The Syneos Health Podcast

In this special edition of the Syneos Health Podcast recorded from the floor of Asembia's AXS25 Summit, host Michael Sarshad sits down with Kim Plesnarski, SVP of Market Access and Patient Support Services at Syneos Health and Kelly Carter, AVP of Patient Support at Amgen, to unpack the evolving landscape of patient support. The discussion explores the blurring lines between general and specialty medicine, the growing administrative burden on providers and the need to embed seamless, tech-enabled support into the healthcare journey. The trio dives into the role of Field Reimbursement Managers (FRMs), payer challenges, affordability barriers and how AI and automation are beginning to transform operations—from personalized patient education to proactive intervention. If you're interested in how manufacturers can shift from reactive to proactive models and scale personalized support in an increasingly complex environment, this episode is a must-listen.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 insightshub.health. 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 of our Navigating Modern Market Access series, recorded from the floor of Asembia's AXS25 Summit, host Sara Rubin sits down with Rob Truckenmiller, the newly appointed CEO of PharmaCord. Drawing from his deep experience across small, mid-sized and large pharmaceutical companies, Rob explores how market access strategies must evolve to meet today's healthcare challenges. From the integration of patient services and payer strategies to the role of technology and data in shaping outcomes, Rob shares his perspective on how pharma companies can empower patients, optimize gross-to-net and navigate the complex US healthcare landscape. Tune in for actionable insights on building a smarter, more patient-centric access model.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 insightshub.health. 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 special episode recorded from the floor at Asembia's AXS25 Summit, host Michael Sarshad sits down with Tiara Green, President of Accessia Health, to explore the evolving landscape of patient support. They discuss how Accessia Health is addressing the growing needs of individuals with rare and chronic conditions—not just through copay assistance, but by tackling social determinants of health like transportation, food insecurity and mental health services. Tiara shares insights on the expanding role of technology, from streamlined eligibility systems to telehealth and AI, and emphasizes the importance of personalized, community-based care. They also dive into provider education, the power of partnerships and how pharma can promote health equity by engaging diverse populations earlier in the care continuum.Tune in for an inspiring conversation about improving access and outcomes through innovation and collaboration.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 insightshub.health. 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 special edition of the Syneos Health Podcast recorded from the floor of Asembia's AXS25 Summit, host Michael Sarshad speaks with Kim Plesnarski, SVP of Market Access and Patient Support Services at Syneos Health and Greg Morris, Chief Strategy Officer at CareMetx. They explore the latest trends shaping patient support services—from the surge of AI-powered solutions to the shift toward hybrid hub models. The conversation dives into the challenges of reactive support programs, the need for continual innovation and the nuanced debate between insourcing and outsourcing. With practical insights and real-world examples, Kim and Greg share strategies for building scalable, tech-forward patient service models that meet the evolving demands of both patients and providers.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 insightshub.health. 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 insightshub.health. 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.

Hosted by Drew Beck, Head of Strategy, Growth and Innovation for Syneos Health Learning Solutions, this limited series dives into the breakthrough trends redefining health in 2025 and beyond. From bold moves in R&D and medical affairs to next-gen trial design, product launch strategies and the future of healthcare communications, each episode connects you with the minds driving real change. Big ideas. Real-world impact. In this episode, Drew dives into launch excellence in 2025 with Syneos Health experts Larry Dollar, VP of Medical Affairs, and Michael Sarshad, Managing Director, Consulting. Together, they unpack how strategic spending, agile planning and early investment in medical resources are driving launch success. They explore the rise of new medical affairs roles using the transformative impact of AI on clinical trials, and the evolving needs of field teams. The discussion also highlights how innovations like machine learning–driven physician segmentation are helping companies identify new clinical trial sites faster and more precisely. Whether you're with an emerging biotech or a large pharma company, you'll get key insights on collaboration, creativity and why the year leading up to launch is more critical than ever. 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 insightshub.health. 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.

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 Magonova, Managing Director, Syneos Health Consulting explore the role of AI in rare disease drug development, diagnosis and treatment. They share how AI is accelerating R&D, improving patient identification and enhancing clinical trials. The discussion also highlights investment trends in AI within the healthcare sector, the emergence of AI-first companies and the ongoing challenges and opportunities of integrating AI into life sciences, underpinned with data from our 2025 Dealmakers' Intentions Survey. Emphasizing the importance of understanding AI's applications and implications, host Drew Beck has a special call to action for the industry to harness AI's power in drug development and commercialization today. 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 insightshub.health. 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.

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 Pharmacy Summit, they dive into the impact of tariffs, the power of AI in streamlining patient support, the ripple effects of the Inflation Reduction Act and how digital transformation is changing the way manufacturers engage population health decision-makers. Tune in for expert insights, preview topics for this year's summit, and discover how the industry is responding to rising complexity with strategic innovation.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 insightshub.health. 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 insightshub.health. 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 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 & 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 insightshub.health. 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.

