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6 BioPharm International ® Partnerships for Outsourcing eBook May 2024 www.biopharminternational.com Analytics • non-bias and independent validation of initial results obtained at companies' facilities. Preclinical CROs fill this need as they often provide these specialized platforms and expertise to assist com- panies to successfully push their products through the R&D to IND process, ultimately resulting in clinical testing required for entry into the market. From in vivo, in vitro, and analytical/bioanalytical services, subcon- tracted organizations can provide turnkey solutions to these companies that may lack internal facilities, instru- mentation, knowledge, and quality systems to success- fully execute the necessary studies to assess their target compound's efficacy and toxicity. For instance, the costs to construct, manage, and maintain in-vivo facilities may be prohibitive for companies, especially for small start- ups with limited capital. Even larger companies, which have traditionally maintained these types of capabilities internally, are downsizing their internal in-vivo capabil- ities due to the ever-increasing regulatory burden and the ever-increasing costs required to staff and maintain these facilities. A CRO with this specific expertise and appropriate facilities can easily execute these types of studies at relatively low cost with a well-trained profes- sional team overseeing all aspects of the study, ensuring a high-quality efficacious project. The example above can also be extended to other ser- vices including in-vitro testing, chemical analysis, and bioanalytical testing. As a matter of fact, CROs with a wide breadth of capabilities under one roof can offer a one-stop shop model where the client can simply pro- vide the test article or compound of interest, and the out- sourced testing company can provide anything from the initial purity analysis to in-vitro toxicity screening on to the more complex in-vivo pharmacokinetic (PK) and efficacy studies along with the associated bioanalysis. This is especially advantageous to early-stage start-up companies with limited internal capabilities. Compre- hensive package testing allows these companies to effi- ciently advance their preclinical program, which helps these start-ups secure additional funding necessary to initiate clinical testing. Pros/cons of outsourcing preclinical testing Outsourcing may appear to be a very appealing option for biopharmaceutical companies to consider for their preclinical testing programs; however, there are specific advantages and disadvantages that must be considered for successful execution of a company's project (2). Some of the pros and cons related to outsourcing preclinical testing projects are outlined in Table I. It is essential that these pros and cons are weighed carefully, and realistic expectations are set when de- ciding to outsource preclinical testing. Some of the advantages of outsourcing have been highlighted previously in this article including taking advantage of the core competencies of the CRO as well as the tech- nological platforms and expertise provided that may not be available to the company requiring this testing. This in turn may allow an organization to reduce oper- ating costs associated with building these capabilities internally, resulting in increased profitability as also previously discussed. Risk sharing between organiza- tions is still another advantage. While there are disadvantages associated with out- sourcing preclinical testing, with effective planning and communication between partners many of these issues may be mitigated. Capacity issues at the testing organization are always a potential issue that arises when outsourcing. With the volume of outsourcing continuing by pharmaceutical, biopharmaceutical, and biotechnology companies, there is obviously a resultant increased demand for and burden on the CRO's ser vices and capacities. Transparency from the CRO in the initial stages of discussion with the client will allow a realistic timeline to be established for the project with accommodation for any testing backlogs considered. Other risk factors such as loss of day-to-day oversight, cost overruns, and logistical is- sues can be alleviated with a defined communication plan between organizations—especially with proj- ect management teams. Initial consultation with the CRO's subject matter experts (SMEs) and scientific staff in the project's study design will ensure that the most appropriate and relevant testing strategies are being undertaken. Considerations for effectively choosing a CRO for preclinical testing While this article outlines why/when companies may outsource their preclinical testing as well as the pros and cons of this strategy, one must also consider the appropriate considerations for choosing the proper CRO for their studies to ensure that their projects have the highest chance for success and within the prescribed budget (3). Please see these considerations summarized in Figure 1. TABLE I. Decisions about outsourcing preclinical testing require consideration of the benefits vs. risks. Pros Cons Core Competencies Loss of day-to-day oversight/control Access to technology and expertise Capacity concerns Risk sharing Supply chain and logistical issues Reduced internal expenditures/increased profitability Potential cost overruns