From Lab to Launch by Qualio

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

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 few years. Tune in to learn how Ibex's innovations are reshaping cancer diagnostics and making a significant impact on patient outcomes.https://ibex-ai.com/ https://www.linkedin.com/in/yossimossel/ 00:00 Introduction to the Podcast00:26 Meet Joseph Mossel, CEO of Ibex01:14 The Founding and Vision of Ibex05:59 Ibex's AI Technology and Its Impact07:41 Challenges and Overcoming Them09:54 AI in Cancer Diagnostics15:12 Future of AI in Pathology17:15 Partnerships and Collaborations19:58 Advice for Labs and Entrepreneurs23:29 Ensuring AI Reliability and Quality25:48 Fun and Final Thoughts 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

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 move the clinical trial industry forward and tackle its current challenges. And it's here that Senior Director of Innovation & Program Management Sarah Englert's mission is focused...https://www.linkedin.com/in/sarah-blake-englert-70557421/https://www.thermofisher.com/us/en/home.html 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 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 manufacturing, and quality management. Their mission-driven approach revolves around simplifying bioproduction complexities with their modular, automated, and fully integrated platform. This transformative technology empowers innovators to swiftly manufacture critical biologic products precisely where they're needed most.https://www.linkedin.com/in/kerry-love-1a197811/ https://sunflowertx.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

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 patient data.CEO and co-founder Salvatore Viscomi, MD, joined Meg to talk about the Carna Health mission, where current kidney care is going wrong, and what the future holds for kidney patients.More about Dr. Viscomi:Dr. Viscomi is the CEO and co-founder of Carna Health, a Boston-based SaMD company focused on revolutionizing how chronic kidney disease is spotted and treated early.https://carna.health/ https://www.linkedin.com/in/salvatore-viscomi/ 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

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 disease detection. Dr. Hill also elaborates on the integration of lab work and data analysis in genetic research, partnerships in diagnostic advancements, the role of AI in the future of genetic testing, and the importance of quality management in product development. Additionally, he speaks about the challenges faced in implementing these technologies and how they are being addressed. The conversation concludes with Dr. Hill's vision for the future of genetic testing and his approach to preparing students for the industry's evolving landscape.00:00 Introduction to the Episode00:25 Meet Dr. Jonathan Hill01:45 Dr. Hill's Journey in Genetics03:27 Understanding DNA Methylation Sequencing06:15 Applications in Personalized Medicine15:06 Challenges in Implementing Assays18:40 Future of Genetic Testing Technology23:14 Importance of Collaborations and Partnerships26:58 Fun and Personal Insights27:43 Conclusion and Contact InformationMore about Dr. Hill:Dr. Hill is the VP of Science and Technology and a co-founder of Wasatch BioLabs, a biotechnology company committed to transforming the field of diagnostics. The company delivers reliable laboratory services, offering transparent testing and accurate results for biotech firms, patients, and research institutions.https://www.wasatchbiolabs.com/ https://www.linkedin.com/in/jonathon-t-hill/  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

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 Immunexpress01:31 Challenges and Innovations in Sepsis Diagnosis03:01 Impact of COVID-19 on Clinical Trials04:17 The Vision Behind Septicite Rapid05:17 Technical Insights into Sepsis Diagnosis14:00 Regulatory Achievements and Quality Management16:58 Integrating Septicite Rapid in Clinical Workflows24:00 Future Innovations in Sepsis Diagnostics25:34 A Personal Note from Dr. Carlson26:29 Conclusion and Farewellhttps://immunexpress.com/ https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/  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 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. David also talks about the recent advancements at Earli, their funding journey, and offers valuable insights on navigating the dynamic field of scientific innovation. The episode concludes with a light-hearted discussion about David's passion for making pizzas in his backyard wood-fired oven.00:00 Introduction and Podcast Overview00:37 Guest Introduction: David Suhy from Earli01:19 The Founding Story of Earli04:24 Earli's Unique Approach to Cancer Detection06:33 Challenges and Innovations in Cancer Treatment10:06 Clinical Trials and Lessons Learned15:30 Funding and Financial Strategies18:56 Future Plans and Developments21:14 Quality and Safety in Research23:43 Advice for Entrepreneurs and Scientists25:27 Fun Facts and Closing Remarkshttps://www.earli.com https://www.linkedin.com/in/davidsuhy/  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

