Published by Qualio
Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA
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In this episode of From Lab to Launch , we’re joined by Noreen Hong , VP and General Manager of Thermo Fisher Scientific’s Growth Protection and Separation business . Noreen shares insights from her extensive career, including what has kept her at Thermo Fisher for so many years and how a strong mission-driven culture and commitment to people development can shape lasting leadership. She discusses the importance of creating more inclusive hiring practices in STEM, encouraging women and underrepresented groups to pursue opportunities even when they don’t meet every requirement. Noreen also reflects on the value of trusting your instincts and taking smart risks to accelerate career growth. The conversation explores how labs can operate more sustainably through equipment upgrades and better data traceability , and looks ahead to the impact of AI and connected technologies in transforming modern laboratories. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
In this episode of From Lab to Launch , we’re excited to welcome Joe Luminiello , CEO of RCG Intel , a firm dedicated to uncovering the insights that drive smarter strategy in the pharmaceutical and biotech industries. Joe brings a sharp perspective on AI adoption, talent development, and long-term organizational strategy . As companies rush to automate entry-level roles, he highlights an often-overlooked risk: removing the very talent pipeline that future leadership depends on. Joe explores why successful organizations must balance AI integration with cultivating the next generation of leaders , treating AI as a powerful tool—not a replacement for human growth and succession planning. Joe joined Meg for a thoughtful conversation about strategic succession planning in the AI era , how organizations can avoid short-sighted automation decisions, and how RCG Intel approaches research like investigative journalism—peeling back layers of information to deliver the context and insights leaders need to see the bigger picture in an increasingly complex healthcare landscape. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
In this episode of From Lab to Launch , we’re excited to welcome Mariano García-Valiño, a four-time entrepreneur and CEO of Axenya, one of Newsweek’s World’s Best Digital Health Companies. He’s built and exited firms worth billions, blending tech, data science and human-centered care to transform healthcare across the globe. Mariano brings deep insights into scaling companies, AI in healthtech, and the future of innovation in Latin America. His Amazon #1 bestseller, Inedible, explores the curious resistance of the healthcare sector to the software-led transformations that we’ve seen in other industries. He’s also an experimental art photographer. Mariano joined Meg for a fascinating chat about the lessons he's learned leading his company, the role of tech in healthcare, and what the future of a stubbornly 'inedible' sector looks like. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
In this episode of From Lab To Launch, Meg is joined by Dr. Les Enterline, Senior VP and Global Head of Functional Service Partnerships at PPD, part of Thermo Fisher Scientific. With decades of experience across clinical research, Les is helping redefine how biopharma companies structure and scale their development teams through what’s known as the FSP model: a flexible outsourcing approach that’s gaining traction as sponsors face increasing pressure to deliver trials faster, more efficiently, and with more adaptive designs. As clinical complexity grows and internal teams get stretched thin, FSPs are helping organizations scale specialized expertise while maintaining oversight, quality, and operational control. Under Les’ leadership, PPD has become one of the industry leaders in offering hybrid and fit-for-purpose models that blend the best of traditional CRO services with strategic resourcing. In today’s conversation, we’ll explore how functional partnerships are evolving, how sponsors are rethinking outsourcing to meet modern challenges, and where the future of trial delivery is headed. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Nora Khaldi is a mathematician with a Ph.D. in Molecular Evolution and Bioinformatics, and her years of research have focused primarily on protein evolution and comparative genomics. Throughout her career, Nora’s ambition has been to disrupt the status quo in areas that have been void of technology by introducing new ways of thinking, big data, and new algorithms. In 2014, she founded Nuritas, a Dublin-based biotech company that counts U2’s Bono and The Edge among its investors. Nuritas has combined life science, nature and artificial intelligence to develop its unique Magnifier Discovery platform and to identify, unlock, clinically test and patent peptides, turning them into powerful and precise ingredients that elevate natural efficacy and make our everyday products healthier, safer, greener and more efficacious. nuritas.com linkedin.com/company/nuritas/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
