In this interview, we speak with Jim Corrigan, CEO of YPrime, about the future of clinical trial technologies. The discussion goes into the impact of the Inflation Reduction Act, the role of AI, patient centricity, and the evolution of clinical trials. Jim Corrigan shares insights on how the industry can navigate these transformative changes.

Moe Alsumidaie: How can clinical trial tech help pharma navigate the Inflation Reduction Act’s challenges?

Jim Corrigan: The Inflation Reduction Act (IRA) presents new challenges for pharma, particularly in accelerating drug development timelines and optimizing R&D investments. Pharma companies need to focus on delivering speed, quality, flexibility, and value through fit-for-purpose technology. This involves leveraging multi-tenancy and multi-service architectures to implement changes efficiently. The IRA imposes economic caps and focuses on specific molecules, especially small ones, requiring pharma to adapt quickly. By offering comprehensive solutions, the industry can ensure high-quality results are delivered faster and more efficiently, helping to navigate these new environments.

Jim Corrigan, CEO of YPrime

Moe Alsumidaie: How will pharma’s operating model evolve post-IRA, and how can tech support efficiency?

Jim Corrigan: The adaptability and flexibility built into systems will enable pharma to explore new approaches. Experience across various therapies and indications allows for faster delivery of solutions. By focusing on configuration-based approaches that do not inhibit flexibility, companies can manage trials more efficiently. This agility is critical as pharma rethinks its business models in response to the IRA, ensuring they can continue to advance science while maintaining profitability. The industry must innovate continuously, allowing studies to be delivered with the highest quality in days and weeks rather than months.

Moe Alsumidaie: How should success metrics for clinical trial tech evolve beyond timelines and costs?

Jim Corrigan: Success metrics should encompass screening and compliance, focusing on how quickly patients can intuitively use devices. A user-centric design ensures that sites and patients can engage with technology seamlessly, reducing the need for support and enhancing the overall trial experience. The ease with which patients and sites can use tech enabled solution  reflects the intuitive nature of the technology. By prioritizing patient centricity, the industry can redefine success metrics to include long-term patient outcomes and accessibility, ensuring that clinical trials are efficient and patient-focused.

Moe Alsumidaie: What ethical considerations must be addressed for AI in clinical trials?

Jim Corrigan: AI should be treated like a clinical trial, ensuring safety and effectiveness before deployment. The industry should first use AI internally to enhance efficiency and quality. Maintaining all quality checks and using AI to improve processes like localization ensures it supports rather than replaces human oversight. While AI handles tasks like translation, thorough quality checks are essential to ensure accuracy and compliance with regulatory standards. By using AI as an enabler of efficiency and quality, the industry can ensure transparency, fairness, and trust in its applications.

Moe Alsumidaie: How do you standardize tech across diverse regulatory and cultural landscapes?

Jim Corrigan: Strong quality teams and transparency with stakeholders are crucial. Compliance with diverse regulatory environments requires involving all stakeholders in the process. Leveraging the best available technology and maintaining rigorous compliance checks help navigate these challenges effectively. Modifying an instrument for a study involving authors, pharma, sites, and patients ensures it meets all regulatory requirements and is suitable for diverse cultural contexts. This collaborative approach ensures that technologies are standardized and compliant across various landscapes, supporting global clinical trial efforts.

Moe Alsumidaie: Can clinical trial tech evolve into a unified ecosystem for seamless data flow?

Jim Corrigan: Absolutely. Using contemporary technologies to enable seamless data flow is essential. As standards become global, the demand for transparency and speed will push the industry towards a unified ecosystem. The IRA and other pressures will drive innovation, much like the COVID crisis did, leading to more integrated solutions. An architecture that provides real-time insights into site performance and patient data enables faster decision-making and trial adjustments. The industry enhances collaboration and efficiency across stakeholders by fostering a unified ecosystem, ultimately improving clinical trial outcomes.

Moe Alsumidaie: How should pharma rethink ROI when investing in tech for profitability and science?

Jim Corrigan: Learning quickly, even from unexpected events, is invaluable. Technologies that help pharma learn fast provide insights that enable better decision-making. Offering real-time  and insights helps pharma companies manage trials more efficiently, ultimately improving ROI. Systems that provide immediate feedback on site performance and patient compliance allow for rapid adjustments that enhance trial efficiency and outcomes. By focusing on learning and adaptability, the industry supports pharma in achieving profitability while advancing scientific discovery.

Moe Alsumidaie: What will be the most disruptive force in clinical trial tech in the next five years?

Jim Corrigan: Enabling everyone within the clinical trial chain to act to the extent of their license will be transformative. Ensuring familiarity and confidence in the tools used can reduce patient burden and improve trial outcomes. This focus on empowerment and efficiency will drive significant change in the industry. By making technology intuitive and user-friendly, study managers, sites, and patients can focus on their core responsibilities, enhancing the trial process. This approach will be a game-changer, ensuring that clinical trials are more effective and patient-centered.

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Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.