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Hire Dr. Alex L.

United Kingdom

Former academic, medical devices regulatory affairs consultant, specialising in clinical and performance evaluation.

Profile Summary

Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manchester Previous Experience: 10 years of academic translational research, developing therapies for rare disease and age-related disorders. Currently I am the principal consultant of Systematic Evaluations Limited and experienced medical devices regulatory affairs consultant specialising in clinical evaluations for the MDR and performance evaluations for the IVDR. Services: Medical Devices - clinical evaluation plans (CEP), clinical evaluation reports (CER) and post-market clinical follow-up (PMCF) to the requirements of the Medical Devices Regulation (MDR) EU 2017/745. In Vitro Diagnostics - performance evaluation plans (PEP), performance evaluation reports (PER) and post-market performance follow-up (PMPF) to the requirements of the In Vitro Diagnostics Regulation (IVDR) EU 2017/746. Scientific Services - systematic and reproducible literature identification and review, data extraction, appraisal and meta-analysis. Medical Writing

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Devices
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Regulatory Affairs
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Medical Writing
• ☆ Systematic Literature Review

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Data Visualization

Work Experience

Managing Director

Systematic Evaluations Limited

April 2021 - Present

Senior Clinical Affairs Operative

SciMed Consultancy Ltd

October 2019 - Present

Education

Doctor of Philosophy (PhD) Haematopoetic Stem Cell Gene Therapy

University of Manchester

April 2008 - April 2011

MBiochem, Molecular and Cellular Biochemistry

University of Oxford

September 2002 - September 2006

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Nicola Edwards, Alexander W W Langford-Smith, Benjamin J Parker, Ian N Bruce, John A Reynolds, M Yvonne Alexander, Eoghan M McCarthy, Fiona L Wilkinson(2018). {QRISK}3 improves detection of cardiovascular disease risk in patients with systemic lupus erythematosus . Lupus Science {\&} Medicine. 5. (1). p. e000272. {BMJ}

Langford-Smith A, Tilakaratna V, Lythgoe PR, Clark SJ, Bishop PN, Day AJ, PloS one, 2016, vol. 11, no. 1, pp. e0147576 .

Martins C, Hůlková H, Dridi L, Dormoy-Raclet V, Grigoryeva L, Choi Y, Langford-Smith A, Wilkinson FL, Ohmi K, DiCristo G, Hamel E, Ausseil J, Cheillan D, Moreau A, Svobodová E, Hájková Z, Tesařová M, Hansíková H, Bigger BW, Hrebícek M, Brain : a journal of neurology, 2015, vol. 138, no. Pt 2, pp. 336-355 .

Martins, C., Hulkova, H., Dridi, L., Dormoy-Raclet, V., Grigoryeva, L., Choi, Y., Langford-Smith, A., Wilkinson, F.L., Ohmi, K., DiCristo, G., et al.(2015). Neuroinflammation, mitochondrial defects and neurodegeneration in mucopolysaccharidosis III type C mouse model . Brain. 138. (2). p. 336-355.

Martins, C., Hulková, H., Dridi, L., Dormoy-Raclet, V., Grigoryeva, L., Choi, Y., Langford-Smith, A., Wilkinson, F.L., Ohmi, K., DiCristo, G., et al.(2015). Erratum: Neuroinflammation, mitochondrial defects and neurodegeneration in mucopolysaccharidosis III type C mouse model ((Brain (2015) DOI: 10.1093/brain/awu355) . Brain. 138. (7).

Langford-Smith, A., Day, A.J., Bishop, P.N., Clark, S.J.(2015). Complementing the sugar code: Role of GAGs and sialic acid in complement regulation . Frontiers in Immunology. 6. (FEB).

Langford-Smith A, Day AJ, Bishop PN, Clark SJ, Frontiers in immunology, 2015, vol. 6, pp. 25 .

Langford-Smith, A., Keenan, T.D.L., Clark, S.J., Bishop, P.N., Day, A.J.(2014). The role of complement in age-related macular degeneration: Heparan sulphate, a ZIP code for complement factor H? . Journal of Innate Immunity. 6. (4). p. 407-416.

