10.Dr.Wanxing Cui_Building-Compliant-Quality-Systems-for-ATMPs.pdf

1、Building Compliant Quality Systems for ATMPsGlobal Practical Pathways to Regulatory SuccessDr.Wanxing Cui,MD,PhD,CABP(H)Dr.Wanxing Cui,MD,PhD,CABP(H)Director,Cell Therapy Manufacturing FacilityMedStar Georgetown University HospitalGPO Pharmaceutical Summit 2026|January 16,2026|09:4510:30Quality Syst

2、ems:The Immune System of ATMP ManufacturingThree paradigm shifts are converging in 20252026 to reshape how advanced therapy medicinal products reach patients.These transformative forces demand that quality systems evolve from compliance checkboxes into strategic enablers of innovation.FDAs Plausible

3、 Mechanism PathwayApproval pathways without traditional randomized controlled trialsbreakthrough for rare diseasesAI-Enabled Regulatory IntelligenceAutomated compliance monitoring and predictive analytics transform quality operationsICH Q9(R1)Risk-Based ScalabilityDocumentation effort now commensura

4、te with risk levelenabling hospital-based manufacturingThailands Strategic OpportunityFollow the 20-Year Path or Leapfrog to 2030?Established FoundationGPO:Six decades of pharmaceutical excellence2,000+ATMP clinical cases completed successfullyPIC/S member since August 2016ATMP Conditional Approval

5、launched October 2024Market OpportunityThe Asia-Pacific ATMP market is projected to grow at 21.43%CAGR21.43%CAGRrepresenting billions in economic value and thousands of lives saved.Thailand stands at a crossroads:replicate the Wests incremental development,or architect next-generation systems from d

6、ay one.Todays RoadmapWhat You Will Learn in 35 Minutes01FDAs Plausible Mechanism PathwayUnderstanding the revolutionary approval framework for personalized therapies02Quality Systems FrameworkBuilding GMP-compliant operations for living cell products03AI-Enabled QualityLeveraging artificial intellig