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 joined by Dr. Shaheen Lakhan, Chief Medical Officer, and Laura Taraboanta, Director of Medical Operations and Strategy, both from Click Therapeutics, to explore the evolving landscape of PDTs.Together, they discuss how PDTs work and for which conditions, the opportunities driven by the FDA's Prescription Drug Use-Related Software (PDURS) guidance—which now enables PDTs to be integrated into drug labels, where PDTs are making inroads to expand access to care, and a future that will include “software enhanced” (SE) drugs that improve adherence, personalization and treatment outcomes.The discussion underscores how PDTs are redefining personalized medicine, transforming healthcare delivery, and expanding into new therapeutic areas beyond mental health.For more from Click Therapeutics and our experts on Digital Therapeutics, check out:Syneos Health Podcast | Digital Therapeutic CommercializationSyneos Health Podcast | Digital Therapeutic Development and Approval10 Ways to Optimize and Accelerate Brand Performance using Prescription DTxHow Digital Therapeutics Developers Can Satisfy Diverse Stakeholder NeedsAbout Click SE™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 insightshub.health. 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 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 that shaped his passion for psychiatry, the pivotal experiences that drove his commitment to understanding the drug development process, and how Segal Trials has remained at the forefront of clinical research. From pioneering psychedelic trials to building innovative quality dashboards, Dr. Kakar offers insights into the future of patient-centric clinical trials, workforce transformation, and the integration of emerging technologies.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 insightshub.health. 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 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 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 insightshub.health. 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.

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. The conversation explores CenExel's mission to advocate for patients, innovate in CNS clinical trials, and embrace the promise of personalized medicine. Ryan's insights into balancing patient needs with evolving study designs and his reflections on the future of life sciences offer a thought-provoking look at the industry's path forward.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 insightshub.health. 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, 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 tools in modernizing clinical research, emphasizing the need to recognize and support patients as key contributors to advancements in medicine. He also delves into the growing challenges faced by clinical sites, the potential of AI and computer modeling to streamline trials, and his vision for a future where the industry prioritizes patient and site experiences over protocol complexity.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 insightshub.health. 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 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 schizophrenia's positive, negative, and cognitive symptoms.The conversation dives into the critical role of clinical trials and the altruism that drives their success, overcoming unprecedented obstacles while developing KarXT, and the importance of pushing boundaries in neuroscience to address unmet needs. 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 insightshub.health. 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, 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 upbringing surrounded by medicine to leading innovations at the intersection of biology, chemistry, and technology. She emphasizes the importance of connecting the "first mile" of biological insight to the "last mile" of patient access and discusses Recursion's mission to decode biology and radically improve lives.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 insightshub.health. 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 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.Dr. Walling shares insights into CenExel's mission as a “Center of Excellence” for clinical research and reflects on his early work with schizophrenia patients, from the development of atypical antipsychotics in the 1990s to today's cutting-edge therapies like KarXT, a newly FDA-approved medication with a novel mechanism of action. The discussion highlights the increasing importance of patient-centered approaches, the integration of patient voices in clinical trial design, and the promise of innovative treatments that address not only positive symptoms but also negative symptoms and cognitive deficits in schizophrenia.Tune in for an engaging and hopeful exploration of advancements in CNS disorders, the challenges of drug development, and the strides being made toward improving patient quality of life. 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 insightshub.health. 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.

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 reshaping drug development, clinical practice, and medical education.From the immune system's role in diseases like Alzheimer's and cancer to the need for diverse clinical trials, this conversation explores the dynamic intersection of science, technology, and humanity.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 insightshub.health. 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, 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 the complexities of drug development in the psychedelic space, the importance of global accessibility, and the profound impact of patient involvement in clinical trial design. Kevin also shares his perspective on the future of the life sciences industry, emphasizing the role of big data, biomarkers, and efficient trial models in advancing mental health care.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 insightshub.health. 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.

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 into the transformative impact of clinical trials, the advancements in schizophrenia research, and the potential for a new era in personalized psychiatry driven by genetic insights and AI. Dr. Brown reflects on the challenges of stigma, the progress in neuroscience, and his hopes for the industry in the next five years, including bridging gaps between academia and pharma and inspiring the next generation of researchers.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 insightshub.health. 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, 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 patient-centric approaches to clinical trials. She discusses how Evinova is driving industry-wide change by creating integrated, scalable solutions that prioritize patient needs while delivering faster, more efficient outcomes for life sciences—emphasizing the importance of collaboration, learning from failures, and connecting across the sector to accelerate progress.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 insightshub.health. 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 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 sciences industry is continuing to reinvent itself in the pursuit of better outcomes for more patients.In this episode, guest host Dr. Alexandria Wise, SVP and Global Neuroscience Head at Syneos Health, is joined by physician-scientist Dr. Amir Kalali, Chairman and Chief Curator of CNS Summit. Dr. Kalali shares the origins of CNS Summit, the unique vision that set it apart, and the milestones achieved along the way—and offers insights on the future of collaboration in clinical development and advice for the next generation of industry leaders.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 insightshub.health. 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.