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 accessibility, and the enduring stigma associated with addiction. The conversation also touches on emerging trends and the future of addiction treatment.Dr. Lee's BioJoshua specializes in medication-assisted treatment of alcohol and opioid use disorders. He conducts clinical trials and treats patients struggling with addiction as a primary care physician. As a Professor at NYU Grossman School of Medicine, he leads the Addiction Medicine Fellowship and conducts research focused on justice and community outcomes. https://www.oarhealth.com/https://med.nyu.edu/faculty/joshua-d-leehttps://x.com/drjoshuadlee00:00 Introduction and Podcast Overview00:38 Introducing Dr. Joshua Lee01:20 Clinical Trials and Medication Insights03:46 Challenges in Alcohol and Opioid Treatment08:50 Telemedicine and Its Impact11:59 Addressing Misconceptions and Barriers19:35 Success Rates and Future Trends30:14 Fun Personal Question 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 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 applications of SynerFuse's technology.Justin's BioJustin Zenanko, CPA, MDiv, is the president, CEO, and co-founder of SynerFuse, Inc., a Minnesota-based company innovating the spine industry with its integrated approach which combines spinal fusion and direct nerve stimulation to address the chronic low back pain that is unaddressed in about 40% of the 500,000 traditional spinal fusion surgeries that take place annually in the US alone. The SynerFuse approach aims to eliminate the post-surgical need for addictive opioids. Link to SynerFuse website: https://www.synerfuse.com/00:00 Introduction and Welcome00:41 Meet Justin Zinenko: From CPA to MedTech Innovator03:16 The Birth of SynerFuse: Combining Spinal Fusion with Nerve Stimulation05:29 Clinical Results and Patient Success Stories08:46 Quality and Regulatory Approaches in MedTech10:29 Future Applications and Innovations14:59 Advice for Aspiring Entrepreneurs17:51 Fun Insights and Closing Remarks 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

**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 disorders, including epilepsy, and its strategic initiatives for advancing treatments. Listen to their inspiring journey from the inception of Ovid Therapeutics to its current breakthroughs, and their perspectives on fostering a quality-driven and risk-tolerant culture in drug development.https://ovidrx.com/00:00 Introduction and Welcome00:40 Meet the Guests: Dr. Toshiya Nishi and Jason Tardia02:04 The Journey of Ovid Therapeutics03:58 Discovering Saticklistat: A Serendipitous Breakthrough08:35 Strategic Initiatives and Future Directions13:48 Collaboration and Culture at Ovid Therapeutics17:38 Ensuring Quality in Drug Development21:50 Personal Insights and Closing Remarks24:07 Conclusion and FarewellQualio 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

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 Platform, and the evolving landscape of viral diagnostics post-COVID-19. Dr. McCracken also shares insights on maintaining high-quality standards in R&D and offers advice for aspiring professionals in the fields of drug development and diagnostics.https://www.viraxbiolabs.com/00:00 Introduction and Welcome00:40 Meet Dr. Nigel McCracken01:29 Nigel's Journey in Pharmacology05:08 Innovations at Virax Biolabs09:05 Impact of COVID-19 on Viral Diagnostics12:53 Ensuring Quality in Diagnostics16:37 Future Trends in Viral Diagnostics20:20 Advice for Aspiring Researchers23:13 Nigel's Personal Insights24:20 Conclusion and FarewellQualio 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

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.Insight into the smartweight technology that sets CapeAble products apart in efficacy and style.Discussion on how CapeAble's products are making a significant impact in the medical field through non-pharmaceutical interventions.CapeAble's expansion into medical applications.https://www.capeable.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

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 transforming mental health treatment. Dr. Clark also explores Terran Biosciences' approach to overcoming drug development hurdles, emphasizing quality management and patent strategies to ensure the delivery of affordable, effective treatments. His insights offer a glimpse into the future of psychedelics in mainstream medicine and the broader implications for treating various disorders beyond mental health.https://terranbiosciences.com/ Dr. Sam Clark's LinkedIn: https://www.linkedin.com/in/sam-clark-md-phd-133139199/ 00:00 Welcome to From Lab to Launch!00:40 Introducing Dr. Sam Clark and Terran Biosciences01:23 Dr. Clark's Journey: From Academia to Neuropsychiatric Therapeutics02:48 The Renaissance of Psychedelic Therapeutics04:36 Challenges and Innovations in Drug Development08:36 Quality Management at Terran Biosciences10:23 The Future of Psychedelics in Mainstream Medicine12:46 Expanding Beyond Neuropsychiatry: Terran's Broader Impact14:02 Navigating Innovation and Ethics in Patenting17:48 Advice for Aspiring Scientists and Innovators20:42 Dr. Clark's Personal Inspirations and Closing Thoughts22:21 How to Follow Dr. Clark and Terran Biosciences23:00 Wrapping Up and How to Engage with From Lab to LaunchQualio 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

