract research In-houseOutsource Personnel2 FTE0.2 FTE Lab spaceIn vitro, vivarium$ 0 EquipmentCell culture, animal housing equipment $ 0 Lead timeHiring, assay development, trouble shooting 2-3 weeks Total time4-6 months3 months Budget$350,000$200, studies using a cancer xenograft model

Example: off-site vivarium In-houseOff-site Facility cost$ 3,500/mo$ 7,000/mo Equipment/supplies$ 50,000 +$ 0 Husbandry services $ 3,500/mo ?$ 7,800/mo Additional resources Additional personnel, IACUC, attending vet Build out cost$200,000 Room 1: 100 cages of mice Room 2: 50 cages of rats HEPA-filtered ventilated caging

Keys to successful outsourcing Due diligence Facility Management system Personnel Project management Plan ahead Define clear project goals Communication management

Effective Execution of Your in vivo Pharmacology Research by using CROs