Greg Verdine’s Post

Schedule a meeting with our experts to discuss your upcoming product development, including Early Phase and Late Phase Trials. #Cliantha #clinicaltrials #clinicalresearch #drugdevelopment

Are you attending ASCPT 2024? Don't miss Certara's Sibylle Neuhoff, PhD's insightful presentation on "Transporter Research for Global Outreach: Unleashing the Power of Everything, Everywhere, All at Once" See a list of all our exciting presentations here: https://ow.ly/yPu250QB9O7 #ascpt2024 #transporterresearch #drugdevelopment

Just wrapped up an insightful keynote with Dr. Klaus Romero at #Certainty! Dr. Romero, CEO and CSO of the Critical Path Institute (C-Path) discussed "The Regulatory Scientist Perspective on MIDD," highlighting how quantitative methods are shaping regulatory reviews. He covered key concerns of regulatory scientists and the critical questions models need to address, using industry examples and case studies. Thanks, Dr. Romero, for your expertise! #Certara #CertaraCertainty #DrugDevelopment #RegulatoryScience #MIDD

Regulatory approval serves as an important differentiator of risk within the life science industry, but the FDA special review pathways and the associated implications of each confuse and disorient passive, life science admirers and experts alike. That's why we crafted this new guide to offer a better understanding of each designation. Enjoy and save this guide to refer back to in the future! Weaver #lifescience #FDA #regulatorystrategy #healthcare

Read key results from the GATHER1 and GATHER2 clinical trials, conducted by IVERIC bio, Inc., An Astellas Company. This plain language summary publication shares easy to understand information about a potential treatment for geographic atrophy, an advanced form of dry age-related macular degeneration which can result in vision loss. Access the #PLSP here: https://lnkd.in/eQTBVHdC.

‼️💊‼️📢DONT FORGET TO JOIN THIS YEARS FDA/CRCG WORKSHOP IN ROCKVILLE, MD, THIS THURSDAY AND FRIDAY IN PERSON OR VIRTUALLY📢‼️💊‼️ I will be attending and co-facilitating at this year’s FDA and Center for Research on Complex Generics workshop titled: Drug-Device Combination Products:  Updates and Challenges with Demonstrating Generic Substitutability on March 14-15th, 2024 at the Universities of Shady Grove in Rockville, MD. The workshop will focus on comparative user interface assessments in generic drug-device combination product (DDCP) development, e.g., comparative use human factors studies, and the challenges thereof. I will be co-facilitating Topic 2 of the workshop, which will focus on “Other” design differences and examples thereof and aim to gather industry’s insights to inform and improve the science and methodologies of human factors comparative user interface assessments in DDCP with respect to such. Please come and join and share your insights, perspectives, experiences, and ideas for improvements. Whether you are in clinical, human factors, engineering, or regulatory, we promise it will be two days of insightful and thought provoking collaborative discussions. Frankly, I can’t hardly wait to see you all there and dive deep into comparative user interface assessments and as always geek out on all things human factors and how to improve the future of it! To learn more about the event and to register please follow the link below. #fda #drugdelivery #combinationproducts #comparativeuse #workshop #workshopfacilitation #generics #genericdrugs #drugdevelopment #drugproduct #science #humanfactors #humancentered #userresearch #userinterface #userinterfacedesign #humancentereddesign

Every clinical research project has a unique set of challenges. That’s why LabConnect offers a full suite of innovative Central Laboratory Services that are designed to meet the unique needs of your #clinicaltrial – of any size and complexity. With access to more global points of service than any other central lab, discover how LabConnect makes it easy to keep your research moving forward. => https://lnkd.in/dJe82SXN #CentralLab #DrugDevelopment #LabConnect

How do you find, identify, and validate hits? 🤔 These are questions that anyone in #DrugDiscovery will be familiar with – and ones we aimed to tackle in our recent Interaction Analysis Masterclass! Our experts Edward A. FitzGerald, Marta Janczuk-Richter, and Stoyan Milev explained how ITC and GCI can be used as complementary technologies for all your early-stage drug discovery needs. Missed it? No worries – you can catch up on the masterclass here 🔗https://lnkd.in/dDcPubrk #DrugDiscovery #InteractionAnalysis #Masterclass #ITC #GCI

By May 2024 labs must declare publicly that their in-house tests meet the GSPRs. Watch the latest IVDReady webinar online to learn more. Watch the webinar: https://lnkd.in/dHXqbFEP Our recent webinar illuminates the basics of the 𝗚𝗲𝗻𝗲𝗿𝗮𝗹 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀, which labs were to have fulfilled by May 2022. By May 2024 labs must take active steps to demonstrate fulfilment of GSPRs, including a public declaration that their in-house tests meet the requirements. This webinar explains it all, including how standards can be applied to reliably fulfil GSPRs. Special guest Prof. Kurt Zatloukal from the Diagnostic and Research Center for Molecular Biomedicine at the Medizinische Universität Graz outlines a prime example of how GSPRs and standards can lead to better diagnostics. #IVDR #IVDReady #regulatory #laboratories

Bimonthly network webinar always deepen my understanding of the complexities of drug discovery and development. Thanks to Professor Maria Laura Bolognesi and all the professors and colleagues in our TClock 4AD network for today’s sharing and discussion. Simple scientific terms are often subconsciously conflated by non-professionals; for instance, toxicity and teratogenicity are not the same. #SciComm #DrugDiscovery #DrugDevelopment