Life Science Solutions

Kymanox
  • 5.0(2개의 평가)
  • 생명 과학
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. 13시간 전

    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.

    22분

  2. 2024. 12. 09.

    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.

    34분

  3. 2024. 11. 18.

    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.

    45분

  4. 2024. 10. 14.

    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.

    26분

  5. 2024. 09. 16.

    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.

    39분

  6. 2024. 08. 12.

    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.

    29분

  7. 2024. 07. 15.

    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.

    34분

  8. 2024. 06. 17.

    Secrets of Biopharma Tech Transfers: Lessons Learned and Best Practices

    Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These transfers are pivotal but extremely complex, prone to issues from changes in facilities, equipment, materials, and process nuances. Failed or delayed tech transfers can derail entire programs, costing companies millions.  So what's the solution? In this episode, biomanufacturing veteran Marcelo Anderson provides a masterclass on mastering tech transfers through fostering cross-functional collaboration and open communication. With 27 years of experience, Marcelo emphasizes the critical "human element" often underestimated. Whether preparing for an upcoming biologics tech transfer or improving existing processes, this discussion offers a blueprint to support success. 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.

    25분
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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.

정보

  • 제작진
    Kymanox
  • 방송 연도
    2022년 - 2025년
  • 에피소드
    29
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    전체 연령 사용가
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    © Kymanox
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    Life Science Solutions

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