Shows
From Lab to Launch by QualioSpecial episode! Digging into Qualio's 2025 quality trends reportWe 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...2025-03-2615 minFrom Lab to Launch by QualioAdvancing Pathology using AI with Joseph Mossel Co-founder & CEO of IbexIn 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 few years. Tune in to learn how Ibex's innovations are reshaping cancer diagnostics and making a significant impact on patient outcomes.https...2024-11-1928 minFrom Lab to Launch by QualioTransforming Neuropsychiatric Therapeutics with Dr. Sam Clark, CEO of Terran BiosciencesThis 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 transforming mental health treatment. Dr. Clark also explores Terran Biosciences' approach to overcoming drug development hurdles, emphasizing quality management and patent...2024-05-1523 minFrom Lab to Launch by QualioTreating Neurodegenerative Diseases with Rob Etherington, CEO of Clene NanomedicineListen 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 of resilience, continuous learning, and strategic partnerships in advancing biotech innovations. The episode also touches on Rob's personal philosophy on leadership and the importance of women in leadership roles....2024-04-2426 minFrom Lab to Launch by QualioSaving Lives by Cancer Prediction and Detection with Dan Lunz, CEO of PreviseToday we interview with Dan Lunz, co-founder and CEO of Previse, an innovative medical solutions company specializing in cancer prevention and early detection. Lunz talks about his journey from being a Marine to leading a pioneering medical company. He discusses the scientific technology behind Previse, which started out as research for predicting esophageal cancer in patients with Barrett's esophagus. Lunz also shares about the company's current fundraising activities, commercialization plans, compliance with regulatory standards, and long-term goals for cancer detection. He hints at exciting future announcements about Previse's new developments, tests, and pipeline technologies.https://previsedx...2024-03-2725 minFrom Lab to Launch by QualioThe Power of Effective Writing in the Life Sciences Industry with Pam Hurley, Founder of Hurley WriteIn this episode we welcome Pam Hurley, the founder and president of Hurley Write Inc., who specializes in professional writing and communication training. Pam discusses how proper writing can lead to more effective professional communication in life sciences, and how precision and confidence in writing can help professionals achieve their goals. She highlights the importance of clear and concise communication, especially in regulatory submissions, research publications, or internal communications. Delving into the common writing challenges, Pam mentions the lack of understanding of the outcome and disregarding reader's readability and understanding as some. She concludes by highlighting the c...2024-03-1322 minFrom Lab to Launch by QualioAdvancing Cancer Diagnostics with Mark McDonough, CEO of ChromacodeIn this episode we interview Mark McDonough, the CEO of ChromaCode. The episode explores McDonough's journey to ChromaCode, from his early career as a naval officer to his roles at various medical and diagnostic companies. Under McDonough's leadership, ChromaCode has excelled in creating a high-definition PCR platform which enables fast, accurate, and affordable cancer diagnosis. The platform is particularly beneficial as it requires less patient tissue, provides rapid results, and has a lower cost than traditional diagnostic methods. McDonough also discusses the importance of partnerships in their go-to-market strategy and shared his insights on hiring and team development in...2024-02-2620 minFrom Lab to Launch by QualioUnlocking Longevity using ESS60 with Chris Burres Co-Founder of MyVitalCJoin us as we dive into the world of groundbreaking scientific discovery with Chris Burres, a renowned Chief Scientist. In this episode, Chris unveils the mysteries of a unique, soccer ball-shaped molecule that could be the key to unlocking secrets of health and longevity.Discover how this extraordinary molecule, small enough to hold any atom from the periodic chart, might revolutionize our understanding of wellness and aging. Chris shares insights into the foundational principles that drive this innovative research and the potential life-changing benefits it holds.Furthermore, hear firsthand the compelling success stories and testimonials...2024-01-2327 minFrom Lab to Launch by QualioInnovative Lab Spaces and Cleanrooms on