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1. Validity of Routine Health Data To Identify Safety Outcomes of Interest For Covid-19 Vaccines and Therapeutics in the Context of the Emerging Pandemic: A Comprehensive Literature Review

Author

Andresen K, Hinojosa-Campos M, Podmore B, Drysdale M, Qizilbash N, and Cunnington M

Subjects
validation, routine health data, covid-19, safety, vaccines, outcomes., Medicine (General), R5-920
Abstract

Kirsty Andresen,1,2 Marina Hinojosa-Campos,3 Bélène Podmore,1– 3 Myriam Drysdale,4 Nawab Qizilbash,1– 3 Marianne Cunnington4,5 1OXON Epidemiology, London, UK; 2London School of Hygiene and Tropical Medicine, London, UK; 3OXON Epidemiology, Madrid, Spain; 4GlaxoSmithKline, Middlesex, UK; 5Analysis Group, London, UKCorrespondence: Kirsty Andresen, Email Kirsty.andresen@oxonepi.comIntroduction: Regulatory guidance encourages transparent reporting of information on the quality and validity of electronic health record data being used to generate real-world benefit-risk evidence for vaccines and therapeutics. We aimed to provide an overview of the availability of validated diagnostic algorithms for selected safety endpoints for Coronavirus disease 2019 (COVID-19) vaccines and therapeutics in the context of the emerging pandemic prior to December 2020.Methods: We reviewed the literature up to December 2020 to identify validation studies for various safety events of interest, including myocardial infarction, arrhythmia, myocarditis, acute cardiac injury, vasculitis/vasculopathy, venous thromboembolism, stroke, respiratory distress syndrome (RDS), pneumonitis, cytokine release syndrome (CRS), multiple organ dysfunction syndrome, and renal failure. We included studies published between 2015 and 2020 that were considered high quality assessed with QUADAS and that reported positive predictive values (PPVs).Results: Out of 43 identified studies, we found that diagnostic algorithms for cardiovascular outcomes were supported by the highest number of validation studies (n=17). Accurate algorithms are available for myocardial infarction (median PPV 80%; IQR 22%), arrhythmia (PPV range > 70%), venous thromboembolism (median PPV: 73%) and ischaemic stroke (PPV range ≥ 85%). We found a lack of validation studies for less common respiratory and cardiac safety outcomes of interest (eg, pneumonitis and myocarditis), as well as for COVID-specific complications (CRS, RDS).Conclusion: There is a need for better understanding of barriers to conducting validation studies, including data governance restrictions. Regulatory guidance should promote embedding validation within real-world EHR research used for decision-making.Keywords: validation, routine health data, Covid-19, safety, vaccines, outcomes

Published
2024

2. A RAC-GEF network critical for early intestinal tumourigenesis

Author

Pickering, K. A., Gilroy, K., Cassidy, J. W., Fey, S. K., Najumudeen, A. K., Zeiger, L. B., Vincent, D. F., Gay, D. M., Johansson, J., Fordham, R. P., Miller, B., Clark, W., Hedley, A., Unal, E. B., Kiel, C., McGhee, E., Machesky, L. M., Nixon, C., Johnsson, A. E., Bain, M., Strathdee, D., van Hoof, S. R., Medema, J. P., Anderson, K. I., Brachmann, S. M., Stucke, V. M., Malliri, A., Drysdale, M., Turner, M., Serrano, L., Myant, K., Campbell, A. D., and Sansom, O. J.

Published
2021
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5. Dyad Interdependence: An Examination of the Student/Supervisor Relationship in Graduate Education.

Author

Drysdale, M. T. B.

