Discover how biotech leaders are responding to global clinical trial challenges.
As clinical development faces mounting funding constraints and operational hurdles, biotech sponsors and CROs are rethinking trial strategies, geographic footprints, and patient engagement models. In a recent GlobalData feature summarizing key themes from the 12th Annual Outsourcing in Clinical Trials (OCT) UK & Ireland conference, Aditya Kotta, Head of Business Development for US and EU at Novotech, provided timely insights into how biotech sponsors are adapting clinical strategies in response to capital constraints and operational headwinds. With investors placing increasing emphasis on later-stage data, Aditya noted that sponsors are prioritizing proof-of-concept milestones and concentrating resources on lead assets to de-risk development. He also highlighted a growing trend among biotech companies to explore “ex-US” strategies, citing Australia, Asia-Pacific, Eastern Europe, and China as increasingly preferred regions for early-phase trials.
“Australia has emerged as a leading location for early-phase trials due to a favorable regulatory environment, lower costs, and high-quality data output,” he said. He also noted that oncology trials have seen significant decline, while obesity and RNA-based therapeutics continue to show resilience.
Key Takeaways from the Report:
- Shift Toward Ex-US Early-Phase Trials: Discover why regions like Australia and Eastern Europe are gaining traction for cost-effective, high-quality studies.
- Oncology Trial Activity Decline: Explore what a 60% year-over-year drop means for sponsors and where growth is happening instead.
- Patient-Centric Engagement Models: Learn how biotech leaders are involving advocacy groups and using real-time feedback to optimize protocols.
- AI and Risk-Based Monitoring: Understand how AI is being applied to enhance trial monitoring, without replacing the human touch.
- UK Operational Challenges: See how decentralized NHS structures and workforce gaps are prompting calls for centralized coordination.
As a CRO focused on helping biotech sponsors reach critical development milestones faster, Novotech’s flexible, regionally informed approach is built to solve today’s challenges—while anticipating what’s next.