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Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes

BIOTECHNOLOGY PrOGrESS 2021年第3期37卷 e3135-e3135页

作者： Panjwani, Shyam Cui, Ivan Spetsieris, Konstantinos Mleczko, Michal Wang, Wensheng Zou, June X. Anwaruzzaman, Mohammad Liu, Shawn Canales, roger Hesse, Oliver Bayer Pharmaceut Engn & Technol 800 Dwight Way Berkeley CA 94710 USA Bayer Pharmaceut Pharma Biotech Pathogen Safety Berkeley CA USA Bayer Pharmaceut Bayer Business Serv Pharma R&D ITO Berkeley CA USA Bayer Pharmaceut Pharma Biotech Lab Automat & Data Management Berkeley CA USA Amazon East Palo Alto CA USA Bayer Crop Sci West Sacramento CA USA Avirmax Inc Hayward CA USA Genentech Inc San Francisco CA 94080 USA

The production of recombinant therapeutic proteins from animal or human cell lines entails the risk of endogenous viral contamination from cell substrates and adventitious agents from raw materials and environment. One of the approaches to control such potential viral contamination is to ensure the manufacturing process can adequately clear the potential viral contaminants. Viral clearance for production of human monoclonal antibodies is achieved by dedicated unit operations, such as low pH inactivation, viral filtration, and chromatographic separation. The process development of each viral clearance step for a new antibody production requires significant effort and resources invested in wet laboratory experiments for process characterization studies. Machine learning methods have the potential to help streamline the development and optimization of viral clearance unit operations for new therapeutic antibodies. The current work focuses on evaluating the usefulness of machine learning methods for process understanding and predictive modeling for viral clearance via a case study on low pH viral inactivation.

关键词： biological manufacturing process low pH viral inactivation machine learning monoclonal antibody pathogen safety

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Changes in Prescription of Psychotropic drugs After Introduction of Polypharmacy reduction Policy in Japan Based on a Large-Scale Claims database

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CLINICAL drUG INVESTIGATION 2019年第11期39卷 1077-1092页

作者： Hirano, Yoko Ii, Yoichi Kitasato Univ Grad Sch Pharmaceut Sci Dept Clin Med Pharmaceut Med Minato Ku 5-9-1 Shirokane Tokyo 1088641 Japan Pfizer Pharmaceut KK Rare Dis Therapeut Area Med Affairs Shibuya Ku Tokyo Japan Pfizer R&D Japan GK Biometr & Data Management Shibuya Ku Tokyo Japan

Background and Objectives In Japan, polypharmacy reduction policy, which reduces the reimbursement of medical cost, was introduced to address unnecessary psychotropic polypharmacy. The rule was applied to the prescriptions of three or more anxiolytics or three or more hypnotics in the policy introduced in 2012. The prescriptions of four or more antidepressants or four or more antipsychotics were added to the rule in the policy revised in 2014. Furthermore, the prescriptions of three or more drugs of anxiolytics, hypnotics, antidepressants, or antipsychotics were subject to the reduction criteria of the policy revision in 2016. Benzodiazepine receptor agonists (BZs) are classified both into anxiolytics and hypnotics, and the reduction rule was not applied to the category of BZs before April 2018. This study aimed to examine the effect of the policy on the prescriptions of four drug categories as well as BZs from the point of view of the number of drugs and doses. Methods This was a retrospective observational study using a large-scale Japanese health insurance claims database. Patients who were prescribed at least one psychotropic drug (anxiolytic, hypnotic, antidepressant, or antipsychotic) during the study period (from April 2011 to March 2017) were selected. Segmented regression analysis was used to analyze the proportions of patients with three or more or four or more drugs as well as patients above clinically recommended doses, and the means of the average daily doses by drug category. results A total of 312,167 patients were identified as a study population. The proportions of patients with three or more drugs in anxiolytics, hypnotics, antidepressants, and antipsychotics significantly decreased after the introduction or revisions of the policy, but not BZs. The proportions of patients with three or more drugs in March 2017 were 0.9%, 2.0%, 1.2%, 2.4%, and 8.9% in anxiolytics, hypnotics, antidepressants, antipsychotics, and BZs, respectively. The effect of the