On today’s episode, we’re changing course a little. Instead of interviewing a life science company leader, we’re speaking to someone who empowers them and helps their companies to grow! Elizabeth Chabe is the CEO of High Touch Group, a marketing consultancy firm specializing in life science clients. Her science marketing playbook, The Giant’s Ladder, is a #1 bestseller, and her work has been featured in The New York Times, Entrepreneur and CNBC, among others. inquiries@elizabethchabe.com Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Today we’re excited to welcome Navin Dewagan, the CEO of Boston-based Digital Health Solutions. Digital Health Solutions acts as the innovation partner for medical device and healthcare firms. Navin and his team help healthcare solution providers accelerate their medical products to market by leveraging years of domain expertise in IoT and cloud development, cybersecurity, mobile development and embedded software development for healthcare applications. Digital Health Solutions offers end-to-end software product expertise, from ideation to design & development, re-engineering, testing and verification & validation. Plus, with a range of services that’s close to our heart at Qualio, the team offers comprehensive quality and compliance support to help customers meet the complex regulatory demands of standards like IEC 62304, ISO 13485 and ISO 14971. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Today, we're thrilled to talk to husband-and-wife dream team, Laurie & John Masiello. The Masiellos have been launching and scaling life science companies together since 1984. After merging their first company, Masy BioServices, with a North Carolina CDMO in 2021, the Masiellos struck again, forming Predictive Monitor in 2022. Their debut product, OverShield, combines IoT sensor technology with AI and data analysis to offer a powerful early warning system for controlled GMP chambers, from freezers to cold and stability rooms. The couple’s mission centers around harnessing Pharma 4.0 technology to maximize equipment uptime, improve operational efficiency, and protect life-saving biopharmaceutical products. Hear Laurie & John walk us through their incredible shared journey and industry insights as they prepare to celebrate their 50th wedding anniversary. https://www.linkedin.com/company/predictive-monitor-llc/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Today we’re talking to Mohan Uttarwar, an accomplished entrepreneur and innovator with extensive expertise in life sciences and precision diagnostics, as he walks us through his fascinating journey from an Indian village without electricity to the bleeding edge of Silicon Valley tech innovation. Mohan's work focuses on addressing unmet needs in oncology and personalized medicine, and he’s particularly focused on the development of next-generation diagnostic tools, specifically in the areas of liquid biopsy and multi-omics. Based in Cupertino, California, Mohan is the co-founder and CEO of OneCell Diagnostics, now 1Cell.AI . 1Cell’s AI-powered cancer diagnostics promise 90% faster detection of cancers, and 80% more accurate therapy response plans. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Today on From Lab To Launch, we’re excited to welcome Dr. Terrance Govender, the VP of Medical Affairs at ClinIntell. ClinIntell, based in Tampa, Florida, supports healthcare executives and leaders in accurately capturing the true severity of their inpatient population using population-based predictive analytics. The results for their customers? More accurate, trustworthy performance data and clinical condition reporting, that can be easily shared and used to drive continuous improvement activities. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
If you’ve been following From Lab to Launch for a while, you may remember a previous conversation with Sapient’s Chief Scientific Officer, Dr. Mo Jain, a couple years back. We’re thrilled to build on that conversation with Dr. Jonathan Usuka, the CEO of Sapient. Sapient is one of the largest capacity biomarker discovery labs in the world, and their mission is to accelerate drug development and improve patient outcomes through biomarker-guided therapeutics. By combining high-resolution biomolecular data with advanced computational approaches, Sapient is helping sponsors and researchers unlock new therapeutic targets and navigate complex biology at unprecedented speed and scale. With more than 25 years of experience at the intersection of business, science, and technology, Jonathan has led innovation strategies across drug development, diagnostics, and AI-driven discovery. From streamlining therapeutic pipelines to pushing the boundaries of integrated diagnostics, his work is helping reshape how biopharma organizations bring life-changing therapies to patients. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
In this episode, Meg speaks to Ilya Burkov, the Global Head of Healthcare & Lifesciences Growth at Nebius AI. Nebius AI’s goal is simple: to provide the cloud infrastructure that will be the groundwork of the AI revolution we can all see happening in front of us. Nebius’ suite of tools helps life science companies gather data and then train, fine-tune and launch their AI models into the world. Ilya’s role is to oversee and drive the adoption of this cloud AI technology within the life science and healthcare sectors, placing him at the cutting edge of this next wave of industry change. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
When we think of medical devices and how they’re built, 3D printing isn’t necessarily the first thing that comes to mind. But Boston Micro Fabrication is at the cutting edge of an exciting development in how life-saving devices are prototyped and created. With the news that the FDA is pivoting away from animal testing towards 3D organoids, and with the growing need to produce miniature, intricate and high-quality devices at speed, BMF’s nanometer-precise microArch 3D printing technology is opening the door to new possibilities - allowing the rapid production of equipment like stents, endoscopes, and even needles. A BMF-built catheter recently featured in a nature.com scientific report, delivering 183x higher drug concentrations for liver cancer treatment than would otherwise have been possible. We were thrilled to talk to the CEO of BMF, John Kawola, about the company's exciting work. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
