26 BioPharm International eBook October 2018 www.biopharminternational.com
angellodeco\Adobe.com
Barriers and Solutions to Effective
External Collaboration in Biopharma
As biopharma companies rapidly change their focus, they may lack
the laboratory space, instrumentation, and the scientific knowledge to
support biologics research.
C
ontract research, development, and man-
ufacturing organizations (CRO/CDMOs)
are well established in the drug develop-
ment lifecycle and are often used for ded-
icated activities along the drug discovery
and preclinical development process. Each of these
main areas (discovery and development) of the drug
development process breaks into specific areas. These
areas can include target identification, target valida-
tion, lead identification, early pharmacology, high
throughput screening (HTS), adsorption, distribution,
metabolism, and excretion (ADME), drug metabolism
and pharmacokinetics (DMPK), bioanalysis, formula-
tions, safety/toxicity, process development, and scale
up, etc. Domain specialist CROs have emerged in this
space as well as larger "platform" CROs who offer full
"end-to-end" service.
T he reliance on CROs as ser v ice prov iders is
becoming crucial; many large pharmaceutical com-
panies increasingly look toward CROs for specialist
capabilities while streamlining their internal opera-
tions. Outsourcing has obvious business benefits in
PAUL DENNY-GOULDSON
PAUL DENNY-GOULDSON is Vice President of Strategic Solutions at IDBS.
Biopharma Laboratory Best Practices Outsourcing
