更新于：2023-06-01
Johnson & Johnson
更新于：2023-06-01
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A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
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2023-12-31Artificial Intelligence in the Life Sciences
Conformal efficiency as a metric for comparative model assessment befitting federated learning
作者: Heyndrickx, Wouter ; Arany, Adam ; Simm, Jaak ; Pentina, Anastasia ; Sturm, Noe ; Humbeck, Lina ; Mervin, Lewis ; Zalewski, Adam ; Oldenhof, Martijn ; Schmidtke, Peter ; Friedrich, Lukas ; Loeb, Regis ; Afanasyeva, Arina ; Schuffenhauer, Ansgar ; Moreau, Yves ; Ceulemans, Hugo
In a drug discovery setting, pharmaceutical companies own substantial but confidential datasets. The MELLODDY project developed a privacy-preserving federated machine learning solution and deployed it at an unprecedented scale. Each partner built models for their own private assays that benefitted from a shared representation. Established predictive performance metrics such as AUC ROC or AUC PR are constrained to unseen labeled chem. space and cannot gage performance gains in unlabeled chem. space. Federated learning indirectly extends labeled space, but in a privacy-preserving context, a partner cannot use this label extension for performance assessment. Metrics that estimate uncertainty on a prediction can be calculated even where no label is known. Practically, the chem. space covered with predictions above an uncertainty threshold, reflects the applicability domain of a model. After establishing a link to established performance metrics, we propose the efficiency from the conformal prediction framework (′conformal efficiency′) as a proxy to the applicability domain size. A documented extension of the applicability domain would qualify as a tangible benefit from federated learning. In interim assessments, MELLODDY partners reported a median increase in conformal efficiency of the federated over the single-partner model of 5.5% (with increases up to 9.7%). Subject to distributional conditions, that efficiency increase can be directly interpreted as the expected increase in conformal i.e. low uncertainty predictions. In conclusion, we present the first indication that privacy-preserving federated machine learning across massive drug-discovery datasets from ten pharma partners indeed extends the applicability domain of property prediction models.
2023-05-01Clinical pharmacology in drug development
A Phase 1 First-in-Human Pharmacokinetic and Pharmacodynamic Study of JNJ-64264681, a Covalent Inhibitor of Bruton′s Tyrosine Kinase
Article
作者: Leu, Jocelyn H. ; Miao, Xin ; Shalayda, Kevin ; Coe, Kevin J. ; Kahnt, Ariane ; Wu, Bonnie ; Schnarr, Megan ; Franks, Carol ; Devlin, James ; Yang, Tong-Yuan ; Palmer, James A. ; Zhang, Mai ; Zhou, Honghui ; Van Damme, Wim ; Smets, Sophie ; Aguilar, Zuleima ; Chaplan, Sandra R.
JNJ-64264681 is an irreversible covalent inhibitor of Bruton's tyrosine kinase. This phase 1, first-in-human, 2-part (single-ascending dose [SAD]; multiple-ascending dose [MAD]) study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD; Bruton's tyrosine kinase occupancy [BTKO]) of JNJ-64264681 oral solution in healthy participants. For SAD (N = 78), 6 increasing doses of JNJ-64264681 (4-400 mg) or placebo were evaluated in fasted males. The effects of sex, food, and a capsule formulation were evaluated in separate cohorts. For MAD (N = 27), sequential cohorts of male and female participants received 36/100/200 mg JNJ-64264681 once daily for 10 days. JNJ-64264681 exposure (peak concentration; area under the concentration-time curve) was less than dose proportional from 4 mg to 36 mg. Dose-normalized area under the concentration-time curves following the 36 mg and 100 mg doses were generally similar. The mean terminal half-life was 1.6-13.2 hours. With multiple doses, steady state was achieved by day 2. A semimechanistic PK/PD model was developed using the first 5 SAD cohorts' data to predict %BTKO in MAD cohorts. PK/PD model guided dose-escalation, and all participants in the 200/400 mg single-dose cohorts achieved ≥90% BTKO at 4 hours after dosing (peak) with prolonged occupancy. As BTKO data became available from MAD cohorts, it was found that observed BTKO data were consistent with model predictions. JNJ-64264681 showed no safety signals of concern. Overall, safety, tolerability, PK, BTKO, and PK/PD modeling guided the rationale for dose selection for the subsequent first-in-patient lymphoma studies.
2023-03-01HIV medicine
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive ( AMBER ) and virologically suppressed ( EMERALD ) participants with neurological and/or psychiatric comorbidities: Week 96 subgroup analysis
Article
作者: Dunn, Keith ; Bushen, Jennifer ; Luo, Donghan ; Cai, Jiyun ; Simonson, Richard Bruce ; Anderson, David
OBJECTIVE:
Our objective was to evaluate the prevalence of pre-existing neurological and/or psychiatric comorbidities (NPCs) and efficacy/safety outcomes for participants with versus without baseline NPCs in AMBER and EMERALD.
METHODS:
AMBER (treatment-naïve population) and EMERALD (virologically suppressed population) were phase III randomized studies of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg. The primary objective of this post hoc analysis was to assess virological response (HIV-1 RNA <50 copies/mL) at week 48 by intent-to-treat US Food and Drug Administration snapshot analysis comparing participants with and without baseline NPCs.
RESULTS:
Among participants in AMBER, 88/362 (24%) in the D/C/F/TAF arm and 99/363 (27%) in the control arm had baseline NPCs; in EMERALD, 294/763 (39%; D/C/F/TAF) and 166/378 (44%; control) participants had baseline NPCs. At baseline, psychiatric NPCs were more common than neurological NPCs in both studies; the most common of each type were depression and headache, respectively. High virological response rates were achieved with D/C/F/TAF across studies regardless of baseline NPCs at weeks 48 (range 86%-95%) and 96 (range 80%-91%). No participants in either study with a baseline NPC prematurely discontinued because of a study drug-related neurological or psychiatric adverse event.
CONCLUSION:
D/C/F/TAF may be a suitable treatment option for individuals with HIV-1 and NPCs.
2023-05-31
上市批准ASH会议临床结果临床2期引进/卖出
2023-05-31
高管变更信使RNA疫苗
管线布局
2023年06月05日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
药物发现
19
54
临床前
临床1期
88
77
临床2期
临床3期
24
4
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103
475
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