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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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Let's Talk Quality

Hemish Ilangaratne

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“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries t ...
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Leaders in Pharma

Impetus Digital

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Together with prominent Pharmaceutical industry leaders, Impetus Digital is covering topics around what it means to be an effective leader in Pharma today. We are also exploring topics related to digital transformation, patient-centricity, industry partnerships, customer engagement, diversity in Pharma, systems thinking, current healthcare challenges, environmental and supply chain concerns, and the myriad of ways that Pharma is working to collectively and positively disrupt healthcare. At I ...
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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 …
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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 assist…
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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 surg…
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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 bioma…
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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 conne…
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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 Consortiu…
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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 re…
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From engineering student to SVP of Quality - Carolina shares how curiosity, resilience, and mentorship shaped her journey. In today’s episode I was joined by Carolina Valoyes, Senior Vice President of Quality and Compliance at BioNova Scientific. I really wanted to speak to Carolina because her story is one of bold decisions, genuine self-awareness…
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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 expe…
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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 s…
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In this episode of Let’s Talk Quality, Hemish speaks with Jose Caraballo, a biotech leader with over 30 years of experience in process engineering, manufacturing science, and quality leadership. Jose started his career in process engineering, optimizing yields and scaling up production. Over time, he made a deliberate shift into quality leadership,…
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This week on Let’s Talk Quality, we sat down with Andrea Karpinecz, VP of Quality Control at Iovance Biotherapeutics, to discuss what it takes to build a successful QC career, scale teams for commercialization, and thrive in a high-pressure environment. Andrea has been in cell therapy for 16+ years, playing a pivotal role in bringing multiple thera…
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🚀 The first-ever returning guest on the podcast! In this episode, Hemish sat down with Brian Nunnally, Enterprise Quality Control Head at CSL, to dive deep into one of the most important topics in career growth - mentorship. Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your…
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🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases? That’s exactly what Katarina Bartle did. She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc. 27 years later, she…
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In today’s episode, I was joined by Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics. I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She’s now leading in the dynamic world of cell and gene therapy, where quality and adaptabili…
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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 acce…
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In today’s episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy. I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadershi…
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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 c…
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In this episode of Let’s Talk Quality, Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob’s experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities. Rob shared inva…
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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 discus…
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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 Excel…
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In today's episode, I'm joined by Jon Voss, one of the all-time quality greats! I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry. Unsurprisingly he has developed some of the leaders I've interviewed on …
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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 sit…
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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 chal…
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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 prec…
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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 individual…
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On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Hanh Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a global CDMO specializing in cell and gene therapies. Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced …
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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 advan…
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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 …
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On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Sang Yoon, VP of Quality Assurance at ImmunityBio, a cell and gene therapy company based in California. Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and…
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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 s…
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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 exper…
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On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan, Executive Director and Head of Quality at Mural Oncology, a fast growing biotech in Waltham, Massachusetts. Here's what they discuss: How Swetha's upbringing shaped her career progression 🚀 Moving from India to the US to pursue a career in s…
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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 fe…
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In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences. Matthew’s journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.…
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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 b…
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In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality…
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Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it. He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality …
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In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality a…
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In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics. Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his pass…
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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 o…
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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 Kell…
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In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to lea…
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In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing. Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! We tal…
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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 …
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In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics. I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discu…
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Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer. Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being abl…
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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…
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In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK. Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opp…
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Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is real…
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