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 “undeve...

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 ...

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 ove...

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:...

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...

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 t...

In this episode of From Lab to Launch by Qualio we interview Joseph Mossel, CEO and co-founder of Ibex Medical Analytics. Joseph shares his journey from computer science to leading a transformative AI-driven company in pathology. Founded in 2016, Ibex aims to provide accurate, timely, and personalized cancer diagnoses using AI technology. Joseph discusses the challenges and insights from deploying AI in clinical settings, the importance of partnerships, and the company's vision for the next f...

Earlier this year, Thermo Fisher Scientific opened its first clinical trial Innovation Lab in Center Valley, Pa., designed to foster a culture of collaboration by providing a dedicated space for industry partners to come together, share ideas and co-create solutions for the industry’s biggest challenges. The global clinical trial market was valued at over $80 billion in 2023, and that’s projected to grow by 6.5% every year until 2030. But alleviating innovation silos is the only way to m...

Today we welcome Kerry Love, the co-founder of Massachusetts-based (and wonderfully named) Sunflower Therapeutics. Established in 2018, Sunflower is dedicated to advancing biologic medicines and enhancing global vaccine accessibility through cutting-edge protein manufacturing technologies.As a women-owned organization, Sunflower has a stellar team of scientists and engineers renowned for their expertise in perfusion fermentation, purification process development, biopharmaceutical manufacturi...

Carna Health is focused on applying technology to revolutionize kidney care by unlocking the early detection and management of chronic kidney disease (CKD). They provide clinical-grade software as medical devices that deliver instant health metrics, such as creatinine, eGFR, and uACR levels, from small patient samples. Their platform integrates with existing healthcare systems and electronic healthcare records, promoting proactive and patient-centric care underpinned by accurate, real-time pa...

Dr. Jonathan Hill, VP of Science and Technology and co-founder of Wasatch Biolabs joins the podcast today to talk about the future of genetic testing technology. Dr. Hill shares his journey in genetics, starting from his undergraduate days to co-founding multiple biotech companies. They discuss the cutting-edge genomic and bioinformatic methods being developed at Wasatch Biolabs, including targeted DNA methylation sequencing and its significant implications for personalized medicine and early...

Join us with guest Dr. Rolland Carlson, CEO of Immunexpress to talk about the transformative work happening in sepsis diagnosis. Dr. Carlson discusses the importance of rapid sepsis diagnosis. The episode covers challenges faced during product development, regulatory achievements, and future plans for sepsis diagnostics. Dr. Carlson also shares advice on ensuring product quality and navigating FDA clearances.00:00 Introduction to From Lab to Launch00:25 Meet Dr. Rolland Carlson, CEO of Immune...

In this episode we bring David Suhy, co-founder and Chief Scientific Officer at Earli back to the podcast. David shares the heartfelt founding story of Earli, the company's mission to make cancer a benign experience by catching it early, and their unique approach utilizing synthetic promoters for early cancer detection and treatment. He discusses challenges faced in clinical trials, the importance of quality and safety in research, and provides advice for other startups in life sciences. Davi...

This episode we're joined by Dr. Joshua Lee, a clinician, researcher, and professor specializing in medication-assisted treatment (MAT) for alcohol and opioid use disorders. Dr. Lee discusses his extensive research on medications such as naltrexone and buprenorphine, their significance in treating substance use disorders, and the transformative potential of telemedicine platforms like Oar Health. He highlights the underutilization of effective medications in primary care, the barriers to acce...

In this episode we're joined by Justin Zenanko, CEO and co-founder of SynerFuse to discuss groundbreaking technique combining spinal fusion and direct nerve stimulation to treat chronic low back pain, aiming to eliminate the need for postoperative opioids. Justin delves into the inspiration behind the technology, its clinical results, and the company's approach to quality and regulatory management. He also provides insights on raising funds in a competitive market and the potential future app...

**UPDATE** Since this episode was recorded, Takeda announced the results of the phase 3 soticlestat trials, which did not meet their primary endpoints.We welcome Dr. Toshiya Nishi and Jason Tardio from Ovid Therapeutics. Dr. Nishi, with over 20 years of experience in drug discovery, discusses his role in the development of soticlestat and ongoing research on KCC2 activators for neurological disorders. Jason Tardio, Ovid's COO, shares insights on the company's focus on rare neurological disord...

Join us as we discuss viral diagnostics and pharmacology with Dr. Nigel McCracken, Chief Operating Officer of Virax Biolabs. Dr. McCracken shares his expertise in drug development, focusing on oncology and infectious diseases, and discusses the company's pioneering work in detecting immune responses and diagnosing viral diseases. The conversation covers the impact of technology advancements in the past decade, the introduction of the Immune Select Profile in the Virax Immune T Cell Diagnostic...

Join us in this inspiring episode of From Lab to Launch as we sit down with Marna Pacheco, the innovative founder of CapeAble Weighted Products. Marna turned a personal challenge into a pioneering enterprise that integrates fashion with function, providing therapeutic weighted products to those in need, from individuals with autism to medical patients across various settings.You'll learn:Marna shares her journey from designing a unique weighted cape for her daughter to founding CapeAble.Insig...

This episode of the From Lab to Launch podcast, brought to you by Qualio, features Dr. Sam Clark, CEO of Terran Biosciences. With a background in neurosciences from MIT and an MD and PhD from Columbia University, Dr. Clark shares his journey from academia to leading a pioneering company in neuropsychiatric therapeutics. He discusses the challenges and innovations in the development and supply of GMP psychedelic compounds, highlighting how these substances are making significant strides toward...

Listen in on our conversation with Rob Etherington, CEO of Clene Nanomedicine, a company pioneering nanotherapeutics for neurodegenerative diseases like ALS, multiple sclerosis, and Parkinson's. Rob discusses Clene's unique approach to improve mitochondrial function through a novel nanotherapeutic called CNM-au8, which has shown promising outcomes in clinical trials. He highlights the challenges in drug development, including funding and FDA approval processes, and underscores the importance ...