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Life Science Solutions
Kymanox
35 episodes
1 week ago
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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Life Sciences
Science
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All content for Life Science Solutions is the property of Kymanox and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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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Life Sciences
Science
Episodes (20/35)
Life Science Solutions
The Blueprint for Science Marketing Success with Elizabeth Chabe

In this episode of Life Science Solutions, we’re joined by Elizabeth Chabe — author of The Giant’s Ladder and CEO of High Touch Group — to unpack one of the most underestimated challenges in life sciences: how to market innovation without losing trust, clarity, or credibility.

From childhood ventures to advising billion-dollar diagnostics companies, Elizabeth’s journey is a masterclass in what it really takes to move science from the lab to the world stage. She shares why so many scientists struggle to communicate their value, how to align messaging with your stage of growth, and why strategic marketing isn’t about selling hype — it’s about building trust.

Whether you're pitching to investors, navigating a product launch, or trying to explain complex science to non-technical stakeholders, this conversation offers a framework to help you:

  • Lead with clarity, not jargon

  • Tell the right story for where you are today

  • Build confidence and credibility at every stage of development

🔗 This episode is essential listening for founders, product leads, and commercial teams working to bring science-based solutions to life — and to market.

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1 week ago
33 minutes

Life Science Solutions
How Startups and Industry Support Each Other

In our latest Life Science Solutions podcast, we sit down with Lydia Thomas from UNCW’s Center for Innovation and Entrepreneurship to talk about the real-world gaps academic startups face—and how her team is helping solve them.

From lacking investor networks to navigating IP challenges, Lydia shares how CIE supports faculty and students developing high-potential innovations. We also dive into the Blue Economy Index, plastic waste reduction in drug delivery, and how startups can partner with established life science companies to scale breakthrough technologies.

Whether you’re in pharma, biotech, or innovation strategy, this episode explores why the next big thing might just be sitting in a university lab—and what it’ll take to bring it to market.


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1 month ago
18 minutes

Life Science Solutions
Capturing Venture Capital: What Makes Life Science Startups Stand Out to Investors


In this special episode recorded live at CED Venture Connect, host Chris Adkins sits down with Dave Ousterout, Co-Founder and General Partner at CapeFear Biocapital. Drawing from his unique journey as both a biotech entrepreneur and now a venture capital investor, Dave shares what it really takes to stand out in the early-stage life sciences space.


Listeners get a behind-the-scenes look at how CapeFear Biocapital is fueling North Carolina’s innovation ecosystem with pre-seed investments tailored for biotech startups. Dave unpacks the key attributes his team looks for in founding teams, the value of thoughtful operational planning, and how to think strategically about capital efficiency and milestone-driven development.


The conversation blends practical fundraising advice with philosophical reflections on trust, focus, and resilience—offering real value for founders, investors, and anyone passionate about advancing healthcare innovation.


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2 months ago
27 minutes

Life Science Solutions
Manufacturing Intelligence for Bioprocessing

On this episode, host Chris Adkins speaks with Gerry Farrell, a seasoned expert with over two decades of experience in the CDMO space and current executive advisor at Kymanox. Their discussion explores three key areas of the evolving bioprocessing landscape: 

1. The Evolution from Antibodies to Gene Therapy. How bioprocessing has grown increasingly complex from the relatively straightforward days of monoclonal antibody manufacturing to today's gene therapy challenges. Gerry highlights the critical importance of analytical development for early-stage companies and why having the right methods—not necessarily more methods—is crucial for success. 

2. Economic Realities and CDMO Dynamics. Gerry offers perspectives on the current economic environment facing biotech, including investor sentiment and funding challenges. The discussion unpacks the paradox of some CDMOs expanding capacity while others close facilities, and explores the strategic considerations driving companies toward either in-house manufacturing or outsourcing. 

3. Manufacturing Technologies and Future Trends. The episode delves into the ongoing debate between single-use and stainless steel manufacturing systems, with insights into why large-scale stainless steel facilities continue to dominate commercial antibody production. Gerry shares thoughts on emerging technologies, the potential impact of AI and machine learning on bioprocessing, and how sponsor companies can better leverage CDMO expertise to navigate these evolving landscapes. 

Resources and Links:

  • Learn more about Kymanox: kymanox.com
  • Connect 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 Walk West.

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3 months ago
29 minutes

Life Science Solutions
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.health
  • Connect with ten23 health on LinkedIn: Ten23 Health LinkedIn
  • Learn more about Kymanox: kymanox.com
  • Connect with Kymanox on LinkedIn: Kymanox LinkedIn

About 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.

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4 months ago
32 minutes

Life Science Solutions
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.com
  • Connect 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.

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5 months ago
22 minutes

Life Science Solutions
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.

Show more...
6 months ago
33 minutes

Life Science Solutions
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.

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7 months ago
44 minutes

Life Science Solutions
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.

Show more...
8 months ago
25 minutes

Life Science Solutions
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.

Show more...
9 months ago
38 minutes

Life Science Solutions
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.

Show more...
10 months ago
29 minutes

Life Science Solutions
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 human
factors 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 device
reliability. 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.

Show more...
11 months ago
33 minutes

Life Science Solutions
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.

Show more...
1 year ago
24 minutes

Life Science Solutions
Aligning with the Right CMO

Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find the right one for them? We're joined by two Kymanox executives, Ryan Doxey, Senior Director of Technical Services, and Jason Martin, Senior Director of CGXP Technical Services.

