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Kymanox, partner for the life science industry
เข้าร่วมเมื่อ 23 ต.ค. 2022
Kymanox® is your trusted life science solutions partner, committed to navigating the complexities of development and commercialization of your modern medicines. With a diverse team of experts, including former FDA, we excel in connecting the dots and providing the right end-to-end solutions for your unique challenges.
We are experts in providing our clients in the combination products, biotechnology, pharmaceutical, medical device, and diagnostics industries with support from early development to post-market. We help bring your products from bench to patient.
www.kymanox.com
View our Podcast:
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.
We are experts in providing our clients in the combination products, biotechnology, pharmaceutical, medical device, and diagnostics industries with support from early development to post-market. We help bring your products from bench to patient.
www.kymanox.com
View our Podcast:
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.
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.
Keywords: #biopharma, #quality #lifescience, Quality by Design, #biologics, #advancedtechnology, #cdmo, #qualitycontrol, #ATMP, #techtransfer, #fda, #pharmacology
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.
Keywords: #biopharma, #quality #lifescience, Quality by Design, #biologics, #advancedtechnology, #cdmo, #qualitycontrol, #ATMP, #techtransfer, #fda, #pharmacology
มุมมอง: 8
วีดีโอ
How RNA Origami is Revolutionizing Drug Development
มุมมอง 3914 วันที่ผ่านมา
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? Watch and Subscribe About the Factor: The Factor, your trusted pod...
Adopting Agile Strategies in Emerging MedTech
มุมมอง 402 หลายเดือนก่อน
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 mark...
Kymanox Culture
มุมมอง 652 หลายเดือนก่อน
Kymanox is your trusted life science solutions partner, committed to navigating the complexities of development and commercialization of your modern medicines. With a diverse team of experts, including former FDA, we excel in connecting the dots and providing the right end-to-end solutions for your unique challenges. We are experts in providing our clients in the combination products, biotechno...
Kymanox CARES
มุมมอง 192 หลายเดือนก่อน
The act of CARING is engrained in human nature, but we can’t take it for granted. CARING must be nourished, fostered, and developed. A world without CARING is inhospitable. It is imperative that Kymanox CARES moves the needle with intentionality - and most importantly - with ACTION. In keeping with our corporate values, Kymanox takes our responsibility to give back to the community very serious...
Balance Claims with Compliance in Healthcare Marketing
มุมมอง 1263 หลายเดือนก่อน
Join Stefanie 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. ...
Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance
มุมมอง 304 หลายเดือนก่อน
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 strat...
Secrets of Biopharma Tech Transfers: Lessons Learned and Best Practices
มุมมอง 775 หลายเดือนก่อน
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 ep...
Aligning with the Right CMO
มุมมอง 536 หลายเดือนก่อน
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 ...
Mastering the Product Development Lifecycle for Commercial Readiness
มุมมอง 557 หลายเดือนก่อน
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...
QMSR, ISO 13485, & Risk Management
มุมมอง 2138 หลายเดือนก่อน
New episode on The Factor. 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 m...
Kymanox: Two Decades of Excellence
มุมมอง 1129 หลายเดือนก่อน
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 p...
The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing
มุมมอง 12210 หลายเดือนก่อน
Sustainability isn’t just a buzzword; it's a crucial aspect of the mission within medical device and combination product design and manufacturing. However, navigating all the design considerations to make products cost-efficient, sanitary, and sustainable isn’t always easy. So, how can the industry achieve this? This episode features Cormac O'Prey Founder of Kestel Consulting Group and Shannon ...
AI Summit Highlights: Transparency, Bias in AI, and Exciting Advances
มุมมอง 2211 หลายเดือนก่อน
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 algorith...
Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry
มุมมอง 1311 หลายเดือนก่อน
In the conclusion of our conversation with Stephen M. Perry 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 g...
Combination Product Universe: PDA Pre-filled Syringes and Injection Devices Conference Recap
มุมมอง 69ปีที่แล้ว
Combination Product Universe: PDA Pre-filled Syringes and Injection Devices Conference Recap
The Role of Human Factors in Medical Product Development
มุมมอง 50ปีที่แล้ว
The Role of Human Factors in Medical Product Development
Navigating the Real-World Environment of Medical Products
มุมมอง 41ปีที่แล้ว
Navigating the Real-World Environment of Medical Products
Creating a Successful Roadmap: Lab, Clinic, Market.
มุมมอง 42ปีที่แล้ว
Creating a Successful Roadmap: Lab, Clinic, Market.
Factors to Consider in Clinical Readiness for Medical Device and Combination Product
มุมมอง 80ปีที่แล้ว
Factors to Consider in Clinical Readiness for Medical Device and Combination Product
Future Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered Care
มุมมอง 40ปีที่แล้ว
Future Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered Care
Transforming Nursing through Medical Technology and Innovation
มุมมอง 149ปีที่แล้ว
Transforming Nursing through Medical Technology and Innovation
Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape
มุมมอง 21ปีที่แล้ว
Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape
Part 1: Exploring EUDAMED Requirements for EU MDR
มุมมอง 108ปีที่แล้ว
Part 1: Exploring EUDAMED Requirements for EU MDR
Part 2: Winning Formula to Navigate Combination Products & ICH Q9 vs. ISO 14971
มุมมอง 73ปีที่แล้ว
Part 2: Winning Formula to Navigate Combination Products & ICH Q9 vs. ISO 14971
Winning formula in navigating Combination Products
มุมมอง 142ปีที่แล้ว
Winning formula in navigating Combination Products
Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence
มุมมอง 149ปีที่แล้ว
Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence
Secret to Success: Human Factors in Medical Product Development
มุมมอง 187ปีที่แล้ว
Secret to Success: Human Factors in Medical Product Development
Why You Need to Utilize Human Factors for the Global Medical Market.
มุมมอง 1152 ปีที่แล้ว
Why You Need to Utilize Human Factors for the Global Medical Market.
Sustainability is a complex and disruptive challenge for any company, but add in the regulatory and patient safety aspects faced in medical and it's daunting. It's also necessary. Post your questions below
What a great podcast. Anyone in combination products should watch Part 1 then Part 2. And then go get the book. Looking forward to the progress on harmonization of the regulations. The next thing is to take her AAMI course