Noninvasive testing, fibrosis assessment and machine learning are changing how researchers think about MASH clinical trials. Dr. Winston Dunn of Summit Clinical Research Solutions and Pinnacle Clinical Research – San Antonio discusses patient screening, risk stratification and the growing need to match treatments to different patient profiles. Read the Xtalks Spotlight interview at xtalks.com/how-noninvasive-t… by @soumya2390. #CDMO #PharmaceuticalManufacturing #FacilityDesign #SterileManufacturing #Biopharma

Transform regulatory writing bottlenecks with Mark Pittman in this webinar hosted by ZyliQ.AI. Gen-AI is reshaping regulatory authoring, yet prompt engineering can create new inefficiencies and inconsistent outputs. Discover a content-driven approach that keeps medical writers focused on scientific judgment, review, and submission-ready quality within familiar workflows. Register for this webinar to learn how to reduce CSR first-draft time, map source content to regulatory documents, and work with Gen-AI directly in Microsoft Word: xtalks.com/webinars/accelera… #ZyliqAi #GenerativeAi #RegulatoryWriting #MedicalWriting #RegulatoryAffairs #LifeSciences #Biopharma #ClinicalDevelopment #ClinicalTrials #MicrosoftWord #ContentReuse #ArtificialIntelligence #DigitalTransformation

Navigate evolving cell and gene therapy access demands with Kim Tedesco, RPh and Dan Powell, PharmD, BCPS, CSP in this webinar hosted by Walgreens. As CGT pipelines move into broader indications and earlier treatment lines, access models must keep pace with more complex patient identification, referral, and care coordination requirements. The path to commercialization increasingly depends on translating precision medicine advances into scalable treatment pathways. Register for this webinar to learn how pipeline trends can shape access strategies, patient pathways, and commercialization readiness: xtalks.com/webinars/improve-… #Walgreens #CellAndGeneTherapy #GeneTherapy #CellTherapy #PrecisionMedicine #Biopharma #LifeSciences #PatientAccess #Commercialization #CareCoordination #PharmaStrategy #RareDisease #AdvancedTherapies

Day 2 at the OECT Summit is a done-done! @kpmorgangroup brought together a strong lineup of speakers tackling some of the biggest conversations shaping clinical trials today, from AI implementation and institutional authorization to patient voice, site engagement, recruitment and the human side of automation. It has been an exciting two days in Toronto, and we hope the discussions sparked here continue well beyond the summit and lead to even more conversations in the days and weeks ahead. This has been Xtalks On Location with Insiya, Mohammad and Stephanie. #OECTSummit #ClinicalTrials #ClinicalResearch #PatientEngagement #Xtalks

Flexible CDMO facilities need to support changing pipelines without adding unnecessary operational complexity. Jason R. Goodwin from @FUJIFILMBiotech discusses equipment selection, automation, vial filling and emerging gloveless technology. Get an exclusive peek from this Xtalks Spotlight interview at buff.ly/fpueQ7b by @soumya2390.

Navigate the market access implications of physician consolidation with Matthew Arnold, Dee Chaudhary, April Collins and Dana Jacoby in this webinar hosted by Clarivate. Physician supergroups are redefining care delivery, formulary influence and product adoption across key specialties. As independent practices scale through shared services, private equity and value-based care models, life sciences teams need sharper account intelligence and engagement strategies. Register for this webinar to learn how leading supergroups shape market growth, drug utilization and launch strategy: xtalks.com/webinars/the-rise… #Clarivate #LifeSciences #Biopharma #MarketAccess #PhysicianSupergroups #HealthcareConsolidation #ValueBasedCare #HealthcareData #CommercialStrategy #ProductLaunch #ProviderEngagement #HealthEconomics #PrecisionMedicine