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 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.https://clene.com/ https://www.linkedin.com/in/rob-etherington-431718/ 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 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.com/ https://www.linkedin.com/in/danlunz/ 00:43 The Journey of Previse: Aiming for Early Cancer Detection05:24 The Previse Technology: A New Approach to Cancer Detection07:45 The Impact of Previse in the Medical Field10:13 Fundraising and the Future of Previse14:51 Navigating the Regulatory Landscape18:02 Balancing Innovation and Compliance21:15 Long-term Goals and Future DevelopmentsQualio 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 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 crucial role of effective writing in business and organizational decision-making and shares tips for enhancing writing skills.LinkedIn.com/in/Hurleywritehttps://www.hurleywrite.com/ 00:40 Meet the Guest: Pam Hurley02:14 Pam's Journey into Professional Writing04:06 The Impact of Effective Writing in Life Sciences08:15 Common Writing Challenges in Professional Settings16:16 The Role of Writing in Decision Making17:50 The Future of Writing: AI and Beyond19:12 Pam's Favorite Writers and Reading Habits21:42 Closing Remarks and Contact InformationQualio 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 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 today's competitive market. Looking ahead, ChromaCode expects to become a leader in developing innovative products for disease diagnosis, with a focus on patient-centered outcomes.https://www.chromacode.com/ https://www.linkedin.com/in/mark-mcdonough-b1055216/ 00:00 Introduction to the Podcast00:40 Meet the Guest: Mark McDonough, CEO of ChromaCode01:47 Mark's Journey to ChromaCode06:05 Insights on Leadership and Building High Performing Teams08:10 ChromaCode's Innovative Approach to PCR Testing10:36 ChromaCode's Contribution to Precision Medicine13:50 The Importance of Partnerships in ChromaCode's Strategy16:33 Future Prospects for ChromaCode18:27 Getting to Know Mark: Personal Interests19:13 Closing Remarks and Contact InformationAbout Mark McDonoughMark has over 25 years of experience helping build high growth HealthCare organizations. He is passionate about his team, his customers, and the patients that he and they are privileged to help serve. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and served as a US Naval Officer.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

Join 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 from users of "MyVitalC." These narratives not only shed light on the practical implications of Chris's work but also illustrate the profound impact this discovery could have on our daily lives.Whether you're a science enthusiast, a health and wellness aficionado, or simply curious about the latest in scientific breakthroughs, this episode promises to offer a fascinating blend of scientific exploration and real-world applications. Tune in to get a glimpse into the future of health science with Chris Burres guiding the way.https://www.myvitalc.com/ More about Chris BurresChris Burres is the Co-Founder of MyVital-C as well as the co-owner of SES Research Inc. and he runs a podcast about SEO marketing which is really popular. Chris is also a health expert specializing in ESS60, a Nobel Prize-winning molecule with exceptional antioxidant properties. He's been on numerous health and wellness podcasts sharing how ESS60 can revolutionize health and wellness. https://www.linkedin.com/in/chrisburresQualio 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" 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 benefits of licensing lab space, offering a hybrid model that accelerates time-to-market for biotech and pharma companies.The conversation explores how Azzur ensures GMP compliance in multiproduct facilities, emphasizing quality systems and strict agreements. Ravi elaborates on Azzur's one-stop-shop approach, providing a range of services under one roof, from testing labs to consulting. The discussion touches on the lab space shortage, both pre- and post-COVID, and the potential implications for the industry.Ravi shares insights into emerging trends, expressing particular excitement for the potential decentralization of cell therapy manufacturing near hospitals. The episode concludes on a lighter note as Ravi reveals his personal interest in geography.Connect and Learn More:For those intrigued by Azzur Group's innovative solutions, virtual facility tours and more content can be found on their YouTube channel. Additionally, the Azzur website offers a wealth of information, including recent articles and client testimonials. Listeners are encouraged to explore further at Azzur Group's Website and YouTube Channel.This episode provides a comprehensive understanding of Azzur Group's transformative contributions to the biotech and pharma sectors, offering a glimpse into the future of flexible and efficient lab spaces.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 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 provides insights into the evolving landscape of healthcare data sharing, emphasizing the potential for emerging trends and technologies to democratize healthcare data, leading to increased innovation and benefits for individuals.This episode provides valuable insights into the challenges, strategies, and future trends in healthcare data access and innovation, making it a must-listen for those interested in the intersection of technology and healthcare. Connect with Troy on LinkedIn for further discussions and updates.https://www.particlehealth.com/ https://www.linkedin.com/in/troy-bannister-259a3235/ 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 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 and pharmaceutical industries. He emphasizes the critical importance of leadership, mission alignment, and the right talent as key factors contributing to a company's success.Discussing the significance of retaining top talent, Darwin offers recommendations for organizations looking to keep their best employees. He stresses the importance of understanding a company's mission and creating a clear distinction between cultural fit and technical skills. He also highlights the need to focus on employee engagement, career growth opportunities, and providing a clear path for advancement.Darwin explains how he initiated various educational initiatives at SSI, such as the SSI Educational Webinar Series and the SSI Executive Conversations Podcast. These platforms serve as valuable resources for professionals in the life sciences industry, offering insights, knowledge, and opportunities to interact with industry experts.The conversation delves into the impact of COVID-19 on talent management and recruitment strategies. Darwin discusses how remote work, decision-making agility, and the cost of hiring have been affected. He emphasizes the increasing importance of autonomy for younger generations entering the workforce.Darwin emphasizes that attracting talent in the life sciences industry is always a challenging endeavor, with roles in clinical, regulatory affairs, scientific development, quality, and leadership positions being particularly demanding. He anticipates a growing need for commercial talent as well, driven by the burgeoning cell and gene therapy sector.Guest Speaker Bio:In this episode, we are joined by Darwin Shurig, the founder and CEO of Shurig Solutions, Inc. (SSI), a seasoned entrepreneur and talent management expert. Darwin has established a thriving executive recruiting firm that collaborates with clients to meet their crucial talent requirements, align strategic goals, and connect top performers with exceptional companies in the life sciences industry.Where to Learn More:To access more content from Darwin Shurig and SSI, you can visit their website at www.shurigsolutions.com. You can also tune in to the SSI Executive Conversations Podcast, available on various platforms including Spotify, Apple Podcasts, and their YouTube channel. For direct inquiries or contact, reach out to SSI at 317-983-HIRE or through their website.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

