0000000000025889

AUTHOR

Samir N. Khleif

showing 3 related works from this author

The European regulatory environment of rna-based vaccines

2016

A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist t…

0301 basic medicineAutologous cellMessenger RNAVaccinesAnticancer vaccinationGenetically modified medicinal productsbusiness.industryGenetic enhancementmRNARNAGenetic therapy03 medical and health sciences030104 developmental biology0302 clinical medicineAntigenPreventive and therapeutic approachesInfectious disease (medical specialty)030220 oncology & carcinogenesisAdvanced therapy medicinal products (ATMP)ImmunologyMedicineVaccination against infectious diseasebusinessRegulatory framework in the EUEx vivo
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The regulatory landscape for actively personalized cancer immunotherapies

2013

Oncologymedicine.medical_specialtybusiness.industryBiomedical EngineeringCancerBioengineeringmedicine.diseaseCancer VaccinesApplied Microbiology and BiotechnologySocial Control FormalDrug developmentNeoplasmsInternal medicineImmunologyBiomarkers TumormedicineHumansMolecular MedicineImmunotherapyPrecision MedicinebusinessBiotechnologyNature Biotechnology
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Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers

2011

Abstract Purpose: To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. Experimental Design: The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here…

Cancer ResearchPathologymedicine.medical_specialtyHealth Planning Guidelinesmedicine.medical_treatmentConsensus Development Conferences as TopicStandardized testImmune monitoringt-cell immunity cytokine flow-cytometry cancer vaccine consortium colony-stimulating factor b elispot assay phase-ii trial dendritic cells clinical-trials hiv vaccine harmonization guidelinesMedical OncologyArticleFood and drug administrationNeoplasmsmedicineBiomarkers TumorHumansMedical physicsPersonalized therapySocieties MedicalAntitumor immunitybusiness.industryQuality assessmentUnited States Food and Drug AdministrationCancerInternational AgenciesImmunotherapymedicine.diseaseNational Cancer Institute (U.S.)United StatesOncologyPractice Guidelines as TopicImmunotherapybusiness
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