8.ดร.ภก.นรภัทร ปีสิริกานต์_GPO summit_Cancer vaccine_Norapath_12012026.pdf

1、Therapeutic,Personalized Cancer Neoantigen VaccineNorapath Pesirikan,BSc.Pharm,PhD Deputy Director of Vaccine and Biological production departmentTable of Content1234567Cancer therapyClassification of personalized cancer vaccines US-FDA perspective on Neoantigen peptide Patient JourneyNeoantigen vac

2、cine productionProduct QualityChallenges Personalized A modern approach that tailors therapy to each patients individual characteristics.It departs from the“one-size-fits-all”approach found in traditional treatments.CANCER THERAPYTraditional Surgery Chemotherapy Radiation therapy Targeted therapy Ho

3、rmone therapyHigh specificityLess severe side effectsClassification of personalized cancer vaccines The US Food and Drug Administrations(FDA)Center for Biologics Evaluation and Research(CBER)regulates therapeutic cancer vaccines,including those using neoantigen polypeptides,under the Public Health S

4、ervice Act.US-FDA perspective on Neoantigen peptide Patient Journey “”1 Patient JourneyConfidentialNEOANTIGEN VACCINE PRODUCTION(Drug substance)Product QualityCertificate of analysisDrug substanceDrug product1.Tumor-specific design&time consuming production.2.One patient requires multiple sequences

5、with different complexity.Each needs unique synthesis,purification,formulation,and QC.3.GMP compliance regulation is uncertain b/c each custom batch is needed for each patient.4.Cold-chain transport is required.5.Cost and specialized multi-disciplinary resources are still big burdens.6.The personalized nature of these therapies complicates traditional clinical trial design,toxicity testing,and regulatory approval ChallengesRevolution of Pharmaceutical BusinessThe Government Pharmaceutical OrganizationChemical DrugsVaccinesATMPs&Cancer VaccinesTHANK YOU