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Article ; Online: Implementation of whole-exome sequencing for pharmacogenomics profiling and exploring its potential clinical utilities.

Wang, Danyi / Bolleddula, Jayaprakasam / Coenen-Stass, Anna / Grombacher, Thomas / Dong, Jennifer Q / Scheuenpflug, Juergen / Locatelli, Giuseppe / Feng, Zheng

Pharmacogenomics

2024 Volume 25, Issue 4, Page(s) 197–206

Abstract: Whole-exome sequencing (WES) is widely used in clinical settings; however, the exploration of its use in pharmacogenomic analysis remains limited. Our study compared the variant callings for 28 core absorption, distribution, metabolism and elimination ... ...

Abstract	Whole-exome sequencing (WES) is widely used in clinical settings; however, the exploration of its use in pharmacogenomic analysis remains limited. Our study compared the variant callings for 28 core absorption, distribution, metabolism and elimination genes by WES and array-based technology using clinical trials samples. The results revealed that WES had a positive predictive value of 0.71-0.92 and a sensitivity of single-nucleotide variants between 0.68 and 0.95, compared with array-based technology, for the variants in the commonly targeted regions of the WES and PhamacoScan™ assay. Besides the common variants detected by both assays, WES identified 200-300 exclusive variants per sample, totalling 55 annotated exclusive variants, including important modulators of metabolism such as rs2032582 (
MeSH term(s)	Humans ; Exome Sequencing ; Pharmacogenetics ; Exome/genetics ; High-Throughput Nucleotide Sequencing/methods
Language	English
Publishing date	2024-03-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2019513-8
ISSN	1744-8042 ; 1462-2416
ISSN (online)	1744-8042
ISSN	1462-2416
DOI	10.2217/pgs-2023-0243
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Article ; Online: Risk assessment of drug-drug interaction potential for bintrafusp alfa with cytochrome P4503A4 substrates: A totality of evidence approach.

Vugmeyster, Yulia / Locke, George / Helwig, Christoph / Rolfe, P Alexander / Dong, Jennifer Q / Venkatakrishnan, Karthik

Clinical and translational science

2022 Volume 15, Issue 12, Page(s) 2838–2843

Abstract: Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-βRII (a TGF-β "trap") fused to a human IgG1 mAb blocking PD-L1, is being evaluated for efficacy and safety in solid tumor indications as monotherapy ...

Abstract	Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-βRII (a TGF-β "trap") fused to a human IgG1 mAb blocking PD-L1, is being evaluated for efficacy and safety in solid tumor indications as monotherapy and in combination with small-molecule drugs. We evaluated the perpetrator drug-drug interaction (DDI) potential of bintrafusp alfa via cytochrome P4503A4 (CYP3A4) enzyme modulation, which is responsible for the metabolism of a majority of drugs. The holistic approach included (1) evaluation of longitudinal profiles of cytokines implicated in CYP3A4 modulation and serum 4β-hydroxycholesterol, an endogenous marker of CYP3A4 activity, in a phase I clinical study, and (2) transcriptomics analysis of the CYP3A4 mRNA levels vs the TGFB gene expression signature in normal hepatic tissues. Bintrafusp alfa was confirmed not to cause relevant proinflammatory cytokine modulation or alterations in 4β-hydroxycholesterol serum concentrations in phase I studies. Transcriptomics analyses revealed no meaningful correlations between TGFB gene expression and CYP3A4 mRNA expression, supporting the conclusion that the risk of CYP3A4 enzyme modulation due to TGF-β neutralization by bintrafusp alfa is low. Thus, bintrafusp alfa is not expected to have DDI potential as a perpetrator with co-administered drugs metabolized by CYP3A4; this information is relevant to clinical evaluations of bintrafusp alfa in combination settings.
MeSH term(s)	Humans ; Cytochrome P-450 CYP3A/metabolism ; Drug Interactions ; Risk Assessment ; RNA, Messenger/genetics ; Transforming Growth Factor beta ; Recombinant Fusion Proteins/pharmacology
Chemical Substances	Cytochrome P-450 CYP3A (EC 1.14.14.1) ; RNA, Messenger ; Transforming Growth Factor beta ; bintrafusp alfa protein, human ; Recombinant Fusion Proteins
Language	English
Publishing date	2022-10-06
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13413
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Article ; Online: Challenges in Drug Development Posed by the COVID-19 Pandemic: An Opportunity for Clinical Pharmacology.