Transform complex IVD study oversight with Jessica Green and Andrew Mercier in this webinar hosted by ARC Regulatory. IVD clinical performance studies demand stronger governance, cleaner data and faster decisions amid growing regulatory and operational complexity. Discover how sponsor delegation and hybrid monitoring can unite central oversight with targeted on-site support to reduce burden without compromising accountability. Register for this webinar to learn how hybrid monitoring can strengthen oversight, improve coordination and reduce operational risk in IVD clinical studies: xtalks.com/webinars/transfor… #ARCRegulatory #InVitroDiagnostics #IVD #ClinicalTrials #ClinicalOperations #HybridMonitoring #SponsorDelegation #RegulatoryAffairs #QualityManagement #ClinicalResearch #MedicalDevices #DiagnosticInnovation #RiskBasedMonitoring #LifeSciences

Meet Xtalks Featured Community Member Lorraine Dishman, Clinical Operations & Program Delivery Leader, Behind the Protocol™. Drawing on experience across site, CRO and academic settings, she focuses on turning complex clinical trial strategies into decisions teams can execute while keeping operational realities and patients in view. Read more: buff.ly/V5NOJ4G #ClinicalOperations #ClinicalResearch #ProgramDelivery #PatientCentricity #XtalksCommunity

Live from the 10th Annual OECT Summit in Toronto today, hosted by @KPMGLOBALS. The theme — From Prediction to Participation: Transforming Trial Success with AI. A question: is AI actually moving the needle on feasibility, trial operations and patient recruitment or is there still a gap between promise and practice? We’re here talking to speakers and listening for the themes that stand out. #OECkpm #ClinicalResearch #AIinClinicalResearch #LifeSciences #XtalksOnLocation

Xtalks is On Location today at the 10th Annual OECT Summit in Toronto, hosted by @KPMGLOBALS! Two days, a packed speaker lineup and one question running through much of the agenda: is AI actually delivering in clinical trials, or are we still chasing the hype? Today’s lineup is digging into where the real progress is, from smarter feasibility and site strategy to patient intelligence and AI-powered clinical operations, and where the gap between promise and practice still shows up. Proud to be media partners again this year. We’re speaking with clinical research leaders and following the conversations shaping clinical trials today. #OECkpm #ClinicalResearch #AIinClinicalResearch #ClinicalOperations #LifeSciences #XtalksOnLocation

Master clearer signal detection in MDD trials with Luka Lucić, PhD and Svenja Wacker, PhD in this webinar hosted by Cogstate. Placebo response can obscure treatment effects, but it is rarely driven by a single factor. Understand how trial design, endpoint quality, measurement practices, and operational variability can weaken drug-placebo separation. Register for this webinar to learn how to distinguish true and pseudo-placebo response, identify endpoint-quality risks, and apply targeted interventions to strengthen trial signal: xtalks.com/webinars/understa… #Cogstate #MajorDepressiveDisorder #MDDTrials #ClinicalTrials #PlaceboResponse #SignalDetection #ClinicalOperations #ClinicalOutcomeAssessments #EndpointQuality #PsychiatryResearch #CNSClinicalTrials #Biopharma #DrugDevelopment

Overcome cell and gene therapy characterization bottlenecks with Kirsty Maclean and Karthikeyan Devaraju in this webinar hosted by Cerba Research. As living drugs grow more complex, sponsors need integrated evidence of safety, identity, purity, potency, and sustained therapeutic activity across global programs. Discover how flow cytometry, genomics, and bioanalysis can connect molecular design to cellular function while supporting scalable, standardized development strategies. Register for this webinar to learn how multi-modality testing can strengthen CGT characterization, reduce translational risk, and support global trial execution: xtalks.com/webinars/bypassin… #CerbaResearch #CellAndGeneTherapy #CGT #CarT #StemCellTherapy #AAV #RNATherapeutics #FlowCytometry #Genomics #Bioanalysis #ClinicalDevelopment #TranslationalScience #Biopharma #ClinicalTrials

