References

Selected References

1. Sharpe, M., Sullivan, M., Hyllner, J. and Thompson K. (2020) The role of governments in the commercial emergence of radical innovation: the example of the UK. In Dowden N, Smith, D M and Qureshi N. Second Generation Cell and Gene-Based Therapies. Oxford: Elsevier Ltd. https://www.sciencedirect.com/science/article/pii/B978012812034700025X?fbclid=IwAR2eDdHzatu1Ouu-0z4g7VpAJ6ksq_T6ZOU2_eYFj-OptRsNIXmcmruj8DQ

2. McBlain, J.; Phul, P and Sharpe, M. (2018) Preclinical Development of Cell Based Products: A European Regulatory Science Perspective. Pharm Res 35, 165. https://www.ncbi.nlm.nih.gov/pubmed/29943208

3.Sharpe, M. (2018) T Cell Immunotherapies and the Role of Nonclinical Assessment; The Balance between Efficacy and Pathology. Toxicologic Pathology. 46: 131-146 https://www.ncbi.nlm.nih.gov/pubmed/29471776

4.Sharpe, M., Leoni, G., & Hyllner, J. (2018) Stem Cells. In: McQueen, C. A., Comprehensive Toxicology, Third Edition. Vol. 12, pp. 23–59. Oxford: Elsevier Ltd. https://www.sciencedirect.com/science/article/pii/B9780128012383642459

5. D. Marshall, M. Sharpe and S. Ward (2016). Cell and gene therapies and the evolving role of personalised medicine. Cell and Gene Therapy Insights, 2: 277-286 https://insights.bio/cell-and-gene-therapy-insights/journal/articles/cell-gene-therapies-and-the-evolving-role-of-personalized-medicine/

6. M. Sharpe, G. Leoni, R. Schutte, J. Barry and N. Mount (2015). Nonclinical studies for cell based medicines. In " Guide to Cell Therapy GXP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments " Editors J. Vives and G. Carmona. Oxford: Elsevier Ltd https://www.sciencedirect.com/science/article/pii/B9780128031155000036

7. R. Haworth and M. Sharpe (2015). The issue of immunology in stem cell therapies: a pharmaceutical perspective. Regenerative Medicine 10:231 – 234 https://www.ncbi.nlm.nih.gov/pubmed/2593323

8. I. Bisson, E. Green, M. Sharpe, C. Herbert, J. Hyllner and N. Mount (2015). Landscape of current and emerging cell therapy clinical trials in the UK: Current status, comparison to global trends and future perspectives. Regenerative Medicine. 10:169-79. https://www.ncbi.nlm.nih.gov/pubmed/25835481

9. M. Sharpe and N. Mount (2015). Genetically modified T cells in cancer therapy: opportunities and challenges. Disease Models & Mechanisms. 8:1-14 https://www.ncbi.nlm.nih.gov/pubmed/26035842

10. M. E. Sharpe (2012). Stem Cell Therapies: Assuring Safety European Pharmaceutical Review. July.

11. M. Sharpe, D. Morton, A. Rossi (2012) Nonclinical Safety Strategies for Stem Cell Therapies. Toxicology and Applied Pharmacology. 262:223-231 https://www.ncbi.nlm.nih.gov/pubmed/22617430

12. Goldring CE, Duffy PA, Benvenisty N, Andrews PW, Ben-David U, Eakins R, French N, Hanley NA, Kelly L, Kitteringham NR, Kurth J, Ladenheim D, Laverty H, McBlane J, Narayanan G, Patel S, Reinhardt J, Rossi A, Sharpe M, Park BK (2011). Assessing the safety of stem cell therapeutics. Cell Stem Cell. 8618-628 https://www.ncbi.nlm.nih.gov/pubmed/21624806

13. S. Jones, K. Evans, H. McElwaine-Johnn, M.Sharpe, J.Oxford, R. Lambkin-Williams, T.Mant, A. Nolan, M.Zambon, J. Ellis, J. Beadle and P. Loudon. (2009). DNA Vaccination against an Influenza challenge in a Phase 1b double blind randomized placebo controlled clinical trial. Vaccine. 27:2506-2512 https://www.ncbi.nlm.nih.gov/pubmed/19368793

14. M. E. Sharpe, D. Lynch, S. Topham, D. Major, J. Wood and P. Loudon. (2007). Protection of mice from H5N1 influenza challenge by prophylactic DNA vaccination using particle mediated epidermal delivery. Vaccine. 25 6392-6398 https://www.ncbi.nlm.nih.gov/pubmed/17640779