Venkatakrishnan, Karthik / Yalkinoglu, Oezkan / Dong, Jennifer Q / Benincosa, Lisa J

Clinical pharmacology and therapeutics

2020 Volume 108, Issue 4, Page(s) 699–702

Abstract: The unprecedented challenges posed by the coronavirus disease 2019 (COVID-19) pandemic highlight the urgency for applying clinical pharmacology and model-informed drug development in (i) dosage optimization for COVID-19 therapies, (ii) approaching ... ...

Abstract	The unprecedented challenges posed by the coronavirus disease 2019 (COVID-19) pandemic highlight the urgency for applying clinical pharmacology and model-informed drug development in (i) dosage optimization for COVID-19 therapies, (ii) approaching therapeutic dilemmas in clinical trial settings, and (iii) maximizing value of information from impacted non-COVID-19 trials. More than ever, we have a responsibility for adaptive evidence synthesis with a Totality of Evidence mindset in this race against time across biomedical research, clinical practice, drug development, and regulation.
MeSH term(s)	Betacoronavirus ; COVID-19 ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Coronavirus Infections/drug therapy ; Coronavirus Infections/epidemiology ; Drug Development/methods ; Drug Development/standards ; Humans ; Pandemics/prevention & control ; Pharmacology, Clinical/methods ; Pharmacology, Clinical/standards ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/epidemiology ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-05-28
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1879
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Article ; Online: Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need.

Klopp-Schulze, Lena / Shaw, Jamie V / Dong, Jennifer Q / Khandelwal, Akash / Vazquez-Mateo, Cristina / Goteti, Kosalaram

Clinical pharmacology and therapeutics

2022 Volume 112, Issue 2, Page(s) 297–306

Abstract: Dual toll-like receptor (TLR) 7 and TLR8 inhibitor enpatoran is under investigation as a treatment for lupus and coronavirus disease 2019 (COVID-19) pneumonia. Population pharmacokinetic/pharmacodynamic (PopPK/PD) model-based simulations, using PK and PD ...

Abstract	Dual toll-like receptor (TLR) 7 and TLR8 inhibitor enpatoran is under investigation as a treatment for lupus and coronavirus disease 2019 (COVID-19) pneumonia. Population pharmacokinetic/pharmacodynamic (PopPK/PD) model-based simulations, using PK and PD (inhibition of ex vivo-stimulated interleukin-6 (IL-6) and interferon-α (IFN-α) secretion) data from a phase I study of enpatoran in healthy participants, were leveraged to inform dose selection for lupus and repurposed for accelerated development in COVID-19. A two-compartment PK model was linked to sigmoidal maximum effect (E
MeSH term(s)	COVID-19/drug therapy ; Dose-Response Relationship, Drug ; Humans ; Interleukin-6 ; Toll-Like Receptor 7
Chemical Substances	Interleukin-6 ; Toll-Like Receptor 7
Language	English
Publishing date	2022-05-21
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2606
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Article ; Online: Challenges in Drug Development Posed by the COVID‐19 Pandemic

Venkatakrishnan, Karthik / Yalkinoglu, Oezkan / Dong, Jennifer Q. / Benincosa, Lisa J.

Clinical Pharmacology & Therapeutics

An Opportunity for Clinical Pharmacology

2020 Volume 108, Issue 4, Page(s) 699–702

Keywords	Pharmacology (medical) ; Pharmacology ; covid19
Language	English
Publisher	Wiley
Publishing country	us
Document type	Article ; Online
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1879
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Burnout and Professional Fulfillment in Early and Early-Mid-Career Breast Surgeons.

