Life Science Solutions

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...

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...

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, Manag...

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...

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...

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 o...

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 regul...

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 &...

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 co...

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 Un...

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...

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 t...

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 i...

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...

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 Cap...

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...

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 chal...

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...

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 conversati...

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 (QM...

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 scie...

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 market...

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 ens...

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 strategi...

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 epis...