Delivering on the promise of personalized healthcare.

Personalized healthcare (PHC) aims to deliver the right medicine, to the right patient, at the right dose and time, and has the potential to benefit everyone in the healthcare system. Delivering the promise of PHC depends on overcoming key challenges (e.g., identifying biomarkers or disease segmentation tools, facilitating partnerships, clinical development, regulatory engagement and market access) in an integrated fashion. Despite this, progress in PHC has been accelerating over the last few years and is now at a turning point. Flexibility from all those involved in PHC, including the pharmaceutical and diagnostic industries, health authorities and payers, will be required to ensure that the field comes to maturity and delivers its potential to improve patients' lives.

[1]  Shashi Amur,et al.  Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use , 2008, Pharmacotherapy.

[2]  Daniel J Sargent,et al.  Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[3]  W. McGuire,et al.  Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. , 1987, Science.

[4]  C. Sawyers,et al.  Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. , 2001, The New England journal of medicine.

[5]  S. Mallal,et al.  Successful Translation of Pharmacogenetics into the Clinic , 2009, Molecular Diagnosis & Therapy.

[6]  Marc Buyse,et al.  Towards validation of statistically reliable biomarkers , 2007 .

[7]  S. Gabriel,et al.  EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy , 2004, Science.

[8]  Masahiro Fukuoka,et al.  Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  G. Castoldi,et al.  The Philadelphia chromosome. , 1973, Biomedicine / [publiee pour l'A.A.I.C.I.G.].

[10]  F. Frueh,et al.  REVIEWTHEME : GENERAL Integration and use of biomarkers in drug development , regulation and clinical practice : a US regulatory perspective , 2008 .

[11]  R. Lieberman.  Personalized medicine enters the US marketplace: KRAS, anti-EGFR monoclonal antibodies, and colon cancer. , 2009, American journal of therapeutics.

[12]  M. Gail,et al.  Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. , 1989, Journal of the National Cancer Institute.

[13]  David Cella,et al.  Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. , 2003, JAMA.

[14]  D. DeMets,et al.  Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework , 2001, Clinical pharmacology and therapeutics.

[15]  Mary K Pendergast,et al.  Regulatory Agency Consideration of Pharmacogenomics , 2008, Experimental biology and medicine.

[16]  N. Hynes,et al.  The biology of erbB-2/neu/HER-2 and its role in cancer. , 1994, Biochimica et biophysica acta.

[17]  L M Hinman,et al.  The drug diagnostic co-development concept paper Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop , 2006, The Pharmacogenomics Journal.

[18]  M. Pirmohamed,et al.  Genotype-guided dosing of coumarin derivatives: the European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design. , 2009, Pharmacogenomics.

[19]  A Jawaid,et al.  Genome-wide pharmacogenetic investigation of a hepatic adverse event without clinical signs of immunopathology suggests an underlying immune pathogenesis , 2008, The Pharmacogenomics Journal.

[20]  S. Teutsch,et al.  Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer? , 2009, Genetics in Medicine.

[21]  F. Frueh,et al.  Payer perspectives on pharmacogenomics testing and drug development. , 2009, Pharmacogenomics.

[22]  Brian Spear,et al.  Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop. , 2009, Pharmacogenomics.

[23]  Razelle Kurzrock,et al.  Philadelphia ChromosomePositive Leukemias: From Basic Mechanisms to Molecular Therapeutics , 2003, Annals of Internal Medicine.

[24]  Patricia L. Harris,et al.  Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. , 2004, The New England journal of medicine.

[25]  Daniel J Sargent,et al.  Clinical Trial Designs for Predictive Biomarker Validation: One Size Does Not Fit All , 2009, Journal of biopharmaceutical statistics.

[26]  E. Elkin,et al.  Clinical practice patterns and cost effectiveness of human epidermal growth receptor 2 testing strategies in breast cancer patients , 2010, Cancer.

[27]  Malorye Allison,et al.  Is personalized medicine finally arriving? , 2008, Nature Biotechnology.

[28]  T. Mok,et al.  Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. , 2009, The New England journal of medicine.

[29]  Edd Fleming,et al.  The microeconomics of personalized medicine: today's challenge and tomorrow's promise , 2009, Nature Reviews Drug Discovery.

[30]  G. Tsai,et al.  A regulatory view of adaptive trial design. , 2008, Journal of the Formosan Medical Association = Taiwan yi zhi.

[31]  Thomas Helleday,et al.  Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase , 2005, Nature.

[32]  Randal J. Kirk,et al.  Implications of pharmacogenomics for drug development. , 2008, Experimental biology and medicine.

[33]  R. March.  Challenges and opportunities of pharmacogenetics in drug development. , 2006, Personalized medicine.

[34]  C. Hill,et al.  Overview of pharmacogenetics in anticoagulation therapy. , 2008, Clinics in laboratory medicine.

[35]  Kevin Carroll,et al.  Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) , 2005, The Lancet.

[36]  J. Coon,et al.  Selecting Patients for Treatment with Epidermal Growth Factor Tyrosine Kinase Inhibitors , 2007, Clinical Cancer Research.