『Navigating the Combination』のカバーアート

Navigating the Combination

Navigating the Combination

著者： Parth Kothari and Jonathan Amaya-Hodges
無料で聴く

Navigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for pharma - each episode draws on 650+ combined years of experience and 120+ successful launches to cut through the complexity of combination product development, from device selection and regulatory strategy to OEM alignment, quality systems, and FDA submissions. Whether you're a VP of Regulatory Affairs weighing your submission strategy, a program director managing a complex OEM relationship, or an executive trying to protect a multi-million-dollar drug investment, this podcast gives you the insight, clarity, and confidence to make the right calls - right the first time.© 2026 Parth Kothari and Jonathan Amaya-Hodges 経済学
エピソード
  • SE01 E05 From Insight to Impact: Serving Pharma Better in Drug Delivery | Nadine Brun

    SE01 E05 From Insight to Impact: Serving Pharma Better in Drug Delivery | Nadine Brun
    2026/09/08
    This interview contains the personal and professional opinions of Nadine Brun which are not necessarily those of BD or any of its affiliates.Nadine Brun, recently appointed Vice President, Greater Asia, Pharmaceutical Systems at BD, and formerly VP Global Marketing & Strategy for BD Pharmaceutical Systems, brings over 20 years of experience in clinical diagnostics and life sciences to a conversation about what it really takes to serve pharma customers well. Drawing on the parallels between diagnostics and drug delivery — regulation, time to market, and patient outcomes at the center of both — Nadine shares how her background shaped a systems-level approach to combination product development. She unpacks the tension at the heart of the industry: unprecedented scientific innovation on one side, and deep resistance to change on the other, and why that gap is only going to matter more as biologics and complex therapies become the norm...etc.The conversation covers the real difference between what pharma customers ask for and what they actually need, how to de-risk drug development from early-stage material selection all the way through to commercial supply, and why co-creation with the right partners at the right time is the fastest route to market — not a slower one. Nadine also shares her definition of genuine thought leadership in pharma, what a strong operating model looks like when you are bridging technical and commercial teams, and the one piece of advice she would give any pharma company before they engage a device supplier.Key takeaways:Clinical diagnostics and pharma share more than people think — regulation, time-to-market pressure, and patient well-being as the core objective are common threadsThe biggest paradox in pharma right now is the push for scientific innovation running alongside deep institutional resistance to changeLarge established pharma and emerging biotech have fundamentally different needs from suppliers — one size does not fit all, and a strong operating model reflects thatDe-risking is not just about early-stage testing — it is an end-to-end process that includes scalable supply capacity from day oneCo-creation with the right expertise around the table — MedTech, pharma, machine makers, service providers — is what actually accelerates development, not what slows it downMarketers in technical environments need genuine scientific knowledge; removing that understanding makes it impossible to serve customers wellThought leadership means identifying customer pain points, building solutions around them, and being willing to take the innovation risks that drive the market forwardNPS surveys and structured customer feedback are practical tools for aligning what you offer with what different customer segments actually valueEngage your supplier partner at the earliest possible stage — waiting until phase two or later to think about regulatory affairs or supply chain is one of the most common and costly mistakes in combination product developmentConnect with Nadine Brun on LinkedIn: https://www.linkedin.com/in/nadine-brun-8515011/I hope you enjoy this episode! Give it a like, share, and subscribe to not miss the content coming your way weekly.– Parth & Jonathan and the Navigating the Combination podcast teamConnect with Parth Kothari on LinkedIn: https://www.linkedin.com/in/parthjkothari/ Connect with Jonathan Amaya-Hodges on LinkedIn: https://www.linkedin.com/in/jonathanwhodges/ Visit the Suttons Creek website here: https://suttonscreek.comListen to Navigating the Combination on these podcast platforms: Spotify: https://open.spotify.com/show/033HRTwEj7aFLx9K8ZEsVGApple Podcasts: https://podcasts.apple.com/us/podcast/navigating-the-combination/id6786238670Amazon Podcasts: https://music.amazon.com/podcasts/12169e2d-2323-41db-bdb4-8a8e7841c799#navigatingthecombination #suttonscreek #combinationproducts #drugdelivery #pharmaconsulting #regulatoryaffairs #medicaldevices #biotech #pharmabiotech #fdaregulation #drugdevicedevelopment #lifesciences #combinationproductdevelopment #pharmapodcast #devicestrategyNavigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for pharma - each episode draws on 650+ combined years of experience and 120+ successful launches to cut through the complexity of combination product development, from device selection and regulatory strategy to OEM alignment, quality systems, and FDA submissions.Whether you're a VP of Regulatory Affairs weighing your submission strategy, a program director managing a complex OEM relationship, or an executive trying to protect a multi-million-dollar drug investment, this podcast gives you the insight, clarity, and confidence to make the right calls - right the first time.
    続きを読む 一部表示
    23 分
  • SE01 E04 Supplier Management in Drug Delivery Systems | Courtney Evans & Max Lerman

