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Particles in Biologics: Advanced Analytics and Tech Transfer
Apr 22, 2026
24m 48s
What Successful CSV and CSA Teams Do Differently
Mar 23, 2026
24m 33s
Navigating a CDMO-Based CRL: From Crisis to Compliance
Feb 17, 2026
31m 47s
5 Steps to Operationalizing FDA’s QMS
Jan 16, 2026
22m 12s
In Silico Modeling: A Drug Developer's Superpower
Dec 15, 2025
30m 09s
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| Date | Episode | Topics | Guests | Brands | Places | Keywords | Sponsor | Length | |
|---|---|---|---|---|---|---|---|---|---|
| 4/22/26 | Particles in Biologics: Advanced Analytics and Tech Transfer✨ | biologicsadvanced analytics+4 | Dr. Tim Menzen | Coriolis Pharma | — | particlesaggregates+5 | — | 24m 48s | |
| 3/23/26 | What Successful CSV and CSA Teams Do Differently | 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 scripting for low-risk systems.If your team is still validating systems simply because “that’s how it’s always been done,” this conversation will help you rethink your approach.Topics Include:The CSA Mindset Shift: Why CSA isn't necessarily "less work," but rather a strategic refocusing of attention onto areas with the highest risk to product quality and patient safety.Unscripted vs. Undocumented: How to leverage knowledgeable Subject Matter Experts (SMEs) for unscripted testing without falling into the trap of failing to document the testing.Organizational Pitfalls: Why siloing your CSV efforts into a separate department often leads to redundant work, stepping on toes, and severely overburdening your Quality Assurance (QA) team.The Future of Validation: The growing necessity of leaning on vendors as subject matter experts, adopting a "trust but verify" approach to vendor testing, and the critical importance of robust vendor onboarding.Taking the First Step: Practical advice for introducing CSA principles, starting with stakeholder conversations and avoiding the conservative trap of labeling every single item as "high risk".This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your quality, validation, and IT teams!📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina. | 24m 33s | ||||||
| 2/17/26 | Navigating a CDMO-Based CRL: From Crisis to Compliance | 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 how to navigate the delicate balance between a Sponsor’s need for oversight and a CDMO’s need to protect proprietary operations, often using a "middleman" strategy to diffuse tension and accelerate compliance.Topics Include:The "Survival Mode" Dynamic: Understanding the friction between a Sponsor’s urgency and a CDMO’s competing resource demands.Common Technical Pitfalls: Why "basic GMPs" and process control strategies (like Annex 1/contamination control) are frequent stumbling blocks during first-time inspections.The Power of Generalists: Why deploying a team of deep, diverse experts is more effective than just "throwing bodies" at a remediation project.6 Keys to Success: David shares six essential steps to prevent CRLs, including robust supplier qualification and monthly governance meetings.Ideal Knowledge Transfer: How to leave the CDMO better than you found it by mentoring staff and improving quality systems for the long haul.Whether you are navigating a current regulatory hurdle or preparing for your first BLA, this conversation offers a strategic roadmap for turning regulatory complexity into clarity. | 31m 47s | ||||||
| 1/16/26 | 5 Steps to Operationalizing FDA’s QMS | 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 explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.Topics Include:The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina. | 22m 12s | ||||||
| 12/15/25 | In Silico Modeling: A Drug Developer's Superpower | 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 viscosity.Topics Include:Defining In Silico: Understanding the spectrum from mechanistic models and molecular dynamics to AI and machine learning.Accelerating Development: How computational tools reduce the need for animal testing and save precious material in early-phase development.The "Why" Behind the "What": Using modeling to uncover the specific mechanisms causing instability or aggregation.The Hybrid Approach: Validating digital predictions with high-throughput wet lab screening for a robust formulation strategy.Regulatory Perspectives: How the FDA and EMA are viewing AI data and the importance of establishing model credibility.Expansion: Coriolis Pharma’s growth into the US market and their new capabilities in Research Triangle Park.Whether you are a formulation scientist, a CMC leader, or a regulatory professional, this episode provides a fascinating look at how digital twins and computational strategies are de-risking the path to market for life-saving therapies.📍Recorded at Kymanox HQ in Research Triangle Park, North Carolina.#Biologics #InSilico #DrugDevelopment #FormulationScience #AIinPharma #CoriolisPharma #LifeSciences #Kymanox | 30m 09s | ||||||
| 11/18/25 | Smarter Design Controls with AI - Is It Possible? | 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:What design controls are and why they matter for medical devices and combination products.How AI is evolving from a personal tool to a professional asset in regulated environments.Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.Specific uses within Design Verification, including sample size determination and data analysis.Managing AI risks: why "hallucinations" happen and the need for expert human oversight.Sustainability considerations: could AI use impact environmental goals in MedTech?Whether you’re a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.#MedTech #AI #DesignControls #MedicalDevices #RegulatoryScience #LifeSciences | 35m 45s | ||||||
| 10/20/25 | Beyond 200 mg/mL: The Science and Scaling of High-Dose Biologics | 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 could dramatically ease the patient experience.The conversation dives deep into what this means for manufacturing, device compatibility, and regulatory pathways, revealing how the future of injectables depends on solving problems once thought unsolvable.Topics include:Why ultra-concentrated biologics often fail in aqueous solutionsHow microparticle suspensions dissolve rapidly in vivo to avoid depot effectsRheology 101: viscosity curves, shear-thinning fluids, and device designThe shift to aseptic manufacturing when sterile filtration isn’t an optionPreclinical safety considerations and scaling studies from rodents to NHPsWhy early conversations with FDA’s Emerging Technology Program matterThis is part two of our deep dive on concentrated biologics - picking up where our Podcast Marathon live episode left off. This episode offers a rare look inside the formulation frontier — where drug science, delivery design, and patient experience intersect.📍Recorded at the Kymanox studio in Research Triangle Park, North Carolina.#Biologics #DrugDelivery #Autoinjectors #Rheology #GMP #PharmaInnovation | 30m 53s | ||||||
