{"id":"W4409814932","doi":"10.2174/0113892010367028250411111549","title":"Challenges and Pathways in Regulating Next-Gen Biological Therapies","year":2025,"lang":"en","type":"article","venue":"Current Pharmaceutical Biotechnology","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":5,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Marketing authorization; Medicine; Genetic enhancement; Commercialization; Clinical trial; Authorization; Cell therapy; Genome editing; Disease; Biotechnology; Bioinformatics; Stem cell; Intensive care medicine; CRISPR; Gene; Business; Biology; Pathology; Genetics; Computer science; Marketing","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"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":[0.02237088,0.0006435749,0.0009040516,0.002372977,0.001597611,0.009357871,0.001992404,0.004007544,0.01039144],"category_scores_gemma":[0.02259071,0.0003704182,0.001104992,0.002750863,0.004015464,0.0149395,0.003728019,0.006014259,0.003299246],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00366883,"about_ca_system_score_gemma":0.01487438,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002147643,"about_ca_topic_score_gemma":0.003273583,"domain_scores_codex":[0.9910008,0.003658508,0.0009203429,0.0009338622,0.002826577,0.0006598545],"domain_scores_gemma":[0.9737703,0.01710084,0.001802667,0.001262579,0.004942306,0.001121317],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.0002036623,0.0001946065,0.002048562,0.01331747,0.0001228092,0.0005700788,0.001737302,0.001786068,0.006795991,0.3719675,0.0826155,0.5186405],"study_design_scores_gemma":[0.00001686381,0.0001106869,0.0007344432,0.005024082,0.00004659776,0.0003168942,0.001427717,0.00049187,0.001933706,0.08632138,0.9035358,0.00003994587],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"review","genre_gemma":"empirical","genre_scores_codex":[0.008127824,0.5070039,0.04195828,0.3466536,0.01041311,0.0003338042,0.001000164,0.0004363121,0.08407308],"genre_scores_gemma":[0.1138821,0.6573955,0.09349488,0.1079263,0.006556733,0.001245508,0.001779292,0.0003657597,0.01735386],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.02237088,"threshold_uncertainty_score":0.11831,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2055594416591689,"score_gpt":0.4059389263711495,"score_spread":0.2003794847119806,"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."}}