Life Science Solutions
Episodes
Particles in Biologics: Advanced Analytics and Tech Transfer
22 Apr 2026
Contributed by Lukas
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 l...
What Successful CSV and CSA Teams Do Differently
23 Mar 2026
Contributed by Lukas
For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But for...
Navigating a CDMO-Based CRL: From Crisis to Compliance
17 Feb 2026
Contributed by Lukas
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 fai...
5 Steps to Operationalizing FDA’s QMS
16 Jan 2026
Contributed by Lukas
The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant upda...
In Silico Modeling: A Drug Developer's Superpower
15 Dec 2025
Contributed by Lukas
Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping th...
Smarter Design Controls with AI - Is It Possible?
18 Nov 2025
Contributed by Lukas
Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage t...
Beyond 200 mg/mL: The Science and Scaling of High-Dose Biologics
20 Oct 2025
Contributed by Lukas
Pushing biologics beyond 200 mg/mL isn’t just a formulation challenge - it’s a delivery, manufacturing, and regulatory challenge too. Aggregation,...
High Stakes, High Concentrations: Inside Biologics Innovation (Part 1)
13 Oct 2025
Contributed by Lukas
In today’s pharma landscape, patient convenience and drug delivery innovation go hand in hand. But how do you deliver life-saving biologics at highe...
Training Tomorrow’s Biopharma Workforce
22 Sep 2025
Contributed by Lukas
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 Onshoring Biomanufacturing Really Happening?
18 Aug 2025
Contributed by Lukas
As pharmaceutical companies grow, they face critical choices: Where should you manufacture your product? How do you choose the right CDMO? What risks ...
AI and the Future of Cancer Research
22 Jul 2025
Contributed by Lukas
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 b...
The Blueprint for Science Marketing Success with Elizabeth Chabe
16 Jun 2025
Contributed by Lukas
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 unp...
How Startups and Industry Support Each Other
19 May 2025
Contributed by Lukas
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...
Capturing Venture Capital: What Makes Life Science Startups Stand Out to Investors
23 Apr 2025
Contributed by Lukas
In this special episode recorded live at CED Venture Connect, host Chris Adkins sits down with Dave Ousterout, Co-Founder and General Partner at CapeF...
Manufacturing Intelligence for Bioprocessing
25 Mar 2025
Contributed by Lukas
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 exec...
The ten23 health Approach to Biologics Development
19 Feb 2025
Contributed by Lukas
How is ten23 health revolutionizing biologics drug delivery and CDMO services?In this episode, we sit down with Hans-Christian Mahler, Founder and CEO...
Disruptive Trends in Drug and Device Development, with Kymanox President Evan Edwards
21 Jan 2025
Contributed by Lukas
In this episode of Life Science Solutions, Evan Edwards, President of Kymanox, explores the key trends shaping the life sciences industry in 2025. Fro...
Project Management Strategies for Effective Communication
09 Dec 2024
Contributed by Lukas
In this episode, we discuss the cornerstone of successful project management: COMMUNICATION. Join Shivali Patel as she sits down with project managem...
Making BioPharma Partnerships Work
18 Nov 2024
Contributed by Lukas
In this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of building successful partn...
How RNA Origami is Revolutionizing Drug Development
14 Oct 2024
Contributed by Lukas
In this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of Helixomer) discuss the innovati...
Adopting Agile Strategies in Emerging MedTech
16 Sep 2024
Contributed by Lukas
In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to disc...
Balancing Claims and Compliance in Healthcare Marketing, with Group 31 CEO Crystal Weber
12 Aug 2024
Contributed by Lukas
Creating labeling claims that support business goals without getting into compliance issues can be a tough sea to navigate.Today, join Kymanox Directo...
Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance
15 Jul 2024
Contributed by Lukas
Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to inefficie...
Secrets of Biopharma Tech Transfers: Lessons Learned and Best Practices
17 Jun 2024
Contributed by Lukas
Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These transfer...
Aligning with the Right CMO
13 May 2024
Contributed by Lukas
Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find the right...
Mastering the Product Development Lifecycle for Commercial Readiness
15 Apr 2024
Contributed by Lukas
How can medical device and combination product companies bridge the difficult "valley of death" between early product design and commercial readiness?...
QMSR, ISO 13485:2016, and What It All Means for Medical Device Risk Management
18 Mar 2024
Contributed by Lukas
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. T...
Kymanox: Two Decades of Excellence
15 Feb 2024
Contributed by Lukas
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 wi...
The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing
09 Jan 2024
Contributed by Lukas
Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and manufacturing. But...
AI Summit Highlights: Transparency, Bias in AI, and Exciting Advances
18 Dec 2023
Contributed by Lukas
The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and share their key takeaways. Th...
Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry
06 Dec 2023
Contributed by Lukas
In the conclusion of our conversation with Stephen M. Perry (part 1) we explore the dynamic intersection of healthcare innovation and patient-centered...
Combination Product Universe: PDA Conference Recap with Keynote Speaker Stephen Perry
20 Nov 2023
Contributed by Lukas
At the PDA Universe of Pre-filled Syringes and Injection Device Conference in Gothenburg, Sweden, Kymanox Founder and CEO Stephen Perry delivered a ke...
Unpacking the Role of Human Factors in Medical Device Development
08 Nov 2023
Contributed by Lukas
Shannon Hoste and Rita Lin discuss Rita's recent presentation at the RAPS Convergence conference in Montreal and share insights about their experience...
Navigating the Real-World Environment of Medical Products
25 Oct 2023
Contributed by Lukas
In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting ...
Creating a Successful Roadmap: Lab, Clinic, Market
11 Oct 2023
Contributed by Lukas
In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox (part 1). They r...
Factors to Consider in Clinical Readiness for Medical Device and Combination Product
25 Sep 2023
Contributed by Lukas
How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The comple...
Future Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered Care
13 Sep 2023
Contributed by Lukas
Dr. Bonnie Clipper, the founder of Innovation Advantage, a consultancy specializing in helping healthcare organizations embrace innovation, discusses ...
Transforming Nursing through AI and Innovation, with Dr. Bonnie Clipper
29 Aug 2023
Contributed by Lukas
Today we explore the dynamic synergy between healthcare innovation and human factors engineering in nursing, with Dr. Bonnie Clipper. We focus on pati...
Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape (Part 2 with Dr. Christiana Hofmann and Richard Houlihan)
16 Aug 2023
Contributed by Lukas
In this episode of The Factor Podcast, industry experts Dr. Christiana Hofmann and Richard Houlihan discuss the complexities of Unique Device Identifi...
Exploring EUDAMED Requirements for EU MDR, with Richard Houlihan and Christiana Hofmann
02 Aug 2023
Contributed by Lukas
In this informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to discuss critical aspects o...
(Part 2) Winning Formula: Combination Products Unveiled, with Susan Neadle
19 Jul 2023
Contributed by Lukas
Today, Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to part one, do that first and then come back to this episod...
Winning Formula: Combination Products Unveiled, with Susan Neadle
05 Jul 2023
Contributed by Lukas
Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that distills her years of industry experience ...
(Part 2) ISO 14971 and Risks in Medical Devices: What You Need to Know
21 Jun 2023
Contributed by Lukas
In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation, digging into...
Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence
08 Jun 2023
Contributed by Lukas
Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shanno...
Secret to Succes: Human Factors for Medical Product Development
05 Dec 2022
Contributed by Lukas
EP1: Human Factors Secrets to Success. In this episode the host, Sophia Kalita, interviews Pat Patterson and Shannon Hoste with Agilis Consulting Gr...