Sepsis 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, the importance of building a quality culture within the organization, and the future of blood culture testing. Greg emphasizes the need for evidence and the delivery of lower costs and better outcomes to gain support in the healthcare industry. He also discusses the role of non-dilutive funding sources and collaborations with key opinion leaders to drive innovation.Magnolia Medical Technologies aims to continue solving the sepsis misdiagnosis problem and expand its reach. The company's vision includes developing additional solutions to improve diagnostic accuracy in various medical testing areas. Greg envisions a future with broader adoption of their technology, significantly reducing sepsis misdiagnosis and improving patient outcomes.Guest Speaker Bio:Greg Bullington is the co-founder and CEO of Magnolia Medical Technologies. Greg is an accomplished leader with a wide range of experience, having worked with senior executive teams in over 50 companies, ranging from Fortune 500 corporations to venture-backed startups. He's also an expert in intellectual property with numerous patents to his name. Greg's mission with Magnolia Medical Technologies is to eliminate the misdiagnosis of sepsis, a condition caused by blood infections and a leading cause of death, costs, and readmissions in hospitals nationwide.Where to Learn More:Website: Magnolia Medical TechnologiesLinkedIn: Company Profile and Greg Bullington's ProfileThis podcast episode provides valuable insights into the mission, innovations, and future goals of Magnolia Medical Technologies in the field of sepsis diagnosis. Listeners interested in healthcare innovation and improving patient outcomes will find this episode informative and engaging.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" 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 outdated practices and inefficiencies in the industry. He explains how Grapevine Technologies aims to address these issues by providing a marketplace for medical practices and hospitals to connect with suppliers and optimize their supply chain.Luca also shares insights into the challenges and opportunities in the healthcare supply chain industry for 2024 and beyond, emphasizing the increasing demand for change and transparency.Listeners can find more information and updates on Grapevine Technologies by visiting their website (www.gograpevine.com) and following them on LinkedIn.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 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/QA Masters Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements. Prior to this, Dave was the Global Regulatory Director of  Strategic Relationships at Colorcon, Inc.Enjoy!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

Dr. 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 exactly what Phil and his team is working on - how to optimize human movement and injury risk mitigation. Any of us who have been to physical therapy for example, can learn something new today. Show notes:Sparta Science websitePhil Wagner on LinkedinQualio 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 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.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 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 author of best sellers What Customers Want and Jobs-to-be-Done: Theory to Practice.He is eager to continue sharing insights that will inspire leaders of organizations, executive teams, and innovators to change the way the world innovates.Show notes:https://strategyn.com/https://www.linkedin.com/in/tonyulwick/https://www.youtube.com/user/strategynQualio 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