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Large-Scale Occupational Skills Normalization for Online recruitment

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AI MAGAZINE 2018年第1期39卷 5-14页

作者： Phuong Hoang Mahoney, Thomas Laved, Faizan McNair, Matt CareerBuilder Data Sci R&D Grp Chicago IL 60601 USA CareerBuilder Candidate & Data Serv Chicago IL USA Human Capital Management Space Stamford CT USA CareerBuilder Data Sci Chicago IL USA Global Serv Strategy Brentwood TN USA

Job openings often go unfilled despite a surfeit of unemployed or underemployed workers. One of the main reasons for this disparity is a mismatch between the skills required by employers and the skills that workers possess. This mismatch, also known as the skills gap, can pose socioeconomic challenges for an economy. A first step in alleviating the skills gap is to accurately detect skills in human capital data such as resumes and job ads. Comprehensive and accurate detection of skills facilitates analysis of labor market dynamics. It also helps bridge the divide between supply and demand of labor by facilitating reskilling and workforce training programs. In this article, we describe SKILL, a named entity normalization (NEN) system for occupational skills. SKILL is composed of (1) a skills tagger, which uses properties of semantic word vectors to recognize and normalize relevant skills, and (2) a skill entity sense disambiguation component, which infers the correct meaning of an identified skill. We discuss the technical design and the synergy between data science and engineering that was required to transform the system from a research prototype to a production service that serves customers from across the organization. We also discuss establishing customer feedback loops, which led to improvements to the system over time. SKILL is currently used by various internal teams at CareerBuilder for big data workforce analytics, semantic search, job matching, and recommendations.

关键词： Labor market Analytics Artificial intelligence Feedback loops Skills Human capital Social research data management Unemployment Job openings Customer feedback Big data design engineering Labor Natural language processing Supply and demand Semantics Word sense disambiguation

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POS0286 INCIdENCE OF MALIGNANCIES IN JAPANESE PATIENTS WITH rHEUMATOId ArTHrITIS: data FrOM A LArGE JAPANESE NATIONAL rEGISTrY

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Annals of the rheumatic diseases 2021年 80卷 368-369页

作者： T. Matsui N. Sugiyama S. Toyoizumi F. Matsuyama T. Murata Y. Urata K. Kawahata S. Tohma National Hospital Organization Sagamihara National Hospital Department of Rheumatology Clinical Research Center for Allergy and Rheumatology Kanagawa Japan Pfizer Japan Inc Inflammation and Immunology Tokyo Japan Pfizer R&D Japan Biometrics and Data Management Tokyo Japan CRECON Medical Assessment Inc Tokyo Japan Tsugaru General Hospital Department of Rheumatology Aomori Japan St. Marianna University School of Medicine Division of Rheumatology and Allergology Department of Internal Medicine Kanagawa Japan National Hospital Organization Tokyo National Hospital Department of Rheumatology Tokyo Japan

