Life Science Solutions

Episode Description:

Most drug delivery devices are mechanical by default: a spring, a click, a color that shifts from yellow to green. As drug delivery and medical devices become more complex, electromechanical engineering is opening new possibilities for functionality, usability, feedback, and patient experience.

In this episode of Life Science Solutions, Chris Adkins talks with Andrew King about what goes into developing electromechanical devices, from the early concept through prototyping, testing, and formal development.  Andrew brings hands-on experience designing drug delivery systems where mechanics, electronics, software, sensors, and controls all have to work as one.

Primary packaging is often treated as a late-stage procurement decision,  in reality, it can influence formulation stability, manufacturing, regulatory strategy, device performance, and ultimately how quickly a therapy reaches patients.

In this episode of Life Science Solutions, host Chris Adkins sits down with Katie Falcone, Director of Technical Services for Integrated Systems at West Pharmaceutical Services. Katie draws on her decade of primary packaging experience to explain why drug developers (especially lean, emerging biotechs) need to integrate primary packaging decisions into early pre-formulation work rather than treating it as a late-stage commodity purchase.

Together, they d...

Every formulation decision made early in development carries downstream implications for stability, manufacturing, scalability, and analytical strategy. As therapies become more complex and development timelines compress, getting formulation right from the start has never mattered more.

In this episode of Life Science Solutions, host Chris Adkins sits down with Kymanox experts Ryan Doxey, VP of Technical Services, and Matt Owen, PhD Associate Director of CMC and Pharmaceutical Sciences. Together, they introduce the newly announced Kymanox Formulation Lab and discuss why having dedicated wet lab space is essential for true IND-enabling formulation development.

While Contract Development...

The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As these treatments mature and reach millions of patients, the pharmaceutical industry is being forced to rethink dose volumes, supply chain sustainability, and device design.

In this episode of Life Science Solutions, host Chris Adkins sits down with Paul Jansen, a recognized industry voice and veteran leader in medical device development and combination products. Drawing from his extensive background, including leadership roles at Sanofi, Paul explains how the massive success of GLP-1 therapies is shaking up the...

For many teams, particles and aggregates are treated as a late-stage compliance headache or a sudden fire drill during manufacturing. But what if we looked closer? Particle populations can actually reveal deep insights about your formulation stability, process robustness, and potential technology transfer risks long before you reach commercial scale.

In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Tim Menzen, Chief Technology Officer at Coriolis Pharma, a science-driven CRO specializing in formulation development and advanced analytics for biopharmaceuticals. With a PhD focused on the thermal unfolding and aggregation of monoclonal antibodies...

For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But for many organizations, it has also become slow, expensive, and overloaded with documentation that does little to improve patient safety or data integrity.

In this episode of Life Science Solutions, host Chris Adkins sits down with Tara Doby, PMP, Manager of Technical Services at Kymanox, to unpack the industry's much-needed transition from traditional CSV to Computer Software Assurance (CSA). Tara explains how CSA utilizes the familiar GAMP 5 risk-based methodology, but strategically reduces the burden of step-by-step...

Dealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a failed inspection at your Contract Development and Manufacturing Organization (CDMO) adds a unique layer of business and operational complexity.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo (Senior Director of Quality at Kymanox) and Anthony Stewart (Senior Process Engineer at Kymanox) to dissect a real-world case study of remediation and return to GMP manufacturing following a failed Pre-Approval Inspection (PAI).

The team explores...

The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David expl...

Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape.

In this episode of Life Science Solutions, host Chris Adkins is joined by Andrea Arsiccio, PhD, Senior Scientist and Team Lead In Silico at Coriolis Pharma, to discuss how in silico modeling is revolutionizing the assessment of developability and formulation strategies for new drug products.

Andrea breaks down how Coriolis Pharma combines physics-based models and Artificial Intelligence with traditional wet lab experimentation to predict molecule behavior, identify liabilities early, and solve complex problems like aggregation and vi...

Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.

In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards.

Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.

