From Lab to Launch by Qualio-logo

From Lab to Launch by Qualio

Business & Economics Podcasts

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA

Location:

United States

Description:

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA

Language:

English


Episodes
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Combatting the Opioid Crisis with Technology with Justin Zenanko CEO of SynerFuse

7/16/2024
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 Bio Justin 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 Welcome 00:41 Meet Justin Zinenko: From CPA to MedTech Innovator 03:16 The Birth of SynerFuse: Combining Spinal Fusion with Nerve Stimulation 05:29 Clinical Results and Patient Success Stories 08:46 Quality and Regulatory Approaches in MedTech 10:29 Future Applications and Innovations 14:59 Advice for Aspiring Entrepreneurs 17:51 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

Duration:00:21:10

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Epilepsy Breakthroughs and Beyond with Jason Tardio and Toshiya Nishi from Ovid Therapeutics

6/28/2024
**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 Welcome 00:40 Meet the Guests: Dr. Toshiya Nishi and Jason Tardia 02:04 The Journey of Ovid Therapeutics 03:58 Discovering Saticklistat: A Serendipitous Breakthrough 08:35 Strategic Initiatives and Future Directions 13:48 Collaboration and Culture at Ovid Therapeutics 17:38 Ensuring Quality in Drug Development 21:50 Personal Insights and Closing Remarks 24:07 Conclusion and Farewell 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

Duration:00:24:36

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Pioneering Viral Diagnostics with Dr. Nigel McCracken COO of Virax Biolabs

6/18/2024
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 Welcome 00:40 Meet Dr. Nigel McCracken 01:29 Nigel's Journey in Pharmacology 05:08 Innovations at Virax Biolabs 09:05 Impact of COVID-19 on Viral Diagnostics 12:53 Ensuring Quality in Diagnostics 16:37 Future Trends in Viral Diagnostics 20:20 Advice for Aspiring Researchers 23:13 Nigel's Personal Insights 24:20 Conclusion and Farewell 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

Duration:00:26:07

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Lowering Anxiety using Smart Weight Technology with Marna Pacheco Founder of CapeAble Weighted Products

5/30/2024
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: 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

Duration:00:22:37

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Transforming Neuropsychiatric Therapeutics with Dr. Sam Clark, CEO of Terran Biosciences

5/15/2024
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 Biosciences 01:23 Dr. Clark's Journey: From Academia to Neuropsychiatric Therapeutics 02:48 The Renaissance of Psychedelic Therapeutics 04:36 Challenges and Innovations in Drug Development 08:36 Quality Management at Terran Biosciences 10:23 The Future of Psychedelics in Mainstream Medicine 12:46 Expanding Beyond Neuropsychiatry: Terran's Broader Impact 14:02 Navigating Innovation and Ethics in Patenting 17:48 Advice for Aspiring Scientists and Innovators 20:42 Dr. Clark's Personal Inspirations and Closing Thoughts 22:21 How to Follow Dr. Clark and Terran Biosciences 23:00 Wrapping Up and How to Engage with From Lab to Launch 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

Duration:00:23:29

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Treating Neurodegenerative Diseases with Rob Etherington, CEO of Clene Nanomedicine

4/24/2024
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

Duration:00:26:09

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Saving Lives by Cancer Prediction and Detection with Dan Lunz, CEO of Previse

3/27/2024
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 Detection 05:24 The Previse Technology: A New Approach to Cancer Detection 07:45 The Impact of Previse in the Medical Field 10:13 Fundraising and the Future of Previse 14:51 Navigating the Regulatory Landscape 18:02 Balancing Innovation and Compliance 21:15 Long-term Goals and Future Developments 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

Duration:00:25:17

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The Power of Effective Writing in the Life Sciences Industry with Pam Hurley, Founder of Hurley Write

3/13/2024
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/Hurleywrite https://www.hurleywrite.com/ 00:40 Meet the Guest: Pam Hurley 02:14 Pam's Journey into Professional Writing 04:06 The Impact of Effective Writing in Life Sciences 08:15 Common Writing Challenges in Professional Settings 16:16 The Role of Writing in Decision Making 17:50 The Future of Writing: AI and Beyond 19:12 Pam's Favorite Writers and Reading Habits 21:42 Closing Remarks and Contact Information 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

Duration:00:22:59

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Advancing Cancer Diagnostics with Mark McDonough, CEO of Chromacode

2/26/2024
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 Podcast 00:40 Meet the Guest: Mark McDonough, CEO of ChromaCode 01:47 Mark's Journey to ChromaCode 06:05 Insights on Leadership and Building High Performing Teams 08:10 ChromaCode's Innovative Approach to PCR Testing 10:36 ChromaCode's Contribution to Precision Medicine 13:50 The Importance of Partnerships in ChromaCode's Strategy 16:33 Future Prospects for ChromaCode 18:27 Getting to Know Mark: Personal Interests 19:13 Closing Remarks and Contact Information About Mark McDonough Mark 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

Duration:00:20:35

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Unlocking Longevity using ESS60 with Chris Burres Co-Founder of MyVitalC

1/23/2024
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 Burres Chris 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/chrisburres 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

Duration:00:27:15

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Innovative Lab Spaces and Cleanrooms on Demand with Azzur Group's Ravi Samavedam

1/9/2024
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

Duration:00:18:05

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Transforming Healthcare Access: Navigating Challenges and Unlocking Data with Particle Health's Troy Bannister

12/7/2023
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

Duration:00:23:21

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Navigating Talent Management Challenges in Life Sciences with Darwin Shurig CEO of Surig Solutions, Inc.

11/15/2023
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: 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

Duration:00:35:22

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Eliminating Misdiagnosis of Sepsis with Greg Bullington, CEO of Magnolia Medical Technologies

10/27/2023
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: Magnolia Medical TechnologiesCompany ProfileGreg 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

Duration:00:26:06

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Revolutionizing Healthcare Supply Chains with Luká Yancopoulos, CEO of Grapevine Technologies

9/21/2023
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

Duration:00:27:24

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Regulatory and quality expertise for solving customer problems with David R. Schoneker from Black Diamond Regulatory Consulting

8/24/2023
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

Duration:01:03:28

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The Moneyball for Injuries with Dr. Phil Wagner CEO & Founder of Sparta Science

8/9/2023
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 website Phil Wagner 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

Duration:00:19:23

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Treating Cancer using Targeted Radiotherapeutics with Jack Hoppin and John Babich of Ratio Therapeutics

7/26/2023
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

Duration:00:27:18

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Outcome-Driven Innovation® with Tony Ulwick, CEO of Strategyn

7/12/2023
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/strategyn 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

Duration:00:24:11

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Amazing biotech at high school incubators with Dr. Linnea Fletcher

6/28/2023
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 educational partners 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. Fletcher https://innovatebio.org/iab-leadership Dr. 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 from 2008 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

Duration:00:24:10