{"id":"W2496582177","doi":"10.1016/j.biologicals.2016.06.002","title":"Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products","year":2016,"lang":"en","type":"article","venue":"Biologicals","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":15,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"Japan Agency for Medical Research and Development","keywords":"Regulatory agency; Agency (philosophy); Quality (philosophy); Regulatory science; Regulatory authority; Business; Political science; Medicine; Public relations; Public administration; Pathology; Sociology","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.04089164,0.002580054,0.001617707,0.002761215,0.006661376,0.01083417,0.003776585,0.06683952,0.010076],"category_scores_gemma":[0.03622175,0.001190538,0.004297265,0.001683905,0.004012467,0.005075898,0.005766878,0.03204846,0.002284945],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006460848,"about_ca_system_score_gemma":0.03600748,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.02588061,"about_ca_topic_score_gemma":0.03108249,"domain_scores_codex":[0.9733234,0.005131421,0.001394941,0.001671855,0.01271755,0.005760929],"domain_scores_gemma":[0.9704626,0.01771572,0.001942033,0.001148339,0.004748559,0.003982758],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0003988628,0.0007514709,0.002065771,0.0006612184,0.00009316784,0.002041122,0.001956428,0.001017208,0.005324759,0.09003034,0.8726074,0.02305225],"study_design_scores_gemma":[0.0001227368,0.0001866904,0.005047163,0.0005852858,0.0001228091,0.0003362052,0.00108539,0.0005904295,0.003313544,0.008690923,0.9798045,0.0001143052],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.02080802,0.02018648,0.0140727,0.6369531,0.1097797,0.001796158,0.003878168,0.0006930864,0.1918326],"genre_scores_gemma":[0.0856782,0.009078668,0.01444822,0.5131939,0.03024133,0.002912109,0.002831828,0.0005598171,0.3410559],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.06683952,"threshold_uncertainty_score":0.2162582,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08972948811793831,"score_gpt":0.3304038332597597,"score_spread":0.2406743451418215,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}