Effective Execution of Your in vivo Pharmacology Research

  • Slides: 8
Download presentation
Effective Execution of Your in vivo Pharmacology Research by using CROs

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

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

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)

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

Example : contract research 10 studies using a cancer xenograft model In-house Outsource Personnel

Example : contract research 10 studies using a cancer xenograft model In-house Outsource Personnel 2 FTE 0. 2 FTE Lab space In vitro, vivarium $0 Equipment Cell culture, animal housing equipment $0 Lead time Hiring, assay development, trouble shooting 2 -3 weeks Total time Budget 4 -6 months 3 months $350, 000 $200, 000

Example: off-site vivarium Room 1: 100 cages of mice Room 2: 50 cages of

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

Keys to successful outsourcing �Due diligence ◦ Facility ◦ Management system ◦ Personnel �Project

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

Effective Execution of Your in vivo Pharmacology Research by using CROs