The Syneos Health Podcast: Early Signals

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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.   If there’s a topic you’d like us to explore, send us a message at podcasts@syneoshealth.com.   For more actionable, future-focused life sciences insights, visit the Syneos Health Insights Hub. 

Episodes

  1. Jul 13

    Early Signals at ASCO 2026 | AI, Multimodal Data and the Next Era of Precision Oncology

    What if artificial intelligence could help remove the uncertainty from cancer treatment decisions? Precision oncology has already transformed cancer care by matching therapies to actionable biomarkers, but today's advances are moving beyond genomics alone. By integrating molecular, clinical and pathology data at scale, AI is helping researchers and clinicians better predict treatment response, identify the right patients for therapies and accelerate the development of more personalized cancer care. 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 Ezra Cohen, MD, Chief Medical Officer at Tempus AI, to discuss how multimodal data and artificial intelligence are reshaping precision oncology. Together, they explore the evolution of biomarker discovery, the growing role of AI in clinical decision-making and what it will take to bring truly individualized cancer care into routine practice. The conversation also explores how digital pathology, real-world data and AI-enabled clinical workflows are improving patient selection, supporting guideline-directed care and laying the foundation for earlier detection and more precise treatment strategies. Topics include: Why precision oncology extends beyond targeted therapies to reducing uncertainty throughout the patient journey How multimodal data and AI are improving biomarker discovery and treatment selection The promise of digital pathology and AI-powered clinical decision support Using real-world data to improve immunotherapy response prediction Closing care gaps through AI-enabled clinical workflows The future of minimal residual disease, early detection and personalized cancer treatment Why collaboration and data sharing will be essential to unlocking AI's full potential in oncology The views expressed in this podcast belong solely to the speakers and do not necessarily represent those of their organizations.   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.

  2. Jul 6

    Early Signals at ASCO 2026 | Can AI Finally Rebuild Clinical Research?

    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 innovationHow AI and large language models are transforming patient identification and trial matchingWhy community health systems may hold the key to expanding oncology research accessHow AI-powered electronic health record integration can automate clinical trial data collection and reduce manual workloadWhat the FDA's real-time clinical trial initiative could mean for sponsors, regulators and patientsWhy the future of clinical research depends on redesigning workflows rather than simply digitizing existing processesHow AI could reshape drug development over the next five years—from smarter trial execution to more predictive development strategiesThe 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.

  3. Jun 30

    Early Signals at ASCO 2026 | How Do You Turn Next-Generation ADC Science Into Global Clinical Success?

    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.

  4. Jun 25

    Early Signals at ASCO 2026 | Reigniting Response: How Oncolytic Viruses May Reshape Ovarian Cancer Treatment

    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 developmentThe science behind Olvi-Vec and its potential role in platinum-resistant ovarian cancerHow tumor microenvironment remodeling may help restore sensitivity to platinum-based chemotherapyCombining oncolytic virus therapy with chemotherapy, immunotherapy and future treatment modalitiesOpportunities and challenges in developing novel oncology therapies for solid tumorsExpanding oncolytic virus approaches beyond ovarian cancer into additional tumor typesEmerging trends shaping the future of immuno-oncology and precision medicineLessons 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.

  5. Jun 23

    Early Signals at ASCO 2026 | Creating a New Therapeutic Class: The Promise of Direct MYC Inhibition

    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.

  6. Jun 19

    Welcome to Early Signals!

    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.

  7. Jun 9

    Project Optimus Series | Clinical Pharmacology and Project Optimus

    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.

  8. Jun 2

    Project Optimus Series | The Role of Biostatistics

    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.

  9. May 26

    Project Optimus Series | Operationalizing Dose Optimization

    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.

  10. May 19

    Project Optimus Series | The Regulatory Implications of Project Optimus

    In this episode, Dr. Wael Harb, Vice President of Medical Management at Syneos Health, continues the exploration of FDA's groundbreaking Project Optimus and its profound implications for oncology drug development. He is joined by Zohra Lomri, Executive Director, Regulatory Affairs at Syneos Health, to discuss how this initiative is transforming dose optimization strategies and reshaping the clinical trial landscape. The conversation delves into the FDA’s emphasis on balancing efficacy and tolerability, the shift away from maximum tolerated doses, and the integration of patient-reported outcomes. Zohra provides valuable insights on the regulatory expectations for dose-ranging studies, the importance of leveraging non-clinical data, and the role of pharmacokinetics (PK) and pharmacodynamics (PD) modeling in optimizing trial designs. Whether you’re in oncology drug development or interested in regulatory innovation, this episode offers actionable advice and a glimpse into the future of patient-focused 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.

  11. May 12

    Project Optimus Series | Navigating the Realities of Project Optimus

    Launched in 2021 by the FDA's Oncology Center of Excellence, Project Optimus seeks to reshape traditional oncology trial designs and dosing paradigms, shifting from maximum tolerated doses to precision dosing strategies. While the FDA's hope was that the added time and cost of collecting comprehensive dose and exposure response data would benefit both patients and sponsors, there is also concern and debate in the biotech community that, if the Optimus formula is closely followed, the additional time, cost, and patient needs may, in fact, be crippling to cash-strapped emerging companies.  So what is the reality around Project Optimus? And how best can it be implemented and navigated? Kicking off a new special series on Project Optimus, in this episode Nick Kenny, Chief Scientific Officer at Syneos Health, is joined by Dr. Wael Harb, Vice President on the Syneos Health Medical Oncology Team, to explore this transformative initiative, diving into the implications for biotech companies and discussing the balance between upfront investment and long-term benefits, the operational challenges of implementation, and the critical role of early planning. Stay tuned for upcoming episodes in this series, which will dive deeper into the regulatory, statistical, clinical, and operational implications of this evolving regulatory framework.   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.

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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.   If there’s a topic you’d like us to explore, send us a message at podcasts@syneoshealth.com.   For more actionable, future-focused life sciences insights, visit the Syneos Health Insights Hub. 

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