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.For more insights from our oncology experts:Syneos Health Podcast | A Site-Specific Approach to Optimizing Diversity in Oncology TrialsWEBINAR | Transforming Oncology Drug Development: Insights from Healthcare Providers on the Frontlines of Cancer CareSyneos Health Podcast | Circulating Tumor DNA: Transforming Oncology Clinical TrialsNavigating Tumor-Agnostic Drug Development: Value, Challenges and Strategic Insights for SponsorsThe 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 insightshub.health. 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.

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 Sing and Lindsay Crampton—along with Dr. Aaron Koenig, CMO of Delix Therapeutics—convened in a roundtable discussion to provide their own unique perspectives about the current and future state of psychedelic drug development and how to actively navigate the rapidly evolving field of clinical trials for these revolutionary treatments. Listen in to hear how psychedelics have progressed from their origins as a spiritual aid, their acceptance as a treatment for neuropsychiatric conditions, and the development of next-generation compounds. For more from our neuroscience experts, check out these insights: Syneos Health Podcast | Can AI Help Get the Right Patients Into Alzheimer's Clinical Trials?Artificial Intelligence and Alzheimer's: Transforming Patient Screening with Predictive ModelsWEBINAR | Psychedelics 3.0: Challenges and OpportunitiesSyneos Health Podcast | World Mental Health Day: The State of Mental Health Clinical DevelopmentBLOG | The Reimbursement Case for Psychedelic Therapies Must Incorporate the Patient's VoiceThe 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 insightshub.health. 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 the biopharma industry strives to ensure that clinical trials reflect the rich diversity of the patient populations they aim to serve, the challenges to make this possible have fallen on the trial sites. In a recent webinar, Syneos Health experts Jane Bentley and Juliette Roberts from our Oncology Therapeutic Strategy & Innovation team, and Kelli Defenbaugh from Patient Recruitment and Retention Management, offered robust strategies and actionable insights tailored to overcome obstacles sites are facing.Listen in to learn more about how sites can contribute to enhanced diversity in oncology trials, with specific actions that sites can take to make each clinical trial better represent the population it seeks to serve.Visit here for more oncology insights from our experts.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 insightshub.health. 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.

Use of circulating tumor DNA (ctDNA) – small fragments of DNA that are released into the bloodstream by cancer cells – as a diagnostic tool represents a significant shift toward more precise, personalized cancer care, enhancing both trial efficiency and patient experience. Unlike traditional tissue biopsies, which sample a single tumor site, ctDNA offers a real-time, comprehensive view of the genetic mutations present in the tumor throughout the body. By offering faster, more detailed insights than traditional imaging, ctDNA can identify tumor mutations earlier and help clinicians adjust treatments sooner.In this episode of the Syneos Health Podcast, Chief Scientific Officer Nick Kenny is joined by oncology experts Dr. Patrick Kelly and Dr. Wael Harb to discuss how circulating tumor DNA (ctDNA) is transforming cancer treatment and clinical trial design, and its potential to drive more patient-centric, adaptive clinical trials. Find all of our oncology-related insights on our Insights Hub here.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 insightshub.health. 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.

Medical science liaisons—or MSLs—within pharmaceutical companies deal in a special currency: scientific exchange and real-world insights gathering. Only they can share certain types of information with a growing number of medical stakeholders. And only they can bring back medical insights to guide strategic development and brand decisions. Yet, can anyone be certain that this highly valuable currency is being spent wisely?Recently, some of our Medical Affairs experts led an engaging webinar on maximizing the value of your MSL team and driving better outcomes in pharmaceutical development.Listen in as they unravel the challenges in quantifying MSLs' value, explore how these teams are enhancing impact through strategic engagement, unpack new ways of measuring value beyond output and illustrate how companies can further empower MSLs with data-driven AI/tech-enabled solutions.Be sure to check out these other insights from our Medical Affairs experts:WEBINAR | From Insight to Impact: Leveraging Early Medical Affairs Engagement for Future Commercial SuccessDriving Impact: Key Themes for Advancing Medical Affairs in the Evolving Pharma LandscapeWebinar | Driving Patient-Powered Medicine: Scientific Communication with Patient CommunitiesIt's Time We Got the Most Out of Medical Affairs DataThe 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 insightshub.health. 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.