Abstract

The purpose of this study was to examine satisfaction with the supervisory relationship, satisfaction with graduate education, reasons why both students and supervisors decide to work together, positive role modeling, and the decision to pursue an academic career. Other variables examined in the study included: gender, age, department/faculty, and student time to completion. Surveys were completed by 121 graduate students and 43 of their supervisors, resulting in 43 student/supervisor dyads. Supervisors reported greater satisfaction with the supervisory relationship than did students. Student satisfaction with the adviser was positively correlated with their satisfaction with graduate education. Point-biserial correlations and Pearson correlations revealed a significant positive relationship between overall satisfaction with the supervisory relationship and positive supervisor role modeling. However, the analyses failed to find significant correlations between the decision to pursue an academic career and overall satisfaction with the supervisory relationship and the decision to pursue an academic career and role modeling. A series of paired samples t-tests revealed significant differences between why students and supervisors decided to work together. Students selected "personality" as the most important reason for working with their supervisors, but supervisors selected "common research interest." (Contains 11 tables and 27 references.) (Author/SLD)

Published
2003

12. A framework for the development of effective anti-metastatic agents

Author

Anderson, RL, Balasas, T, Callaghan, J, Coombes, RC, Evans, J, Hall, JA, Kinrade, S, Jones, D, Jones, PS, Jones, R, Marshall, JF, Panico, MB, Shaw, JA, Steeg, PS, Sullivan, M, Tong, W, Westwell, AD, Ritchie, JWA, Berg, R, Drysdale, M, Eccles, S, Elvin, P, Harris, A, Ireson, C, Machesky, L, McLeod, R, Muschel, R, Newell, H, Pittman, M, Roman, B, Santos, C, Sibson, N, Smith, A, and Waddell, I

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Drug development, Antineoplastic Agents, Disease, Metastasis, Tumour biomarkers, 03 medical and health sciences, 0302 clinical medicine, Circulating tumor cell, Internal medicine, medicine, Animals, Humans, Molecular Targeted Therapy, Epithelial–mesenchymal transition, Neoplasm Metastasis, Bladder cancer, business.industry, Consensus Statement, Cancer, Bone metastasis, medicine.disease, Xenograft Model Antitumor Assays, United Kingdom, 030104 developmental biology, 030220 oncology & carcinogenesis, Drug therapy, business, Biomarkers
Abstract

Most cancer-related deaths are a result of metastasis, and thus the importance of this process as a target of therapy cannot be understated. By asking ‘how can we effectively treat cancer?’, we do not capture the complexity of a disease encompassing >200 different cancer types — many consisting of multiple subtypes — with considerable intratumoural heterogeneity, which can result in variable responses to a specific therapy. Moreover, we have much less information on the pathophysiological characteristics of metastases than is available for the primary tumour. Most disseminated tumour cells that arrive in distant tissues, surrounded by unfamiliar cells and a foreign microenvironment, are likely to die; however, those that survive can generate metastatic tumours with a markedly different biology from that of the primary tumour. To treat metastasis effectively, we must inhibit fundamental metastatic processes and develop specific preclinical and clinical strategies that do not rely on primary tumour responses. To address this crucial issue, Cancer Research UK and Cancer Therapeutics CRC Australia formed a Metastasis Working Group with representatives from not-for-profit, academic, government, industry and regulatory bodies in order to develop recommendations on how to tackle the challenges associated with treating (micro)metastatic disease. Herein, we describe the challenges identified as well as the proposed approaches for discovering and developing anticancer agents designed specifically to prevent or delay the metastatic outgrowth of cancer., Most cancer-related deaths are attributable to metastasis, but few treatments are specifically designed to disrupt this process. In this Position Paper, representatives of the joint Cancer Research UK and Cancer Therapeutics CRC Australia Metastasis Working Group describe the challenges associated with discovering and developing anticancer agents designed specifically to prevent or delay the metastatic outgrowth of cancer and provide guidance on how these challenges might be overcome., Key points Metastasis is associated with a poor patient prognosis and is the foremost cause of cancer-related death, with approximately 90% of patients who succumb to cancer dying of metastatic disease.Metastasis is inherently complex, with different distant sites having a distinct and specific extracellular matrix and cellular composition compared with that of the originating site, and therefore metastases must be considered biologically different from the primary tumour.The standard cancer drug discovery and development pathway, including that for molecularly targeted and immunotherapies, generally ignores the ability of experimental medicines to inhibit metastasis.A wealth of potential preclinical targets for anti-metastatic drug discovery and development have already been identified but remain to be validated using appropriate preclinical models that reflect the pathogenesis of metastatic disease in patients.Despite some successes in the treatment of bone metastases, following extensive analyses in preclinical models, multiple late-stage failures in clinical development have resulted in anti-metastatic drug development efforts being deprioritized by the pharmaceutical industry.Successful development of effective anti-metastatic therapies will require the regulatory agencies to work together with researchers, drug developers and statisticians to redefine the clinical development paradigm in order to encourage development of this complex but high-potential category of oncology drugs.