    SE01 E04 Supplier Management in Drug Delivery Systems | Courtney Evans & Max Lerman
    2026/08/25

    What are the biggest combination product compliance risks companies are facing today—and how is FDA enforcement evolving?

    In this episode of Navigating the Combination, hosts Jonathan Amaya-Hodges and Parth Kothari are joined by Max Lerman of Suttons Creek and Courtney Evans of Abbvie (formerly Suttons Creek - at the time of recording) for a deep dive into the regulatory and quality challenges shaping the combination product industry. Drawing on their experience as former FDA reviewers, they discuss how FDA expectations for combination product oversight have changed, where companies commonly fall short, and what organizations can do to build more resilient quality systems.

    The conversation explores the differences between pharmaceutical and medical device approaches to CAPA, why supplier oversight has become a major FDA focus area, and how sponsors should think about device constituent suppliers as true development partners rather than traditional vendors. Max and Courtney also break down the reasoning behind FDA’s well-known five nines reliability expectation for emergency-use auto injectors, including what it means for design robustness, testing strategies, and lifecycle management.

    In this episode, you’ll learn:
    The biggest CAPA pitfalls for combination product companies
    How FDA views systemic vs. action-oriented CAPA approaches
    Why supplier oversight is becoming more rigorous for combination products
    The importance of sharing risk information with device partners
    When CDRH and CDER collaborate during combination product reviews
    How to think about variables data, reliability, and process capability
    The regulatory rationale behind five nines reliability for emergency-use injectors
    Why quality culture matters more than ever before FDA inspection
    Best practices for proactive quality management and continuous improvement

    Whether you work in combination products, regulatory affairs, quality assurance, medical devices, pharmaceuticals, supplier quality, manufacturing, or FDA compliance, this episode provides practical insights into building systems that can withstand regulatory scrutiny and support long-term product success.

    I hope you enjoy this episode! Give it a like, share, and subscribe to not miss the content coming your way weekly.
    – Parth & Jonathan and the Navigating the Combination podcast team

    Connect with Parth Kothari on LinkedIn: https://www.linkedin.com/in/parthjkothari/ Connect with Jonathan Amaya-Hodges on LinkedIn: https://www.linkedin.com/in/jonathanwhodges/ Visit the Suttons Creek website here: https://suttonscreek.com
    Listen to Navigating the Combination on these podcast platforms:
    Spotify: https://open.spotify.com/show/033HRTwEj7aFLx9K8ZEsVG
    Apple Podcasts: https://podcasts.apple.com/us/podcast/navigating-the-combination/id6786238670
    Amazon Podcasts: https://music.amazon.com/podcasts/12169e2d-2323-41db-bdb4-8a8e7841c799

    #navigatingthecombination #suttonscreek #combinationproducts #drugdelivery #pharmaconsulting #regulatoryaffairs #medicaldevices #biotech #pharmabiotech #fdaregulation #drugdevicedevelopment #lifesciences #combinationproductdevelopment #pharmapodcast #devicestrategy
    Navigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for pharma - each episode draws on 650+ combined years of experience and 120+ successful launches to cut through the complexity of combination product development, from device selection and regulatory strategy to OEM alignment, quality systems, and FDA submissions.
    Whether you're a VP of Regulatory Affairs weighing your submission strategy, a program director managing a complex OEM relationship, or an executive trying to protect a multi-million-dollar drug investment, this podcast gives you the insight, clarity, and confidence to make the right calls - right the first time.
    続きを読む 一部表示
    29 分
  • SE01 E03 Revolutionizing Drug Packaging | Matt Wills