Demand with Azzur Group's Ravi SamavedamIn this episode of "From Lab to Launch" by Qualio, Meg welcomes Ravi Samavedam, the Chief Innovation Officer of Azzur Group. With over two decades of experience as a seasoned biochemical engineer, Ravi is a driving force behind Azzur's groundbreaking approach to lab spaces and cleanrooms.Discussion Highlights:Ravi delves into Azzur Group's evolution since its formation in 2010, emphasizing its roots in equipment and facilities for the biopharma industry. The conversation unfolds with a focus on Azzur's revolutionary "Cleanrooms on Demand" concept, drawing parallels to Legos for its flexibility and efficiency. Ravi explains the...2024-01-0918 minFrom Lab to Launch by QualioTransforming Healthcare Access: Navigating Challenges and Unlocking Data with Particle Health's Troy BannisterIn this episode, Meg is joined by Troy Bannister, the co-founder and chief strategy officer at Particle Health. Particle Health is a company revolutionizing the accessibility, sharing, and utilization of healthcare data to simplify navigation for patients and healthcare providers. Troy shares his inspiration behind starting Particle Health and dives into the challenges and strategies the company employed to navigate regulatory compliance and foster successful partnerships in the highly regulated healthcare industry.The conversation delves into the importance of caring passionately about the mission, overcoming setbacks, and the role of partnerships in achieving Particle Health's mission. Troy...2023-12-0723 minFrom Lab to Launch by QualioNavigating Talent Management Challenges in Life Sciences with Darwin Shurig CEO of Surig Solutions, Inc.In this podcast episode, host Meg interviews Darwin Shurig, the founder and CEO of Shurig Solutions, Inc. (SSI), a talent management and executive recruiting firm. Darwin is a seasoned entrepreneur and talent management expert who has built a successful firm partnering with clients to fulfill their talent needs and strategically support initiatives. He also emphasizes the importance of hiring and retaining high-performing teams in life sciences.Episode Highlights:In the ever-evolving world of talent management, Darwin sheds light on the current trends and challenges associated with recruiting top talent, particularly in the medical device...2023-11-1535 minFrom Lab to Launch by QualioEliminating Misdiagnosis of Sepsis with Greg Bullington, CEO of Magnolia Medical TechnologiesSepsis is often misdiagnosed, with approximately 40% of positive sepsis blood tests being incorrect. This leads to patients receiving unnecessary treatments, extended hospital stays, and risks associated with inaccurate diagnoses. In this episode, Greg Bullington CEO of Magnolia Medical Technologies discusses the mission and innovations of Magnolia Medical Technologies, which is focused on improving the accuracy of sepsis diagnosis and reducing the overuse of antibiotics. Greg and his team have developed a technology to improve the accuracy of sepsis diagnosis and significantly reduce false positives.The conversation touches on the challenges of bringing innovations to market, th...2023-10-2726 minFrom Lab to Launch by QualioRevolutionizing Healthcare Supply Chains with Luká Yancopoulos, CEO of Grapevine TechnologiesIn this episode of "From Lab to Launch" by Qualio, host Meg welcomes Luca Yancopoulos, the CEO of Grapevine Technologies. Grapevine Technologies is a platform that revolutionizes the healthcare supply chain by connecting buyers with trusted wholesale suppliers, offering lower prices and a seamless online ordering process. Luca's passion for improving healthcare supply chain inefficiencies was sparked when he founded a medical supplies distribution company, Pandemic Relief Supply (PRS), during the COVID-19 pandemic, which delivered over $20 million in critical supplies.During the podcast, Luca discusses the impact of COVID-19 on healthcare supply chains, highlighting the o...2023-09-2227 minFrom Lab to Launch by QualioRegulatory and quality expertise for solving customer problems with David R. Schoneker from Black Diamond Regulatory ConsultingOn the podcast today we have David Schoneker who is currently the President of Black Diamond Regulatory Consulting, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns. With over 45 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University’s School of Pharmacy in their RA...2023-08-241h 03From Lab to Launch by QualioThe Moneyball for Injuries with Dr. Phil Wagner CEO & Founder of Sparta ScienceDr. Phil Wagner is