Langford-Smith A, Keenan TD, Clark SJ, Bishop PN, Day AJ, Journal of innate immunity, 2014, vol. 6, no. 4, pp. 407-416 .

Sergijenko A, Langford-Smith A, Liao AY, Pickford CE, McDermott J, Nowinski G, Langford-Smith KJ, Merry CL, Jones SA, Wraith JE, Wynn RF, Wilkinson FL, Bigger BW, Molecular therapy : the journal of the American Society of Gene Therapy, 2013, vol. 21, no. 10, pp. 1938-1949 .

Langford-Smith, K.J., Sandiford, Z., Langford-Smith, A., Wilkinson, F.L., Jones, S.A., Wraith, J.E., Wynn, R.F., Bigger, B.W., Langford-Smith, K.J., Sandiford, Z., et al.(2013). Signal One and Two Blockade Are Both Critical for Non-Myeloablative Murine HSCT across a Major Histocompatibility Complex Barrier . PLoS ONE. 8. (10).

Sergijenko, A., Langford-Smith, A., Liao, A.Y., Pickford, C.E., McDermott, J., Nowinski, G., Langford-Smith, K.J., Merry, C.L., Jones, S.A., Wraith, J.E., et al.(2013). Myeloid/Microglial driven autologous hematopoietic stem cell gene therapy corrects a neuronopathic lysosomal disease . Molecular Therapy. 21. (10). p. 1938-1949.

Langford-Smith KJ, Sandiford Z, Langford-Smith A, Wilkinson FL, Jones SA, Wraith JE, Wynn RF, Bigger BW, PloS one, 2013, vol. 8, no. 10, pp. e77632 .

Langford-Smith, A., Wilkinson, F.L., Langford-Smith, K.J., Holley, R.J., Sergijenko, A., Howe, S.J., Bennett, W.R., Jones, S.A., Wraith, J.E., Merry, C.L.R., et al.(2012). Hematopoietic stem cell and gene therapy corrects primary neuropathology and behavior in mucopolysaccharidosis IIIA mice . Molecular Therapy. 20. (8). p. 1610-1621.

Wilkinson, F.L., Holley, R.J., Langford-Smith, K.J., Badrinath, S., Liao, A., Langford-Smith, A., Cooper, J.D., Jones, S.A., Wraith, J.E., Wynn, R.F., et al.(2012). Neuropathology in mouse models of mucopolysaccharidosis type I, IIIA and IIIB . PLoS ONE. 7. (4).

Alex Langford-Smith, Kia J. Langford-Smith, Simon A. Jones, Robert F. Wynn, J. E. Wraith, Fiona L. Wilkinson, Brian W. Bigger, Stephen D. Ginsberg(2011). Female Mucopolysaccharidosis {IIIA} Mice Exhibit Hyperactivity and a Reduced Sense of Danger in the Open Field Test . {PLoS} {ONE}. 6. (10). p. e25717. Public Library of Science ({PLoS})

Langford-Smith, A., Malinowska, M., Langford-Smith, K.J., Wegrzyn, G., Jones, S., Wynn, R., Wraith, J.E., Wilkinson, F.L., Bigger, B.W., Langford-Smith, A., et al.(2011). Hyperactive behaviour in the mouse model of mucopolysaccharidosis iiib in the open field and home cage environments . Genes, Brain and Behavior. 10. (6). p. 673-682.

Langford-Smith, A., Langford-Smith, K.J., Jones, S.A., Wynn, R.F., Wraith, J.E., Wilkinson, F.L., Bigger, B.W., Langford-Smith, A., Langford-Smith, K.J., Jones, S.A., et al.(2011). Female mucopolysaccharidosis IIIA mice exhibit hyperactivity and a reduced sense of danger in the open field test . PLoS ONE. 6. (10).

Malinowska, M., Wilkinson, F.L., Langford-Smith, K.J., Langford-Smith, A., Brown, J.R., Crawford, B.E., Vanier, M.T., Grynkiewicz, G., Wynn, R.F., Ed Wraith, J., et al.(2010). Genistein improves neuropathology and corrects behaviour in a mouse model of neurodegenerative metabolic disease . PLoS ONE. 5. (12).