Presentation by Explora BioLabs at BIOCOM CRO Event May 2013

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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.

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Presentation by Explora BioLabs at BIOCOM CRO Event May 2013

  1. 1. Effective Execution of Your in vivoPharmacology Research by usingCROs
  2. 2. Target identificationTarget validationIn vitro compound screeningIn vivo efficacyPharmacologyToxicologyIND
  3. 3. Nature of in vivo pharmacologyresearch High start up cost◦ Facility◦ Equipment◦ Personnel High regulatory burden Long start up time High maintenance cost Personnel-centric “Low tech” Routine
  4. 4. Different levels of outsourcing Contract Personnel Contract Facility/incubator Contract Research (outsourcing)
  5. 5. Example : contract researchIn-house OutsourcePersonnel 2 FTE 0.2 FTELab space In vitro, vivarium $ 0Equipment Cell culture, animal housingequipment$ 0Lead time Hiring, assay development,trouble shooting2-3 weeksTotal time 4-6 months 3 monthsBudget $350,000 $200,00010 studies using a cancer xenograft model
  6. 6. Example: off-site vivariumIn-house Off-siteFacility cost $ 3,500/mo $ 7,000/moEquipment/supplies$ 50,000 + $ 0Husbandryservices$ 3,500/mo ? $ 7,800/moAdditionalresourcesAdditional personnel,IACUC, attending vetBuild out cost $200,000Room 1: 100 cages of miceRoom 2: 50 cages of ratsHEPA-filtered ventilated caging
  7. 7. Keys to successfuloutsourcing Due diligence◦ Facility◦ Management system◦ Personnel Project management◦ Plan ahead◦ Define clear project goals◦ Communication management
  8. 8. Effective Execution of Your in vivoPharmacology Research by usingCROs

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