Zhang, Jennifer Q / Dong, Joe / Pardo, Jaime / Emhoff, Isha / Serres, Stephanie / Shanafelt, Tait / James, Ted

Annals of surgical oncology

2021 Volume 28, Issue 11, Page(s) 6051–6057

Abstract: Background: Prior work has shown that burnout among breast surgeons is prevalent and highest in those earlier in their clinical practice career. Therefore, we sought to better understand and identify specific contributors to early-career breast surgeon ... ...

Abstract	Background: Prior work has shown that burnout among breast surgeons is prevalent and highest in those earlier in their clinical practice career. Therefore, we sought to better understand and identify specific contributors to early-career breast surgeon burnout. Methods: We analyzed data from our 2017 survey of members of the American Society of Breast Surgeons. The 16-items of the Professional Fulfillment Index were used in determining overall burnout and professional fulfillment scores. Multivariable regressions were performed to evaluate factors related to overall burnout and professional fulfillment. Results: The mean overall burnout score was 1.23 (0-4 scale; higher score unfavorable) for surgeons in practice < 5 years, compared with 1.39 for surgeons in practice 5-9 years and 1.22 for those in practice ≥ 10 years. The mean professional fulfillment score was 2.71 (0-4 scale; higher score favorable) for surgeons in practice < 5 years, 2.66 for surgeons in practice 5-9 years, and 2.67 for surgeons in practice ≥ 10 years. Multivariable analysis showed that burnout was positively correlated with ≥ 60 work hours per week in the group practicing for < 5 years, and dedicating less than full time to breast surgery in the group in practice 5-9 years. Professional fulfillment was negatively associated with single relationship status in surgeons practicing < 5 years, and dedicating less than full time to breast surgery for those in practice 5-9 years. Conclusion: Our study suggests that breast surgeons who have been in practice for 5-9 years have particularly high overall burnout rates and additional support focused on this group of breast surgeons may be needed.
MeSH term(s)	Burnout, Professional/epidemiology ; Humans ; Job Satisfaction ; Personal Satisfaction ; Surgeons ; Surveys and Questionnaires ; United States
Language	English
Publishing date	2021-04-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	1200469-8
ISSN	1534-4681 ; 1068-9265
ISSN (online)	1534-4681
ISSN	1068-9265
DOI	10.1245/s10434-021-09940-w
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Article: Challenges in Drug Development Posed by the COVID-19 Pandemic: An Opportunity for Clinical Pharmacology

Venkatakrishnan, Karthik / Yalkinoglu, Oezkan / Dong, Jennifer Q / Benincosa, Lisa J

Clin Pharmacol Ther

Abstract	The unprecedented challenges posed by the coronavirus disease 2019 (COVID-19) pandemic highlight the urgency for applying clinical pharmacology and model-informed drug development in (i) dosage optimization for COVID-19 therapies, (ii) approaching therapeutic dilemmas in clinical trial settings, and (iii) maximizing value of information from impacted non-COVID-19 trials. More than ever, we have a responsibility for adaptive evidence synthesis with a Totality of Evidence mindset in this race against time across biomedical research, clinical practice, drug development, and regulation.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #154957
Database	COVID19

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Article ; Online: Antiviral Therapy Utilization and 10-Year Outcomes in Resected Hepatitis B Virus- and Hepatitis C Virus-Related Hepatocellular Carcinoma.

Huang, Daniel Q / Hoang, Joseph K / Kamal, Rubayet / Tsai, Pei-Chien / Toyoda, Hidenori / Yeh, Ming-Lun / Yasuda, Satoshi / Leong, Jennifer / Maeda, Mayumi / Huang, Chung-Feng / Won Jun, Dae / Ishigami, Masatoshi / Tanaka, Yasuhito / Uojima, Haruki / Ogawa, Eiichi / Abe, Hiroshi / Hsu, Yao-Chun / Tseng, Cheng-Hao / Alsudaney, Manaf /

Yang, Ju Dong / Yoshimaru, Yoko / Suzuki, Takanori / Liu, Joanne K / Landis, Charles / Dai, Chia-Yen / Huang, Jee-Fu / Chuang, Wan-Long / Schwartz, Myron / Dan, Yock Young / Esquivel, Carlos / Bonham, Andrew / Yu, Ming-Lung / Nguyen, Mindie H

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2024 Volume 42, Issue 7, Page(s) 790–799

Abstract: Purpose: There are limited data on antiviral treatment : Methods: This cohort study included 1,906 participants (1,054 HBV-related HCC and 852 HCV-related HCC) from 12 international sites. All participants had HBV- or HCV-related HCC and underwent ... ...

