7.ดร.ภญ.อิสริยา เตชะธนะวัฒน์_ATMPs.pdf

1、Evolving Pharma for TomorrowAdvanced Therapy Medicinal P FDA Approvals by Major Technology GroupSmall MoleculeMonoclonal AntibodyBiologics(excl cell,gene,monoclonal)Cell and Gene TherapyDecrease numbers of small molecule approvalParadigm ShiftSmall MoleculesBiologicsin Pharmaceutical IndustryNext Ge

2、neration Therapeutics ATMPsAdvanced Therapy Medicinal Products1.Gene Therapy Medicines2.Cell Therapy Medicines3.Tissue-engineered Medicines4.Combined-ATMPsClassification of ATMPs AutologousHigher Cost Lower Host Immune RejectionATMPs TherapyAllogenicLower Cost Possible Host Immune Rejection1.1.2.3.4

3、.5.6.7.8.9.Basic ResearchPreclinical DevelopmentCTD PreparationClinical DevelopmentQualitySystem ATMPs DevelopmentGMPGLPGCPPharmacovigilanceATMPs Supply Management Cold-Chain ManagementGMPGDPManufacturing QC&ReleaseCTDCollaborative NetworkGMP Certified Biopharmaceutical ManufacturerCold ChainManagem

4、entAffordable Access01020403Key Success factors for ATMPs1001 Collaborative Network Osteoarthritis Domestic and International Collaboration Linkage between Multidisciplinary teamsResearchers,Regulatory Bodies&Hospitals Cancer 1102 GMP Certified Biopharmaceutical ManufacturerContract Development and Manufacturing Organization(CDMO)12Temperature Monitoring Logistic System03 Cold Chain Management 04 Affordable AccessCost Reduction for Public Health SystemHealth Benefits Package for Universal Health CoverageUltimate GoalTo Deliver InnovationFrom Bench to Bedside