PreclinicalConsiderationsforProductsRegulatedinOCT：用于调节OCT产品临床前的注意事项.pptVIP

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PreclinicalConsiderationsforProductsRegulatedinOCT：用于调节OCT产品临床前的注意事项.ppt

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PreclinicalConsiderationsforProductsRegulatedinOCT：用于调节OCT产品临床前的注意事项.ppt

Preclinical Considerations for Products Regulated in OCTGT Allen Wensky, PhD CBER/DCEPT/PTB Presentation Outline Regulatory review principles OCTGT regulated products Potential safety concerns Preclinical evaluation Animal species/models Pharm/Tox study designs Communication with the FDA Critical Path Development of Biotherapeutic Agents Investigational products regulated by OCTGT originate from basic research projects OCTGT provides regulatory and scientific input on the pre-clinical program for these investigational products through pre?preIND and preIND phases Guidance documents generated by FDA and ICH available which can be used to support the IND Safety is Always Primary “FDA’s primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug’s effectiveness and safety.” IND Regulations [21 CFR 312.22 (a)] How Are Animal Studies Integrated into the Proposed Clinical Plan? 21 CFR, part 312.23(a)(8) Pharmacologic Toxicologic Studies “…adequate information about the pharmacological toxicological studies…on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations. The kind, duration, scope of animal and other tests required varies with the duration nature of the proposed clinical investigations.” Examples of CBER/OCTGT-Regulated Products Cell and Gene Therapies Cancer vaccines Therapeutic vaccines Xenotransplantation Products Tissue engineered Products Devices Combination Products Examples of Cell Therapies (CT) Stem cell-derived Adult (hematopoietic, mesenchymal, cardiac, neuronal, adipose) Perinatal (placental, umbilical cord blood) Fetal, (amniotic fluid, neuronal) Embryonic Functionally mature/differentiated human/ xenogeneic cells (i.e. chondrocytes, islet cells, hepatocytes, neu