AI is seemingly everywhere now in our lives, including healthcare and drug discovery and development. AI certainly has the potential to enable major advances than development of more effective and safe medical products. And in fact, GenAI has already been successfully used in drug discovery. But are we fully leveraging the current AI yet in practical ways? Are our trial designs informed appropriately by AI and data? From the mundane document generation and handling to the complex patient engagement, what is the here and now of how we can and should apply AI to support more informed, more effective drug development?In this episode of the Syneos Health Podcast, Nick Kenny, Chief Scientific Officer at Syneos Health is joined by industry experts Nataraj Dasgupta, Vice President of Advanced Analytics at RxDataScience and Greg Christie, Chief Product Officer at StudyKIK to dive deep into the transformative potential of Artificial Intelligence (AI) in the realm of drug development and clinical trials. The discussion explores the practical applications of AI—from improving patient recruitment and engagement to revolutionizing document generation and protocol design—and touches on the exciting promise of Generative AI (GenAI) in streamlining processes, enhancing patient experiences, and democratizing access to clinical trials. The panel also confronts the challenges, including data accuracy, regulatory concerns, and the ethical implications of AI-driven decisions.Tune in to understand how AI is reshaping the future of healthcare and what lies ahead in this rapidly evolving field. For more AI insights from our experts:Syneos Health Podcast | Can AI Help Get the Right Patients Into Alzheimer's Clinical Trials?Artificial Intelligence and Alzheimer's: Transforming Patient Screening with Predictive ModelsSyneos Health Podcast | Turbo-Charging Clinical TrialsWEBINAR | How AI is Supercharging Clinical TrialsThe 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 insightshub.health. 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.

The World Economic Forum projects that by 2050, climate change could cause 14 million additional deaths and $12 trillion in global healthcare costs. And this will exacerbate global health inequities with our most vulnerable populations, including women, youth, elderly, lower-income groups, and hard-to-reach communities bearing the brunt of this change. We think we know the culprits…but do we really?The fact is, the healthcare sector is responsible for almost 5% of global greenhouse gas emissions and has a carbon footprint equivalent to 514 coal-fired power plants. And if the healthcare sector was a country, it would be the 5th largest polluter on Earth. (Source)In this episode of the Syneos Health Podcast, Nick Kenny is joined by Syneos Health colleagues Sharon Gordon, leader of our Social Impact practice and Beth Anne McPheeters, head of ESG programming, to discuss the intersection of climate change, ESG (Environmental, Social, and Governance), and healthcare.The conversation delves into the responsibilities of big industries versus collective action, the role of ESG in driving meaningful change, and the importance of integrating ESG into business goals to mitigate risks and create value, ultimately benefiting both business and patient outcomes—reinforcing that addressing climate change and promoting ESG is not just corporate responsibility but also essential for improving global health and equity.For more on how Syneos Health is committed to making purposeful actions upholding our responsibility to create a more sustainable world for each other, read our 2023 ESG Report.Check out more of our insights on the role of ESG in the healthcare industry:BLOG | Pharma Reputation Slipping, Leaving Fewer Allies in Intense EnvironmentBLOG | 4 Reasons ESG Priorities are Becoming More Important in the Life Sciences IndustryClinical Trials and Environmental, Social and Governance: Plans for Operations LeadersThe 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 insightshub.health. 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.

Alzheimer's disease is a challenging and devastating diagnosis that affects memory and cognitive skills, with no known way to predict, track, treat, or cure it effectively. In 2024, around 90 million people over the age of 65 will be living with Alzheimer's. Clinical trials for new treatments have faced high failure rates, partly because it's difficult to identify the right patients at the right stage of the disease. The potential solution to this dilemma might lie in AI, which could help analyze vast amounts of clinical data and provide a practical prognostic tool.Our host Nick Kenny, Chief Scientific Officer at Syneos Health, is joined by Dr. Claudine Brisard, Senior Vice President of Neurosciences at Syneos Health and Dr. Christian Dansereau, CEO of Perceiv AI, to explore how AI and prognostic models might solve the challenges of selecting the right patients for Alzheimer's clinical trials. Check out these insights for more from our experts on Alzheimer's Disease or the use of AI to accelerate clinical trials:BLOG: Artificial Intelligence and Alzheimer's: Transforming Patient Screening with Predictive ModelsSyneos Health Podcast | Turbo-Charging Clinical TrialsWebinar | How AI is Supercharging Clinical TrialsArtificial Intelligence, Machine Learning and a New Epoch for Clinical TrialsThe 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 insightshub.health. 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.