Published
2018

13. A framework for the development of effective anti-metastatic agents

Author

Anderson, RL, Balasas, T, Callaghan, J, Coombes, RC, Evans, J, Hall, JA, Kinrade, S, Jones, D, Jones, PS, Jones, R, Marshall, JF, Panico, MB, Shaw, JA, Steeg, PS, Sullivan, M, Tong, W, Westwell, AD, Ritchie, JWA, Berg, R, Drysdale, M, Eccles, S, Elvin, P, Harris, A, Ireson, C, Machesky, L, McLeod, R, Muschel, R, Newell, H, Pittman, M, Roman, B, Santos, C, Sibson, N, Smith, A, Waddell, I, Anderson, RL, Balasas, T, Callaghan, J, Coombes, RC, Evans, J, Hall, JA, Kinrade, S, Jones, D, Jones, PS, Jones, R, Marshall, JF, Panico, MB, Shaw, JA, Steeg, PS, Sullivan, M, Tong, W, Westwell, AD, Ritchie, JWA, Berg, R, Drysdale, M, Eccles, S, Elvin, P, Harris, A, Ireson, C, Machesky, L, McLeod, R, Muschel, R, Newell, H, Pittman, M, Roman, B, Santos, C, Sibson, N, Smith, A, and Waddell, I

Abstract

Most cancer-related deaths are a result of metastasis, and thus the importance of this process as a target of therapy cannot be understated. By asking 'how can we effectively treat cancer?', we do not capture the complexity of a disease encompassing >200 different cancer types - many consisting of multiple subtypes - with considerable intratumoural heterogeneity, which can result in variable responses to a specific therapy. Moreover, we have much less information on the pathophysiological characteristics of metastases than is available for the primary tumour. Most disseminated tumour cells that arrive in distant tissues, surrounded by unfamiliar cells and a foreign microenvironment, are likely to die; however, those that survive can generate metastatic tumours with a markedly different biology from that of the primary tumour. To treat metastasis effectively, we must inhibit fundamental metastatic processes and develop specific preclinical and clinical strategies that do not rely on primary tumour responses. To address this crucial issue, Cancer Research UK and Cancer Therapeutics CRC Australia formed a Metastasis Working Group with representatives from not-for-profit, academic, government, industry and regulatory bodies in order to develop recommendations on how to tackle the challenges associated with treating (micro)metastatic disease. Herein, we describe the challenges identified as well as the proposed approaches for discovering and developing anticancer agents designed specifically to prevent or delay the metastatic outgrowth of cancer.

Published
2019

18. Evaluating the respiratory bioaccessibility of nickel in soil through the use of a simulated lung fluid

Author

Drysdale, M., Bjorklund, K., Jamieson, H., Weinstein, P., Cook, A., Watkins, Ronald, Drysdale, M., Bjorklund, K., Jamieson, H., Weinstein, P., Cook, A., and Watkins, Ronald

Abstract

Simulated lung fluids are solutions designed to mimic the composition of human interstitial lung fluid as closely as possible. Analysis of mineral dusts using such solutions has been used to evaluate the respiratory bioaccessibility of various elements for which solubility in the lungs is a primary determinant of reactivity. The objective of this study was to employ simulated lung fluid analysis to investigate the respiratory bioaccessibility of nickel in soils. Current occupational guidelines in Australia regulate nickel compounds in terms of water solubility, though this may not be an accurate estimation of the total nickel that will dissociate in the lungs. Surface soils were collected from the city of Kalgoorlie in Western Australia, the site of an operational nickel smelter and metal mining activities. The fraction of the samples less than 10 μm was extracted from the soil, and it was this sub-10-μm fraction that was found to hold most of the total nickel present in the soil. The fine fraction was analyzed using a simulated lung fluid (modified Gamble’s solution) to isolate the nickel phases soluble in the lungs. In addition, a sequential extraction was employed to compare the bioaccessible fraction to those dissolved from different binding forms in the soil. In all samples, the simulated lung fluid extracted more nickel than the two weakest leaches of the sequential extraction combined, providing a more representative nickel bioaccessibility value than the current water leach method.

