Less than 5% of patients participate in clinical trials today; a statistic that has remained virtually unchanged for more than two decades despite massive advances in science and technology.

In this episode of Early Signals, Dr. Wael Harb sits down with Kent Thoelke, Founder and CEO of Paradigm Health, to explore why clinical research still relies on outdated workflows and how AI, electronic health records and real-time data are creating an opportunity to fundamentally redesign the clinical trial ecosystem.

Drawing on more than 30 years in clinical research, Kent explains why simply digitizing existing processes isn't enough. Instead, he argues the future lies in embedding research directly into routine patient care, using AI to identify eligible patients before they're missed, automate manual data collection and accelerate decision-making across sponsors, investigators and regulators.

The conversation also explores Paradigm's collaboration with the FDA to pilot real-time clinical trials, where AI-generated clinical signals are transmitted directly from electronic health records to support faster regulatory review and more efficient trial execution.

Whether you're leading oncology development, clinical operations or regulatory strategy, this episode offers a practical look at how AI may reshape the future of clinical research—not by replacing people, but by removing the operational barriers that keep patients from accessing clinical trials.

In This Episode, You'll Learn:

• Why clinical trial participation has remained below 5% despite decades of innovation
• How AI and large language models are transforming patient identification and trial matching
• Why community health systems may hold the key to expanding oncology research access
• How AI-powered electronic health record integration can automate clinical trial data collection and reduce manual workload
• What the FDA's real-time clinical trial initiative could mean for sponsors, regulators and patients
• Why the future of clinical research depends on redesigning workflows rather than simply digitizing existing processes
• How AI could reshape drug development over the next five years—from smarter trial execution to more predictive development strategies

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.

Antibody-drug conjugates (ADCs) are transforming oncology, but scientific innovation alone isn't enough. As platforms become more sophisticated—with novel linker technologies, diversified payloads and increasingly targeted approaches—the challenge shifts from discovery to execution. How do sponsors successfully translate next-generation ADC science into global clinical development programs?

In this episode of Early Signals, Wael Harb, MD, sits down with Diana Chen, Vice President of Global Clinical Operations at MediLink Therapeutics, to discuss what it takes to operationalize innovation at scale. From building a rapidly growing ADC pipeline and managing global partnerships with leading biopharma companies to navigating cross-cultural clinical operations, Diana shares practical insights into the strategies shaping the next generation of oncology drug development.

Together, they explore how platform technologies like MediLink's TMALIN® linker are expanding the potential of ADCs, why global collaboration is becoming a competitive advantage and what operational excellence looks like in an increasingly complex development landscape.

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.

What happens when an established treatment regains its effectiveness against resistant disease?

In this episode of the Syneos Health Podcast: Early Signals, Wael Harb, MD, Head of R&D and Scientific Strategy in Oncology at Syneos Health, sits down with Jason Litten, MD, Chief Medical Officer of Genelux, to discuss the evolving role of oncolytic virus therapy in oncology and its potential to reshape treatment strategies for patients with difficult-to-treat cancers.

Together, they explore the science behind Olvi-Vec, a modified vaccinia oncolytic virus designed to directly attack tumors, remodel the tumor microenvironment and potentially restore sensitivity to platinum-based chemotherapy. The conversation examines emerging approaches to immuno-oncology, the future of combination therapies and the opportunities and challenges of advancing innovative oncology programs from early development through pivotal clinical trials.

Topics include:

• Why oncolytic viruses are gaining renewed attention in oncology drug development
• The science behind Olvi-Vec and its potential role in platinum-resistant ovarian cancer
• How tumor microenvironment remodeling may help restore sensitivity to platinum-based chemotherapy
• Combining oncolytic virus therapy with chemotherapy, immunotherapy and future treatment modalities
• Opportunities and challenges in developing novel oncology therapies for solid tumors
• Expanding oncolytic virus approaches beyond ovarian cancer into additional tumor types
• Emerging trends shaping the future of immuno-oncology and precision medicine
• Lessons from clinical development across targeted therapies, cell therapies and oncolytic viruses

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 MYC finally be drugged? Learn how MycRx is advancing a direct MYC inhibitor and navigating the science and business of oncology innovation.

