Life Science Solutions

Kymanox
Life Science Solutions

Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility.

  1. FEB 19

    The ten23 health Approach to Biologics Development

    How is ten23 health revolutionizing biologics drug delivery and CDMO services? In this episode, we sit down with Hans-Christian Mahler, Founder and CEO of ten23 health, to break down the latest advancements in sterile fill-finish capabilities and combination product development. From prefilled syringes to large-volume subcutaneous administration, we’ll look at how ten23 health is tackling the challenges of high-concentration, high-viscosity formulations. Plus, we’ll dig into their unique approach to integrating formulation development, manufacturing, and testing services to support complex biologics. Key Takeaways: Industry Evolution: While advancements in drug delivery and patient convenience have progressed, many challenges persist, including slow adoption of on-body injectors and functional container innovations.Subcutaneous Administration Trends: There’s a growing shift towards sub-Q administration, yet many pharmaceutical companies are hesitant to adopt these delivery methods due to concerns about volume limits, costs, and supply chain disruptions.The Role of Partnerships: Collaboration between formulation, packaging, and device companies is critical in bridging industry gaps and ensuring seamless product development.ten23 health’s Mission: By integrating development, manufacturing, and testing, ten23 health provides comprehensive solutions that enhance drug delivery and patient experience while maintaining quality and compliance.Scaling and Growth: The recent expansion of ten23 health, including the launch of the Visp Valley 2 facility, represents a significant milestone in the company’s journey to provide cutting-edge solutions in pharmaceutical manufacturing.Resources and Links: Learn more about ten23 health: ten23.healthConnect with ten23 health on LinkedIn: Ten23 Health LinkedInLearn more about Kymanox: kymanox.comConnect with Kymanox on LinkedIn: Kymanox LinkedInAbout ten23 health:ten23 health provides innovative solutions in sterile drug product development, manufacturing, and testing. With a strong focus on sustainability and collaboration, the company partners with pharmaceutical and biotech organizations to deliver high-quality, patient-centric therapies. Their expertise spans formulation development, fill-finish services, and analytical testing, ensuring seamless product development from early-stage R&D to commercial manufacturing. About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. Life Science Solutions is edited and produced by Earfluence.

    32 min
  2. JAN 21

    Disruptive Trends in Drug and Device Development, with Kymanox President Evan Edwards

    In this episode of Life Science Solutions, Evan Edwards, President of Kymanox, explores the key trends shaping the life sciences industry in 2025. From groundbreaking advancements in cell and gene therapies to the rise of GLP-1 drugs and the essential scaling of CDMO operations, Evan highlights the innovations driving product development and commercialization.  Key Takeaways: Kymanox Growth: The company is expanding its capabilities, workforce, and global footprint, now employing nearly 300 people across the U.S. and Europe.Industry Trends:Cell and Gene Therapy: Emerging targeted treatments are transforming patient outcomes and delivery methods, including potential home-based solutions.GLP-1 Drugs: These revolutionary therapies are disrupting healthcare and driving rapid market growth.Manufacturing Challenges: A rising need for capacity to meet demand for both innovative and traditional therapies.Artificial Intelligence: Kymanox is leveraging AI responsibly to enhance drug discovery, manufacturing, and regulatory processes.Strategic Focus for 2025:Doubling down on core services like product development, engineering, and regulatory strategy.Expanding into strategic services like CMC, CQV, and human factors expertise.Supporting clients in reaching critical milestones efficiently, saving time and resources.The Hypervirtual Model: Acting as a trusted co-pilot, Kymanox partners with clients of all sizes, from startups to global pharma giants, to drive innovation and commercialization. Resources and Links: Learn more about Kymanox: kymanox.comConnect with Kymanox on LinkedIn: Kymanox LinkedIn About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. Life Science Solutions is edited and produced by Earfluence.

    22 min
  3. 12/09/2024

    Project Management Strategies for Effective Communication

    In this episode, we discuss the cornerstone of successful project management: COMMUNICATION.  Join Shivali Patel as she sits down with project management experts Max Tenebaum and Natalie Hrabrick to discuss overcoming communication challenges, aligning stakeholders, and keeping teams on track. From navigating written misunderstandings to crafting effective communication workflows, this conversation is packed with actionable insights and relatable experiences.  Discover:  The critical role of communication in team alignment and project success Strategies for handling common breakdowns in project teams Tools and techniques to streamline collaboration and manage expectations Plus, enjoy a fun rapid-fire round and a role-play scenario showcasing real-world problem-solving in project management. Whether you're a seasoned PM or just starting out, this episode has something for everyone! About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    34 min
  4. 11/18/2024

    Making BioPharma Partnerships Work

    In this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of building successful partnerships in biopharma manufacturing. With over 40 years of experience, Bill shares how aligning operations, quality, and patient focus is essential for success. From preparing CDMOs for FDA scrutiny to designing flexible Quality Management Systems (QMS) and fostering patient-first cultures, this episode provides actionable insights for navigating the complexities of biologics and advanced therapies. If you're scaling operations or managing critical partnerships, this conversation is a must-listen. About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    45 min
  5. 10/14/2024

    How RNA Origami is Revolutionizing Drug Development

    In this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of Helixomer) discuss the innovative potential of RNA Origami in transforming drug development and precision medicine, and the challenges faced by startups in this complex landscape. So what exactly is RNA Origami? About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    26 min
  6. 09/16/2024

    Adopting Agile Strategies in Emerging MedTech

    In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to discuss the importance of agility, strategic planning, and value creation for life science startups. Duane shares his insights on effective fundraising, the vital role of treating consultants as team members, and the need for startups to optimize marketing and value proposition in the healthcare ecosystem.  He also delves into the significance of building a unique company culture and the phased approach to implementing quality management systems. This conversation is essential for MedTech professionals ready to take their idea from concept to commercialization, offering practical advice and real-world examples to navigate the complex landscape of medical technology innovation. About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    39 min
  7. 08/12/2024

    Balancing Claims and Compliance in Healthcare Marketing, with Group 31 CEO Crystal Weber

    Creating labeling claims that support business goals without getting into compliance issues can be a tough sea to navigate. Today, join Kymanox Director of Regulatory Affairs Stefanie Johns as she sits down with Crystal Weber, CEO of Group 31, in this episode on The Factor, to discuss the complexities of marketing in the highly regulated healthcare industry. From navigating FDA regulations to ensuring ADA compliance, Crystal shares invaluable insights on how biotech and pharma companies can effectively communicate their message while staying within legal boundaries.  Discover why early-stage planning, strategic partnerships, and a deep understanding of regulatory nuances are crucial for success in healthcare marketing. About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    29 min
  8. 07/15/2024

    Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance

    Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to inefficient servicing, increased downtime, and potential safety risks. In this episode, we explore the importance of applying humanfactors principles to medical device maintenance and servicing. Our expert guest, Avital Zik from Medtronic, discusses strategies for incorporating service personnel needs into device design, creating more user-friendly maintenance processes, and improving overall devicereliability. Rita Lin, Director of HFE at Kymanox, also offers her insight from past experiences working at the FDA and in industry. Learn how considering the full lifecycle of medical devices, from installation to repair, can enhance patient safety, reduce costs, and streamline healthcare operations. Join us as we uncover the hidden world of medical device maintenance and its impact on healthcare delivery. About the Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.   About Kymanox: Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/. The Factor is edited and produced by Earfluence.

    34 min

Ratings & Reviews

5
out of 5
2 Ratings

About

Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility.

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