Abstract	Purpose: There are limited data on antiviral treatment Methods: This cohort study included 1,906 participants (1,054 HBV-related HCC and 852 HCV-related HCC) from 12 international sites. All participants had HBV- or HCV-related HCC and underwent curative surgical resection. The primary outcome was the Results: The mean (±standard deviation [SD]) age was 62.1 (±11.3) years, 74% were male, and 84% were Asian. A total of 47% of the total cohort received antiviral therapy during a mean (±SD) follow-up of 5.0 (±4.3) years. The overall antiviral Conclusion: Antiviral therapy is associated with long-term survival in people with HBV- or HCV-related HCC who undergo curative resection but is severely underutilized.
MeSH term(s)	Male ; Humans ; Middle Aged ; Aged ; Female ; Carcinoma, Hepatocellular/pathology ; Hepatitis B virus ; Liver Neoplasms/pathology ; Hepacivirus ; Cohort Studies ; Hepatitis C/complications ; Hepatitis C/drug therapy ; Antiviral Agents/therapeutic use ; Hepatitis B/complications ; Hepatitis B/drug therapy ; Retrospective Studies
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2024-01-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.23.00757
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Article ; Online: Glucuronidation and covalent protein binding of benoxaprofen and flunoxaprofen in sandwich-cultured rat and human hepatocytes.

Dong, Jennifer Q / Smith, Philip C

Drug metabolism and disposition: the biological fate of chemicals

2009 Volume 37, Issue 12, Page(s) 2314–2322

Abstract: Benoxaprofen (BNX), a nonsteroidal anti-inflammatory drug (NSAID) that was withdrawn because of hepatotoxicity, is more toxic than its structural analog flunoxaprofen (FLX) in humans and rats. Acyl glucuronides have been hypothesized to be reactive ... ...

Abstract	Benoxaprofen (BNX), a nonsteroidal anti-inflammatory drug (NSAID) that was withdrawn because of hepatotoxicity, is more toxic than its structural analog flunoxaprofen (FLX) in humans and rats. Acyl glucuronides have been hypothesized to be reactive metabolites and may be associated with toxicity. Both time- and concentration-dependent glucuronidation and covalent binding of BNX, FLX, and ibuprofen (IBP) were determined by exposing sandwich-cultured rat hepatocytes to each NSAID. The levels of glucuronide and covalent protein adduct measured in cells followed the order BNX > FLX > IBP. These results indicate that 1) BNX-glucuronide (G) is more reactive than FLX-G, and 2) IBP-G is the least reactive metabolite, which support previous in vivo studies in rats. The proportional increases of protein adduct formation for BNX, FLX, and IBP as acyl glucuronidation increased also support the hypothesis that part of the covalent binding of all three NSAIDs to hepatic proteins is acyl glucuronide-dependent. Moreover, theses studies confirmed the feasibility of using sandwich-cultured rat hepatocytes for studying glucuronidation and covalent binding to hepatocellular proteins. These studies also showed that these in vitro methods can be applied using human tissues for the study of acyl glucuronide reactivity. More BNX-protein adduct was formed in sandwich-cultured human hepatocytes than FLX-protein adduct, which not only agreed with its relative toxicity in humans but also was consistent with the in vitro findings using rat hepatocyte cultures. These data support the use of sandwich-cultured human hepatocytes as an in vitro screening model of acyl glucuronide exposure and reactivity.
MeSH term(s)	Adult ; Animals ; Anti-Inflammatory Agents, Non-Steroidal/metabolism ; Benzoxazoles/metabolism ; Benzoxazoles/toxicity ; Biotransformation ; Cell Culture Techniques ; Collagen ; Dose-Response Relationship, Drug ; Drug Combinations ; Feasibility Studies ; Glucuronates/metabolism ; Glucuronates/toxicity ; Glucuronosyltransferase/metabolism ; Hepatocytes/metabolism ; Humans ; Ibuprofen/metabolism ; Kinetics ; Laminin ; Male ; Microsomes, Liver/metabolism ; Models, Biological ; Propionates/metabolism ; Propionates/toxicity ; Protein Binding ; Proteoglycans ; Rats ; Rats, Sprague-Dawley
Chemical Substances	Anti-Inflammatory Agents, Non-Steroidal ; Benzoxazoles ; Drug Combinations ; Glucuronates ; Laminin ; Propionates ; Proteoglycans ; matrigel (119978-18-6) ; benoxaprofen (17SZX404IM) ; benoxaprofen glucuronide (67472-42-8) ; Collagen (9007-34-5) ; Glucuronosyltransferase (EC 2.4.1.17) ; flunoxaprofen (UKU5U19W9M) ; Ibuprofen (WK2XYI10QM)
Language	English
Publishing date	2009-09-22
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	186795-7
ISSN	1521-009X ; 0090-9556
ISSN (online)	1521-009X
ISSN	0090-9556
DOI	10.1124/dmd.109.028944
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Article ; Online: Translation and validation of the Chinese version of the comprehensive breastfeeding knowledge scale (CBKS).

