The Syneos Health Podcast

Syneos Health

The Syneos Health Podcast Series dissects some of the most complex issues biopharma leaders are facing today. Our clinical and commercial experts provide time-tested solutions, as well as perspectives on the news of the day. Each episode explores the challenges and considerations involved with bringing biopharmaceuticals to the market.

  1. JAN 30

    Functionally Speaking Series: Regulatory Intelligence, Medical Writing and the AI Inflection Point

    In this episode, Lynn Hamilton speaks with Stuart Goodall, Senior Vice President at Syneos Health, about how regulatory functions are evolving in response to growing complexity, accelerating timelines and emerging technologies. With more than 35 years of global experience, Stuart offers an unfiltered perspective on what regulatory and medical writing teams need to succeed today—and how to scale smartly for what’s next.   Topics explored include: ·      The shift from information advantage to decision advantage in regulatory intelligence ·      How AI is changing—not replacing—medical writing and regulatory operations ·      What sponsors need to consider when building scalable, tech-enabled models ·      Why FSP is no longer just transactional and how strategic partnerships are redefining value ·      Why storytelling and judgment remain irreplaceable in an automated world   Whether you're exploring your next medical writing solution or rethinking regulatory infrastructure, this conversation offers grounded insights with a forward-looking lens. The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    37 min
  2. JAN 22

    Functionally Speaking Series: Reimagining Site Experience: CRAs, AI and the Future of Functional Models

    In this forward-looking episode, Lynn Hamilton sits down with Bret Couturier, Executive Director, FSP 360 at Syneos Health, to explore how sponsors can shift from incremental improvements to intentional design when it comes to site experience. With a career spanning frontline monitoring to strategic FSP leadership, Bret offers practical insights into what's working, and what’s holding teams back.   Key themes include: Why the CRA role isn’t disappearing, but rather evolving with AI and data-driven toolsThe importance of designing from the site’s perspective, not just for internal efficiencyHow functional service provider (FSP) models can go beyond staffing to drive systemic improvementSimple but powerful steps sponsors can take now to reduce burden and build stronger site relationshipsWhat it means to move from reactive fixes to strategic collaboration, and why the time is now  If you’re rethinking site engagement, functional models or the next phase of FSP delivery, this conversation offers both strategic clarity and real-world takeaways. The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    30 min
  3. JAN 15

    Functionally Speaking Series: Modernizing Safety and Pharmacovigilance, The Human in the Loop

    In this episode of the Functionally Speaking series, host Lynn Hamilton speaks with Carol Aliyar, Executive Vice President and Global Head of Safety and Pharmacovigilance (PV) at Syneos Health, about the transformation of PV from a highly regulated, task-oriented function into a more strategic and technology-enabled discipline. With over 30 years in the industry and a career that spans commercial, clinical and safety roles, Carol brings a rare full-spectrum perspective.   Listeners will gain insight into: How PV is shifting from transactional taskwork to strategic lifecycle integrationWhat AI and automation really mean for safety operations and talent needsThe enduring importance of human judgment, especially in the age of AI agentsWhy functional service provider (FSP) models are now resonating in PVHow consistency, flexibility and subject matter depth strengthen long-term partnerships  Whether you're expanding your PV model, exploring AI adoption or rethinking how functional teams deliver value, this conversation offers real-world perspective and practical foresight. The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    24 min
  4. JAN 8

    Functionally Speaking Series: Clinical Operations for Large Pharma, Navigating Model Evolution With Agility

    What does it take to run a truly effective Functional Service Provider (FSP) model in today’s biopharma landscape? From harmonizing global teams to embedding innovation into daily delivery, FSP engagement is more than a resourcing solution — it’s about strategic collaboration and approaches that accelerate delivery. The Syneos Health Podcast: Functionally Speaking series explores the nuances that make these models work.  In this episode of the Functionally Speaking series, host Lynn Hamilton sits down with Wayne Wise, Vice President of Clinical Operations at Syneos Health, to explore the real-world shifts happening in large pharma partnerships. With nearly two decades at the company and deep cross-functional experience, Wayne shares how agility, strategic governance and trust-based team leadership are reshaping FSP delivery models.   From evolving CRA roles and co-created governance to the increasing use of AI, Wayne offers a firsthand look at how functional teams are adapting in real time to operational and strategic shifts across the industry.    You will walk away with insights on: Moving beyond transactional models to strategic, insight-driven partnershipsBuilding agile teams that thrive amid complexityTransforming governance to focus on action, not just KPIsHow the CRA role is evolving with tech-enabled site engagementWhat sponsors can do to unlock value through co-creationThe views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    30 min
  5. JAN 8