Dr. 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 is full of start-up companies and students interning or working for these companies. About innovATEBIO www.innovATEBIO.org InnovATEBIO, the National Biotechnology Education Center funded by NSF (National Science Foundation). The center was funded 4 years ago at 7.5M for 5 years to coordinate over 134 two-year biotechnology programs and their educationalpartners for the purpose of creating a biotechnology workforce focusing on technician education. Every senior scientist needs 5 to 7 technicians for R&D, biomanufacturing and quality assurance and regulatory matters. (National Science Board report 2019). At the moment, there is not enough technicians being produced to meet the needs of the US biotechnology industry.About Dr. Fletcherhttps://innovatebio.org/iab-leadershipDr. Linnea Fletcher enjoys all forms of exercise but especially biking, hiking, and swimming. Her favorite pastimes are family events in the outdoors and travel. She received her Ph.D. in microbiology from the University of Texas at Austin, did two postdocs one at the Southwestern Medical Center and another in the Biochemistry Department at the University of Texas. She joined Austin Community College as a Department Chair in Biology and started the Biotechnology Program in 1999. At the same time, she joined the first NSF Funded National Biotechnology Education Center, Bio-Link and received her first NSF funded ATE grant to start Biotechnology high school programs in Texas. She worked as an NSF Program Officer from2008 to 2010 and was involved setting up the first Vision and Change Meeting. Once back on the job as Biotechnology Department Chair in 2015, she received an Emerging Technology Fund Grant to build a Bioscience Incubator at ACC and several additional grants to equip it. Today the incubator is full of startup companies and students interning or working for these companies. She was PI of the AC2 Bio-Link Regional Center, and is now the PI of InnovATEBIO, the NSF funded National Biotechnology Center. Combining economic development with educational opportunities is her passion. She is also PI and Co-PI on several other grants associated with the work of the center. Linnea Fletcher believes the best way to engage educate students is to involve them in industry projects from high school on –and show them that their education has a purpose and matters—involvement in startup companies does this!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

Dr. 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.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'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 about improving the lives of others which aligns with Qualio's vision.  Meg started with us in 2020 building out our own Quality System to achieve our ISO 9001 certification, followed by ISO 27001 certification in 2022.  Meg was also an instrumental part of the Qualio Plus program, where we provide the necessary procedures and advisory level guidance to our customers as they're coming onboard with Qualio.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

Is 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 Standing Out." Beginning as a child and then into adulthood he suffered years of trauma at varying levels before stumbling across Dr. Lipov and the Dual Sympathetic Reset Procedure or DSR. Today we're going to dive into their groundbreaking revelation that psychological trauma manifests as a physical injury that can be seen and monitored on a brain scan, and their revolutionary approach to resetting the sympathetic nervous system that has helped countless patients suffering from chronic pain, anxiety, PTSD, and other related conditions.THE INVISIBLE MACHINE: The Startling Truth About Trauma and the Scientific Breakthrough That Can Transform Your Life [April 11, 2023]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

Hypertension 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 how the world's most common disease – hypertension – is understood and managed.  Also an angel investor and advisor, he is passionate about applying technology to solve practical problems in medicine and believes strongly in the power of positive thinking and collaboration.Website: www.aktiia.com Social media: @aktiiaglobal LinkedIn: linkedin.com/in/jshahmdQualio 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 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 bio Marcus A. Conant, MDChief Medical Officer at American Gene TechnologiesMarcus A. Conant, MD is a physician who treated thousands of HIV patients in the early 80s 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, he took the lead in forming the Kaposi's Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. Marcus conducted early clinical trials, persevering despite seeing 94% of patients die during the epidemic's first years. His clinical experience sensitized him to the suffering caused by the disease. As a physician with a holistic perspective, his work expanded beyond the strictly clinical, to include education, research, and advocacy. Marcus is currently a clinical professor emeritus at the University of California Medical Center in San Francisco. He has published more than 70 articles on the treatment of AIDS, testified in front of Congress multiple times, and is a powerful advocate for the LGBTQ community.LinksMarcus Conant, MD, LinkedIn: https://www.linkedin.com/in/marcus-conant-056699229/American Gene Technologies Website: https://www.americangene.com/American Gene Technologies LinkedIn: https://www.linkedin.com/company/1127234/American Gene Technologies Facebook: https://www.facebook.com/amerigene/American Gene Technologies Twitter: https://twitter.com/americangeneAmerican Gene Technologies Instagram: https://www.instagram.com/americangenetechnologies/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 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 goal is to horizontally integrate the entire mental health process for healthcare professionals.About ErnieErnie Wallerstein is of Cuban decent and has over 30 years of executive management and sales experience in software and cloud computing. Prior to founding MHT in 2018, Ernie was the president of Americas, for Enghouse Interactive, a publicly traded telecommunications company. Prior to Enghouse, Ernie Wallerstein held management positions in a tech start-up that went public as well as the SVP of Sales in a $500M+ company that was sold to private equity. Ernie enjoys golfing and spending quality time with his family and friends.  But most of all Ernie is proudest of his two sons, Eric who lives in Manhattan and writes for the Wall Street Journal and Nicholas who is a sophomore at Marquette University.https://www.mhtech.comhttps://www.linkedin.com/company/mentalhealthtech/https://www.linkedin.com/in/ernie-wallerstein-jr-6906081Qualio 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 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 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Prior to founding Sapient, he formed and was director of Jain Laboratory at the University of California San Diego (UCSD). There he led a multi-disciplinary research team of chemists, engineers, mathematicians, epidemiologists, and physicians to develop next-generation rapid liquid chromatography-mass spectrometry (rLC-MS) systems to probe the non-genetic landscape of disease across population-scale human studies. His work was supported by the National Institutes of Health Outstanding New Environmental Scientist (ONES) Program grant and over $30M in federal, foundation, and industry funding. Dr. Jain founded Sapient in 2021 as a spinout of Jain Laboratory to expand upon the mission of accelerating human discovery and drug development through the nexus of high throughput analytical mass spectrometry, computational biology, and population-scale clinical studies. As CEO, he develops and directs the organization's strategy and guides Sapient's scientific, business, and technical operations. Dr. Jain has held faculty positions at UCSD since 2013, most currently as a Professor of Medicine and Pharmacology. He obtained his MD and PhD from Boston University School of Medicine, and subsequently performed clinical residency and fellowship training in Internal Medicine, Cardiology, and Preventative Cardiology at Brigham and Women's Hospital, Harvard Medical School. His postdoctoral work was performed at the Broad Institute and Massachusetts General Hospital in the HHMI laboratory, developing methods for large scale, mass spectrometry-based metabolomics and integrative computational analysis to define the role of bioactive metabolites in human disease.https://www.linkedin.com/in/mo-jain-md-phd-373895ba/ 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

