Virtual Drug Development in Southern California: A Pre-Clinical Focus Please visit www.biocomcro.org for more information on BIOCOM's CRO Initiative & CRO events.

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

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

3. 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

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

5. Example : contract research
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 4-6 months 3 months
Budget $350,000 $200,000
10 studies using a cancer xenograft model

6. Example: off-site vivarium
In-house Off-site
Facility cost $ 3,500/mo $ 7,000/mo
Equipment/suppli
es
$ 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

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

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