The Syneos Health Podcast: 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.

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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 [email protected]. 

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 [email protected]. 

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 [email protected]. 

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 [email protected]. 

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 [email protected]. 

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 [email protected].