{"id":"W3045442701","doi":"10.1016/j.jcyt.2020.06.011","title":"Transitioning from development to commercial: risk-based guidance for critical materials management in cell therapies","year":2020,"lang":"en","type":"article","venue":"Cytotherapy","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":4,"is_retracted":false,"has_abstract":false,"ca_institutions":"International Society for Cellular Therapy","funders":"","keywords":"Commercialization; Risk analysis (engineering); New product development; Risk management; Process (computing); Product (mathematics); Business; Risk assessment; Computer science; Process management; Operations management; Engineering; Marketing","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":[0.07271848,0.001282968,0.001092341,0.002056918,0.005652796,0.01728851,0.005781373,0.03408724,0.005508324],"category_scores_gemma":[0.09848136,0.0009090334,0.001813301,0.00074691,0.02035716,0.01060879,0.01107722,0.02059084,0.00321308],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.008255259,"about_ca_system_score_gemma":0.03725797,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004470434,"about_ca_topic_score_gemma":0.007209153,"domain_scores_codex":[0.9184616,0.03608958,0.004934679,0.003148137,0.03382604,0.003539981],"domain_scores_gemma":[0.9029547,0.06510107,0.006968967,0.005576645,0.01619286,0.003205793],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00008017638,0.0003507487,0.001239629,0.0004648188,0.00003674441,0.0007108883,0.005790062,0.003792284,0.003533854,0.850889,0.06799352,0.0651184],"study_design_scores_gemma":[0.00006109925,0.0002330726,0.001369817,0.002412158,0.00004748301,0.001035214,0.002697226,0.005386265,0.005784405,0.6328458,0.347904,0.0002234883],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.01391689,0.00891409,0.2595678,0.4854271,0.002860271,0.001383966,0.0001774364,0.0007031361,0.2270493],"genre_scores_gemma":[0.4791509,0.006950172,0.3297557,0.1324624,0.002904911,0.002340714,0.0001955214,0.000571099,0.0456687],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.07271848,"threshold_uncertainty_score":0.3845767,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0426857138788415,"score_gpt":0.327336909325029,"score_spread":0.2846511954461875,"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."}}