Breast cancer is the most common type of cancer among women worldwide, and it can be treated with different modalities, such as surgery, chemotherapy, radiation, hormone therapy and targeted therapy. However, even after the primary treatment, some cancer cells may remain in the body and cause recurrence or metastasis. This is where adjuvant therapies come in: they are additional treatments that aim to reduce the risk of cancer coming back or spreading to other parts of the body.In this episode, Syneos Health colleagues Dr. Juan Manuel Carrera, Senior Medical Director and Lisamarie Burgio, Executive Director, Therapeutic Strategy and Innovation join the podcast to explore the role of adjuvant therapies in breast cancer, with a focus on the latest developments and challenges in this field. They share their extensive experiences and insights from both clinical and operational perspectives, emphasizing the importance of personalized treatment approaches based on the latest genomic information and the evolving landscape of clinical trials, offering a comprehensive view of the strides being made and the challenges that remain. For the latest oncology insights from our experts, check out: Bridging the Gap in Male Breast Cancer Research Through Inclusive Clinical Trial StrategyOncology and the Evolution of Master Clinical Trials | Lessons from the Beat AML Master TrialReadiness Assessment: What Strategies Can You Deploy to Improve Diversity in Your Oncology Trials?Syneos Health Podcast | The Case for Genetic MedicineIs Your NSCLC Asset Ready to Create Value Post-FDA Approval? | 2024 UpdateThe 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 insightshub.health. 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.

This is an exciting time in the development of new medicines to treat both rare and age-related eye diseases. But what is it like in the trenches to develop and deliver clinical trials that evaluate both the safety and efficacy of these potential new medicines for diseases of the eye?In this episode, Nick Kenny, Syneos Health CSO and interim podcast host, is joined by Eileen Schramm, Senior Clinical Trial Manager, and Nicole Curry, Senior Project Manager, both in the Syneos Health Ophthalmology team, to discuss the challenges and realities of developing and delivering clinical trials for ophthalmology studies. They highlight the importance of finding and engaging clinical investigators who have the necessary equipment, training, and patient stream to conduct these complex trials; the need for proper site staffing, minimizing staff turnover, and investing in training for study coordinators; and the critical role of patient engagement and providing trial participants with clear expectations and tools to navigate the study journey. For more from our ophthalmology experts, check out these insights:Navigating Biometrics Challenges in Ophthalmology Clinical Trials: Lessons LearnedSyneos Health Podcast | Ophthalmology Clinical Trials: Low Vision and AMD Awareness MonthThe 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 insightshub.health. 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 March 2024, the FDA approved a groundbreaking gene therapy for children with a specific form of leukodystrophy, offering hope to those with no current care options. However, the approval came with a hefty price tag, making headlines as the most expensive medicine in the world at $3,500,000 per patient. With the cost of innovation so high, what can we do to de-risk development, ensure affordability and achieve equitable access to these potentially life-changing therapies for the long term?Nick Kenny, CSO for Syneos Health and host for this episode, is joined by colleagues Abhi Gupta, Head of Genetic Medicine, and Dr. Prateet Minhas, Managing Director, Value & Access Consulting, to explore the evolution of genetic medicines, from the early days of clinical trials fraught with challenges to the recent surge in approvals and the promise of curative potential. Abhi and Prateet discuss the landscape for genetic medicines today, touching on topics such as manufacturing challenges, regulatory considerations, and the importance of demonstrating durability of response in clinical development.As they navigate the complexities of the field, they address key questions surrounding the value proposition of genetic medicines, including their potential to transform patient outcomes and the challenges of reimbursement and access. They also examine the role of collaboration and innovation in driving progress in the field, highlighting the need for a balanced approach that prioritizes both scientific advancement and real-world impact. For more from our cell & gene therapy experts, check out these insights: BLOG: Three Lessons Learned in Adoptive Cell Therapy Trials: A Look at the Road Ahead for ImmunologyBLOG: A Holistic Approach to Genetic Medicines is Next for the Life Science IndustryExploring an Expedited Regulatory Pathway for Cell and Gene TherapiesBLOG: Cell and Gene Therapy Sponsors Must Overcome Unique Hurdles to Realize Promise to Patients 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 insightshub.health. 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.

After 7 years as the Syneos Health Podcast's founding and flagship host, Jeff Stewart is stepping down. Here, he reflects on his experience and bids farewell.It doesn't end here - stay tuned for new episodes with new host(s), coming soon!(Jeopardy! clip courtesy of Ken Jennings.)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 insightshub.health. 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.