There'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 Woods and his management philosophy of sustainable growth.https://www.argenx.com/ https://www.linkedin.com/in/keith-woods-5b8b67117/More about KeithKeith is was COO since 2018 and is currently a strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on). He comes with 25+ years of leadership experience in the biopharmaceutical industry, with the likes of Alexion, Roche, and Amgen. He has sage advice to offer about navigating market downturns, while still managing to grow and scale sustainably.**UPDATE** After recording this interview Keith transitioned from COO to Advisor on the argenx Board of Directors.  https://www.globenewswire.com/news-release/2023/03/02/2618906/0/en/argenx-Announces-Planned-Transition-of-Chief-Operating-Officer.html About argenxThe team at Argenx has created an antibody innovation ecosystem where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies. We'll get more into their discoveries, culture, and how our listeners can bring about innovation by focusing more and more on 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

On 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. duane.mancini@projectmedtech.com Project Medtech Webpage Project Medtech LinkedInDuane Mancini LinkedInQualio 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

Chuck Rinker, CEO of PRSONAS, a self-proclaimed Human-AI Innovator, joins the podcast to discuss programming humanity into AI and revolutionizing the clinical trial industry through their iHealthAssist product. Chuck has gone from developing black-ops military tech and NASA/space-borne avionics through gaming to the creation of nuMedia Innovations and the patented technologies behind it including the Digital Personality Engine that brings human engagement to self-service solutions for airports, hospitals, and commercial markets. Listen how this applies to the healthcare and life science industries.https://www.prsonas.com/https://www.linkedin.com/in/chuckrinker/More about ChuckMy professional career has taken me from developing black-ops military tech and NASA/space-borne avionics through gaming, including directing the NCAA / Madden series of games for EA Sports. This lead to the creation of nuMedia Innovations and the patented technologies behind it. Our premier offering is the PRSONAS™ Digital Personality Engine bringing human engagement to self-service solutions for airports, hospitals, and commercial markets.About PRSONASSince inception, the team at PRSONAS have worked passionately to implement their vision of a digital workforce - empowering companies and organizations to automate the mundane, freeing time for human innovation. Leading international innovators such as Google for Entrepreneurs, Silicon Valley Open Doors, and FGNoviteiten Juryprijs have recognized us for our efforts.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 Michael Tarselli Chief Scientific & Knowledge Officer of TetraScience. Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. You can read the full bio in the show notes. TetraScience is bringing the future of scientific data to today and has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, and data science partners, creating seamless interoperability and an innovation feedback loop that will drive the future of life sciences and the delivery of life-saving therapeutics. More about Mike TarselliChief Scientific & Knowledge Officer of TetraScience, Mike Tarselli, explores the Tetra Scientific Data Cloud™ through knowledge capture, GxP compliance, and use case research. Previously, Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. Mike received his Ph.D. from UNC Chapel Hill, completed postdoctoral work at Scripps Research, and his MBA through Quantic School of Business & Technology.Show Notes:Tetra Science Website - https://tetrascience.com/Demo of TetaScience - https://www.tetrascience.com/demoBenchmark Data from TetraScience  -https://go.tetrascience.com/researchreport_Scientific-Data-Imperative-Establishing-a-New-Benchmark-After-Two-Decades.htmlGXP Solution Brief - https://www.tetrascience.com/solution-brief/gxp-with-tetra-scientific-data-cloudQualio 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 Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that connects labs, clinicians and consumers. Listen to get more details about how 1Health is bringing diagnostic to the modern age. We love the mission of 1Health which is to bring advanced diagnostics to market faster and to make them more accessible, affordable and simple. Love that and it's similar to our mission at Qualio. About Mehdi MaghsoodniaMehdi is an industry fellow at UC Berkeley where he teaches innovation and entrepreneurship. He earned his Bachelor's at UC Berkeley and his MS from Stanford with an emphasis in AI and Machine learning. https://1health.io/https://www.linkedin.com/in/mmaghsoodnia/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