Zhu, Qin / Abbass-Dick, Jennifer / Tian, Ce / Li, Ya-Min / Xiong, Dong-Dong / Dennis, Cindy-Lee / Zhao, Hong

Midwifery

2023 Volume 128, Page(s) 103858

Abstract: Background: The level of breastfeeding knowledge of nursing students may influence their ability to support breastfeeding families. However, to date, it has not been possible to measure this accurately due to the lack of existence of a validated tool in ...

Abstract	Background: The level of breastfeeding knowledge of nursing students may influence their ability to support breastfeeding families. However, to date, it has not been possible to measure this accurately due to the lack of existence of a validated tool in Chinese. Objectives: To translate the Comprehensive Breastfeeding Knowledge Scale (CBKS) into Chinese, and then evaluate its psychometric properties among Chinese undergraduate nursing students in order to inform and evaluate a nursing breastfeeding education programme. Methods: The Brislin translation model was followed, and a three-phase process (translation, back-translation and cultural adaptation) was used to sinicize the CBKS and evaluate its content validity. Construct validity was evaluated with exploratory factor analysis (EFA), and the reliability of internal consistency of the Chinese version of the CBKS was tested by calculating Cronbach's alpha coefficient and the half reliability coefficient. Settings: Two nursing schools in Beijing and Nanjing, China. Participants: Four hundred and thirty-nine undergraduate nursing students (257 from Beijing and 182 from Nanjing). Results: Five experts rated the content validity of the Chinese version of the CBKS as excellent. EFA showed that the Chinese version of the CBKS had three subscales and 23 items. Cronbach's alpha coefficient of the Chinese version of the CBKS and the half reliability coefficient were 0.70 and 0.73, respectively. Students who had completed an obstetrics or paediatric nursing course had significantly higher total scores and mean scores for most items compared with those who had not taken a course. Most of the indictors of EFA met the standards of construct validity, and some were very close to the cut-off. Conclusion: Overall, the 23-item Chinese version of the CBKS is an acceptable tool to measure the level of breastfeeding knowledge among undergraduate nursing students. This scale can be used to inform the design and evaluation of breastfeeding education materials for nursing students or other health profession students.
MeSH term(s)	Female ; Pregnancy ; Child ; Humans ; Education, Nursing, Baccalaureate ; Reproducibility of Results ; Breast Feeding ; Students, Nursing ; China ; Psychometrics ; Surveys and Questionnaires
Language	English
Publishing date	2023-11-04
Publishing country	Scotland
Document type	Journal Article
ZDB-ID	1036567-9
ISSN	1532-3099 ; 0266-6138
ISSN (online)	1532-3099
ISSN	0266-6138
DOI	10.1016/j.midw.2023.103858
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