Background: Patients (pts) with rheumatoid arthritis (rA) have an increased risk of some malignancies vs the general population, and this can vary by region/race. 1,2 data on the epidemiology and impact of biological (b)dMArds and targeted synthetic (ts)dMArds, such as Janus kinase (JAK) inhibitors, on the incidence of malignancies in Japanese pts with rA are limited. The National database of rheumatic diseases in Japan (NinJa) is one of the largest rA registries in Japan. Objectives: To evaluate the incidence of malignancies in Japanese pts with rA using NinJa registry data. Methods: This retrospective observational study analysed NinJa registry data for Japanese pts with rA aged ≥18 years with ≥1 data entry between 2013 (first JAK inhibitor approval for rA in Japan) and 2018. The overall cohort included all pts with rA, and two sub-cohorts were analysed: pts exposed and unexposed to bdMArds (exposure defined as ≥1 bdMArd reported in database). Crude incidence rates (Irs) for malignancies (including non-melanoma skin cancer) were calculated as the number of events per 100 pt-years of follow-up (time between start of follow-up or the date of first bdMArd exposure [for bdMArd-exposed pts] and end of observation period, or withdrawal from database). The most recent data for incidence of malignancy in the Japanese general population (2013–2017 data from the National Cancer Center, Japan) were used to calculate standardised incidence ratios (SIrs) and age- and sex-adjusted standardised rates (ASrs) for malignancies. Cross-sectional (per calendar year) and cumulative analyses were performed for the overall cohort. Cumulative rates were calculated for sub-cohorts, and all cumulative analyses were repeated excluding pts exposed to JAK inhibitors (ie ≥1 JAK inhibitor reported in database). results: data were collected for 26 607 Japanese pts with rA from 2013–2018. In the cross-sectional analysis (Table 1), the SIr and ASr for malignancies in all pts with rA were generally

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AB1523-HPr USABILITY ANd ACCEPTABILITY OF A NEW AUTOINJECTOr dEVICE ANd ITS ASSOCIATEd APP IN AUSTrALIAN, FrENCH, GErMANY ANd JAPANESE rHEUMATOLOGY PATIENTS

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Annals of the rheumatic diseases 2022年 81卷 1864-1864页

作者： r. Alten M. Latymer d.C. Gruben L. Gunther-Lavergne S. Moss H. Kameda Schlosspark-Klinik University Medicine Internal Medicine Rheumatology Berlin Germany Pfizer Ltd I&I Medical Affairs Sandwich United Kingdom Pfizer Global Biostatistics and Data Management Groton United States of America Farm Design A Flex Company Human Factors Engineering Hollis United States of America Pfizer R&D UK Devices Centre of Excellence Cambridge United Kingdom Toho University (Ohashi Medical Center) Division of Rheumatology Tokyo Japan

Background Smartclic/ClicWise is a new reusable autoinjector with a dose-dispensing cartridge for subcutaneous self-administration of biotherapeutics in development for patients with rheumatoid arthritis (rA) and other diseases. The device can connect to an optional mobile phone app (Smartclic, or ClicNote in Japan) to aid in tracking injections and other treatment or symptom data. Objectives The study objective was to collect ease of use and usability data on the Smartclic injector and companion app from experienced patients. Methods After completing a patient profiling questionnaire, adult patients (≥18 yrs) from Australia, France, Germany, and Japan with rA, psoriatic arthritis, or an original diagnosis of juvenile idiopathic arthritis who were prescribed an injectable biologic were enrolled in this study. For Japan, only patients with rA were enrolled. Each patient received training individually on the use of the Smartclic injector device and insertable cartridge and gained experience by performing simulated injections. Participants completed a questionnaire with evaluations of the device categories (number of questions): ‘ease of use' (14), ‘usability effectiveness' (11), ‘benefit of features' (8), and ‘form factor' (7). Participants also separately received a storyboard presentation summarizing the key features of the app, during which patients could explore the app (on a phone with either an android or iOS operating system), and completed 16 questions on the connectivity, usability, and benefit. responses were recorded as Likert scale ratings from 1 (‘extremely negative') to 7 (‘extremely positive'). respondents also provided an estimate of patient training time for the device. Mean values were reported. The percentage of negative (Likert scale rating 1-2), neutral (3-5), and positive (6-7) responses for each category were determined. results A total of 139 patients (mean age [range], 52 [18-84] yrs; 73% female) participated in the study ( Table 1 ). Mean sco

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doxorubicin-loaded Polymeric Biotin-PEG-SeSe-PBLA Micelles with surface Binding of Biotin-Mediated Cancer Cell Targeting and redox-responsive drug release for enhanced anticancer efficacy

