{"id":"W4281709393","doi":"10.1016/j.omtm.2022.05.012","title":"Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US","year":2022,"lang":"en","type":"review","venue":"Molecular Therapy — Methods & Clinical Development","topic":"CRISPR and Genetic Engineering","field":"Biochemistry, Genetics and Molecular Biology","cited_by":11,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"CMC Microsystems","keywords":"Genetically modified organism; Timeline; Biotechnology; Genetically engineered; Organism; Risk analysis (engineering); Business; Biology; Computational biology; Gene; Genetics; Geography","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.004786896,0.0005759471,0.0007932509,0.001311714,0.000328438,0.00161205,0.0009571558,0.001706032,0.002320536],"category_scores_gemma":[0.003223117,0.0002423028,0.0006587951,0.001557542,0.001043551,0.001791909,0.0009456046,0.002719847,0.0006672944],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001995131,"about_ca_system_score_gemma":0.005337866,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004357358,"about_ca_topic_score_gemma":0.004366385,"domain_scores_codex":[0.9979259,0.0004795523,0.0003564225,0.0002313243,0.0008536594,0.0001531188],"domain_scores_gemma":[0.9968874,0.001435696,0.00058868,0.0001241626,0.0008189671,0.0001451072],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001100185,0.00006463705,0.0003903675,0.01068268,0.0000702144,0.0003516835,0.0002283889,0.00106093,0.007924038,0.04301503,0.02765235,0.9084496],"study_design_scores_gemma":[0.0000143398,0.000158784,0.00132062,0.002770429,0.0000924473,0.000746618,0.00008688265,0.00009923048,0.002954082,0.002204979,0.9895286,0.00002304703],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.001440525,0.9817823,0.001249839,0.003211184,0.0008919326,0.00001968298,0.00007118496,0.00002601831,0.01130736],"genre_scores_gemma":[0.007106542,0.9859196,0.001964867,0.002273819,0.0003191605,0.00004766331,0.0001546829,0.00001532765,0.00219829],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.004786896,"threshold_uncertainty_score":0.02531582,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1404626413961258,"score_gpt":0.5092570239269937,"score_spread":0.3687943825308678,"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."}}