Joy Duemke’s Post

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

Heading to RESI / JPM conference today. If you want to hear how Opsin Biotherapeutics, Inc. is addressing the chronic pain epidemic using our disruptive neuromodulation therapy using gene therapy and light, reach out and we can set up a time to meet! #chronicpain #neuromodulation #spinalcordstimulation

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

Exciting Day 2 of Advanced Therapies Week down in Miami! So far, we’ve had the privilege to connect with some of the leading innovators in the field of Cell & Gene Therapy, one of the youngest fields in science today that holds a lot of promise for the future tomorrow. Between learning about innovative drug delivery methods to actual patient saving cell replacement therapy, this field holds so much promise for a better tomorrow. We are excited to sync up innovative strategies for how #CGT can prevent the progression of type two to type three diabetes. Share your interesting ideas below! #MindfulDiabetes #JOINTHECAMINO

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

Make the smart choice and register for this webinar!

Dr. Paolo Siciliano, Martin Sowden, Shanton Wilcox, and Harry Ustik, my colleagues at PA Consulting wrote a thought-provoking piece on the intricacies of manufacturing in the cell and gene therapy space for SupplyChainBrain. #GeneTherapy #MedicalManufacturingChallenges #AutologousCommercialCellTherapy

Operationalizing #cellandgenetherapy trials is a significant and complex task that takes expert planning and implementation. Check out our webinar (https://lnkd.in/g87QdfCj) where Allucent experts Desmond Cabrera (VP, Project Management), Joyce Moore, PhD (Global Head, Patient Engagement), Francisca Samson - Graveland (Director, Data Management), and Marita Kruskopf Osterberg, PhD (Senior Manager, Study Start-Up) share insights and strategies on how to successfully conduct cell and gene therapy trials. #Allucent #BringNewTherapiesToLight #DrugDiscovery #ClinicalTrials #PatientEngagement #DrugDevelopment

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