Patient assistance programs can make a huge difference for patients who need expensive medicines but can't afford them. In this episode, Jeff Stewart talks with Dave MacLeod, Managing Director, Value & Access at Syneos Health about the benefits and challenges of patient assistance programs, which provide free or low-cost medicines to eligible patients. They discuss how these programs can improve access, adherence, and outcomes, as well as the operational and regulatory issues involved in running them. Covering key topics such as the Inflation Reduction Act (IRA), the impact of technology and AI in patient services, and the challenges posed by copay accumulators and maximizers, Dave sheds light on the complexities of navigating copay assistance optimization and the strategies employed to mitigate the effects on patients and manufacturers alike. For more from our Value & Access experts, check out these topics: Syneos Health Podcast | Real Talk About the Inflation Reduction ActBLOG: Industry Cheers “Co-Pay Accumulator” Ruling, Should Prep for What's Next Potential Impact of European Pharma Legislation on Commercialization and Access of New Therapies BLOG: What Can We Learn From ICER's New Value Framework Syneos Health Podcast | Market Access for Weight Loss Drugs MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key Accounts  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 insightshub.health. 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.

The Inflation Reduction Act (IRA), signed into law by President Joe Biden in August 2022, brings significant changes to the U.S. pharmaceutical market as it rolls out over the next 10 years.Today we dive deep into the IRA with Tiffany McCaslin, Managing Director, Value, Access and Health Outcomes at Syneos Health. Drawing from her extensive background in healthcare policy and industry strategy, Tiffany offers invaluable insights into the practical implications of this landmark legislation for the pharmaceutical industry. From dissecting the intricacies of price negotiation to unraveling the complexities of data collection requirements, this episode provides a clear roadmap for pharmaceutical companies and life sciences firms navigating the post-IRA era. For more from our Value & Access experts, check out these insights: BLOG: Industry Cheers “Co-Pay Accumulator” Ruling, Should Prep for What's Next Potential Impact of European Pharma Legislation on Commercialization and Access of New Therapies BLOG: What Can We Learn From ICER's New Value Framework Syneos Health Podcast | Market Access for Weight Loss Drugs MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key Accounts BLOG: What ICER's Draft Sickle Cell Disease Report Means for CGT Pricing 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 insightshub.health. 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.

For the first time, the technology behind Wall Street and Formula One racing is being used in pharmaceuticals—and it's offering unparalleled potential for innovation in clinical trial execution and healthcare delivery.In this episode, host Jeff Stewart is joined by Darren Coleman, the general manager of RxDataScience, a Syneos Health company, who discusses KX technology, the world's fastest time series database and analytics engine, and how it is now being applied to improve clinical trial efficiency, reduce costs and speed time to market for life-changing therapies for patients. From current applications to optimize site selection, predict enrollment rates, and identify trial risks months in advance, to future use cases including patient selection and predicting drug efficacy, Coleman outlines exciting possibilities for the future of clinical trials and healthcare.For more from Syneos Health on AI applications in biopharma, check out these insights:WEBINAR | How AI is Supercharging Clinical TrialsSyneos Health Podcast | 2024 Health Trends: Managing the Healthcare RevolutionIt's Time We Got the Most Out of Medical Affairs DataArtificial Intelligence, Machine Learning and a New Epoch for Clinical Trials 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 insightshub.health. 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.

When it comes to launching a pharmaceutical product in today's market—especially as an emerging company—strategic investment can make all the difference.Drawing from a recent study on investing for commercial success, Michael Sarshad, Managing Director in the Commercial Advisory Group at Syneos Health, discusses the key factors for successfully launching a drug in today's market; the importance of strategic investment, timing and team experience in exceeding launch forecasts; and the diverse areas where this investment is crucial, from medical affairs and market access to clinical strategy and supply chain logistics.Tune in for expert insights into the intricacies of launching pharmaceutical products and how strategic investment can make all the difference.For more of our insights on launch and commercialization, check out this content on our Insights Hub: Investing for Launch Success: The “Goldilocks” RatioInvesting for Launch Success: Tailoring Your Strategy for EuropeGood Science Is Not Good Enough: For Emerging Companies, Differentiation Requires a Commercial Value Creation StorySupporting the Launch of BiosimilarsWEBINAR | The Three Perils of Cross-Functional Commercialization: Time, Insight and IntegrationThe 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 insightshub.health. 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.

Age-related vision loss is a rising concern for our growing aging population. According to the most recent data published by the CDC, nearly 20 million Americans aged 40+ have been diagnosed with some form of age-related macular degeneration (AMD). By the age of 75, roughly 1 in 3 people living in the United States will have some form of AMD, and about 1 in 4 of those will have a vision-threatening, late-stage form of AMD. These statistics underscore the need for heightened public awareness and increased accessibility to innovative treatments.February is Low Vision and Age-Related Macular Degeneration (AMD) Awareness Month. In this episode, Laszlo Bekesi, MD, Vice President of Strategy and Innovation, and Jonathan Angelastro, Executive Director of Project Delivery at Syneos Health provide valuable insights into the evolving field of ophthalmology and the efforts to address the growing burden of age-related vision impairment—with a  focus on understanding both wet and dry AMD types, the complexities of AMD, its impact on vision and the urgency for early detection and treatment. They also discuss the current landscape of research and development in the space and highlight the opportunities for—and inherent operational challenges of—conducting clinical trials in ophthalmology.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 insightshub.health. 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.

