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28 BioPharm International eBook May 2021 www.biopharminternational.com Demystifying Complex Clinical Trial Kit Preparation Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials. D evelopments in biolog ics and persona l- ized medicines are reshaping the clinical trial landscape. According to Grandview Research, the global biologics market is anticipated to reach $398 billion by 2025, with growth supported by faster drug approval processes (1). Simultaneously, the increasing prevalence of cancer and rare diseases is providing the catalyst for investment in the devel- opment of targeted therapies. These precision medicines, which are tailor-made to meet unique patient needs, are expected to reach $85 billion over the next five years, repre- senting a substantial 9.9% compound annual growth rate (2). The increase in complex, targeted, large-molecule prod- ucts brings with it disruption to traditional drug develop- ment. In an increasingly competitive market, expediting biologic drug development, approval, and commercialization in a bid to achieve timely return on investment is key. As such, clinical trials are shifting from developed nations to emerging countries, including Latin America and Western Europe, which possess greater disease variations (1) and can represent more efficient and cost-effective operations that promote faster completion of key study milestones. CONDITIONS FOR A PERFECT STORM While developing biologics and personalized medicines present clear opportunities to advance human health, it also makes designing strategic and streamlined supply chains more challenging and risk intensive. NATALIE BAL ANVOSK Y is jus t-in -time manufac turing solutions manager, and BRYAN THOMPSON is production manager, both with Almac Clinical Services. NATALIE BALANVOSKY AND BRYAN THOMPSON Partnerships for Outsourcing Operations SCOTT CORNELL - STOCK.ADOBE.COM