ISPE SC Chapter’s Post

Before: Contract service providers did one thing — discovery, development, or manufacturing — but never all three. Now: We've got alphabet soup with all the CADMOs, CRDMOs, and CTDMOs out there trying to do everything under one roof. It's a lot to take in, but Bernardo Estupiñán Gaisbauer has the Rosetta stone to help decode all those letters and see what's really underneath. He breaks down some key questions you should ask when evaluating a contractors' capabilities.

It’s about time to give a shoutout to the laboratory team at our #Parexel #EPCUBerlin led by Melanie Nickel and Almuth Mittermayer: In 2022, our lab achieved formal accreditation by the German authorities (Deutsche Akkreditierungsstelle - DAkkS) per DIN EN ISO IEC 17025, got re-accredited last year and now also reached #GCLP (Good Clinical Laboratory Practice) certification in December 2023.  These recognitions not only underscore our commitment to quality but also serve as a testament to the lab team’s stellar work and our adherence to the most stringent standards and protocols. If that wasn’t enough, the team also established Next Generation Sequencing for onsite #genotyping capabilities at our unit with a turnaround time of ~24 hours. This is a real differentiator as genotyping is being asked for in many of our #EarlyPhase studies. It goes a long way and is much more cost effective being able to manage and analyze those samples completely on site. Add to that the implementation of a Lab Information Management System - with the support of our great Technical Services team led by Laurent Venerucci - so that resulting of our in-house assessments can be automatized ...and the thousands of samples being processed and analyzed every year: Thank you all for your hard work! PS: The fact that it only took 2 attempts to take a picture and that everyone agreed on which one to use within seconds also shows how good a team you are!

Coming this week... A major challenge facing the #CGT community is understanding how to adequately support phase-appropriate readiness of analytical assays used in all phases of clinical development on the pathway towards regulatory filing. The BioPhorum #ATMP Phase Appropriate Approach to Assay Validation workstream have generated a presentation consolidating opinions and recommendations with an aim to promote alignment on a common phase-appropriate approach to analytical assay development in some of the most common CGT modalities. The goal of the collaboration is to provide a faster, more efficient development route that is compliant with regulatory standards. Thank you to all who have contributed to this important discussion: Jenny Kim, R. Alan Llenado, Ph.D., Aparna Subramanian, Ph.D, Manjula Aysola, Kieron McIntyre, santoshkumar khatwani, Ying Li, PING CARLSON, Nasser Sadr, Katie Holton, Jeanette Young Astellas Pharma US, Dominic Hildebrand, Zhu Pirot Bayer, Jason Matthews, Stuart Beattie, Douglas Brown, Silke Wissing, Berangere Tissot, Srividya Ramanathan, Weihong Wang, Kamran Abbas, Dengyun (Daisy) Sun, Yan Zhao, Roland Pach, Michael Molony, Shashi Prajapati (Ph.D) and Anne-Sophie Cottard Sarah Currie, PMP, Steven Wall, Christine Boswell, Kathleen O’Hagan, Rachel Hodges, Evelyn Camon, Simon Walker #CAR-T #AAV #phaseappropriate #assayvalidation 

https://lnkd.in/dJeZ2KVk Breaking Ground in Pharma Supply Chain: Check out our latest article on The Wolf Practice website, diving deep into the game-changing strategies for tackling serialization challenges! 🚀 💼 #PharmaInnovation #SupplyChainSolutions #TheWolfPractice

We're at the RSC Fragments Meeting in Hinxton today and tomorrow - come and say hello if you want to talk about fragments and how we can help you integrate them into your drug discovery projects. #fragments24 #drugdiscovery #FBLD #DEL

Thoughts on this? >> Icahn gives up seat on Illumina board, backing away from challenge to diagnostics company >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #productmarketing #pharmaceutical #pharma #biotech

LORENZ Life Sciences Group and Egnyte announced today an integration in the upcoming LORENZ 24.1 release. "Halloran is happy to partner with LORENZ and Egnyte to deliver an effective solution," said Sheila Gwizdak. "This is an example of a technology integration improving efficiency, maintaining control of critical submission documents, and enabling Halloran to provide high-quality regulatory services to the life science companies we serve." Read the full press release to learn more about the integration. https://hubs.la/Q02wrk3s0 #eCTD #RegulatoryOperations #DataIntegrity #TechnologyEnablement #Lifesciences

Thoughts on this? >> Icahn gives up seat on Illumina board, backing away from challenge to diagnostics company >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharmaceutical #pharma #productmarketing #biotech

4am Software is the reseller for Certara Inc., in Australia and NZ regions, this is a copy of their post below. Customers from Australia and NZ, planning on visiting this event can also contact us for any details or pricing. REPOST - Are you keeping pace with the pivotal role of Model-Informed Drug Development (MIDD) and biosimulation modeling in shaping the future of Drug Development? With #CERTAINTY just around the corner, securing your spot for the session "How QSP and PMX Complement the Drug Approval Process" is a must. Join us to witness the dynamic collaboration between Quantitative Systems Pharmacology (QSP) and Pharmacometrics (PMX) in expediting drug approval processes. Our esteemed facilitators, Piet Van Der Graaf, Senior Vice President and Head of QSP, and Mirjam Trame, Vice President, Certara Drug Development Solutions, will guide us through this enlightening session. Don't miss out on the opportunity to engage in insightful discussions and gain leading-edge insights from our distinguished guest panelists, including Balaji Agoram from Genentech, Larry Lesko from the Center for Pharmacometrics & Systems Pharmacology at the University of Florida College of Pharmacy, Gianluca Nucci from Pfizer, and Megan Gibbs from AstraZeneca. Space is limited. Register now to secure your complimentary seat to our client-only event:  https://lnkd.in/eNiTGkgn #QSP #Pharmacometrics #DrugDevelopment #CERTAINTY #ClientSummit

ZENOVEL enhances clinical phase studies!🌟 As we gear up for DCAT (Drug, Chemical & Associated Technologies Association) Week, let's revisit our stellar GCP #milestones of 2023. Ready to revolutionize your clinical phase studies? Connect with us, and let's discuss the possibilities! Schedule your meeting now: palak@zenovel.com #Zenovel #GCP #ClinicalInnovation #DCATWeek #PharmaCollaboration #dcat2024 #clinicalresearch #clinicaltrials