| 10/13/25 | High Stakes, High Concentrations: Inside Biologics Innovation (Part 1) | 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 what makes high-concentration biologics both technically challenging and clinically promising.Topics Include:Why high-concentration biologics matter for patient convenience and complianceThe science of formulation: balancing potency, viscosity, and stabilityScale-up and manufacturing barriers innovators must solveLifecycle management and the competitive edge of delivery innovationThis is part one of a two-part conversation with Ryan Doxey, offering an inside look at how advanced biologics are being reimagined for the patients who need them most.📍 Recorded live during the Podcast Marathon at Walk West studio in Raleigh North Carolina.#Biologics #DrugDelivery #PharmaInnovation #CMC #LifeSciences | 30m 18s | ||||||
| 9/22/25 | Training Tomorrow’s Biopharma Workforce | 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 beyondGary shares insights from decades of experience in both industry and education—from the early days of stainless-steel facilities to the rise of single-use technology, to today’s booming demand for GMP-trained professionals. Topics Include:How BTEC bridges academia and industry to prepare talent for biopharma careersWhy North Carolina has become a hub for biomanufacturing growthThe rise of single-use technologies and what they mean for training and efficiencyThe importance of hands-on GMP experience for students and professionals alikeThis episode highlights the strategies, infrastructure, and people driving innovation in biopharma—and why workforce development is the key to keeping pace with the industry’s future.#Biomanufacturing #Biopharma #GMP | 34m 03s | ||||||
| 8/18/25 | Is Onshoring Biomanufacturing Really Happening? | 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 shiftThe labor and infrastructure gap in U.S. biologics manufacturingHow CDMO specialization is reshaping the global pharma supply chainFrom 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 | 31m 30s | ||||||
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| 7/22/25 | AI and the Future of Cancer Research | 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. | 32m 52s | ||||||
| 6/16/25 | 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 jargonTell the right story for where you are todayBuild 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. | 33m 35s | ||||||
| 5/19/25 |  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. | 18m 31s | ||||||
| 4/23/25 | 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. | 27m 52s | ||||||
| 3/25/25 | 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.comConnect with Kymanox on LinkedIn: Kymanox LinkedInAbout 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. | 29m 16s | ||||||
| 2/19/25 | 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.healthConnect with ten23 health on LinkedIn: Ten23 Health LinkedInLearn more about Kymanox: kymanox.comConnect with Kymanox on LinkedIn: Kymanox LinkedInAbout 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. | 32m 16s | ||||||
| 1/21/25 | Disruptive Trends in Drug and Device Development, with Kymanox President Evan Edwards | In this episode of Life Science Solutions, Evan Edwards, President of Kymanox, explores the key trends shaping the life sciences industry in 2025. From groundbreaking advancements in cell and gene therapies to the rise of GLP-1 drugs and the essential scaling of CDMO operations, Evan highlights the innovations driving product development and commercialization. Key Takeaways:Kymanox Growth: The company is expanding its capabilities, workforce, and global footprint, now employing nearly 300 people across the U.S. and Europe.Industry Trends:Cell and Gene Therapy: Emerging targeted treatments are transforming patient outcomes and delivery methods, including potential home-based solutions.GLP-1 Drugs: These revolutionary therapies are disrupting healthcare and driving rapid market growth.Manufacturing Challenges: A rising need for capacity to meet demand for both innovative and traditional therapies.Artificial Intelligence: Kymanox is leveraging AI responsibly to enhance drug discovery, manufacturing, and regulatory processes.Strategic Focus for 2025:Doubling down on core services like product development, engineering, and regulatory strategy.Expanding into strategic services like CMC, CQV, and human factors expertise.Supporting clients in reaching critical milestones efficiently, saving time and resources.The Hypervirtual Model: Acting as a trusted co-pilot, Kymanox partners with clients of all sizes, from startups to global pharma giants, to drive innovation and commercialization.Resources and Links:Learn more about Kymanox: kymanox.comConnect with Kymanox on LinkedIn: Kymanox LinkedInAbout 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. | 22m 22s | ||||||
| 12/9/24 | 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. | 33m 37s | ||||||
| 11/18/24 | 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. | 44m 33s | ||||||
| 10/14/24 | 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. | 25m 56s | ||||||
| 9/16/24 | 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. | 38m 58s | ||||||
| 8/12/24 | 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. | 29m 16s | ||||||
| 7/15/24 | Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance | Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to inefficient servicing, increased downtime, and potential safety risks. In this episode, we explore the importance of applying humanfactors principles to medical device maintenance and servicing. Our expert guest, Avital Zik from Medtronic, discusses strategies for incorporating service personnel needs into device design, creating more user-friendly maintenance processes, and improving overall devicereliability. Rita Lin, Director of HFE at Kymanox, also offers her insight from past experiences working at the FDA and in industry.Learn how considering the full lifecycle of medical devices, from installation to repair, can enhance patient safety, reduce costs, and streamline healthcare operations. Join us as we uncover the hidden world of medical device maintenance and its impact on healthcare delivery.About the Factor:The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry. About Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.The Factor is edited and produced by Earfluence. | 33m 39s | ||||||
| 6/17/24 | 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. | 24m 30s | ||||||
| 5/13/24 | 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. | 33m 02s | ||||||
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