Biomarkers


References 1 Biomarkers Definitions Working Group (2001). Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69: 89-95. 2 Gerber, Rush, Stemman, Kirscher, Gygi (2003). Absolute quantification of proteins and phosphoproteins from cell lysates by tandem MS. PNAS 100: 6940-6945. 3 Anderson, NL, Anderson, NG, Haines. LR, Hardie, DB, Olafson, RW, Pearson, TW (2004). Mass spectrometric quantification of peptides and proteins using Stable Isotope Standards and Capture by Anti-Peptide Anti-bodies (SISCAPA). J. Proteome Research 3: 235-244. 4 Cummings, J, Ward, TH, Greystoke, A, Ranson, M and Dive, C (2008). Biomarker method validation in anticancer drug development. British J Pharmacology 153: 646-656. 5 Usdin, S (2008). Getting real about biomarkers. SciBx 1 (13): 1-4.


Authorities are paying increasing attention to the challenges that this process may present. The US Food and Drug Administration has issued a concept paper on ‘Drug-Diagnostic Co-Development’ (www.fda.gov/Cder/genomics/pharmacocon- ceptfn.pdf) that specifically addresses this issue. A number of working groups, including the International Conference on Harmonisation are also currently addressing aspects related to this issue, from coining unified terminology and language around biomarkers and companion diagnostics, to formal issues relating to regulatory submissions and the evidentiary standards that will be required to accept a companion diagnostic as valid and useful (Figure 1).


Conclusion: information content counts – proteins as the richest source The challenges for biomarker science are clear and rather daunting. Those markers that ultimately will provide the kind of information content that will qualify them in the clinical arena as diagnostic or prognostic tools will need to satisfy high stan- dards both with regard to sensitivity/specificity and prediction of health outcomes on a prospective timeframe. Importantly, these requirements will have to be judged and adjusted in a context-specif- ic way – different clinical applications will require different qualities of biomarkers. In considering the attributes that will render a biomarker truly useful, it may be argued that protein markers are likely to dominate the field – with the associated cost and complexity of assaying these most demanding markers.


Successfully realising the promise of biomarker- driven personalised healthcare will require a high- ly collaborative and integrated, multidisciplinary and multifaceted coalition of basic scientists, clini- cal investigators, the pharmaceutical and diagnos- tic/device industry, healthcare professionals and payers. Last, but by no means least, patients will have to play a seminal role in this effort as mem- bers of the coalition, since improving their lives is where, as always, ultimate proof for the value of biomedical innovation rests.


DDW


Dr M. Walid Qoronfleh is currently the Executive Director of Life Science business at SDIX, serving the diagnostics (IVD) and immunoassay markets where he has general management accountability. Dr Qoronfleh has more than 20 years’ of scientif- ic and business experience. Most recently, he served as the Vice-President of Business Development at NextGen Sciences, a commercially-driven biotech-


28 Drug Discovery World Winter 2010/11


nology company engaged in the area of protein biomarkers and personalised medicine. Dr Qoronfleh held appointments with increasing responsibilities at SmithKline Beecham (now GSK), Sterling-Winthrop (now Sanofi-Aventis), the National Cancer Institute, AntexPharma and ThermoFisher. Dr Qoronfleh is the founder of three biotechnology companies and is the Founder and Managing Director of the boutique consulting company Q3CG. He obtained his PhD from The University of Louisville Medical School and received his MBA from Penn State University.


Dr Klaus Lindpaintner has been Vice-President of Research & Development and Chief Scientific Officer of Strategic Diagnostics Inc since February 2010. Prior to joining SDIX, Dr Lindpaintner was with F. Hoffmann-La Roche Ltd for 13 years. He most recently served as Director of the ‘Roche Molecular Medicine Laboratories’ at the compa- ny’s headquarters in Basel, Switzerland, and as Roche’s Global Head, Molecular Medicines Policy and External Affairs, co-ordinating the company’s efforts and activities in implementing biomarker research based on genetics, genomics, proteomics, and associated disciplines from early discovery to late-stage clinical trials. Dr Lindpaintner graduat- ed from the Innsbruck University Medical School with a degree in Medicine and from Harvard University with a degree in Public Health.


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