the CEO & Founder of Sparta Science, a Movement Health Intelligence company dedicated to helping the world move better.Founded in 2014, Sparta Science applies modern data science techniques that advance industry best practices and optimize how organizations assess, understand, and improve health & well-being.With 4 patents, several more pending, and over 20 published, peer-reviewed research studies, Sparta Science continues to advance the Movement Health technology industry.You may not know this but musculoskeletal issues are by far the largest diagnosis in America yet get a fraction of our healthcare budget. This is...2023-08-0919 minFrom Lab to Launch by QualioTreating Cancer using Targeted Radiotherapeutics with Jack Hoppin and John Babich of Ratio TherapeuticsToday we have Dr. Jack Hoppin CEO of Ratio Therapeutics and Dr. John Babich Chief Science Officer of Ratio Therapeutics. The team at Ratio Therapeutics is developing a suite of innovative technologies to develop best-in-class targeted radiotherapeutics for the treatment of cancers. They just recently opened a 19,000-square-foot headquarters and R&D facility in Boston to continue their exciting innovation. We’ll dive into how Ratio started, their growth, and what you can learn from their journey from Lab to Launch. Show notes:https://ratiotx.com/ Qualio website:https://www...2023-07-2627 minFrom Lab to Launch by QualioOutcome-Driven Innovation® with Tony Ulwick, CEO of StrategynToday we have Tony Ulwick on the show. Tony is the pioneer of Jobs-to-be-Done Theory, the inventor of the Outcome-Driven Innovation® (ODI) process, and founder of strategy and innovation consulting firm, Strategyn. He has applied his ODI process at some of the world's leading companies and across nearly all industries to inform breakthrough innovations - achieving a success rate that is 5 times better than the industry average.Philip Kotler calls Tony "the Deming of Innovation" and credits him with bringing predictability to innovation. Published in Harvard Business Review and MIT Sloan Management Review, Tony is also the a...2023-07-1224 minFrom Lab to Launch by QualioAmazing biotech at high school incubators with Dr. Linnea FletcherDr. Linnea Fletcher is a true pioneer at bridging biotech and education. On the show she explains how high school biotech incubators got started and how others can get involved. She also shares more about the upcoming innovATEBIO conference. Dr. Fletcher she simultaneously joined the first National Science Foundation-funded National Biotechnology Education Center, Bio-Link, and received her first NSF-funded Advanced Technological Education grant to start Biotechnology high school programs in Texas. In 2015, she received an Emerging Technology Fund grant to build a Bioscience Incubator at ACC and several Wagner Peyser grants to equip it. Today, the incubator i...2023-06-2824 minFrom Lab to Launch by QualioTackling Aging with Dr. Carl Giordano Chief Science Officer at RebesanaDr. Carl Giordano joins us on From Lab To Launch!Carl is the co-founder and Chief Science Officer at Rebesana, a company dedicated to healthy aging and longevity. After years of studying science-backed research on health and aging, orthopedic spine surgeon Carl developed a proprietary supplement to target health on a molecular level.That supplement, backed by scientific publications, delivers a direct signal to cellular pathways in order to maintain health, longevity, and an athletic lifestyle as we age. The secret to slowing aging and extending our lives is closer than we think.2023-06-1429 minFrom Lab to Launch by QualioSpecial Episode Welcoming New Podcast Host Meg SinclairWe're welcoming a new host to From Lab to Launch! Kelly hands the baton over to Meg Sinclair. Listen in on their conversation about all things podcasting for life sciences, quality and transitioning over the podcast. A little about our new host. Meg has over 10 years of experience in Quality Assurance, Regulatory Affairs and Compliance across a range of industries - from non-profits to medical device start-ups. Like many other Quality professionals who start out in another field or department, Meg found Quality after starting her career in Public Health, but her career path has always been ab...2023-06-1414 minFrom Lab to Launch by QualioThe physical effects of psychological trauma: with Dr. Eugene Lipov and Jamie MustardIs psychological trauma really just in the mind? Research suggests it isn't.Today we’re interviewing two innovators on the front lines of life sciences and co-authors of a