What if one of cancer's most important drivers was no longer considered "undruggable"?

For decades, MYC has remained one of oncology's most elusive targets—a transcription factor implicated in the majority of human cancers yet notoriously difficult to inhibit with small molecules. Today, advances in structural biology, medicinal chemistry and translational science are challenging that assumption.

In this episode of Early Signals, Wael Harb, MD, Head of R&D and Scientific Strategy in oncology at Syneos Health sits down with Nick Glover, CEO of MycRx, to discuss the company's efforts to develop a direct small-molecule MYC inhibitor. Together, they explore the science behind MYC biology, the challenges of targeting transcription factors, how real-world data is helping identify MYC-driven tumors and what it takes to advance a first-in-class oncology program from discovery toward the clinic.

The conversation also examines the realities of modern biotech leadership—from designing efficient global development strategies to balancing scientific innovation with the business of drug development.

Topics include:

· Why MYC has long been considered "undruggable"

· The scientific breakthroughs enabling direct MYC inhibition

· Identifying patient populations most likely to benefit

· Balancing efficacy and tolerability when targeting MYC

· Global strategies for accelerating early-phase oncology development

· Lessons for biotech leaders developing novel mechanisms of action

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

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.

What are the signals today that will define the future of oncology treatment tomorrow?

The Syneos Health Podcast: Early Signals brings together leaders across biopharma, healthcare, academia and technology to explore the innovations reshaping drug development in oncology. Hosted by experts across Syneos Health, including Wael Harb, MD, Head of Research and Development and Scientific Strategy in oncology, each episode captures candid conversations about emerging science, evolving market dynamics and the trends poised to influence the future of patient care.

Tune in for timely perspectives on what's next—and what it means for the oncology industry, its stakeholders and most importantly its patients.

Subscribe to The Syneos Health Podcast: Early Signals for new episodes.

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.

We continue our Project Optimus series with a focus on clinical pharmacology—a foundational element in redefining dose optimization in oncology drug development.

Dr. Wael Harb is joined by Pierre-Olivier Tremblay, Vice President of Clinical Pharmacology at Syneos Health, to discuss how model-informed strategies, exposure-response analysis and biomarkers are transforming early phase trials. They examine how tools like PK/PD modeling and tumor dynamics simulations enable a shift from traditional maximum tolerated dose approaches to more patient-centric dosing strategies, and explore how AI, data sharing and regulatory innovation are shaping the future of precision oncology.

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.

As regulatory expectations evolve under the FDA’s Project Optimus oncology dosing initiative, biostatistics is emerging as a central pillar in designing and executing trials that move beyond the traditional maximum tolerated dose (MTD) approach.

In this fourth episode of our Project Optimus series, host Dr. Wael Harb is joined by biostatistics expert X.Q Xue, PhD, Vice President and Global Head, Biostatistics at Syneos Health to explore how statistical science is transforming dose optimization in oncology drug development. Dr. Xue discusses the limitations of legacy 3+3 dose-escalation designs and introduces innovative alternatives, including Bayesian modeling, adaptive trial strategies and randomized parallel dose-response studies, which support more precise dose selection and can ultimately improve patient outcomes and trial efficiency.

Together, Drs. Harb and Xue examine how smaller biotech companies can overcome barriers to implementation, the role of simulation and AI in trial planning and how a biostatistics-driven approach may increase the likelihood of late-phase success, reduce post-marketing adjustments and support faster regulatory approvals.

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.

In this episode, we continue our exploration of Project Optimus and the evolution of dose optimization in oncology drug development. Following our discussion on regulatory expectations in the previous episode, we now turn to the operational challenges and strategies required to implement optimized dosing in real-world settings.

Host Dr. Wael Harb is joined by Patrick Melvin, Vice President, Oncology & Hematology and Global Head, Novel and Emerging Therapies at Syneos Health, to discuss the complexities of operationalizing Project Optimus. Together, they examine how drug developers, investigator sites and patients are affected by these changes, the role of adaptive study designs, and how AI-driven technologies and digital health innovations are helping to streamline dose optimization.

Tune in to gain valuable insights into the future of precision dosing and the long-term benefits of this industry shift, from improving patient outcomes to enhancing drug development efficiency.

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.