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Trends, challenges, and success factors in pharmaceutical portfolio management: Cognitive biases in decision-making and their mitigating measures 药品投资组合管理的趋势、挑战和成功因素:决策中的认知偏差及其缓解措施
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-10-01 DOI: 10.1016/j.drudis.2023.103734
Linn Bieske , Maximillian Zinner , Florian Dahlhausen , Hubert Trübel
{"title":"Trends, challenges, and success factors in pharmaceutical portfolio management: Cognitive biases in decision-making and their mitigating measures","authors":"Linn Bieske ,&nbsp;Maximillian Zinner ,&nbsp;Florian Dahlhausen ,&nbsp;Hubert Trübel","doi":"10.1016/j.drudis.2023.103734","DOIUrl":"10.1016/j.drudis.2023.103734","url":null,"abstract":"<div><p>Effective portfolio management is crucial for innovation and sustaining revenue in pharmaceutical companies. This article holistically reviews trends, challenges, and approaches to pharmaceutical portfolio management and focuses, in particular, on cognitive biases in portfolio decision-making. Portfolio managers strongly rely on external innovation and face increasing competitive pressure and portfolio complexity. The ability to address biases and make robust decisions remains a challenge. Portfolio management practitioners most commonly face confirmation bias, champion bias, or misaligned incentives, which they seek to mitigate through expert input, team diversity, and rewarding truth-seeking. Ultimately, highest-quality portfolio management decision-making could be enabled by three factors: high-quality data, structured review processes, and comprehensive mitigating measures against biases in decision-making.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 10","pages":"Article 103734"},"PeriodicalIF":7.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10283112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Human serum albumin binders: A piggyback ride for long-acting therapeutics 人血清白蛋白结合剂:长效治疗药物的便车
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-10-01 DOI: 10.1016/j.drudis.2023.103738
Aziz Ullah , Goeun Shin , Sung In Lim
{"title":"Human serum albumin binders: A piggyback ride for long-acting therapeutics","authors":"Aziz Ullah ,&nbsp;Goeun Shin ,&nbsp;Sung In Lim","doi":"10.1016/j.drudis.2023.103738","DOIUrl":"10.1016/j.drudis.2023.103738","url":null,"abstract":"<div><p>Human serum albumin (HSA) is the most abundant protein in the blood and has desirable properties as a drug carrier. One of the most promising ways to exploit HSA as a carrier is to append an albumin-binding moiety (ABM) to a drug for <em>in situ</em> HSA binding upon administration. Nature- and library-derived ABMs vary in size, affinity, and epitope, differentially improving the pharmacokinetics of an appended drug. In this review, we evaluate the current state of knowledge regarding various aspects of ABMs and the unique advantages of ABM-mediated drug delivery. Furthermore, we discuss how ABMs can be specifically modulated to maximize potential benefits in clinical development.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 10","pages":"Article 103738"},"PeriodicalIF":7.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10522482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Analysis of pharma R&D productivity – a new perspective needed 医药研发生产率分析——需要一个新的视角
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-10-01 DOI: 10.1016/j.drudis.2023.103726
Alexander Schuhmacher , Markus Hinder , Alexander von Stegmann und Stein , Dominik Hartl , Oliver Gassmann
{"title":"Analysis of pharma R&D productivity – a new perspective needed","authors":"Alexander Schuhmacher ,&nbsp;Markus Hinder ,&nbsp;Alexander von Stegmann und Stein ,&nbsp;Dominik Hartl ,&nbsp;Oliver Gassmann","doi":"10.1016/j.drudis.2023.103726","DOIUrl":"10.1016/j.drudis.2023.103726","url":null,"abstract":"<div><p>R&amp;D productivity continues to be the industry’s grand challenge. We analyzed the R&amp;D input, output, and outcome of 16 leading research-based pharmaceutical companies over 20 years (2001–2020). Our analysis shows that pharma companies increased their R&amp;D spending at a compound annual growth rate of 6% (2001–2020) to an average R&amp;D expenditure per company of $6.7 billion (2020). The companies in our investigation launched 251 new drugs representing 46% of all CDER–related FDA approvals in the past 20 years. The average R&amp;D efficiency of big pharma was $6.16 billion total R&amp;D expenditures per new drug. Almost half of the leading companies needed to compensate for their negative R&amp;D productivity through mergers and acquisitions.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 10","pages":"Article 103726"},"PeriodicalIF":7.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9942321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Causal inference in drug discovery and development 药物发现和开发中的因果推理
