Suttons Creek

Ask Max the questions you wish you could ask your FDA Reviewer! Max Lerman, PhD, Suttons Creek Senior Principal Consultant and former FDA Reviewer, will be at PODD with our combination product expert team to give insider answers to your questions about your regulatory pathway. Email?[email protected]?or complete our online contact form to schedule your meeting! #drugdelivery?PODD: Partnership Opportunities in Drug Delivery Community News #FDA #deliverydevice?#medtech?#combinationproduct?#pharma #biotech Jonathan Amaya-Hodges Rob Schulz Craig Voellmicke

Don’t forget to add @Craig Voellmicke's?Tech Talk to your PDA Universe agenda – Wed. Oct. 23 at 12:25pm. If you HAVE TO miss it, you can always stop by our booth #119 to get the crib notes. ;) More information at?suttonscreek.com #drugdelivery?PODD: Partnership Opportunities in Drug Delivery Community News #FDA #deliverydevice?#medtech?#combinationproduct?#pharma #biotech Steven Badelt, PhD?Rob Schulz Albana Thorpe, PMP Kelly Wedig?Brian Pullins

Current regulations pose a significant impediment to studying novel drugs and devices together in the EU. The European Commission has investigated these challenges, and our combination product experts have created a breakdown of key points addressed in their recent report.?We?are sending?the breakdown in?an email to our subscribers this?Thursday.?To?receive?it, and?more combination product tips like it, click here: https://lnkd.in/gA4ngeWi. #europeancommission #clinicaltrialregulation #mdr #ctr #ivdr #medicaldeviceregulation #invitrodiagnosticregulation #combinationproduct #drugdelivery #deliverydevice #devicedevelopment #combineproject #medicaldevice #pharma #biotech #medtech #celltherapy #genetherapy

It is important for Commerical Teams to understand what decisions impact Combination Product development timelines. Identifying the downstream and upstream implications of certain development decisions made by various functional partners in the development process is critical to keeping your project on time and on budget. Click to see a list of some common example decisions that can affect your development timeline and influence the types of design choices and devices available to you. ?https://lnkd.in/g8cEbNJg #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #commercialteam

Let’s meet up! Join our team at PDA Universe in Arizona on October 22 and 23 to talk all things drug delivery device. Our experts support all stages of your combination product lifecycle from initial strategic planning through?postmarketmanagement. If you are experiencing challenges with your drug delivery device, we can point you in the right direction. Take advantage of Suttons Creek having SIX experts at this show and pick some combination product brains! You can schedule a meeting in advance by emailing?[email protected]?or simply find us at booth 119. #drugdelivery?PODD: Partnership Opportunities in Drug Delivery Community News #FDA #deliverydevice?#medtech?#combinationproduct?#pharma #biotech Steven Badelt, PhD?Rob Schulz Craig Voellmicke??Albana Thorpe, PMP Kelly Wedig?Brian Pullins

Meet us at booth #34 during the PODD Conference! We are setting meetings to share our expertise on challenges our industry colleagues are facing in drug delivery device development. In addition to key Suttons Creek leaders (Jonathan Amaya-Hodges, Rob Schulz and Craig Voellmicke), Max Lerman, PhD, Suttons Creek Senior Principal Consultant and former FDA Reviewer, will be blocking off time for special regulatory-related meetings. Email?[email protected]?or complete our online contact form to schedule your meeting! #drugdelivery?PODD: Partnership Opportunities in Drug Delivery Community News #FDA #deliverydevice?#medtech?#combinationproduct?#pharma #biotech

The US Food and Drug Administration (FDA) is preparing to release a draft guidance on the use of artificial intelligence/machine learning (AI/ML) in drug development in the next few months. In part, this Guidance aims to get ahead of the growing advancements in AI/ML and fulfill a mandate in Executive Order 14110. The FDA has seen a significant increase in submissions with AI components, from one in 2016 to 128 in 2021, spanning various therapeutic areas. In response to an earlier discussion paper published by the FDA on the topic, the agency received 800 comments seeking clarity on AI oversight, risk-based approaches, transparency, and documentation requirements. This feedback, along with the FDA’s experience and research, will inform the upcoming guidance, which will also include best practices and consistent terminologies related to AI. The development of the guidance will incorporate contributions from the FDA’s medical product centers, the Oncology Center for Excellence (OCE), and the Office of Combination Products. If you would like to discuss with our experts, including a few former FDA Reviewers, on what to expect from this draft guidance or get clarification when it is published on its effects to your business, please reach out anytime. https://lnkd.in/g2gNw-_2 #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #FDA

Hope to see everyone at AFDO/RAPS in Providence next month!

Looking forward to meeting up at PODD - let me know if you'll be there!

You should meet Max!