Published
2012

19. Targetting conserved water molecules: Design of 4-aryl-5-cyanopyrrolo [2,3-d] pyrimidine Hsp90 inhibitors using fragment-based screening and structure-based optimization

Author

Davies, N.G.M., primary, Browne, H., additional, Davies, B., additional, Foloppe, N., additional, Geoffrey, S., additional, Gibbons, B., additional, Hart, T., additional, Drysdale, M., additional, Mansell, H., additional, Massey, A., additional, Matassova, N., additional, Moore, J.D., additional, Murray, J., additional, Pratt, R., additional, Ray, S., additional, Roughley, S.D., additional, Jensen, M.R., additional, Schoepfer, J., additional, Scriven, K., additional, Simmonite, H., additional, Stokes, S., additional, Surgenor, A., additional, Webb, P., additional, Wright, L., additional, and Brough, P., additional

Published
2012
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24. Inhibition of the HSP90 molecular chaperone in vitro and in vivo by novel, synthetic, potent resorcinylic pyrazole, isoxazole amide analogs

Author

Sharp, S.Y., primary, Prodromou, C., additional, Boxall, K., additional, Powers, M.V., additional, Holmes, J.L., additional, Box, G., additional, Matthews, T.P., additional, Cheung, K.M., additional, Kalusa, A., additional, James, K., additional, Hayes, A., additional, Hardcastle, A., additional, Dymock, B., additional, Brough, P.A., additional, Barril, X., additional, Cansfield, J.E., additional, Wright, L.M., additional, Surgenor, A., additional, Foloppe, N., additional, Aherne, W., additional, Pearl, L., additional, Jones, K., additional, McDonald, E., additional, Raynaud, F., additional, Eccles, S., additional, Drysdale, M., additional, and Workman, P., additional

Published
2007
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26. Human Hsp90-alpha with 8-(2-chloro-3,4,5-trimethoxy-benzyl)-9-pent-4-ylnyl-9H-purin-6-ylamine

Author

Wright, L., primary, Barril, X., additional, Dymock, B., additional, Sheridan, L., additional, Surgenor, A., additional, Beswick, M., additional, Drysdale, M., additional, Collier, A., additional, Massey, A., additional, Davies, N., additional, Fink, A., additional, Fromont, C., additional, Aherne, W., additional, Boxall, K., additional, Sharp, S., additional, Workman, P., additional, and Hubbard, R.E., additional

Published
2004
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27. Human Hsp90-alpha with 8-(2-chloro-3,4,5-trimethoxy-benzyl)-2-fluoro-9-pent-4-ylnyl-9H-purin-6-ylamine

Author

Wright, L., primary, Barril, X., additional, Dymock, B., additional, Sheridan, L., additional, Surgenor, A., additional, Beswick, M., additional, Drysdale, M., additional, Collier, A., additional, Massey, A., additional, Davies, N., additional, Fink, A., additional, Fromont, C., additional, Aherne, W., additional, Boxall, K., additional, Sharp, S., additional, Workman, P., additional, and Hubbard, R.E., additional

Published
2004
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28. Human Hsp90-alpha with 9-Butyl-8-(2,5-dimethoxy-benzyl)-2-fluoro-9H-purin-6-ylamine

Author

Wright, L., primary, Barril, X., additional, Dymock, B., additional, Sheridan, L., additional, Surgenor, A., additional, Beswick, M., additional, Drysdale, M., additional, Collier, A., additional, Massey, A., additional, Davies, N., additional, Fink, A., additional, Fromont, C., additional, Aherne, W., additional, Boxall, K., additional, Sharp, S., additional, Workman, P., additional, and Hubbard, R.E., additional

Published
2004
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30. Australian Journal of Career Development: Footprints Forwards blocked by a failure discourse: Issues in providing advice about medicine and other health science careers to Indigenous secondary school students

Author

Chesters, J., Drysdale, M., Ellender, I., Faulkner, S., Turnbull, L., Kelly, H., Robinson, A., and Chambers, H.