    SE01 E03 Revolutionizing Drug Packaging | Matt Wills
    2026/08/11
    The container a drug product lives in has always mattered, but as biologics and gene therapies push the limits of sensitivity and complexity, it matters a great deal more. Matt Wills has spent over a decade at the intersection of material science and primary packaging, and in this episode he breaks down what is actually happening at the drug contact surface — and why that surface, not the bulk material, is where the real compatibility story plays out. He explains why glass is hitting its limits with certain advanced formulations, what is lost and gained in a switch to plastic, and how PECVD-based coating technology is opening up a third option that was not on the table a decade ago.The conversation goes well beyond material selection. Matt walks through how siliconisation introduces risk that teams often underestimate, why container closure integrity failures are rarely a single-component problem, and why the weakest link in a syringe system is so often the interface between components rather than any component in isolation. He also introduces the concept of maintaining a common drug contact surface across the entire manufacturing chain — from API storage through to the final filled container — and what that approach could mean for bridging studies, regulatory validation, and the speed at which programmes can progress.Key takeaways:The drug contact surface is the critical parameter in container selection, not the bulk material — glass, plastic, and hybrid containers all behave differently at that surface layer, and understanding the mechanism of interaction is what drives root cause investigationsGlass remains robust and well-characterised, but faces real limitations at high pH (risk of delamination), in complex formulations, and in design flexibility for combination product integrationPlastic offers more design freedom and better compatibility with auto injectors and on-body devices, but introduces trade-offs including oxygen barrier performance and different CCI behaviour at cold storage temperaturesPECVD-based coatings (such as SiO2's technology) allow the drug contact surface to be engineered independently of the bulk container, combining glass-like inertness with the design flexibility of plastic — but regulatory data, while growing, is still newer than glassSiliconisation solves a real engineering problem but introduces its own risk profile; the question is not whether silicone oil is harmful, but whether its interaction with a specific molecule is acceptable and controllable — and whether an alternative lubrication system might be easier to design around.Container closure integrity is a pass-fail requirement, not a nice-to-have — Teflon-coated plungers can compromise CCI at cold storage conditions due to differential shrinkage rates, and this needs to be understood before committing to a systemThe syringe is a multi-component system, not a single unit — plunger, barrel, siliconisation, needle geometry, and luer design all interact, and optimising components in isolation without understanding their interfaces is where programmes run into troubleMaintaining a common drug contact surface across the full manufacturing chain (API storage, processing, final container) can reduce validation unknowns, support bridging arguments, and shift the focus from reproving drug-surface interaction to proving like-for-like equivalence between container sizes.Connect with Matt Wills on LinkedIn: https://www.linkedin.com/in/mattswills/Visit SiO2 Materials Science: https://sio2med.com/Subscribe to Navigating the Combination for more conversations on primary packaging, drug-device integration, and the science behind combination product development.I hope you enjoy this episode! Give it a like, share, and subscribe to not miss the content coming your way weekly.– Parth & Jonathan and the Navigating the Combination podcast teamConnect with Parth Kothari on LinkedIn: https://www.linkedin.com/in/parthjkothari/ Connect with Jonathan Amaya-Hodges on LinkedIn: https://www.linkedin.com/in/jonathanwhodges/ Visit the Suttons Creek website here: https://suttonscreek.comListen to Navigating the Combination on these podcast platforms: Spotify: https://open.spotify.com/show/033HRTwEj7aFLx9K8ZEsVGApple Podcasts: https://podcasts.apple.com/us/podcast/navigating-the-combination/id6786238670Amazon Podcasts: https://music.amazon.com/podcasts/12169e2d-2323-41db-bdb4-8a8e7841c799#navigatingthecombination #suttonscreek #combinationproducts #drugdelivery #pharmaconsulting #regulatoryaffairs #medicaldevices #biotech #pharmabiotech #fdaregulation #drugdevicedevelopment #lifesciences #combinationproductdevelopment #pharmapodcast #devicestrategyNavigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for ...
    続きを読む 一部表示
    24 分
adbl_web_anon_alc_button_suppression_t1
まだレビューはありません