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10 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook February 2024 PharmTech.com fgnopporn - stock.adobe.com T o reduce costs and streamline their internal pro- cesses, bio/pharmaceutical and biotech compa- nies are increasingly outsourcing many of their internal operations related to the development of their therapeutic compounds, including preclini- cal testing. That said, contract research organizations (CROs) are playing a more important role in providing critical testing services required for internal validation purposes and submission to regulatory agencies. Navi- gating the preclinical testing process can be a somewhat confusing, if not difficult, task including identifying the proper 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 complexity of pharmaceutical 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 capabil- ities internally required for full development of promis- ing lead compounds to the initiation of the clinical test- ing phase. Academic institutions often collaborate with companies on early stage R&D with later-stage testing and manufacturing being outsourced to CROs and con- tract manufacturing 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 rea sed f le x ibi l it y to pivot resea 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.