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COLLOIdS ANd SUrFACES B-BIOINTErFACES 2024年 241卷 114028页

作者： Gebrie, Hailemichael Tegenu Thankachan, darieo Tsai, Hsieh-Chih Lai, Juin-Yih Chang, Hao-Ming Wu, Szu-Yuan Natl Taiwan Univ Sci & Technol Grad Inst Appl Sci & Technol Taipei 106 Taiwan Natl Taiwan Univ Sci & Technol Adv Membrane Mat Ctr Taipei 106 Taiwan Chung Yuan Christian Univ R&D Ctr Membrane Technol Taoyuan 320 Taiwan Univ Gondar Coll Nat & Computat Sci Dept Biol POB 196 Gondar Ethiopia Natl Taiwan Univ Sci & Technol Dept Mat Sci & Engn Taipei 106 Taiwan Triserv Gen Hosp Natl Def Med Ctr Div Gen Surg Taipei Taiwan Lotung Poh Ai Hosp Lo Hsu Med Fdn Dept Med Div Radiat Oncol Yilan Taiwan Asia Univ Coll Hlth Sci Dept Hlth & Nutr Biotechnol Taichung Taiwan Lotung Poh Ai Hosp Lo Hsu Med Fdn Big Data Ctr Yilan Taiwan Asia Univ Coll Med & Hlth Sci Dept Healthcare Adm Taichung Taiwan Fu Jen Catholic Univ Coll Management Grad Inst Business Adm Taipei Taiwan Fu Jen Catholic Univ Artificial Intelligence Dev Ctr Taipei Taiwan Taipei Med Univ Wan Fang Hosp Ctr Reg Anesthesia & Pain Med Taipei Taiwan

Biotin receptors are overexpressed in various cancer cell types, essential in tumor development, metabolism, and metastasis. Chemotherapeutic agents may be more effective and have fewer adverse effects if they specifically target the biotin receptors on cancer cells. Polymeric micelles (PMs) with nanoscale size via the EPr effect to accumulate near tumor tissue. We utilized the solvent exchange technique to crate polymeric Biotin-PEG-SeSePBLA micelles. This underwent self-assembly to create uniformly dispersed PMs with a hydrodynamic diameter of 81.54 +/- 0.23 nm. The resulting PMs characterized by 1HNMr, 13CNMr, FTIr, and raman spectroscopy. PMs exhibited a high efficacy of doxorubicin encapsulation (EE) and loading content (dLC), with values of 5.93 wt% and 74.32 %, respectively. dOX@Biotin-PEG-SeSe-PBLA micelles showed optimal dOX release, around 89 % and 74 % in 10 mM glutathione and 0.1 % H2O2, respectively, within 72 hours, in the simulated cancer redox pool. Fascinatingly, the blank Biotin-PEG-SeSe-PBLA micelles did not affect the HaCaT or HeLa cell lines;approximately 85 % of the cells were metabolically active. Contrarily, at a 5 mu g/ml concentration, dOX@Biotin-PEGSeSe-PBLA specifically inhibited the proliferation of roughly 76 % of HeLa cells and 11 % of HaCaT cells. The fluorescence microscopy results demonstrated that biotin-decorated micelles were more successfully internalized by HeLa cells, which overexpress the biotin receptor, than by non-targeted micelles in vitro. In summary, the diselenide-linked Biotin-PEGSeSe-PBLA formed smart PMs that could offer dOX specific to cancer cells with precision and are physiologically durable.