    Functionally Speaking Series: FSP for SMID Sponsors, Navigating Complexity with Flexibility and Trust

    What does it take to run a truly effective Functional Service Provider (FSP) model in today’s biopharma landscape? From harmonizing global teams to embedding innovation into daily delivery, FSP engagement is more than a resourcing solution — it’s about strategic collaboration and approaches that accelerate delivery. The Syneos Health Podcast: Functionally Speaking series explores the nuances that make these models work.    In this episode of Functionally Speaking, host Lynn Hamilton welcomes Matt Lawton, Executive Director of FSP Delivery at Syneos Health, to explore the unique challenges and opportunities facing small-to-mid-size (SMID) biopharma sponsors. Often operating with leaner resources and evolving pipelines, these companies require partners who can flex with their journey—not just deliver headcount. With over 15 years of experience guiding functional partnerships, Matt offers grounded insights on how to build trust-based FSP models tailored to each sponsor’s origin, stage and future goals.    Listeners will gain a practical understanding of: What truly defines the SMID segment—and why it’s a space of rapid innovationHow functional support needs vary widely across early- to mid-stage sponsorsThe critical role of adaptability in both delivery teams and partnership modelsWhy strong cultural fit and team integration matter more in SMID engagementsWhen to start considering FSP—and how a conversation, not a contract, is often the best first stepIf you're working in or with an emerging biopharma organization, this episode offers a valuable look into how functional partnerships can evolve to meet you where you are—and grow with you. The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    35 min
  6. 2025 CNS Summit Series: Scaling Psychedelic Medicines Responsibly, A Conversation with Dr. Dan Karlin, CSO, MindMed

    JAN 8

    2025 CNS Summit Series: Scaling Psychedelic Medicines Responsibly, A Conversation with Dr. Dan Karlin, CSO, MindMed

    What does it take to redefine psychiatric care with psychedelic therapies? In this episode, Dr. Dan Karlin of MindMed joins host Dr. Talar Hopyan to discuss the clinical, regulatory and cultural shifts underway in mental health.  They explore the momentum behind MindMed’s LSD program for anxiety and depression, how the team is preparing for NDA filing and commercialization and why purposeful growth—not hype—is key to long-term success in psychedelics.  What you’ll learn:  Why MindMed’s MM120 program could reshape the treatment landscape for anxiety How collaboration with regulators is enabling more responsible innovation What intentional scaling means for the future of psychedelic biotech The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    13 min
  7. 2025 CNS Summit Series: Rewriting the Rules of Neurodegeneration, A Conversation with Arvinas CSO Angela Cacace, PhD

    12/11/2025

    2025 CNS Summit Series: Rewriting the Rules of Neurodegeneration, A Conversation with Arvinas CSO Angela Cacace, PhD

    What if protein degradation could address neurodegenerative diseases, not just cancer? In this episode, Dr. Angela Cacace, CSO at Arvinas, speaks with Dr. Talar Hopyan, Global Head of CST at Syneos Health, about how the company is advancing a degrader targeting LRRK2 in Parkinson’s disease and why early-stage signals in healthy volunteers are raising new possibilities for CNS care.  They discuss how Arvinas is engineering blood-brain barrier-penetrant molecules, the translational challenges in neurodegeneration and what’s required to move from platform to patient.  What you’ll learn:  How Arvinas is expanding targeted protein degradation into neurology Why LRRK2 degradation is a promising approach for Parkinson’s disease What it takes to translate platform innovation into measurable clinical outcomes The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us! We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

    10 min
4.8
out of 5
45 Ratings

About

The Syneos Health Podcast Series dissects some of the most complex issues biopharma leaders are facing today. Our clinical and commercial experts provide time-tested solutions, as well as perspectives on the news of the day. Each episode explores the challenges and considerations involved with bringing biopharmaceuticals to the market.

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