Can real-world evidence do more than support regulatory decisions? Could it fundamentally change how clinical research is designed, delivered and connected to patient care?

In this episode of The Syneos Health Podcast: Early Signals, Wael Harb, MD, sits down with Justin Spencer, Chief Executive Officer of Azimuth Research Group, to explore how real-world evidence is reshaping oncology drug development. Together, they discuss why bridging the gap between healthcare delivery and clinical research has become one of the industry's greatest opportunities—and what it will take to generate higher-quality evidence while improving patient access to innovative therapies.

The conversation examines the growing importance of integrated health system data, patient-centered research models and real-world evidence in supporting protocol design, trial recruitment and oncology development. Spencer also shares his perspective on how aligning healthcare providers, sponsors and patients around a common goal could accelerate drug development while improving access to new treatments.

In this episode, you'll learn:

• Why high-quality real-world evidence depends on understanding the clinical context behind the data.
• How closer integration between healthcare systems and research may improve trial design and patient recruitment.
• The growing role of real-world evidence in oncology drug development and regulatory decision-making.
• Why patient-centered research models could help accelerate access to innovative cancer therapies.
• What the future of oncology development may look like as healthcare, data and research become more connected.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

If clinical trials are already digitized, why do clinical operations remain so complex, manual and resource-intensive?

In this episode of Early Signals, Wael Harb, MD, speaks with Ram Yalamanchili, Founder and CEO of Tilda Research, about the next frontier for AI in clinical trials: moving beyond digitization to tackle the operational complexity that can slow clinical development.

They explore how agentic AI and “AI teammates” can support clinical operations teams across complex workflows, from site startup and trial oversight to data management and regulatory activities. Rather than replacing clinical research professionals, these technologies are designed to take on repetitive coordination and operational tasks, creating greater capacity for teams to focus on work that requires human expertise.

The conversation also examines what successful AI adoption requires beyond the technology itself, including AI fluency, governance and human oversight. Ram shares examples of how AI-enabled clinical operations can potentially improve productivity, quality and timeliness and discusses where CROs and biopharma organizations may see the greatest near-term opportunities.

In this episode, you’ll hear about:

• Why digitization alone hasn’t eliminated clinical trial operational bottlenecks
• How agentic AI and AI teammates differ from traditional copilots
• Opportunities to use AI in site startup and other complex clinical trial workflows
• The importance of human-in-the-loop AI governance and workforce AI fluency
• How AI can help clinical operations teams increase capacity without simply reducing headcount
• Potential applications across trial master file management, data management and monitoring, finance and trial oversight
• What AI-enabled operating models could mean for the future of CROs, biopharma sponsors and clinical development

Listen to the full episode to explore how AI could help clinical research teams move beyond digitization toward more intelligent, scalable and efficient clinical trial execution.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Can the next generation of tumor-infiltrating lymphocyte (TIL) therapies overcome the barriers that have limited broader adoption of cell therapy in solid tumors?

In this episode of Early Signals, recorded live at ASCO 2026, Wael Harb, MD sits down with Parameswaran Hari, MD, Chief Medical Officer at Obsidian Therapeutics, to discuss how engineered TIL therapies are evolving beyond first-generation approaches. Drawing on his experience leading the clinical development of lifileucel and now advancing OBX-115, Dr. Hari explores how controllable cytokine expression, streamlined manufacturing and patient-centric trial design may help make cell therapies safer, more accessible and easier to deliver across a broader range of treatment centers.

Together, they examine preliminary clinical data from an ongoing study of OBX-115, an investigational therapy that has not been approved by regulatory authorities. The conversation also explores where TIL therapy fits within an increasingly complex immuno-oncology landscape and why continued innovation in manufacturing, accessibility and global drug development will be essential to bringing these therapies to more patients.

In this episode, you'll learn:

• Why next-generation TIL therapies are being engineered to improve safety, scalability and patient access.
• What preliminary ASCO 2026 findings from the ongoing OBX-115 study show to date, and the limitations of interpreting early efficacy and safety data from a small patient population.
• What early ASCO 2026 clinical data suggest about efficacy, durability and safety in checkpoint inhibitor-resistant melanoma.
• How innovations in manufacturing and trial design may expand the future role of cell therapy across solid tumors.
• Why Dr. Hari believes accessibility, affordability and global collaboration will define the next era of oncology drug development.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.