As pharmaceutical companies grow, they face critical choices: Where should you manufacture your product? How do you choose the right CDMO? What risks come with global supply chains?

In this episode of Life Science Solutions, host Chris Adkins sits down with Roger Lias, PhD a 35-year veteran of the biologics manufacturing industry, to dig into the realities of onshoring in pharma and the evolving CDMO landscape.

Roger walks through geopolitics and the BIOSECURE Act to the practical hurdles of talent shortages and infrastructure buildouts. Roger outlines what sponsor companies need to consider when choosing a domestic or international partner, from experience working in APAC. 

Topics include:

• Why “onshoring” may be more political theater than operational shift
• The labor and infrastructure gap in U.S. biologics manufacturing
• How CDMO specialization is reshaping the global pharma supply chain

From navigating regulatory risks to building smart tech transfer plans, this episode gives growing pharma teams the tools to make better decisions.

📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.

#Biomanufacturing #CDMO #Onshoring #LifeSciences #Biologics #PharmaManufacturing

In this eye-opening episode of Life Science Solutions, Chris Adkins sits down with Marcel Frenkel, PhD, CEO and Co-Founder of Ten63 Therapeutics—a biotech startup using AI and quantum physics to design drugs for the most elusive and "undruggable" cancer targets.

Marcel shares the groundbreaking science behind Ten63’s BEYOND platform, which navigates a chemical space of 10⁶³ possible molecules to find solutions the pharmaceutical industry previously considered impossible. With personal insight from his mother’s cancer journey, Frenkel explains how traditional drug discovery fails patients—and how Ten63 is flipping the script.

Whether you're in biotech, pharma, or just passionate about the future of AI in medicine, this episode is a powerful look into the next frontier of oncology and therapeutic innovation.

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.

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.

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.

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.

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.

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.

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.

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.