They highlight the importance of finding a CMO with the right capabilities and expertise, as well as the significance of project managers in successful collaborations. Trust, cultural fit, and regulatory compliance are crucial factors when selecting a CMO - and there are complexities of CMO selection and strategic planning in delivering better therapies to patients.

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.

Show more...
1 year ago
33 minutes

Life Science Solutions
Mastering the Product Development Lifecycle for Commercial Readiness

How can medical device and combination product companies bridge the difficult "valley of death" between early product design and commercial readiness? 

In this episode, Nick Ciccarelli, Chief Technology Officer at Kymanox, shares insights into their integrated product design, development, and commercialization approach with host Evan Edwards, Chief Innovation Officer. He explains how their cross-functional teams leverage diverse expertise to provide streamlined end-to-end services tailored to each client's specific stage in the product lifecycle. The podcast covers understanding phase-appropriate activities, using the right tools like prototyping and human factors studies at the optimal times, and
successfully navigating that critical path to market viability.

Other topics include industry trends like minimally invasive surgery, drug delivery innovation, sustainability balanced with usability, connectivity, and the role of AI.

Throughout, Nick emphasizes focusing on the core goal of safe and effective patient treatment.

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.

Show more...
1 year ago
25 minutes

Life Science Solutions
QMSR, ISO 13485:2016, and What It All Means for Medical Device Risk Management

Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is the cornerstone to success. 

The new Quality Management System Regulation (QMSR) from the FDA represents a significant shift in expectations for how medical device companies manage their quality systems. At its core, QMSR requires companies to take a more process-based and risk-based approach that fully integrates risk management activities throughout the entire product lifecycle and organizational processes.

This episode features:
Naveen Agarwal, Ph.D. - Principal and Founder, Let’s Talk Risk!
Nathan Blazei, Senior Director, Regulatory Affairs, Kymanox 
with your host Shannon Hoste, Vice President of Human Factors Engineering at Kymanox 

Key Points:

- Risk management can no longer be a separate activity but must be embedded into all quality processes under QMSR.
- Process mapping and understanding information/data flows is critical for building an integrated risk management system.
- A lifecycle approach to continually updating risk assessments based on real-world data is expected, not just a one-time activity.
- The two-year transition period allows companies to identify gaps, update processes, and make a plan to implement QMSR’s risk-based expectations.
- While not mandating ISO 14971 specifically, the FDA acknowledges it provides an excellent model for risk management that most companies should leverage.


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.

Show more...
1 year ago
50 minutes

Life Science Solutions
Kymanox: Two Decades of Excellence

Take a trip to 2004 for a moment. Yahoo was the #1 website on the planet. Mark Zuckerberg came up with Facebook. 14-year-old Taylor Swift signed on with Sony to pursue her career in country music.

 

And from Stephen and Sarah Perry's perspectives, the Life Science industry was in desperate need of improvement. There was a lot of bureaucracy and red tape, and modern medicine that needed to be in patients' hands were slowed down by extra expense and scheduling delays.

 

So, they did something about it, creating Kymanox, which means Ideal Knowledge Transfer.

 

Today, 20 years and 300+ employees later, Stephen and Sarah share their first memories of starting Kymanox, the challenges faced, and the pivotal moments that shaped its growth and success. We also hear from employees who have been involved in the company's growth and success. They reflect on their experiences, the culture, and the impact Kymanox has had on their professional development and personal growth.

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.

Show more...
1 year ago
58 minutes

Life Science Solutions
The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing

Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and manufacturing. But it’s not always easy to figure out all the design considerations that make products cost efficient, sanitary, AND sustainable. 


So how can we do it as an industry?


Today, Cormac O’Prey, Principal and Director at the Kestrel Consultancy Group, and Agilis VP of Human Factors Engineering Shannon Hoste explore strategies for reducing waste, meeting NHS sustainability goals, and the work being done on standards by the BSI and ASTM.

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.

Show more...
1 year ago
55 minutes

Life Science Solutions
AI Summit Highlights: Transparency, Bias in AI, and Exciting Advances

The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and share their key takeaways. They showcased a notable shift in AI discussions from continuous learning to the evaluation of large language learning models. Transparency in AI, particularly using SHAP values, emerged as a critical theme, contributing to the usability of algorithms. 

The summit delved into addressing bias in AI, emphasizing the importance of understanding how user interfaces can influence bias in datasets. Stakeholder involvement, especially healthcare providers, was highlighted as crucial in the development process to design for end-users. The summit also tackled the broader issues of medical errors as a system design problem, emphasizing the need for transparency in medical outcomes. Overall, the summit provided valuable insights into the evolving landscape of AI, its challenges, and the collaborative efforts needed to advance the field.

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.

Show more...
1 year ago
19 minutes

Life Science Solutions
Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry

In the conclusion of our conversation with Stephen M. Perry (part 1) we explore the dynamic intersection of healthcare innovation and patient-centered solutions. Exploring the evolution from traditional clinic-based treatments to innovative home-based therapies, they highlight the impact on patient experiences, emphasizing dignity, reduced anxiety, and improved quality of life.


Discover how Kymanox, a global life science solutions provider, is navigating challenges, fostering a culture of collaboration, and driving innovation to create a higher quality of life for patients.

Join the conversation as they share powerful stories, discuss industry challenges, and illuminate the path toward a patient-centric future in healthcare.

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.

Show more...
1 year ago
19 minutes

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.