4 BioPharm International
®
Partnerships for Outsourcing eBook May 2024 www.biopharminternational.com
T
o reduce costs and streamline their internal
processes, bio/pharmaceutical and biotech
companies are increasingly outsourcing
many of their internal operations related to
the development of their therapeutic compounds,
including preclinical testing. That said, contract re-
search organizations (CROs) are playing a more im-
portant role in providing critical testing services
required for internal validation purposes and sub-
mission to regulatory agencies. Navigating the pre-
clinical testing process can be a somewhat confusing,
if not dicult, task including identifying the prop-
er partner for conducting the necessary studies to
help advance a promising lead compound from the
discovery phase to the initiation of investigational new
drug (IND) process.
This article will ser ve as a usef ul guide, includ-
ing why/when to outsource preclinical testing, the
advantages and disadvantages of outsourcing this
testing, and how to effectively choose a partner to
conduct this testing.
Why outsource preclinical testing?
With the ever-growing complexit y of pharmaceu-
tical therapeutic development, it is becoming more
and more difficult for companies, both small start-
ups and even large global entities, to maintain all
the relevant capabilities internally required for full
development of promising lead compounds to the
initiation of the clinical testing phase. Academic in-
stitutions often collaborate with companies on early
stage R&D with later-stage testing and manufactur-
ing being outsourced to CROs and contract manufac-
turing organizations (CMOs).
The following are some of the reasons why outsourc-
ing is becoming more and more prevalent in pharma-
ceutical development (1):
• i nc re a s e d f le x ibi l it y to pivot res e a rc h a nd
development focus
• reduced personnel and facilities costs to companies
• leveraging of CRO's specific technologies and
expertise in study design and execution, project
management, and quality assurance
Navigating the Preclinical
CRO Outsourcing Process
Daniel Radiloff, PhD,
is director of
Business Development,
Pacific BioLabs.
The need for preclinical testing expertise is
growing as molecular complexity increases.
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