recent book. Dr. Lipov has been called the “Einstein of modern anesthesiology” He’s a renowned board-certified pain specialist and a huge proponent of the stellate ganglion block, a minimally invasive procedure that has been proven effective in treating PTSD symptoms. Jamie Mustard is an artist and a renowned strategic consultant. He is the author of the bestselling book “The Iconist: The Art and Science of...2023-06-0748 minFrom Lab to Launch by QualioSolving hypertension with Dr. Jay Shah from AktiiaHypertension affects almost half of all American adults and over 1 billion people globally. Dr. Jay Shah is Chief Medical Officer of Aktiia, a transformative company empowering providers and patients to greatly improve the diagnosis, monitoring, and treatment of hypertension.Jay joined us to share how he plans to tackle this massive problem in public health. More about Dr. Jay ShahDr. Shah has 15+ years of medical expertise and 11+ years of leadership experience. He has brought his experience and expertise to the Swiss startup Aktiia, to change the paradigm of h...2023-05-2429 minFrom Lab to Launch by QualioPioneering Treatment of HIV with Dr. Marcus Conant CMO of American Gene TechnologiesToday on the show we welcome Dr. Marcus Conant, chief medical officer of American Gene Technologies. Dr. Conant was one of the first physicians to treat AIDS in San Francisco while running the inpatient dermatology service at the University of California San Francisco. Before anyone recognized the virus or understood that it was about to become a global epidemic, Dr. Conant took the lead in forming the Kaposi’s Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. He’s dedicated much of his career to fighting for an end to HIV.Full...2023-05-0328 minFrom Lab to Launch by QualioErnie Wallerstein, Jr. CEO of Mental Health TechnologiesToday we’re excited to have with us Ernie Wallerstein, Jr., President and CEO of Mental Health Technologies or MHT. Ernie founded MHT back in 2018 and before that spent his career in big and startup tech companies. You can read his full bio in the show notes. Mental Health Technologies is a cloud-based platform for testing and screening patients for behavioral health disorders. It aids professionals in addressing the growing challenge in providing services for mental health and substance abuse. By focusing on ease-of-use for both patients and providers, objective data collection, and enhanced billing practices, MHT’s go...2023-04-1831 minFrom Lab to Launch by QualioEnabling the next generation of biomarker discovery with Dr. Mo Jain CEO of SapientToday we’re excited to have Dr. Mo Jain, CEO of Sapient. Dr. Jain or Mo as he prefers to be called is a physician-scientist with nearly 20 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Sapient is one of the largest capacity biomarker discovery labs in the world and well on its way to transform biomedicine forever. For all of our science and bio nerds, you'll sure be fascinated by the insights from Mo. https://sapient.bio/ About Mo Jain - Dr. Jain is a physician-scientist with nearly 20 year...2023-04-0527 minFrom Lab to Launch by QualioGetting Treatments to Patients Faster by Focusing on Your Strengths with Keith WoodsThere’s no question that 2022 was a tumultuous year for biotech companies. As 2023 is underway, we're talking to Keith Woods, former COO and current strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on), a biotech company whose strong earnings come amid a downturn for the wider market and especially the biotech industry in 2022. While other companies continue to face challenges in this climate, this biotech is hitting its stride – argenx has managed rapid growth, and a successful drug launch.One major factor driving argenx’s success: argenx’s seasoned COO Keith Wo...2023-03-2920 minFrom Lab to Launch by QualioWhat all MedTech Founders Should Know with Duane Mancini CEO of Project MedTechOn the show today we have Duane Mancini, CEO & Managing Partner of Project MedTech and proud to be a “nerd” of the MedTech industry. Duane has extensive experience in go-to-market strategy including regulatory & reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design & execution. With all of the complexities of running a Medtech company and taking a product to the market, Duane partners with start-ups to develop strategies and milestones.He runs the Project MedTech podcast series which has over 120 episodes. We’re excited to jump more into the medtech world and what companies need from inception to market...2023-03-1525 min