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-10-01 DOI: 10.1016/j.drudis.2023.103737
Tom Michoel , Jitao David Zhang
{"title":"Causal inference in drug discovery and development","authors":"Tom Michoel ,&nbsp;Jitao David Zhang","doi":"10.1016/j.drudis.2023.103737","DOIUrl":"10.1016/j.drudis.2023.103737","url":null,"abstract":"<div><p>To discover new drugs is to seek and to prove causality. As an emerging approach leveraging human knowledge and creativity, data, and machine intelligence, causal inference holds the promise of reducing cognitive bias and improving decision-making in drug discovery. Although it has been applied across the value chain, the concepts and practice of causal inference remain obscure to many practitioners. This article offers a nontechnical introduction to causal inference, reviews its recent applications, and discusses opportunities and challenges of adopting the causal language in drug discovery and development.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 10","pages":"Article 103737"},"PeriodicalIF":7.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1359644623002532/pdfft?md5=e1fbfbc6ba138643f378631d35c450ba&pid=1-s2.0-S1359644623002532-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10173654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Toward responsible clinical n-of-1 strategies for rare diseases 针对罕见病的负责任临床n-of-1策略。
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-10-01 DOI: 10.1016/j.drudis.2023.103688
Victoria M. Defelippe , Ghislaine J.M.W. van Thiel , Willem M. Otte , Roger E.G. Schutgens , Bas Stunnenberg , Helen J. Cross , Finbar O'Callaghan , Valentina De Giorgis , Floor E. Jansen , Emilio Perucca , Eva H. Brilstra , Kees P.J. Braun
{"title":"Toward responsible clinical n-of-1 strategies for rare diseases","authors":"Victoria M. Defelippe ,&nbsp;Ghislaine J.M.W. van Thiel ,&nbsp;Willem M. Otte ,&nbsp;Roger E.G. Schutgens ,&nbsp;Bas Stunnenberg ,&nbsp;Helen J. Cross ,&nbsp;Finbar O'Callaghan ,&nbsp;Valentina De Giorgis ,&nbsp;Floor E. Jansen ,&nbsp;Emilio Perucca ,&nbsp;Eva H. Brilstra ,&nbsp;Kees P.J. Braun","doi":"10.1016/j.drudis.2023.103688","DOIUrl":"10.1016/j.drudis.2023.103688","url":null,"abstract":"<div><p><em>N</em>-of-1 strategies can provide high-quality evidence of treatment efficacy at the individual level and optimize evidence-based selection of off-label treatments for patients with rare diseases. Given their design characteristics, <em>n</em>-of-1 strategies are considered to lay at the intersection between medical research and clinical care. Therefore, whether <em>n</em>-of-1 strategies should be governed by research or care regulations remains a debated issue. Here, we delineate differences between medical research and optimized clinical care, and distinguish the regulations which apply to either. We also set standards for responsible optimized clinical <em>n</em>-of-1 strategies with (off-label) treatments for rare diseases. Implementing clinical <em>n</em>-of-1 strategies as defined here could aid in optimized treatment selection for such diseases.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 10","pages":"Article 103688"},"PeriodicalIF":7.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1359644623002040/pdfft?md5=0ec274864e82ec2cead4c8049fc7384a&pid=1-s2.0-S1359644623002040-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10191453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is the blockbuster imperative broken? 重磅命令被打破了吗？
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-09-27 DOI: 10.1016/j.drudis.2023.103789
Alexander Schuhmacher, Markus Hinder, Nikolaj Boger, Oliver Gassmann, Dominik Hartl
{"title":"Is the blockbuster imperative broken?","authors":"Alexander Schuhmacher,&nbsp;Markus Hinder,&nbsp;Nikolaj Boger,&nbsp;Oliver Gassmann,&nbsp;Dominik Hartl","doi":"10.1016/j.drudis.2023.103789","DOIUrl":"10.1016/j.drudis.2023.103789","url":null,"abstract":"","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 11","pages":"Article 103789"},"PeriodicalIF":7.4,"publicationDate":"2023-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41093141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lactose in tablets: Functionality, critical material attributes, applications, modifications and co-processed excipients 片剂中的乳糖:功能，关键材料属性，应用，修改和协同加工辅料