What does a modern lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make an impact. Today Nathan Clark, Co-founder of Ganymede, one of the fastest-growing software startups in biotech joins to talk about how to automate and integrate basically everything in a lab. Before Ganymede Nathan was a product manager at Benchling which is another darling startup in biotech we've had our eyes on. You can read his full bio in the show notes but we're excited to have him on today to talk about how the lab of the future will look and much much more.About Nathan ClarkNathan Clark is the Co-Founder of Ganymede.bio, one of the fastest-growing software startups in biotech. Ganymede is the modern, cloud-native, data platform for life sciences companies, and it's focused on integrating physical lab instruments with digital workflows. Prior to Ganymede, Nathan was the product manager at Benchling for Machine Learning and Insights Analytics. He also has a background in financial technology and trading, and notably launched affirm.com/savings.https://www.linkedin.com/in/nathan-clark-4b850134/About GanymedeGanymede is the only whole-lab automation and data integration platform. Connect any lab instrument with any app or pipeline, all in one simple low-code platform.https://www.ganymede.bio/ 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

Dr. Brian Fengler joins us on the show to talk about the latest in healthtech and innovating EHR technology to save lives in fewer clicks. Brian is the Co-Founder and Chief Medical Officer of EvidenceCare (recently named as an Inc. 5000 Fastest-Growing Company), a company that provides a clinical decision support system (CDSS) that's uniquely integrated with the Electronic Health Record (EHR) to optimize clinician workflows.Dr. Fengler authored a treatment protocol for Pulmonary Embolisms when he was a resident at The University of Virginia. Despite being an expert in the field, he encountered a challenge while treating a 36-week pregnant patient suffering from a massive pulmonary embolism. Like 80% of healthcare decisions, he had to make a snap decision based on a quick internet search. Even though he was able to save both the mother and the unborn baby, he realized there was a gap in evidence-based information available to providers when they need it the most.Looking to fill the gap in 2014, Brian founded EvidenceCare with Co-Founder, Jim Jamieson, to create software that would help physicians make better decisions for their patients and hospital. Before EvidenceCare, he was an Assistant Professor of Emergency Medicine at St Thomas Midtown and Rutherford Hospitals, one of the Founding Physicians and Managing Partners of Physicians Urgent Care, and a partner-owner of the Middle Tennessee Emergency Partners physician group. Dr. Fengler is now revolutionizing decision support at the bedside by providing what clinicians need to give better, evidence-based care.Today, Brian shares more about his journey starting a healthcare tech company, EHR innovation, optimizing clinical workflows, and how the healthcare system can and should be improved.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've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to be actual engineers in the traditional sense (like mechanical engineering) - Matt Wictome's children think this way. But Matt explains how quality really is an engineering function because processes, products, and companies are being built or fixed—just as a mechanical engineer may build or fix an airplane. Tune into this episode to learn more about how quality can be a central part of meeting patient needs. About Matt and Datod ConsultingMatthew P. Wictome, PhD, is Managing Director and founder of Datod Consulting. Datod specializes in building better and more effective Quality organizations. Over the past thirty years he has worked closely with a wide range of companies implementing impactful change to better serve the customer, benefit the shareholder, and improve regulatory compliance. As well as holding qualifications in lean & Six Sigma he is an ISO 13485 Quality System lead auditor. He holds a PhD and graduate degree in Biochemistry and an Executive Masters in Strategy, Change and Leadership with the University of Bristol.  He is passionate in designing and implementing quality systems that are effective, efficient and outcome driven. His interests include how organizations function in the real world and the role of organizational culture has on the management of quality. Datod's mission is to be the go-to partner for medical device companies who want to transform their Quality organizations to better serve their patients and grow their businesses.www.datod-consulting.co.ukQualio 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're going to deviate from our typical life sciences for just a few moments just for fun to talk about dogs. We've heard about dogs using their olfactory system to detect biologic changes related to disease. Having a bit of a soft spot for dogs ourselves here at Qualio, when our friend Kayla Fratt reached out to be on the show, we thought it'd be fun