关键词： diselenide bond Biotin Micelles SMVT Stimuli-sensitive polymers

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Therapeutic targeting of ATr yields durable regressions in small cell lung cancers with high replication stress

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CANCEr CELL 2021年第4期39卷 566-+页

作者： Thomas, Anish Takahashi, Nobuyuki rajapakse, Vinodh N. Zhang, Xiaohu Sun, Yilun Ceribelli, Michele Wilson, Kelli M. Zhang, Yang Beck, Erin Sciuto, Linda Nichols, Samantha Elenbaas, Brian Puc, Janusz dahmen, Heike Zimmermann, Astrid Varonin, Jillian Schultz, Christopher W. Kim, Sehyun Shimellis, Hirity desai, Parth Klumpp-Thomas, Carleen Chen, Lu Travers, Jameson McKnight, Crystal Michael, Sam Itkin, Zina Lee, Sunmin Yuno, Akira Lee, Min-Jung redon, Christophe E. Kindrick, Jessica d. Peer, Cody J. Wei, Jun S. Aladjem, Mirit, I Figg, William douglas Steinberg, Seth M. Trepel, Jane B. Zenke, Frank T. Pommier, Yves Khan, Javed Thomas, Craig J. NCI Dev Therapeut Branch Ctr Canc Res NIH Bethesda MD 20892 USA Natl Ctr Adv Translat Sci Div Preclin Innovat NIH Rockville MD 20850 USA EMD Serono Res & Dev Inst Inc Biopharma R&D Translat Innovat Platform Oncol Billerica MA 01821 USA Biopharma R&D Translat Innovat Platform Oncol Merck KGaA Frankfurter St 250 D-64293 Darmstadt Germany NCI Technol Transfer Ctr 9609 Med Ctr Dr Rockville MD 20850 USA NCI Clin Pharmacol Program Ctr Canc Res NIH Bethesda MD 20892 USA NCI Genet Branch Ctr Canc Res NIH Bethesda MD 20892 USA NCI Biostat & Data Management Sect Ctr Canc Res NIH Bethesda MD 20892 USA NCI Lymphoid Malignancies Branch Ctr Canc Res NIH Bethesda MD 20892 USA Merck KGaA Darmstadt Germany

Small cell neuroendocrine cancers (SCNCs) are recalcitrant cancers arising from diverse primary sites that lack effective treatments. Using chemical genetic screens, we identified inhibition of ataxia telangiectasia and rad3 related (ATr), the primary activator of the replication stress response, and topoisomerase I (TOP1), nuclear enzyme that suppresses genomic instability, as synergistically cytotoxic in small cell lung cancer (SCLC). In a proof-of-concept study, we combined M6620 (berzosertib), first-in-class ATr inhibitor, and TOP1 inhibitor topotecan in patients with relapsed SCNCs. Objective response rate among patients with SCLC was 36% (9/25), achieving the primary efficacy endpoint. durable tumor regressions were observed in patients with platinum-resistant SCNCs, typically fatal within weeks of recurrence. SCNCs with high neuroendocrine differentiation, characterized by enhanced replication stress, were more likely to respond. These findings highlight replication stress as a potentially transformative vulnerability of SCNCs, paving the way for rational patient selection in these cancers, now treated as a single disease.

关键词： replication stress dNA damage response cell-cycle checkpoints SCLC small cell neuroendocrine cancers translational research dNA topoisomerases ataxia telangiectasia mutated and rad3 related

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Probabilistic forecasting for daily electricity loads and quantiles for curve-to-curve regression

arXiv

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arXiv 2020年

作者： Xu, Xiuqin Chen, Ying Goude, Yannig Yao, Qiwei NUS Graduate School for Integrative Sciences & Engineering Institute of Data Science National University of Singapore Singapore Department of Mathematics & Risk Management Institute National University of Singapore Singapore Électicité de France R&D Laboratoire de Mathématique d’Orsay Paris France Department of Statistics London School of Economics and Political Science London United Kingdom

