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19 Petterson, M et al. PROteolysis TArgeting Chimeras (PROTACs) – Past, present and future. Drug Discovery Today: Technologies – Volume 31, April 2019, Pages 15-27 https://doi.org/10.1016/j.ddtec.2019.01.002. 20 How does gene therapy work? National Library of Medicine (US). Genetics Home Reference [Internet]. Bethesda (MD): The Library; 2019 Sep 10. Available from: https:// ghr.nlm.nih.gov/primer/therapy/procedures. 21 CAR-T Therapy. NHS England. https://www.england.nhs.uk/cancer/cdf/ car-t-therapy/. 22 Biehl, J et al. Introduction to Stem Cell Therapy. he Journal of Cardiovascular Nursing. 24(2):98-103, March-April 2009. https://DOI.org/ 10.1097/JCN.0b013e318197a6a5. 23 Rettner, R. Live Science. April 18, 2019. Rare ‘Bubble Boy Disease’ Likely Cured with New Gene Therapy. https://www.livescience.com/ 65270-bubble-boy-disease-gene-therapy.html. 24 FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. https://www.fda.gov/news-events/press- announcements/fda-approves-novel-gene- therapy-treat-patients-rare-form-inherited- vision-loss. 25Wall Street Wants the Best Patents, Not the Best Drugs. https://www.bloomberg.com/ opinion/articles/2018-11-27/gilead-s-cures-for- hepatitis-c-were-not-a-great-business-model. 26 Keohane, N et al. Outcomes-based reimbursement of medicines. Social Market Foundation. August 2017. http://www.smf.co.uk/ wp-content/uploads/2017/07/Data-for- Outcomes-final.pdf. 27 Jørgensen, Jesper and Kefalas, Panos (2017). Annuity payments can increase patient access to innovative cell and gene therapies under England’s net budget impact test. Journal of Market Access & Health Policy. Volume 5, 2016 – Issue 1. https://doi.org/10.1080/20016689. 2017.1355203. 28 Beasley, D et al. Novartis pitches discounts on pricey gene therapy for deadly muscle disorder. Reuters May 10, 2019. https://uk.reuters.com/article/uk-novartis-sma- insurers-exclusive/exclusive-novartis-pitches- discounts-on-pricey-gene-therapy-for-deadly- muscle-disorder-idUKKCN1SG22C. 29 Schroeder, B et al. Signals from the gut microbiota to distant organs in physiology and disease. Nature Medicine volume 22, pages 1079-1089 (2016). https://doi/10.1038/nm.4185. 30 Fernandez, C. No Guts, No Glory: How Microbiome Research is Changing Medicine. Labiotech.eu (2019). https://labiotech.eu/ features/gut-microbiome-research/. 31 Saji, N, Niida, S, Murotani, K et al. Analysis of the relationship between the gut microbiome and dementia: a cross-sectional study conducted in Japan. Sci Rep 9, 1008 (2019) doi:10.1038/s41598-018-38218-7.


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46 Hiring and Beyond: How to Resource Data Scientists in your Business. Frontline Genomics (2019). http://www.frontlinegenomics.com/ news/27331/hiring-and-beyond-how-to- resource-data-scientists-in-your-business/. 47 Rowell, A. Adaptive licensing: a model approach? (2019). https://united- kingdom.taylorwessing.com/synapse/regulatory_ adaptivelicense.html. 48 EMA Regulatory Science to 2025 – Strategic Reflection. European Medicines Agency (2018). https://www.ema.europa.eu/en/documents/regul atory-procedural-guideline/ema-regulatory- science-2025-strategic-reflection_en.pdf. 49 Framework for the Regulation of Regenerative Medicine Products. FDA (2019). https://www.fda.gov/vaccines-blood- biologics/cellular-gene-therapy- products/framework-regulation-regenerative- medicine-products. 50 Cellular & Gene Therapy Guidances. FDA (2019). https://www.fda.gov/vaccines-blood- biologics/biologics-guidances/cellular-gene- therapy-guidances. 51 CMS Law – New Trends: Reform to Drugs and Medical Devices in China (2017). https://www.cms-lawnow.com/ealerts/2017/11/ new-trends-reform-to-drugs-and-medical- devices-in-china?cc_lang=en. 52 NICE – About. https://www.nice.org.uk/about. 53 ICHOM. International Consortium for Health Outcomes Measurement. https://www.ichom.org/mission/. 54 European Network for Health Technology Assessment. https://www.eunethta.eu/. 55 Lesser, N. How biopharmaceutical collaborations are fueling biomedical innovation. Deloitte. https://www2.deloitte.com/us/en/ pages/life-sciences-and-health-care/articles/how- biopharma-collaborations-are-fueling- biomedical-innovation.html. 56 Open Targets https://www.opentargets.org/. 57 van den Heuvel, R et al (2018). R&D 2030 – Reinvent innovation and become an R&D front- runner by 2030. KPMG https://assets.kpmg/ content/dam/kpmg/xx/pdf/2018/11/r-and-d- 2030-thriving-on-disruption-series.pdf. 58The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). https://www.ich.org/. 59Towards Access 2030: WHO Essential Medicines and Health Products Strategic Framework 2016-2030. Geneva: World Health Organization; 2017 (WHO/EMP/2017.01). Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/medicines/publications/ Towards_Access_2030_Final.pdf.


Drug Discovery World Winter 2019/20


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