{"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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0003848006,0.00006785907,0.0001231029,0.00002343846,0.00004515788,0.00000312266,0.00008457228,0.0001486215,0.00007679254],"category_scores_gemma":[0.00007618835,0.00002282132,0.00004657371,0.00004831465,0.0005153918,0.00001097226,0.00003407272,0.0000664977,0.000001572017],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0000130954,"about_ca_system_score_gemma":0.00003153326,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000003006959,"about_ca_topic_score_gemma":2.899079e-7,"domain_scores_codex":[0.9992892,0.00003808388,0.0001943266,0.0001927603,0.0002013649,0.00008426622],"domain_scores_gemma":[0.9994512,0.00004796854,0.00012978,0.0002445235,0.00009123741,0.00003528724],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"observational","study_design_scores_codex":[0.00008562582,0.0001483231,0.01008982,0.000003848226,0.00002061668,0.000003816726,0.00001614562,2.416661e-8,0.9524093,0.003154831,0.0009958132,0.03307187],"study_design_scores_gemma":[0.001081618,0.0004330025,0.4965804,0.00004358282,0.000002633268,0.00002658416,0.000005801102,9.69615e-7,0.4412214,0.004084066,0.05647161,0.00004833071],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9468628,0.0005240062,0.000009985327,0.05118252,0.0001891659,0.000237437,0.00000408208,0.0000148249,0.0009752159],"genre_scores_gemma":[0.9960465,0.0007775602,0.0001154105,0.001229116,0.0001773027,0.000006776474,0.000007457502,0.000004545704,0.001635285],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5111878,"threshold_uncertainty_score":0.1898983,"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."}}