The Syneos Health Podcast: Early Signals

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sits down with Kent Thoelke , Founder and CEO of Paradigm Health , to explore why clinical research still relies on outdated workflows and how AI, electronic hea...

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? I...

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 re...

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 notorious...

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 on...

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...

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,...

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, Oncol...

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...

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...