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      A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials

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          Abstract

          Multiple components factor into the assessment of combination safety risks when two or more novel individual products are used in combination in clinical trials. These include, but are not limited to, biology, biochemistry, pharmacology, class effects, and preclinical and clinical findings (such as adverse drug reactions, drug target and mechanism of action, target expression, signaling, and drug–drug interactions). This paper presents a science-based methodology framework for the assessment of combination safety risks when two or more investigational products are used in clinical trials. The aim of this methodology framework is to improve prediction of the risks, to enable the appropriate safety risk mitigation and management to be put in place for the combination, and the development of the project combination safety strategy.

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          The online version contains supplementary material available at 10.1007/s40290-023-00465-z.

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          Proteomics. Tissue-based map of the human proteome.

          Mathias Uhlén, Linn Fagerberg, Björn Hallström … (2015)
          Resolving the molecular details of proteome variation in the different tissues and organs of the human body will greatly increase our knowledge of human biology and disease. Here, we present a map of the human tissue proteome based on an integrated omics approach that involves quantitative transcriptomics at the tissue and organ level, combined with tissue microarray-based immunohistochemistry, to achieve spatial localization of proteins down to the single-cell level. Our tissue-based analysis detected more than 90% of the putative protein-coding genes. We used this approach to explore the human secretome, the membrane proteome, the druggable proteome, the cancer proteome, and the metabolic functions in 32 different tissues and organs. All the data are integrated in an interactive Web-based database that allows exploration of individual proteins, as well as navigation of global expression patterns, in all major tissues and organs in the human body. Copyright © 2015, American Association for the Advancement of Science.
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            Combination therapy in combating cancer

            Reza Bayat Mokhtari, Tina Homayouni, Narges Baluch … (2017)
            Combination therapy, a treatment modality that combines two or more therapeutic agents, is a cornerstone of cancer therapy. The amalgamation of anti-cancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner. This approach potentially reduces drug resistance, while simultaneously providing therapeutic anti-cancer benefits, such as reducing tumour growth and metastatic potential, arresting mitotically active cells, reducing cancer stem cell populations, and inducing apoptosis. The 5-year survival rates for most metastatic cancers are still quite low, and the process of developing a new anti-cancer drug is costly and extremely time-consuming. Therefore, new strategies that target the survival pathways that provide efficient and effective results at an affordable cost are being considered. One such approach incorporates repurposing therapeutic agents initially used for the treatment of different diseases other than cancer. This approach is effective primarily when the FDA-approved agent targets similar pathways found in cancer. Because one of the drugs used in combination therapy is already FDA-approved, overall costs of combination therapy research are reduced. This increases cost efficiency of therapy, thereby benefiting the “medically underserved”. In addition, an approach that combines repurposed pharmaceutical agents with other therapeutics has shown promising results in mitigating tumour burden. In this systematic review, we discuss important pathways commonly targeted in cancer therapy. Furthermore, we also review important repurposed or primary anti-cancer agents that have gained popularity in clinical trials and research since 2012.
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              A single–cell type transcriptomics map of human tissues

              Max Karlsson, Cheng. Zhang, Loren Méar … (2021)
              Single-cell RNA analysis has been integrated with spatial protein profiling to create a single–cell type map of human tissues. Advances in molecular profiling have opened up the possibility to map the expression of genes in cells, tissues, and organs in the human body. Here, we combined single-cell transcriptomics analysis with spatial antibody-based protein profiling to create a high-resolution single–cell type map of human tissues. An open access atlas has been launched to allow researchers to explore the expression of human protein-coding genes in 192 individual cell type clusters. An expression specificity classification was performed to determine the number of genes elevated in each cell type, allowing comparisons with bulk transcriptomics data. The analysis highlights distinct expression clusters corresponding to cell types sharing similar functions, both within the same organs and between organs.
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                Author and article information

                Contributors
                Andriani C. Patera: andriani.patera@astrazeneca.com
                Journal
                Journal ID (nlm-ta): Pharmaceut Med
                Journal ID (iso-abbrev): Pharmaceut Med
                Title: Pharmaceutical Medicine
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 1178-2595
                ISSN (Electronic): 1179-1993
                Publication date (Electronic): 26 April 2023
                Publication date PMC-release: 26 April 2023
                Publication date (Print): 2023
                Volume: 37
                Issue: 3
                Pages: 183-202
                Affiliations
                [1 ]GRID grid.418152.b, ISNI 0000 0004 0543 9493, Patient Safety Oncology, Oncology R&D, , AstraZeneca, ; 101 Orchard Ridge Way, Gaithersburg, MD 20878 USA
                [2 ]GRID grid.417815.e, ISNI 0000 0004 5929 4381, Patient Safety Oncology, Oncology R&D, , AstraZeneca, ; Cambridge, UK
                Author information
                http://orcid.org/0000-0002-9727-7668
                Article
                Publisher ID: 465
                DOI: 10.1007/s40290-023-00465-z
                PMC ID: 10205853
                PubMed ID: 37099245
                SO-VID: 0ea6f4e8-9a1e-4e89-9a6a-33f728374fb8
                Copyright © © The Author(s) 2023
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date accepted : 26 February 2023
                Categories
                Subject: Current Opinion
                Custom metadata
                issue-copyright-statement © Springer Nature Switzerland AG 2023

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