Dr Lucy Studholme (née Findlay)
Dr Lucy Studholme joined NIBSC in 2003 where she completed her PhD on therapeutic mAb candidate TGN1412 and subsequently became Head of Pyrogen Science. More recently, she has moved into the field of platelet, granulocyte and erythrocyte immunohaematology, involving the production of international reference materials (WHO and CE marked) for the standardisation of biological assays/tests. Other interests include the use of autoantibodies as diagnostic biomarkers of disease.
Lucy is also responsible for the Official Control Authority Batch Release (OCABR) testing of therapeutic immunoglobulins, more specifically, for the screening of anti-blood group antibodies in intravenous immunoglobulins (IVIG) and for potency confirmation of prophylactic anti-D preparations.
Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D, Mistry Y, Dilger P, Liefooghe E, Cludts I, Fox B, Tarrant G, Robinson J, Meager T, Dolman C, Thorpe SJ, Bristow A, Wadhwa M, Thorpe R, Poole S. "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol. 2007; 179(5):3325-31.
Findlay L, Eastwood D, Stebbings R, Sharp G, Mistry Y, Ball C, Hood J, Thorpe R, Poole S. Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412. J Immunol Methods. 2010; 352(1-2):1-12.
Eastwood D, Findlay L, Poole S, Bird C, Wadhwa M, Moore M, Burns C, Thorpe R, Stebbings R. Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br J Pharmacol. 2010; 161(3):512-26
Findlay L, Eastwood D, Ball C, Robinson CJ, Bird C, Wadhwa M, Thorpe SJ, Thorpe R, Stebbings R, Poole S. Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy. J Immunol Methods. 2011; 371(1-2):134-42.
Findlay L, Sharp G, Fox B, Ball C, Robinson CJ, Bird C, Stebbings R, Eastwood D, Wadhwa M, Poole S, Thorpe R, Thorpe SJ. Endothelial cells co-stimulate peripheral blood mononuclear cell responses to monoclonal antibody TGN1412 in culture. Cytokine. 2011; 55(1):141-51.
Ball C, Fox B, Hufton S, Sharp G, Poole S, Stebbings R, Eastwood D, Findlay L, Parren PW, Thorpe R, Bristow A, Thorpe SJ. Antibody C region influences TGN1412-like functional activity in vitro. J Immunol. 2012; 189(12):5831-40.
Eastwood D, Bird C, Dilger P, Hockley J, Findlay L, Poole S, Thorpe SJ, Wadhwa M, Thorpe R, Stebbings R. Severity of the TGN1412 trial disaster cytokine storm correlated with IL-2 release. Br J Clin Pharmacol. 2013; 76(2):299-315.
Thorpe SJ, Stebbings R, Findlay L, Eastwood D, Poole S, Thorpe R. How predictive are in vitro assays for cytokine release syndrome in vivo? A comparison of methods reveals worrying differences in sensitivity and frequency of response. Cytokine. 2013; 64(1):471-2.
Thorpe SJ, Stebbings R, Findlay L, Eastwood D, Poole S, Thorpe R. Reply to the Response from Babette Wolf et al. to our Letter to the Editor: How predictive are in vitro assays for cytokine release syndrome in vivo? A comparison of methods reveals worrying differences in sensitivity and frequency of response. Cytokine. 2013; 64(1):476.
L. Findlay, T. Desai, A. Heath, S. Poole, M. Crivellone, W. Hauck, M. Ambrose, T. Morris, A. Daas, G. Rautmann, KH. Buchheit, JM. Spieser and E. Terao. Collaborative study for the establishment of the WHO 3rd International Standard for Endotoxin, the Ph. Eur. Endotoxin Biological Reference Preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354. Pharmeuropa Bio&SN, June 2015
C. Vipond, L. Findlay, I. Feavers and R. Care. Limitations of the Rabbit Pyrogen Test for Assessing Meningococcal OMV Based Vaccines. Altex. 2016; 33(1)
L. Studholme, J. Sutherland, T. Desai, J. Hockley, R. Care, K. Nordgren, C. Vipond. Collaborative Study Group. Evaluation of the Monocyte Activation Test for the safety testing of meningococcal B vaccine Bexsero: a collaborative study. Vaccine. 2018
C. Vipond, J. Sutherland, K. Nordgren, G. Kemp, A. Heath, R. Care, L. Studholme. Development and validation of a monocyte activation test for the control/safety testing of an OMV-based meningococcal B vaccine. Vaccine. 2018.
Bernard Fox, Giles Sharp, Eleanor Atkinson, Graham Roberts, Peter Rigsby
and Lucy Studholme. The third international standard for anti-D immunoglobulin: international collaborative study to evaluate candidate preparations. Vox Sanguinis. DOI: 10.1111/vox.12822. Accepted June 2019.
Fox B, Hockley J, Studholme L. The British Standard for (European Conformity [CE] Marked) Anti-D: Its rarely discussed but important role in quantitating anti-D in patient plasma. Transfus Med. 2020;30(1):75-7.
Contribution made to The Duff Report, 2006. Expert Scientific Group.