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-09-01 DOI: 10.1016/j.drudis.2023.103696
Chuting Shi , Haiyue Zhao , Ying Fang , Lan Shen , Lijie Zhao
{"title":"Lactose in tablets: Functionality, critical material attributes, applications, modifications and co-processed excipients","authors":"Chuting Shi ,&nbsp;Haiyue Zhao ,&nbsp;Ying Fang ,&nbsp;Lan Shen ,&nbsp;Lijie Zhao","doi":"10.1016/j.drudis.2023.103696","DOIUrl":"https://doi.org/10.1016/j.drudis.2023.103696","url":null,"abstract":"<div><p>Lactose is one of the most widespread excipients used in the pharmaceutical industry. Because of its water solubility and acceptable flowability, lactose is generally added into tablet formulation to improve wettability and undesirable flowability. Based on Quality by Design, a better understanding of the critical material attributes (CMAs) of raw materials is beneficial in guiding the improvement of tablet quality and the development of lactose. Additionally, the modifications and co-processing of lactose can introduce more-desirable characteristics to the resulting particles. This review focuses on the functionality, CMAs, applications, modifications and co-processing of lactose in tablets.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 9","pages":"Article 103696"},"PeriodicalIF":7.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"1557217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Update on the treatment of cancer cachexia 癌症恶病质治疗的最新进展
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-09-01 DOI: 10.1016/j.drudis.2023.103689
Kenichi Nishie , Tomomi Nishie , Seiichi Sato , Masayuki Hanaoka
{"title":"Update on the treatment of cancer cachexia","authors":"Kenichi Nishie ,&nbsp;Tomomi Nishie ,&nbsp;Seiichi Sato ,&nbsp;Masayuki Hanaoka","doi":"10.1016/j.drudis.2023.103689","DOIUrl":"https://doi.org/10.1016/j.drudis.2023.103689","url":null,"abstract":"<div><p>Cancer cachexia is a complex multifaceted syndrome involving functional impairment and changes in body composition that cannot be reversed by nutritional support. Cancer cachexia is characterized by decreased skeletal muscle mass, increased lipolysis, and decreased food intake. Cancer cachexia decreases chemotherapy tolerance as well as quality of life. However, because no fully effective interventions are available, cancer cachexia remains an unmet need in cancer treatment. In recent years, several discoveries and treatments for cancer cachexia have been studied, and guidelines have been published. We believe that the development of effective strategies for the diagnosis and treatment of cancer cachexia will lead to breakthroughs in cancer treatment.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 9","pages":"Article 103689"},"PeriodicalIF":7.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"2578071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
The pharmaceutical innovator’s dilemma 制药创新者的困境
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-09-01 DOI: 10.1016/j.drudis.2023.103699
Michael S. Kinch (Executive Dean of Science)
{"title":"The pharmaceutical innovator’s dilemma","authors":"Michael S. Kinch (Executive Dean of Science)","doi":"10.1016/j.drudis.2023.103699","DOIUrl":"https://doi.org/10.1016/j.drudis.2023.103699","url":null,"abstract":"","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 9","pages":"Article 103699"},"PeriodicalIF":7.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"1756093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificial intelligence in pharmaceutical regulatory affairs 药品监管事务中的人工智能
IF 7.4 2区 医学
Drug Discovery Today Pub Date : 2023-09-01 DOI: 10.1016/j.drudis.2023.103700
Ruchika S. Patil , Samruddhi B. Kulkarni , Vinod L. Gaikwad
{"title":"Artificial intelligence in pharmaceutical regulatory affairs","authors":"Ruchika S. Patil ,&nbsp;Samruddhi B. Kulkarni ,&nbsp;Vinod L. Gaikwad","doi":"10.1016/j.drudis.2023.103700","DOIUrl":"https://doi.org/10.1016/j.drudis.2023.103700","url":null,"abstract":"<div><p>Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system. Human–AI interaction opens up new opportunities in regulatory affairs. This article explores the potential role of AI in pharmaceutical regulatory affairs.</p></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"28 9","pages":"Article 103700"},"PeriodicalIF":7.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"1756100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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