ACT Brief: CRO Selection as Incentive Design, Integrated Tech Stack Strategy, and Pricing Disruption in Pharma

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a new contributed article, the authors presented a game-theoretic framework for CRO and vendor selection based on science-first qualification, ecosystem formation, mechanism-designed procurement, and outcome-aligned contracting. Rather than traditional vendor evaluation, this approach treats selection as incentive design where truthful disclosure and collaboration become optimal strategies for all parties, creating conditions for genuine partnership.
• In part one of a new video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, discussed why an effective clinical tech stack must be purpose-built, fully integrated, and designed to simplify research execution rather than add complexity across fragmented platforms.
• In a new interview from Pharmaceutical Technology, Tony Lakavage, executive vice president and head of global external affairs at USP, addressed mega trends including IRA-driven price negotiations, Most Favored Nation initiatives, and FDA's revised biosimilar guidance allowing analytical data instead of costly clinical efficacy trials. Together, these changes are reshaping R&D investment and manufacturing strategies while accelerating biosimilar market entry.

That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.