The FDA has finalized a rule that addresses how drug ads must be presented in TV and radio commercials. The rule, proposed in 2010 and now effective from May of this year, aims to provide clarity and guidelines for pharmaceutical companies in presenting side effects and contraindications in a balanced manner. But it's still a 27-page document.Here, we'll boil it down for you.Matthew Snodgrass, head of US Digital and Social Strategy at Syneos Health, sheds light on the 13-year journey from proposal to finalization, exploring key aspects of the rule, restrictions on distracting visuals during side effect discussions, and the use of quantitative terminology to convey information more precisely. The conversation delves into the challenges faced by regulatory teams in interpreting and implementing these rules and highlights the importance of understanding and following FDA guidelines in pharmaceutical advertising.For a more detailed exploration of the FDA rule, check out our highlighted version of the full document in a downloadable PDF format. 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 insightshub.health. 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.

Nervousness and uncertainty surround the question of what Artificial Intelligence (AI) may mean for the future of work. How can we deploy AI transformation—thoughtfully—across an organization and help workforces see what the new models will signify and require of us?In the first episode in this series related to our 2024 Health Trends, host Jeff Stewart is joined by Celeste Mosby, Senior Vice President and General Manager of Syneos Health Learning Solutions, to discuss the challenges of managing this healthcare revolution, especially in terms of training and adapting to the rapidly evolving landscape.The conversation highlights the shift in the industry over the past five years, where technology, data and AI are now shaping the healthcare landscape—requiring professionals to keep up with the dynamic changes—and explores the impact of AI on human-to-human interactions, workforce training and the importance of thought leaders staying ahead of evolving trends.For additional insights into Revolution Management, Learning and Change in the New World of Work—as well as the year(s) of reinvention ahead for the life sciences sector—download our 2024 Health Trends report.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 insightshub.health. 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.

October is National Depression and Mental Health Screening Month, with October 10th specifically recognized as World Mental Health Day. A recent study co-led by Harvard Medical School and the University of Queensland established that one out of every two people in the world will develop a mental health disorder in their lifetime. This staggering number underscores the critical need to reduce the stigma of mental health, and to make sure that people who are suffering understand the diverse help and treatment options that are available to them.Dr. Alexandria Wise, Global Head of Therapeutic Strategy and Innovation and Andy Moniz, VP, Therapeutic Strategy and Innovation at Syneos Health, join the podcast to help raise mental health awareness, discussing the evolution in mental health treatment over the past 30 years and where it stands today; the challenges of mental healthcare access for certain patient groups and what is being done to ease this; and the unique aspects of psychedelics in mental health clinical trials and their potential for promising results.For more content on neuroscience topics, check out these insights:Understanding the Role of the Placebo Response in Clinical TrialsDigital Flexibility and the Digital Divide: Meeting Patients Where They're At With Mental Health ServicesWEBINAR | Psychedelics 3.0: Drug Development Challenges and Opportunities in a Rapidly Evolving FieldThe 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 insightshub.health. 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.

Radiosensitizers have emerged as potential game-changers in head and neck cancer therapy. A diverse group of compounds, radiosensitizers enhance radiation therapy's impact on tumor cells. Ongoing research seeks radiosensitizers that augment radiotherapy's efficacy without increasing toxicity, offering exciting prospects for the APAC region and beyond.Our new APAC Edition host Lance Eminger, Executive Director of Business Development is joined by Dr. Juan Manuel Carrera, Senior Medical Director at Syneos Health to discuss what radiosensitizers are and how they work—highlighting the potential of new radiosensitizers to redefine cancer treatment, fostering better results with fewer side effects.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 insightshub.health. 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.

One of the biggest trends making headlines and impacting the healthcare industry to date is the rising popularity of GLP-1 drugs. Initially developed for diabetes management, these products have recently gained traction for weight loss indications. But with promising efficacy and growing popularity, is the healthcare industry truly prepared for the challenges posed by these drugs becoming such a hot commodity in the market?Tom Albers, Vice President of Strategy at Syneos Health company Spherico, joins the podcast to discuss his insights on the future of weight loss drugs – payer challenges, the transformative potential of these drugs, and the need for smart investments in data and evidence.For more content on value and access, check out these insights: MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key AccountsSyneos Health Podcast: The Inflation Reduction ActBuilding a Market Access Case for Real World Evidence in OncologyThe 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 insightshub.health. 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 of the Syneos Health Podcast, we embark on a journey into the metaverse – a revolutionary concept that's transforming the way we approach training and learning. As we delve into the world of the metaverse and its implications for healthcare training, Michael Shim, PharmD, National Director, Field Medical Affairs and Marie Latsa, PharmD, Community Medical Director at Syneos Health, will share their firsthand experiences with metaverse-based training for Medical Science Liaisons (MSLs), and provide valuable insights into the current state and future potential of this cutting-edge technology that offers an immersive and efficient training alternative.Join us on this exciting journey into the metaverse and discover its role in shaping the future of education and training in healthcare.For more of our insights on MSLs and Medical Affairs, check out these pieces on our Insights Hub:A Field MSL Perspective on Tech-Enablement Using the MetaverseLeveraging Metaverse Capabilities for Medical AffairsMedical Science Liaisons: Your Role in Creating a Culture of ExcellenceEarly Adoption of Metaverse Technology in Medical AffairsUsing Omnichannel to Drive Integration between Medical and CommercialEngaging Patient Communities: The Changing Role of Medical AffairsThe 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 insightshub.health. 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.

