In this episode of the Syneos Health Podcast: Site Realities series, Tammy D’Lugin-Monroe, Head of Sites and Patient Solutions at Syneos Health, sits down with Mimi Fenton, MPH, PhD, CEO of Cedar Health Research, to explore what it truly means to operate on the front lines of clinical research. Drawing on her experience across pharma, CRO and site leadership, Mimi offers a candid view into the operational, financial and human realities that shape today’s clinical trial landscape.

The conversation highlights the growing disconnect between protocol design and real-world execution—and how sponsors and CROs can close that gap by engaging sites earlier, simplifying technology integration and prioritizing patient-centered approaches. Mimi also underscores the critical role of trust, emphasizing that sites serve as the face of the sponsor within communities and are essential to improving access, diversity and retention in clinical trials.

From the burden of fragmented technology to the importance of long-term partnerships over transactional relationships, this episode offers practical insights on how the industry can better collaborate to accelerate trial delivery and improve outcomes for 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 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.

In this episode of The Syneos Health Podcast, Conversations on Commercialization, Tyler Cowan, VP, Commercial speaks with Paul Rittman, President and General Manager of Almirall US, about how payer consolidation and PBM influence are reshaping dermatology commercialization.

They discuss how pharmaceutical companies must adapt launch strategy, market access planning and clinical differentiation to succeed in today’s competitive specialty landscape. The conversation explores the growing role of digital engagement, direct-to-consumer (DTC) strategy, telehealth and cash-pay models in improving patient access.

Listeners will gain practical insights into how innovation, payer strategy and patient-centric commercialization drive success in dermatology and specialty pharma.

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.

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.

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 tools
• The importance of designing from the site’s perspective, not just for internal efficiency
• How functional service provider (FSP) models can go beyond staffing to drive systemic improvement
• Simple but powerful steps sponsors can take now to reduce burden and build stronger site relationships
• What 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.

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 integration
• What AI and automation really mean for safety operations and talent needs
• The enduring importance of human judgment, especially in the age of AI agents
• Why functional service provider (FSP) models are now resonating in PV
• How 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.

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 partnerships
• Building agile teams that thrive amid complexity
• Transforming governance to focus on action, not just KPIs
• How the CRA role is evolving with tech-enabled site engagement
• What sponsors can do to unlock value through co-creation

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.

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 innovation
• How functional support needs vary widely across early- to mid-stage sponsors
• The critical role of adaptability in both delivery teams and partnership models
• Why strong cultural fit and team integration matter more in SMID engagements
• When to start considering FSP—and how a conversation, not a contract, is often the best first step

If 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.

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.