The upcoming Outsourcing in Clinical Trials (OCT) West Coast conference, scheduled for February 11-12 at the Hyatt Regency San Francisco Airport, is set to address crucial developments in clinical trial management and innovation. The two-day event, organized by Arena International, will feature four specialized streams covering outsourcing, clinical operations, technology innovation, patient engagement, and medical devices.
Efficiency and AI Integration Take Center Stage
RenovoRx's Chief Clinical Officer Leesa Gentry will deliver the opening keynote, focusing on optimizing efficiency at clinical trial sites. "Clinical trial sites do not need us as much as we need them," Gentry emphasizes, advocating for a more localized approach to trial management. "We need to think global but act local, using local requirements as an advantage rather than a disadvantage."
The integration of artificial intelligence emerges as a key theme for improving trial efficiency. "AI is going to be pervasive in every aspect of our industry," Gentry notes, highlighting its potential in document generation and regulatory approval processes. Sessions will explore how AI is transforming healthcare and how Contract Research Organizations (CROs) can enhance efficiency while maintaining quality standards.
Regulatory Landscape and Political Impact
With significant political changes on the horizon, the conference will examine their impact on the biotech landscape. Aditya Kotta, head of business development US and EU at Novotech, will lead discussions on trends observed during the JP Morgan Healthcare 2025 conference and the implications of the new administration on clinical trials.
Abbott's head of regulatory affairs, Katie Bessette, will present recent FDA guidance on clinical research, covering crucial topics such as consent form requirements and decentralized trial elements to improve patient engagement and retention.
Global Diversity and Patient-Centric Approaches
The conference will feature extensive discussions on implementing the World Health Organization's recently released guidance on clinical trial best practices. Archana Sah, founder of AS Pharma Advisors, will examine how sponsors can enhance trial diversity while ensuring regulatory compliance.
"The true definition of patient centricity is thinking about the patient throughout the patient journey as you're designing the protocol," Sah explains. The conference will explore practical approaches to patient-centric trial design, including:
- Building community-based trials
- Incorporating patient voice from informed consent onwards
- Collaborating with CROs for enhanced patient focus
- Implementing digital and decentralized tools
Real-World Patient Perspectives
A notable highlight includes a presentation by Nisha Trivedi, a rare disease patient advocate, who will share insights from her experience in hybrid clinical trials. Her session will provide valuable recommendations for improving patient-centric trial design based on first-hand experience.
The conference aims to address the industry's most pressing challenges while providing practical solutions for improving trial efficiency, patient engagement, and regulatory compliance in an evolving healthcare landscape.