The emergency department (ER) can be a place of chaos, panic and infinite amounts of unpredictability. Not knowing what can come through the doors at any given time makes this environment impossible to foresee and prepare for.  Because of this uncertainty, the ER (and its patients) can be a particularly challenging target for clinical trials.  In this episode, Dr. Ruth Henrice-Desrosiers, Medical Director, Syneos Health joins the podcast to discuss critical aspects to be considered by biopharma companies when choosing to bring a clinical trial to the ER—from location and cost implications to informed consent challenges, and everything in between.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 insightshub.health. 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.

The game continues to change in biotech as continued macroeconomic uncertainty has far reaching implications for the future of the biopharma ecosystem. Biotechs can no longer operate toward the single goal of being acquired by, or of licensing their assets to, large pharma—and players may need to develop products further than in the past, and therefore strategic pathway optionality needs to be weaved into and maintained throughout product and corporate development. But with a multitude of new challenges facing this industry come multifold new opportunities for value creation and chances to reach new heights. In this episode, Lee Taurman, Global Head of Syneos One and Keith Ruark, SVP Strategic Business Development, Syneos Health are joined by Ali Pashazadeh and Max Baumann, Co-Founders of Treehill Partners, to discuss strategic and operational implications for the biotech C-suite and share perspectives on how companies can succeed in an increasingly competitive environment.  learn strategic and operational implications for the biotech C-suite and share perspectives on how companies can succeed in an increasingly competitive environment. 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 insightshub.health. 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 is the healthcare industry up against in terms of recruiting, hiring, and retention, in the increasingly competitive job markets of China, Korea and Japan? Leigh Householder and Sam Wilson, commercial solutions lead for APAC, Syneos Health,  discuss how changing customer needs, evolving market dynamics and shifts in customer engagement  continue to be  challenges when recruiting top talent in the region.Learn more about 2023 Health Trends here.More Episodes in the 2023 Health Trends Series:Syneos Health Podcast: 2023 Health Trends: Personally, Purposefully Building What's NextTrend Talks: AgeTech with Musician, Actor & Patient Advocate, James IanTrend Talks: AI: Finally fit for PurposeTrend Talks: A New Field for the Field Force Trend Talks: The Data EffectThe 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 insightshub.health. 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 our previous episode, we covered how companies can harness the power of digital therapeutics to improve their brand's value proposition. But what does it really take to get a clinically validated prescription digital product to market? Dr. Shaheen Lakhan, Chief Medical Officer, Click Therapeutics joins us on the second episode of our two-part series on digital therapeutics to discuss the diligence required to help regulators, health plans and payers, clinicians, and patients understand the potential of these digital solutions outside of entertainment—and how to apply the principles of traditional, biopharmaceutical types of drug development, validation and regulatory exercises to get them into the hands of patients. Listen to part one of our conversation on digital therapeutics with Austin Speier, Chief Strategy Officer of Click Therapeutics, here.  And for a deeper dive into how companies can implement DTx to expand or augment the potential of their pharmaceutical and biologic therapeutic assets, read our article 10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx.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 insightshub.health. 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.

Digital therapeutics (DTx) are projected to be $50 billion industry by 2025. While many minds may immediately jump to unregulated companion apps when they hear “digital,” there are also clinically validated prescription digital products that act complementary to or in combination with traditional biopharmaceutical therapies. As these prescription DTx gain traction, how can companies harness their power to improve their brand's value proposition? In this first of two episodes on DTx, Michael Sarshad, Managing Director, Commercial Advisory at Syneos Health and Austin Speier, Chief Strategy Officer, Click Therapeutics, join the podcast to discuss the growing market and opportunities for DTx across the product lifecycle, where DTx can add value and ways to think about how to integrate them into a brand strategy. For a deeper dive into how companies can implement DTx to expand or augment the potential of their pharmaceutical and biologic therapeutic assets, read our article 10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx.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 insightshub.health. 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.