Kymanox’s Post

Not to be missed, these townhalls are so valuable not just to understand the Agency’s current thinking but also to get insights into how companies have approached certain topics to date and their acceptability.

Thoughts on this? >> Lab group sues FDA over final rule regulating laboratory-developed tests >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #biotech #productmarketing #pharmaceutical

Metrion Biosciences performed a GLP compliant study in accordance with the ICH E14/S7B Q&A best practice guidelines to generate in-house IC50 values for the FDA's positive control compounds; ondansetron, moxifloxacin and dofetilide. Gary Clark and John Ridley have enjoyed discussions at the #JSPS meeting this week. If you missed them, you can download the poster that presents this case study and find out more about GLP hERG screening at: https://buff.ly/3OLRZOC #Ionchannels #GLP #hERG #CardiacSafety #DrugDiscovery #DrugSafety #LifeSciences #JSPS24 #Screening"

Have you explored the possibilities of harnessing phase-specific regulatory strategies when bringing your ATMP to market? In our upcoming webinar ‘ATMPs in Focus: Essential CMC Strategies for Every Phase’, taking place on January 25, we’ll uncover the key details for taking a phase-appropriate approach.  We’ll also dive into the stability strategies required for early-phase development and how to ensure the success of your approach.  Sign up now: https://lnkd.in/d3T8STpn #ATMPs #CMC #DrugManufacturing #PharmaWebinar 

Thoughts on this? >> Lab group sues FDA over final rule regulating laboratory-developed tests >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #productmarketing #pharmaceutical #healthcare

You do not see very often route scouting & GMP batch production efforts in Org. Lett. but this one definitely deserve it! Still a 92 step long sequence in total after optimization (not all under GMP of course 😀 ). I am waiting to read the full story in a more detailed paper, especially regarding the CMC strategy chosen for analyzing the batch and identifying process impurities! Very nice collaboration between academia and industry on this https://lnkd.in/dtydCcm7

Tomorrow we are live for our exclusive webinar for emc compliance and emc regulatory customers: 🎧 QR codes for prescribing information ahead of the ABPI code update. We're also inviting customers to share their questions ahead of this online event - if you've already registered and would like to submit your question for the panel to answer, see: 👉 https://bit.ly/4dbaYvV If you haven't registered and would like to attend, there's still time: https://bit.ly/3yjeo0G *this webinar is for emc compliance and emc regulatory customers only #Pharma #compliance #QRcodes #ABPIcode

📣 Start preparing for the FDA's final rule on Laboratory Developed Tests! An updated ruling on LDTs is imminent as the FDA partners with Congress to revise its original draft, and diagnostics manufacturers should be prepared to meet new premarket review requirements in the immediate future. Find out how the FDA's new regulation works, how the industry is reacting, and how you can get prepared: https://bit.ly/3YlY3mu #Diagnostics #FDA #LaboratoryDevelopedTests

Our webinar on how taking a phase-specific approach can help you overcome your ATMP project’s CMC challenges has come to an end. If you missed it you can catch up with the discussion via the on-demand recording at any time that suits you. Uncover our expert insights into how this approach can help you overcome these challenges while also: ◼ Saving time  ◼ Reducing costs  ◼ Staying ahead of the ever-evolving regulatory landscape. Watch now: https://lnkd.in/d3T8STpn ?utm_source=LinkedIn&utm_medium=social&utm_campaign=bio_general #ATMPs #CMC #DrugManufacturing #PharmaWebinar 

Better than us telling you that ValGenesis iRisk is the #QbD tool for CMC development, is seeing it written and published by the hands of the #CMC expert Irwin Hirsh. Take a look 👉https://lnkd.in/d2GjQ4Pc