Subjects
Australian aborigines -- Educational aspects -- Vocational guidance -- Training, Medical sciences -- Vocational guidance -- Research -- Educational aspects, Career development -- Research -- Educational aspects, High school students -- Training -- Vocational guidance, Family and marriage, Social sciences
Abstract

As part of the Footprints Forward project investigating 'opportunities for and barriers to Indigenous student entry to medical education', researchers designed a survey instrument to evaluate the type of advice [...]

Published
2009

35. Novel, Potent Small-Molecule Inhibitors of the Molecular Chaperone Hsp90 Discovered through Structure-Based Design

Author

Dymock, B. W., Barril, X., Brough, P. A., Cansfield, J. E., Massey, A., McDonald, E., Hubbard, R. E., Surgenor, A., Roughley, S. D., Webb, P., Workman, P., Wright, L., and Drysdale, M. J.

Abstract

The crystal structure of a previously reported screening hit 1 (CCT018159) bound to the N terminal domain of molecular chaperone Hsp90 has been used to design 5-amide analogues. These exhibit enhanced potency against the target in binding and functional assays with accompanying appropriate cellular pharmacodynamic changes. Compound 11 (VER-49009) compares favorably with the clinically evaluated 17-AAG.

Published
2005

36. Synthesis and SAR of 4-Aryl-2-hydroxy-4-oxobut-2-enoic Acids and Esters and 2-Amino-4-aryl-4-oxobut-2-enoic Acids and Esters:  Potent Inhibitors of Kynurenine-3-hydroxylase as Potential Neuroprotective Agents

Author

Drysdale, M. J., Hind, S. L., Jansen, M., and Reinhard, J. F., Jr.

Abstract

The synthesis and structure−activity relationship of a series of 4-aryl-2-hydroxy-4-oxobut-2-enoic acids and esters and 2-amino-4-aryl-4-oxobut-2-enoic acids and esters as potent inhibitors of kynurenine-3-hydroxylase are described. These compounds are the most potent inhibitors of the kynurenine-3-hydroxylase enzyme so far disclosed. Additionally methyl 4-(3-chlorophenyl)-2-hydroxy-4-oxobut-2-enoate (2d), 4-(3-chlorophenyl)-2-hydroxy-4-oxobut-2-enoic acid (3d), methyl 4-(3-fluorophenyl)-2-hydroxy-4-oxobut-2-enoate (2f), and 4-(3-fluorophenyl)-2-hydroxy-4-oxobut-2-enoic acid (3f) prevent the increase in the interferon-γ-induced synthesis of quinolinic acid in primary cultures of cultured human peripheral blood monocyte-derived macrophages.

Published
2000

42. Endocardial pacing electrode design and rate of displacement.

Author

Charles, R G, Clarke, L M, Drysdale, M, and Sequeira, R F

Abstract

In a series of 184 patients with a permanent endocardial pacing system the rate of electrode displacement was 3-0 per cent using the Devices L120SR electrode, and 23-1 per cent using the Devices S120 electrode. The technique and pacing team were unchanged during the period of study. It is suggested that the design and mechanical characteristics of the elctrodes were responsible. [ABSTRACT FROM PUBLISHER]

Published
1977
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43. Early in the Evening.

Author

Drysdale, M. Dickey

Subjects
EARLY in the Evening (Poem), DRYSDALE, M. Dickey
Abstract

Presents the poem "Early in the Evening," by M. Dickey Drysdale. First Line: Early in the evening; Last Line: Quietly depleting.

Published
2008

44. November.

Author

Drysdale, M. Dickey

Subjects
NOVEMBER (Poem), DRYSDALE, M. Dickey
Abstract

Presents the poem "November," by M. Dickey Drysdale. First Line: November galloped into town today on a gale, Last Line: Worse.

Published
2007

45. Remote.

Author

Drysdale, M. Dickey

Subjects
REMOTE (Poem), DRYSDALE, M. Dickey
Abstract

Presents the poem "Remote," by M. Dickey Drysdale. First Line: Yesterday, I saw a man; Last Line: The tear in the boy's eye.

Published
2005

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