Molecular Diagnostics
Continued from page 67
11 Pharma 2010: Threshold of Innovation. IBM Consulting Services. www-
07.ibm.com/services/pdf/pharm a_es.pdf. 12 Dankin,P.
http://www.hpcgg.org/PM/pres entations/Tue_09_Dahlen_No7 _Patrik_Boston2006. 13 PamGene website. See
http://www.pamgene.com/. 14 Naylor, S. Overview of Biomarkers in Disease, Drug Discovery and Development. Drug Discov. World. Spring Edition: 21-30 (2005). 15 Culbertson, AW, Valentine, SJ and Naylor, S. Personalized Medicine: Technological Innovation and Patient Empowerment or Exuberant Hyperbole? Drug Discov. World. Summer Edition: 16-31 (2007). 16 Bender, R. Successfully Validating, Commercializing and Fostering Adoption of Novel Biomarkers. Three Different Issues, One Common Goal. Cambridge Healthtech Institute (CHI) Next Generation Dx Summit. Pre-Conference Symposium, August 9th, 2009. Washington DC, USA. 17 Little, S. Personalized Healthcare. Qiagen Investor Day Symposium, February11th, 2010. New York, NY, USA.
http://www.qiagen.com/about/i nvestorrelation/aboupdf/confca ll/05_sl_100211_final_web.pdf. 18 Ferrara, J. Personalized Medicine: Challenging Pharmaceutical and Diagnostic Company Business Models. McGill J. Medicine.10: 59-61 92007). 19 FDA Critical Path Opportunities Report 2005.
http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/ CriticalPathInitiative/CriticalPat hOpportunitiesReports/UCM0 77254.pdf. 20 Meltzer, JC and Johnston, DM. Commercialization of Companion Diagnostics. Next Gen Pharma 12: 36-40 (2010). 21 Ratner, ML. Novartis Follows its own Business Model into Molecular Diagnostics. In Vivo 5/1/2010 Article # 2010800083.
68
Conclusions
The growth of the CD sector has been significant in the past several years. This is evidenced by the num- ber of major pharmaceutical companies undertak- ing deals as well as the number of CD companies. There appears to be widespread acceptance of the potential usefulness of Companion Diagnostics. Based on the current optimism it is possible that CDs afford part of the panacea needed to produce cheaper, safer more efficacious drugs. In part this is fuelled by the common goals of the pharmaceutical and CD companies in recognising the usefulness of CD assays in the DDD process. Numerous business models are evolving for both the CD and pharma- ceutical companies as they seek to address the var- ied issues raised above. Ultimately, the regulatory and reimbursement issues will be delineated by the regulatory authorities and the payors respectively, and this will have a dramatic impact on any future business model development for both the CD and pharmaceutical companies. Meltzer and Johnston20 have suggested that: “It is likely that the successful models will require the co-operation and co-ordi- nation of a diverse array of companies to navigate the evolving regulatory and reimbursement envi- ronments. Part of this will also include devising ways of sharing the economic rents of success and the risks and costs associated with development, which in many cases will be a moving target”. At present we will continue to watch the fascinating growth of this important new diagnostic applica- tion arena.
Acknowledgements
SN acknowledges the support of the National Institutes of Health through an SBIR Grant (5R44- HL082382-03) in partial support of this work.DDW
Dr Stephen Naylor is a co-Founder, Chairman of the Board and CEO of D2D Inc, a start-up Companion Diagnostics company. He is also Founder, President and Chairman of MaiHealth Inc, a molecular bioprofile diagnostics company in the health and wellness sector, as well as Founder, Chairman and former CEO of Predictive Physiology and Medicine Inc, a personalised med- icine company offering a series of information con- tent tools to consumers.
Toby Cole is the Founder of Triad Group a con- sulting company in the arena of high tech start-ups. His expertise resides in company start-ups, mergers & acquisitions and investment banking. In addi- tion he is also a co-Founder, Board Member and President of D2D Inc.
Drug Discovery World Summer 2010
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92