Life Science Solutions
από Kymanox
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What Should AI Do in a Regulated Environment?
What Should AI Do in a Regulated Environment?
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Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility.
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Τα νεότερα 20 από 50 επεισόδια
- What Should AI Do in a Regulated Environment? · 30 λεπ. · Επεισόδιο 50To err is human. To make things up is AI. So in a regulated industry, how should the two work together? In this episode, host Chris Adkins talks with David Dlugo, Senior Director…
- Mechanical or Electromechanical? Designing for the User · 32 λεπ. · Επεισόδιο 49Episode 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…
- Reducing Risk in Injectable Drug Development Starts with Primary Packaging · 32 λεπ. · Επεισόδιο 48Primary packaging is often treated as a late-stage procurement decision, in reality, it can influence formulation stability, manufacturing, regulatory strategy, device…
- De-Risking Early-Stage Formulation Development: Inside the Kymanox Lab · 30 λεπ. · Επεισόδιο 47Every formulation decision made early in development carries downstream implications for stability, manufacturing, scalability, and analytical strategy. As therapies become more…
- GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery · 33 λεπ. · Επεισόδιο 46The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As these treatments mature and…
- Particles in Biologics: Advanced Analytics and Tech Transfer · 25 λεπ. · Επεισόδιο 45For 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…
- What Successful CSV and CSA Teams Do Differently · 25 λεπ. · Επεισόδιο 44For 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…
- Navigating a CDMO-Based CRL: From Crisis to Compliance · 32 λεπ. · Επεισόδιο 43Dealing 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…
- 5 Steps to Operationalizing FDA’s QMS · 22 λεπ. · Επεισόδιο 42The 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…
- In Silico Modeling: A Drug Developer's Superpower · 30 λεπ. · Επεισόδιο 41Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape. In…
- Smarter Design Controls with AI - Is It Possible? · 36 λεπ. · Επεισόδιο 40Design 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…
- Beyond 200 mg/mL: The Science and Scaling of High-Dose Biologics · 31 λεπ. · Επεισόδιο 39Pushing 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…
- High Stakes, High Concentrations: Inside Biologics Innovation (Part 1) · 30 λεπ. · Επεισόδιο 38In 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…
- Training Tomorrow’s Biopharma Workforce · 34 λεπ. · Επεισόδιο 37As 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…
- Is Onshoring Biomanufacturing Really Happening? · 32 λεπ. · Επεισόδιο 36As 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…
- AI and the Future of Cancer Research · 33 λεπ. · Επεισόδιο 35In 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…
- The Blueprint for Science Marketing Success with Elizabeth Chabe · 34 λεπ. · Επεισόδιο 34In 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…
- How Startups and Industry Support Each Other · 19 λεπ. · Επεισόδιο 33In 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…
- Capturing Venture Capital: What Makes Life Science Startups Stand Out to Investors · 28 λεπ. · Επεισόδιο 32In 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…
- Manufacturing Intelligence for Bioprocessing · 29 λεπ. · Επεισόδιο 31On 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…
