Solid Biosciences’ Post

Let's connect at #ISCT2024! Join our panel discussion on current state and future directions of process analytical technologies. We're elevating your process with cell collections, cell expansion, and fill-finish. Looking forward to seeing you there. #CellandGeneTherapy #CGT ISCT, International Society for Cell & Gene Therapy

Less than a week to go for #EUCROF24! CROs are telling us sponsor study protocols are becoming increasingly complex and sample-intensive. What we often hear: 🏨 More sites, more patients, and strict timelines... ..... Will the kits be customized for study needs? ..... Will sites have the kits in time for FPI? ..... Are the kits easy to use? What if the site makes collection errors? 🔍 More endpoints and specialized testing. It's hard to find the right labs... ..... Is there a lab near the site to process short-stability samples in<24h? ..... Can the lab develop and validate this biomarker assay on-time? ..... Can the lab do the testing according to protocol? ✈ Thousands of samples scattered across sites, labs, and with couriers... ..... Where is sample X? Is it collected? ..... Do I have sample visibility? How will I keep the sponsor informed? ..... Can I ensure sample & data integrity? 📊 Millions of data points generated - from disparate data sources... ..... When and how will data be transferred? What about ad hoc transfers? ..... Will I have a unified dataset in time for submission? ..... Is the data accurate, consistent and usable? Sounds familiar? Stop by our booth #4 if you're open to learning more about how we help CROs and sponsors generate endpoint data for their complex trials - while preventing delays and reducing costs. #clinicalresearch #clinicaltrials #clinicaloperations

It was an absolute pleasure to attend and speak at the Gene Therapy Patient Engagement Summit again last week! A few takeaways: 📩 Direct and indirect engagement with the patient community should start even before the pre-clinical phase, as soon as a target condition has been identified   🤝 Early internal cross-functional alignment is critical to ensure patient advocacy is integrated into and considered in every functions' outputs   🏥 More consideration is needed when communicating the commitment of the long-term follow-up required post-gene therapy trials; for patients who have lived around hospital appointments and procedures for decades, we cannot underestimate the burden of having to continue this for a further 15 years    📺 When planning engagements and outreach to patients, it is critical to meet the communities where they're at

As clinical trials grow in complexity, study sponsors and investigators are adapting with agile and risk-based approaches, focusing oversight on critical data and high-risk processes. Join Kelsey Schertz. MPH, CCRC, CCDM of NMDP BioTherapies at #ACRP2024 for the session "Understanding Roles and Responsibilities in a World of Increasing Data Complexity" to gain insights into risk-based monitoring and strategies for cell and gene therapy clinical trials. Explore more session details > https://bit.ly/49qKvst #GoForIt #GoForEducation #ClinicalTrials #ClinicalResearch #Study #SiteManagement #Data

Only one week until our 'Overcoming Challenges in the Industrialisation of iPSC-derived therapies' webinar! Cell and Gene Therapy Catapult's Márcia F. Mata, will be discussing examples of how we are working to address key manufacturing challenges within the allogeneic cell therapy field; developing scalable, automated, and controlled processes to help bring these pioneering advanced therapies to patients will be discussed. Register now: https://buff.ly/3y9Z5XJ #iPSC #AdvancedTherapies #CellTherapies #GeneTherapies

Make the smart choice and register for this webinar!

Check out this on-demand webinar on long-term follow-up (LFTU) considerations for cell and gene therapy studies featuring our colleagues from Thermo Fisher Scientific as well as industry experts.

Our Development Head of Cell and Gene Therapy, Carolyn Sasse, recently shared her predictions on #clinicaltrial trends for the #biopharma industry in 2024 as part of Citeline’s #ScripAsks series. Explore Carolyn’s perspectives on the importance of patient centricity in clinical trials: https://bit.ly/42uY7Ae

Check out this on-demand webinar on long-term follow-up (LFTU) considerations for cell and gene therapy studies featuring our colleagues from Thermo Fisher Scientific as well as industry experts.

Last week, Trudy Straetemans presented at the regular floor meeting of Regenerative Medicine Utrecht. She shared insights from her invaluable work at the GMP Simulation Facility of the Innovation Center for Advanced Therapies (ICAT). 💡 During her presentation, Trudy Straetemans delved into innovative strategies aimed at optimizing the translation of cellular and gene therapy medicinal products into clinical practice. Her expertise shed light on key pathways for enhancing efficiency and efficacy in this critical process. 🔬 Follow Innovation Center for Advanced Therapies (ICAT) for more exciting updates! 🌟 #RegenerativeMedicine #Innovation #GMPsimulation #ICAT