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Precision Medicine


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30 National Institutes of Health. Understanding Precision Medicine in Cancer Treatment. https://www.cancer.gov/about- cancer/treatment/types/precisi on-medicine. 31 Schork, NJ. Personalized Medicine: Time for One- Person trials. Nature 520, 609- 611 (2015). 32 Leucht, S, Helfer, B, Gartlehner, G and Davis, JM. How Effective are Common Medications: A Perspective Based on Meta-Analyses of Major Drugs. BMC Medicine 13, 253-258 (2015). 33 Pritchard, D. Personalized Medicine at FDA: 2016 Progress Report. J. Precision Med. 8, 74-75 (2017). 34 PMC. The Personalized Medicine Report: 2017- Opportunity, Challenges and the Future. http://www. personalizedmedicinecoalition. org/Userfiles/PMC-Corporate/ file/The-Personalized- Medicine-Report1.pdf (2017). 35 Naylor, S and Cole, T. Overview of Companion Diagnostics in Pharmaceutical Industry. Drug Discov. World Spring Edition. 67-76 (2010). 36 Naylor, S and Cole, T. Companion Diagnostics in Pharmaceutical Industry- Part II Business Models. Drug Discov. World Summer Edition. 61-72 (2010). 37 Herceptin http://scienceblog.cancerresear chuk.org/2013/09/20/counting- copies-her2-and-the- development-of-herceptin/. 38 NIH/NCI. How Imatinib Transformed Leukemia Treatment and Cancer Research https://www.cancer.gov/researc h/progress/discovery/gleevec. 39 PMC. Personalized Medicine at the FDA: 2017 Progress Report. http://www. personalizedmedicinecoalition. org/Userfiles/PMC-Corporate/ file/PM_at_FDA_2017_Progres s_Report.pdf (2018). 40 Jørgensen, JT. When Biomarkers Define a Drug Indication. Expert Rev. Mol. Diagnostics. 4, 315-317 (2018).


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profile in areas such as cardiovascular and neuro- logical health and wellness. At that time there was a great deal of focus on providing individual tools for the prevention, prediction and diagnosis of dis- ease states. However, there was little progress on the impact of personalised medicine in DDD, but significant discussion about how the costly, time- consuming and risky DDD process could provide therapeutic drugs for individual patients. The con- clusions at the time were that such efforts were prohibitively expensive and economically unfeasi- ble. However the advent of precision medicine and its focus on the grouping and identification of sub- populations (1-in-N model), as well as the tools to identify such populations led to the concept and implementation of Precision Medicine Drug dis- covery and development. In 2005 only 5% of all drugs approved by the FDA were Precision Medicine Drugs. Last year that percentage had risen to an all time high of 35% (Table 1), and in 2018 is predicted to go even higher. The pharma- ceutical sector has recognised the value of such an approach, and it is clear that Precision Medicine Drugs are here to stay. They are indeed a reality and not a pleonasm!


Acknowledgements We thank Dr Daryl Pritchard, Senior Vice-President for Science Policy at the Personalized Medicine Coalition, for helpful comments and correspon- dence during this manuscript preparation. DDW


Dr Urban A. Kiernan is a Co-Founder, CEO and Board Director of


iMetabolic Biopharma


Corporation, a biopharmaceutical company that is developing precision medicine drugs for the treat- ment of obesity-related diseases. He has almost 20 years of industrial experience in the biotechnology and life sciences fields. In the past he served as a Global Business Development Manager within the Laboratory Consumables Division of Thermo Fisher Scientific (Waltham, MA). He previously served as the Director of Biomarker Discovery and a Principal Investigator while tenured with Intrinsic Bioprobes, Inc (based in Tempe, AZ). He has a PhD in Bio-Analytical Chemistry from the Department of Chemistry at Arizona State University.


Dr Stephen Naylor is Co-Founder, COO and Board Chairman of iMetabolic Biopharma Corporation. He is also the Co-Founder, CEO and Board Chairman of ReNeuroGen LLC, a virtual pharmaceutical company developing therapies for the treatment of neurological diseases. In addition,


Drug Discovery World Summer 2018


he is the Founder, Chairman and CEO of MaiHealth Inc, a systems/network biology level diagnostics company in the health/wellness and precision medicine sector. He was also the Founder, CEO and Chairman of Predictive Physiology & Medicine (PPM) Inc, one of the world’s first per- sonalised medicine companies. He serves also as an Advisory Board Member of CureHunter Inc, a computational biology drug discovery company, and as a business adviser to the not-for-profit Cures Within Reach. In the past he has held pro- fessorial chairs in Biochemistry & Molecular Biology; Pharmacology; Clinical Pharmacology and Biomedical Engineering, all at Mayo Clinic in Rochester, MN, USA. He holds a PhD from the University of Cambridge (UK), and undertook a NIH-funded fellowship at MIT located in the ‘other’ Cambridge, USA. Address correspondence to him at snaylor@imbiopharma.com.


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