Topics Include:

Pushing biologics beyond 200 mg/mL isn’t just a formulation challenge - it’s a delivery, manufacturing, and regulatory challenge too. Aggregation, precipitation, and sky-high viscosity make scaling these therapies a gauntlet for drug developers.

In this episode of Life Science Solutions, host Chris Adkins continues the conversation on hyper-concentrated biologics with Ryan Doxey, VP of Tech Ops & CMC at Kymanox, and Nick Letourneau, PhD, Associate Director of Product Development & Commercialization. Together, they unpack how dehydrated protein microparticles suspended in hydrophobic carriers (like MCT oils or ethyl oleate) can dissolve instantly upon injection, and why this breakthrough coul...

In today’s pharma landscape, patient convenience and drug delivery innovation go hand in hand. But how do you deliver life-saving biologics at higher concentrations without sacrificing safety, stability, or patient comfort?

In this live-recorded episode of Life Science Solutions, host Chris Adkins sits down with Ryan Doxey, Vice President of Technical Services at Kymanox, for part one of their conversation together. Ryan unpacks the opportunities and challenges of hyper-concentrated formulations, from why patients stand to benefit to how technical hurdles like viscosity, stability, and scale-up shape the path forward.

Chris and Ryan dig into wh...

As the biopharmaceutical industry expands, companies face a constant challenge: How do you find and train the talent needed to sustain growth? And how is technology reshaping the way we prepare the workforce?

In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Gary Gilleskie, Executive Director of the Biomanufacturing Training and Education Center (BTEC) at NC State University. Together, they explore the evolution of biologics manufacturing in NC, BTEC’s hybrid industry-academia training model, and the center’s unique impact on workforce development in biopharma and beyond

Gary shares insights from...

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...

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, ph...

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...

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 episod...

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 op...

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 D...

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:

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:

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: 

Plus, enjoy a fun ra...

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...

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 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 r...

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 r...

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...

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 t...

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...

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 t...

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, Sen...

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 Tr...

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...

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 e...

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...

At the PDA Universe of Pre-filled Syringes and Injection Device Conference in Gothenburg, Sweden, Kymanox Founder and CEO Stephen Perry delivered a keynote address titled "The Inspiring Evolution of Parenteral Combination Products from 2004 to Today from an Entrepreneurial Perspective – And a Peek at What Is Coming."

Stephen Perry provides a comprehensive overview of the historical evolution of combination products, emphasizing the pivotal role of insulin and diabetes in driving innovation. Technologies like insulin pumps and reusable pen injectors have played a crucial role in advancing injection systems.

The discussion extends to Step...

Shannon Hoste and Rita Lin discuss Rita's recent presentation at the RAPS Convergence conference in Montreal and share insights about their experiences in the field of human factors and regulatory affairs in the medical device industry. They touch on various topics, including the challenges and opportunities in combination product development, the importance of risk management, regulatory considerations, and the impact of AI and machine learning in healthcare. The conversation also delves into the importance of real-world evidence, collaboration, and education within the industry.

About the Factor:

The Factor, your trusted podcast for the life...

In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into healthcare, describing how she ventured into remote areas to provide support with donated medical devices. This eye-opening experience underscored the critical importance of considering usability and human factors in product design.

Shannon Hoste shares a similar background, transitioning from a more conventional engineering role to human factors engineering after encountering issues related to device usability in post-market settings. Their experiences highlight the vital role of understanding user...

In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox (part 1). They review how companies can a create a successful roadmap to bring their product from lab to clinic and commercialization. Reviewing the importance in understanding the therapeutic index, understanding users, how best to manage risk, and incorporating the right data safety monitoring.

Additionally, Stefanie and Shannon emphasize the importance of collaboration with regulatory authorities and leveraging risk management plans throughout the product development process. They stress that there is no one-size-fits-all approach to being c...

How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of harmonizing drug and device elements, managing risks, and understanding variability can be overwhelming. If clinical readiness is on your product development plan, join our discussion with Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox, as she shares her strategies to solve the clinical readiness puzzle.

Shannon Hoste, Vice President of Agilis by Kymanox and Stefanie delve into factors like patient safety, human factors engineering, and the challenges faced b...