If you’ve ever seen a medical drama, you know how intense it gets when a patient is bleeding and doctors have to act fast. But in real life, understanding why someone is bleeding—and how best to stop it—isn’t always straightforward. That’s where Dr. Francesco Viola’s work at HemoSonics comes in. HemoSonics provides a solution for doctors to get a clear picture of how a patient’s blood is clotting. Instead of waiting for slow lab results or guessing which blood products to give, doctors can now make informed decisions in real time—right at the bedside. Dr. Viola brings a unique blend of engineering precision and clinical vision to HemoSonics. With a background in biomedical engineering and more than a decade of experience in medical ultrasound, signal processing, and instrumentation, he’s led the charge in developing HemoSonics’ groundbreaking Sonic Estimation of Elasticity via Resonance (SEER) technology. Under his leadership, HemoSonics is addressing one of the most critical gaps in patient care: the need for fast, accurate, and actionable blood clotting data—whether during surgery, in the ICU, or at the point of trauma. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
As complexity in pharmaceutical development reaches new heights — especially with over 60% of recent FDA novel molecular entities falling outside traditional drug design rules — the need for advanced formulation and manufacturing strategies has never been greater. Precision medicine is no longer a future goal; it’s a present necessity. And that’s exactly where AustinPx comes in. At the forefront of this shift is AustinPx’s KinetiSol technology, a powerful platform designed to make the “undevelopable” developable — transforming poorly soluble, highly potent small molecules into scalable, patient-ready therapies. Dr. Dave Miller, CSO, has spent more than 20 years in pharmaceutical R&D, helping drug developers navigate the challenges of bioavailability, permeability, and manufacturability for complex molecules. Today, we’ll explore with Dave how CDMOs like AustinPx are empowering a new era of personalized treatment—while offering product protection strategies that help biopharma companies stand out in a competitive, cost-sensitive market. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Understanding how cells interact is a critical cornerstone of modern life science, and Axion BioSystems is right at the confluence of live-cell analysis and next-generation technology. Axion’s Maestro and Multiwell products are helping to unlock the secrets of cellular behavior and allow the tracking of the health and function of thousands of cells at once, in real time. CEO Julien Bradley joined Meg on the show to discuss why understanding cellular behavior is so important - and what exciting possibilities come from Axion's vital work. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Today we’re heading across the Atlantic to speak to Dr. James Field, CEO of London-based LabGenius Therapeutics. LabGenius has a really exciting mission. James and his team of 60 scientists and engineers believe in the powerful combination of human and artificial intelligence, and are pioneering an ML-driven protein engineering platform - EVA - that can design and execute experiments for the development of next-gen antibodies, including complex multispecifics. LabGenius has already raised over $75m in venture capital and built R&D deals with some major pharma and biotech players. After founding the company in 2012, James was named in Forbes’ ‘30 Under 30’ list for science and healthcare, and even won Innovator of the Year award from the UK’s Biotech & Biological Sciences Research Council. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
We made a bonus episode of From Lab To Launch to mark a special occasion: the launch of Qualio's fourth annual life science quality trends report in March 2025. Our very own Kat and Clive dug into the report and its fascinating findings to see how life science quality teams are spending their time, what they're planning for 2025, and what headaches and frustrations they're looking to conquer this year. Join us and dive into our report - and read the full thing at reports.qualio.com! Note: the audio in this episode has been made using artificial intelligence Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
As the organ transplant list continues to grow, experts in the transplant diagnostics industry are looking for ways to address the supply and demand challenges within the field. New tactics, like retransplantation and xenotransplantation, and new testing methods, such as HLA testing and transplant diagnostics, are being explored to boost transplant success rates and ensure more patients get the lifesaving transplants they need. As President of Thermo Fisher Scientific’s transplant diagnostics division, Tina Liedtky is at the cutting edge of meeting this challenge. She’s also passionate about addressing health equity issues, such as ingrained biases regarding gender and race, to help bridge the transplantation gap. Tina joined Meg for a fascinating discussion about the future of transplantation, closing 'the gap', and Thermo Fisher's recent award. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
As more preventative approaches to health are set to take center stage, some diseases can’t be prevented but can be managed more proactively. Blood-based biomarkers, such as p-tau217, hold great promise for earlier, more proactive detection and monitoring of diseases such as Alzheimer’s, and it’s here that Quanterix plays a critical role. Their Simoa digital health platform serves as the backbone for the majority of p-tau217 tests on the market today, reducing reliance on costly PET and CSF testing and streamlining the diagnostic journey for Alzheimer’s disease. Mark has been a leader in the biotech space for over 2 decades, with a string of leadership roles before he joined Quanterix in 2014 and became their CSO in 2022. Mark joined Meg on From Lab To Launch to discuss the exciting predictive power of biomarker technology, and what the future holds for spotting and treating diseases early. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
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