Transform AI productivity into measurable enterprise value with Shweta Singh Maniar, Gaurav Sharma and Akshat Jhaveri in this webinar hosted by Cognizant. AI adoption is accelerating across life sciences, but tool usage and local efficiency gains rarely translate into validated business outcomes. Discover the integration, operating-model, and measurement gaps that can quietly undermine AI ROI at enterprise scale. Register for this webinar to learn how to uncover hidden AI ROI barriers and measure impact beyond usage and perception: xtalks.com/webinars/the-prod… #Cognizant #LifeSciences #ArtificialIntelligence #GenerativeAI #AIROI #EnterpriseAI #DigitalTransformation #Biopharma #ClinicalOperations #HealthcareInnovation #DataStrategy #OperatingModel #BusinessValue #DigitalHealth

Navigate critical starting material changes with Sandeep Yadav, PhD in this webinar hosted by 4basebio. A change in critical starting material can reshape comparability requirements, stability strategy, regulatory risk, and development timelines. Learn how a science-led, risk-based CMC approach can support confident decisions through supplier transitions, scale-up, and urgent change scenarios. Register for this webinar to learn how to define critical starting materials and build regulatory-ready, risk-based CMC submissions for successful implementation: xtalks.com/webinars/future-p… #4basebio #LifeSciences #Biopharma #CMCStrategy #RegulatoryAffairs #StartingMaterials #AnalyticalComparability #DrugDevelopment #CellAndGeneTherapy #GeneTherapy #Biologics #ManufacturingStrategy #QualityByDesign #FDA #EMA

Master consistent antibody quality for lower-risk ADC conjugation with Dave Briggs, PhD in this webinar hosted by Avid Bioservices. As ADC programs advance, antibody variability can compromise conjugation efficiency, process reproducibility, and final product performance. Learn how upstream, downstream, and scale-up decisions shape critical quality attributes before payload attachment. Register for this webinar to learn how antibody quality, process control, and CDMO expertise can support reliable ADC conjugation and scalable manufacturing: xtalks.com/webinars/reduce-a… #AvidBioservices #AntibodyDrugConjugates #ADCDevelopment #AntibodyManufacturing #Biopharma #Oncology #MonoclonalAntibodies #CDMO #BiologicsManufacturing #ProcessDevelopment #Conjugation #CellLineDevelopment #DrugDevelopment

Navigate the evolving role of translational models with Gourav Roy-Choudhury, PhD, DABT, Thierry Decelle, DVM, MSc and Andrea Varrone, MD, PhD in this webinar hosted by Bioculture. As NAMs mature and regulatory expectations evolve, model selection demands stronger scientific, ethical, and commercial justification. Explore where non-human primates remain uniquely informative, where alternatives add value, and how evidence-led decisions can advance both development strategy and the 3Rs. Register for this webinar to learn how to assess when NHP use is justified, compare complementary alternatives, and apply real-world preclinical insights to clinical decision-making: xtalks.com/webinars/assessin… #Bioculture #TranslationalResearch #NonHumanPrimates #PreclinicalResearch #DrugDevelopment #NewApproachMethodologies #OrganOnChip #ComputationalToxicology #ClinicalDevelopment #Toxicology #Neuroscience #Oncology #AnimalWelfare #ThreeRs #LifeSciences

Meet Xtalks Featured Community Member Sarah Ropp, Specialist, Paramedic Education, Advanced Care Paramedic at Peel Regional Paramedic Services. Her work combines prehospital clinical research with frontline education, including randomized controlled trials and high-fidelity simulation training aimed at strengthening emergency care and patient outcomes. Read more: buff.ly/NZNjdSu #Paramedicine #PrehospitalResearch #EmergencyMedicine #ClinicalEducation #XtalksCommunity

From evolving submission expectations and clinical trial models to AI-supported safety monitoring, life sciences teams are working across increasingly connected regulatory, clinical and pharmacovigilance challenges. At the DIA Canada Annual Meeting 2026, dedicated Regulatory, Clinical and Safety and Pharmacovigilance tracks will bring together regulators, researchers, industry professionals and patient representatives to exchange perspectives on these changes across healthcare product development. 👉 See what’s on the agenda and register:buff.ly/JfJCb4w #ClinicalResearch #RegulatoryAffairs #Pharmacovigilance #DrugSafety #Pharma #MedTech #DIACanada2026