to hear about her work in ecology and in the field doing conservation work.Kayla is the founder of K9 Conservationists and Journey Dog Training. She trains dogs to detect data for researchers, agencies, and NGOs. Along with the rest of the K9 Conservationists team, Kayla travels the world collecting data with her dogs and offering support to conservation detection dog programs. As a dog lover myself I'm thrilled to chat with Kayla today and how dogs are leaving their “paw prints” on the world. About KaylaKayla Fratt is the founder of K9 Conservationists and Journey Dog Training. With her nonprofit K9 Conservationists, Kayla trains dogs to detect data for researchers, agencies, and NGOs. Along with the rest of the K9 Conservationists team, Kayla travels the world collecting data with her dogs and offering support to conservation detection dog programs. Her other business, Journey Dog Training, provides the financial stability and freedom to pursue the nonprofit. Journey Dog Training offers free and low-cost behavior advice to owners struggling with their pet's behaviors.Show notes:k9conservationists.orgjourneydogtraining.comPatreon.com/k9-conservationistshttps://www.instagram.com/k9.conservationists/ https://www.facebook.com/k9conservationists https://twitter.com/kaylafratthttps://www.linkedin.com/in/kayla-fratt/ 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're excited to dive into the world of full-service medical outsourcing with Jeff Barrett, President and CEO OF J-Pac Medical. Jeff Barrett has more than 25 years of experience building high-growth medical product-based companies. He leads the advancement of J-Pac's growth strategy, pursuing opportunities to further drive adoption of the company's offerings and optimizing capabilities to better serve customers.Prior to joining J-Pac Medical, Barrett held CEO positions at GI Supply and Optim LLC and Vice President of Operations roles at Haemonetics and Aspect Medical Systems. He is also a successful entrepreneur. By applying his operational and engineering aptitude, Barrett founded Eggrock Modular Solutions, which became a disruptive business in the building technology industry. Barrett has proven expertise building and managing high performance management teams, developing and implementing optimized operating infrastructure and manufacturing processes, and both improving existing product pipelines and growing new ones.Barrett holds an MBA from Boston University's Graduate School of Management, a B.S. in industrial engineering, and a B.A. in economics from Rutgers University.About J-Pac MedicalJ-Pac Medical has a 40-year track record of building industry partnerships based on trust, transparency, technical expertise and quality work above all else.To learn more about our journey to becoming the unique full-service medical outsourcing provider we are today, read our company history here.Show notesQualio website:https://www.qualio.com/Previous episodes:https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez

Today, we are chatting with Navid Alipour. Navid is the founder and CEO of AI Med Global. Navid believes that with consistent advancements in the healthcare industry, the best care is even more accessible than ever before. When treating cancer, Oncologists are attempting to match the best course of treatment to the individual but every cancer is as unique as the patient!His company, AI Med Global is making curated medicine accessible to cancer patients all over the world. By utilizing genetic information and a cleverly programmed AI, the technology behind CureMetrix and CureMatch are saving lives and improving healthcare. Listen in this chat with Navid to learn more about how advanced AI is allowing curated individualized treatments for cancer and other exciting progress in the AI and medical industry. More about Navid:Navid Alipour is the Chief Executive Officer at AI Med Global, a company focused on Artificial Intelligence Technology that improves healthcare and helps save lives. AI Med Global is a roll-up of two companies Navid cofounded, CureMetrix and CureMatch. He is also a founder of AI focused VC fund, Analytics Ventures. Through the founding of multiple Artificial Intelligence (AI) companies, Navid is a long-time entrepreneur in the AI space with an emphasis on the convergence of AI and the life sciences, which is also called Wellness Science. He seeks to identify scientists and domain experts in their respective fields to that are solving massive pain problems to take to market, by building companies from inception. While he is a VC and part of the founding of Analytics Ventures, he considers himself an entrepreneur at heart.Links:https://conquer-magazine.com/issues/2022/vol-8-no-4-august-2022/1895-precision-medicine-might-have-made-a-difference-for-my-mom-it-could-help-patients-with-cancer-todayhttps://academic.oup.com/jbi/advance-article-abstract/doi/10.1093/jbi/wbac046/6693780?login=falsehttps://www.linkedin.com/in/navid-alipour-a295777/https://aimedglobal.com/Qualio website:https://www.qualio.com/Previous episodes:https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez