The Syneos Health Podcast

2025 Health Trends meets The Syneos Health Podcast for a limited series exploring how Trends come alive in the life sciences industry with host Drew Beck, Head of Strategy, Growth and Innovation for Syneos Health Learning Solutions.

Syneos Health experts Brian Carver, Executive Director of Therapeutic Strategy and Innovation, Rare Disease Consortium, Vik Chawla, Managing Director, Syneos Health Consulting and Katya Magon...

The biopharma market is booming—but not without turbulence. In this kickoff episode of our special podcast series in collaboration with Asembia, hosts Michael Sarshad, Managing Director, Commercial Advisory, Syneos Health and Sara Rubin, Senior Vice President, Market Access Strategy at Spherico, a Syneos Health company, unpack the dynamic forces reshaping how therapies reach patients. Recorded ahead of Asembia’s AXS25 Specialty Pha...

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 exp...

In this episode of The Syneos Health Podcast, 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 &...

Unlike general health and wellness apps, Prescription Digital Therapeutics (PDTs) are FDA-authorized, prescribed by healthcare professionals, and rigorously studied in clinical trials. With the global PDT market projected to reach $43 billion by 2032, new regulatory pathways, including CMS billing codes in 2025, are set to enhance adoption and accessibility.

In his final episode hosting the Syneos Health Podcast, Nick Kenny is joine...

In this episode, we welcome Dr. Rishi Kakar, Chief Scientific Officer and Medical Director at Segal Trials. Host Andy Moniz, Vice President, Therapeutic Strategy & Innovation at Syneos Health, sits down with Dr. Kakar to explore his inspiring journey from a 15-year-old immigrant discovering neuroscience in a Queens library to becoming a leader in clinical research and innovation.

Dr. Kakar shares the personal moments t...

In this episode of the Syneos Health Podcast, series host 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...

For our special series celebrating 15 years of innovation with CNS Summit, host Dr. Alexandria Wise sits down with Ryan Brooks, Executive Chairman and CEO of CenExel, a leading specialty site network. In this discussion, recorded from the floor of CNS Summit 2024, Ryan shares his journey from a farm in Idaho to leading a network of Centers of Excellence, driven by personal health challenges and a passion for advancing healthcare. T...

In this episode, Dr. Alexandria Wise speaks with Steve Rosenberg, CEO of uMotif, recorded from the CNS Summit 2024 exhibit floor. With over four decades of experience in software development and two decades in clinical research, Steve shares his journey from early tech innovations to his current mission of revolutionizing patient engagement and site support in clinical trials.

Steve discusses the pivotal role of patient-centric tool...

In this inspiring look at the progress and potential in psychiatry research, Dr. Alexandria Wise sits down with Dr. Stephen Brannan, former Chief Medical Officer of Karuna Therapeutics, to discuss the groundbreaking approval of KarXT—the first muscarinic mechanism antipsychotic in decades. Dr. Brannan reflects on his journey in psychiatry, the challenges of clinical trials, and the transformative impact of KarXT on treating schizop...

In this episode, host Dr. Alexandria Wise sits down with Dr. Najat Khan, Chief R&D Officer and Chief Commercial Officer at Recursion Pharma, live from the floor of CNS Summit 2024. Together, they explore how cutting-edge technologies like AI and machine learning are transforming drug discovery and development, shortening timelines, and driving precision medicine.

Dr. Khan shares her inspiring journey, from her upbringi...

In this special edition of The Syneos Health Podcast, host Dr. Alexandria Wise celebrates 15 years of innovation with CNS Summit by interviewing Dr. David Walling, Chief Clinical Officer at CenExel CNS. Recorded from the floor of CNS Summit 2024, the conversation dives into Dr. Walling’s career journey, his passion for advancing care for individuals with schizophrenia, and the evolution of clinical trials over the past two decades....

Recorded from the 15th annual CNS Summit, Andy Moniz, Vice President of Therapeutic Strategy Innovation at Syneos Health, sits down with Jane Metcalfe, Board Chair of the Human Immunome Project, to discuss the transformative potential of immunology in medicine. Jane shares her inspiring journey into this groundbreaking field, highlighting how advanced biological measurements, machine learning, and personalized immune profiling are ...

In this episode, Dr. Alexandria Wise celebrates 15 years of innovation at CNS Summit 2024 by sitting down with Kevin Craig, Senior Vice President of Clinical Development at atai Life Sciences. Recorded from the floor of the conference, Kevin shares his journey from research and medicine to leading drug development in mental health, with a focus on the company's pioneering work in psychedelics.

This episode delves into...

Join host Andy Moniz, Vice President of Therapeutic Strategy Innovation at Syneos Health, as he sits down with Dr. David Brown from Community Clinical Research in Austin, Texas, for a compelling conversation recorded from the floor of CNS Summit. In this episode, Dr. Brown shares his journey into psychiatry, inspired by his experiences in medical school and his personal connection to mental health.

The discussion delves in...

In this episode, recorded from the floor of the CNS Summit, host Andy Moniz, Vice President of Therapeutic Strategy and Innovation at Syneos Health, sits down with Cristina Duran, CEO of Evinova, to discuss her transformative journey in life sciences and the future of patient-centric innovation in healthcare.

Cristina shares insights from her experience leading R&D transformation at AstraZeneca, where she pioneered pat...

In this special series of the Syneos Health Podcast, we celebrate 15 years of innovation in collaboration with CNS Summit, a community of innovators and life science industry leaders devoted to discovering better, more efficient ways to advance the industry through innovation, collaboration, and technology. Over the course of the series, we will feature conversations with key experts and members of the community on how the life sci...

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 ...

There is a significant unmet need for medicines to treat neuropsychiatric and neurological conditions in underserved patient populations. Recently, there has been renewed interest in psychedelic, hallucinogenic and dissociative compounds to meet those needs. In clinical trials, a wide array of these compounds are showing efficacy across a variety of indications.

Syneos Health experts Andy Moniz, Dr. Leslie Moldauer, Zelma Gandy Don...