Probabilistic forecasting of electricity load curves is of fundamental importance for effective scheduling and decision making in the increasingly volatile and competitive energy markets. We propose a novel approach to construct probabilistic predictors for curves (PPC), which leads to a natural and new definition of quantiles in the context of curve-to-curve linear regression. There are three types of PPC: a predict set, a predictive band and a predictive quantile, and all of them are defined at a pre-specified nominal probability level. In the simulation study, the PPC achieve promising coverage probabilities under a variety of data generating mechanisms. When applying to one day ahead forecasting for the French daily electricity load curves, PPC outperform several state-of-the-art predictive methods in terms of forecasting accuracy, coverage rate and average length of the predictive bands. For example, PPC achieve up to 2.8-fold of the coverage rate with much smaller average length of the predictive bands. The predictive quantile curves provide insightful information which is highly relevant to hedging risks in electricity supply management. Copyright © 2020, The Authors. All rights reserved.

关键词： Forecasting

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disturbance of questionable publishing to academia

arXiv

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arXiv 2021年

作者： You, Taekho Park, Jinseo Lee, June Young Yun, Jinhyuk Jung, Woo-Sung School of AI Convergence Soongsil University 369 Sangdo-ro Dongjak-gu Seoul06978 Korea Republic of Department of Industrial and Management Engineering Pohang University of Science and Technology 77 Cheongam-ro Pohang Gyeongsangbukdo 37673 Korea Republic of Center for Global R&D Data Analysis Korea Institute of Science and Technology Information 66 Heogi-ro Dongdaemun-gu Seoul02456 Korea Republic of Department of Physics Pohang University of Science and Technology 77 Cheongam-ro Pohang Gyeongsangbukdo 37673 Korea Republic of

Questionable publications have been accused of "greedy" practices;however, their influence on academia has not been gauged. Here, we probe the impact of questionable publications through a systematic and comprehensive analysis with various participants from academia and compare the results with those of their unaccused counterparts using billions of citation records, including liaisons, i.e., journals and publishers, and prosumers, i.e., authors. Questionable publications attribute publisher-level self-citations to their journals while limiting journal-level self-citations;yet, conventional journal-level metrics are unable to detect these publisher-level self-citations. We propose a hybrid journal-publisher metric for detecting self-favouring citations among QJs from publishers. Additionally, we demonstrate that the questionable publications were less disruptive and influential than their counterparts. Our findings indicate an inflated citation impact of suspicious academic publishers. The findings provide a basis for actionable policy-making against questionable publications. Copyright © 2021, The Authors. All rights reserved.

关键词： Publishing

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Opportunistic remote sensing of rainfall using microwave links from cellular communication networks

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WILEY INTErdISCIPLINArY rEVIEWS-WATEr 2018年第4期5卷 e1289页

作者： Uijlenhoet, remko Overeem, Aart Leijnse, Hidde Wageningen Univ & Res Hydrol & Quantitat Water Management Grp POB 47 NL-6700 AA Wageningen Netherlands Royal Netherlands Meteorol Inst KNMI R&D Observat & Data Technol De Bilt Netherlands

Microwave backhaul links from cellular communication networks provide a valuable opportunistic source of high-resolution space-time rainfall information, complementing traditional in situ measurement devices (rain gauges, disdrometers) and remote sensors (weather radars, satellites). Over the past decade, a growing community of researchers has, in close collaboration with cellular communication companies, developed retrieval algorithms to convert the raw microwave link signals, stored operationally by their network management systems, to hydrometeorologically useful rainfall estimates. Operational meteorological and hydrological services as well as private consulting firms are showing an increased interest in using this complementary source of rainfall information to improve the products and services they provide to end users from different sectors, from water management and weather prediction to agriculture and traffic control. The greatest potential of these opportunistic environmental sensors lies in those geographical areas over the land surface of the Earth where the densities of traditional rainfall measurement devices are low: mountainous and urban areas and the developing world. This article provides a nonexpert summary of the history, theory, challenges, and opportunities toward continental-scale rainfall monitoring using microwave links from cellular communication networks. This article is categorized under: Science of Water > Methods Science of Water > Hydrological Processes

关键词： cellular communication networks microwave links opportunistic sensing rainfall remote sensing

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