Biomarkers and Sustainable Innovation in Cardiovascular Drug Development: Lessons from Near and Far Afield

[1]  P. Barter,et al.  Translation of High-Density Lipoprotein Function Into Clinical Practice: Current Prospects and Future Challenges , 2013, Circulation.

[2]  Markus Abt,et al.  Effects of dalcetrapib in patients with a recent acute coronary syndrome. , 2012, The New England journal of medicine.

[3]  P. Libby Inflammation in Atherosclerosis , 2012, Arteriosclerosis, thrombosis, and vascular biology.

[4]  John Spertus,et al.  Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study , 2012, The Lancet.

[5]  Samia Mora,et al.  High-density lipoprotein cholesterol and particle concentrations, carotid atherosclerosis, and coronary events: MESA (multi-ethnic study of atherosclerosis). , 2012, Journal of the American College of Cardiology.

[6]  A. Hauschild,et al.  Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial , 2012, The Lancet.

[7]  P. Libby,et al.  Molecular imaging of atherosclerosis for improving diagnostic and therapeutic development. , 2012, Circulation research.

[8]  G. Steven Burrill,et al.  Innovating in the New Austerity , 2012 .

[9]  D. Pfister,et al.  Molecular-targeted therapies in head and neck cancer. , 2012, Seminars in radiation oncology.

[10]  Shah Ebrahim,et al.  European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (Version 2012) , 2012, International Journal of Behavioral Medicine.

[11]  R. Collins,et al.  Lipids and Lipoproteins and Risk of Different Vascular Events in the MRC/BHF Heart Protection Study , 2012, Circulation.

[12]  D. Waters,et al.  Determinants of Residual Risk in Secondary Prevention Patients Treated With High- Versus Low-Dose Statin Therapy: The Treating to New Targets (TNT) Study , 2012, Circulation.

[13]  Zahi A Fayad,et al.  Cholesterol efflux and atheroprotection: advancing the concept of reverse cholesterol transport. , 2012, Circulation.

[14]  C. Porta,et al.  Treatment selection in metastatic renal cell carcinoma: expert consensus , 2012, Nature Reviews Clinical Oncology.

[15]  H. Eichler,et al.  Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval , 2012, Clinical pharmacology and therapeutics.

[16]  D. Mozaffarian,et al.  Heart disease and stroke statistics--2012 update: a report from the American Heart Association. , 2012, Circulation.

[17]  William Weintraub,et al.  Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. , 2011, The New England journal of medicine.

[18]  Hatem Soliman,et al.  The effect of Oncotype DX recurrence score on treatment recommendations for patients with estrogen receptor-positive early stage breast cancer and correlation with estimation of recurrence risk by breast cancer specialists. , 2011, The oncologist.

[19]  A. Kontush,et al.  Biological activities of HDL subpopulations and their relevance to cardiovascular disease. , 2011, Trends in molecular medicine.

[20]  Edward S. Kim,et al.  The BATTLE to Personalize Lung Cancer Prevention through Reverse Migration , 2011, Cancer Prevention Research.

[21]  K. Anderson,et al.  The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development. , 2011, Cancer discovery.

[22]  Edward S. Kim,et al.  The BATTLE trial: personalizing therapy for lung cancer. , 2011, Cancer discovery.

[23]  Joel Lexchin,et al.  The cost of drug development: a systematic review. , 2011, Health policy.

[24]  R. Krauss,et al.  HDL measures, particle heterogeneity, proposed nomenclature, and relation to atherosclerotic cardiovascular events. , 2011, Clinical chemistry.

[25]  Sunil Badve,et al.  Personalized medicine: the road ahead. , 2011, Clinical breast cancer.

[26]  D. Mozaffarian,et al.  Heart disease and stroke statistics--2011 update: a report from the American Heart Association. , 2011, Circulation.

[27]  S. Yusuf,et al.  The polypill in the prevention of cardiovascular diseases: key concepts, current status, challenges, and future directions. , 2010, Circulation.

[28]  L. Santarpia,et al.  Breast cancer assessment tools and optimizing adjuvant therapy , 2010, Nature Reviews Clinical Oncology.

[29]  K. Flaherty,et al.  Inhibition of mutated, activated BRAF in metastatic melanoma. , 2010, The New England journal of medicine.

[30]  A. Hofman,et al.  Genetic Variation at the Phospholipid Transfer Protein Locus Affects Its Activity and High-Density Lipoprotein Size and Is a Novel Marker of Cardiovascular Disease Susceptibility , 2010, Circulation.

[31]  Christine M. Micheel,et al.  Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease , 2010 .

[32]  P. Fitzgerald,et al.  A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. , 2010, Journal of the American College of Cardiology.

[33]  R. Kirk Risk factors: Oncotype DX® assay predicts local recurrence in breast cancer , 2010, Nature Reviews Clinical Oncology.

[34]  Soonmyung Paik,et al.  Gene-expression-based prognostic assays for breast cancer , 2010, Nature Reviews Clinical Oncology.

[35]  Robert M Califf,et al.  Biomarker bonanza? , 2010, Journal of the American College of Cardiology.

[36]  Paul T. Williams,et al.  Ion Mobility Analysis of Lipoprotein Subfractions Identifies Three Independent Axes of Cardiovascular Risk , 2009, Arteriosclerosis, thrombosis, and vascular biology.

[37]  J. DiMasi,et al.  Drug development costs when financial risk is measured using the Fama-French three-factor model. , 2009, Health economics.

[38]  J. Zujewski,et al.  Trial assessing individualized options for treatment for breast cancer: the TAILORx trial. , 2008, Future oncology.

[39]  Jean-Claude Tardif,et al.  Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial , 2008, The Lancet.

[40]  M. Caulfield,et al.  Effects of torcetrapib in patients at high risk for coronary events , 2008 .

[41]  R. Karas,et al.  Prevalence of low high-density lipoprotein cholesterol in patients with documented coronary heart disease or risk equivalent and controlled low-density lipoprotein cholesterol. , 2007, The American journal of cardiology.

[42]  Shah Ebrahim,et al.  European guidelines on cardiovascular disease prevention in clinical practice: executive summary. , 2007, Atherosclerosis.

[43]  J. Couzin,et al.  Boom and Bust , 2007, Science.

[44]  Colin Berry,et al.  Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. , 2007, JAMA.

[45]  M. Cronin,et al.  Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[46]  H. Bloomfield,et al.  Low-Density Lipoprotein and High-Density Lipoprotein Particle Subclasses Predict Coronary Events and Are Favorably Changed by Gemfibrozil Therapy in the Veterans Affairs High-Density Lipoprotein Intervention Trial , 2006, Circulation.

[47]  Serkalem Demissie,et al.  Value of High-Density Lipoprotein (HDL) Subpopulations in Predicting Recurrent Cardiovascular Events in the Veterans Affairs HDL Intervention Trial , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[48]  L. Cupples,et al.  High-Density Lipoprotein Subpopulation Profile and Coronary Heart Disease Prevalence in Male Participants of the Framingham Offspring Study , 2004, Arteriosclerosis, thrombosis, and vascular biology.

[49]  R. Katz,et al.  Biomarkers and surrogate markers: An FDA perspective , 2004, NeuroRX.

[50]  A. Gotto,et al.  Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease: a working group report and update. , 2004, Journal of the American College of Cardiology.

[51]  Paul Schoenhagen,et al.  Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. , 2003, JAMA.

[52]  A. Kontush,et al.  Small, Dense HDL Particles Exert Potent Protection of Atherogenic LDL Against Oxidative Stress , 2003, Arteriosclerosis, thrombosis, and vascular biology.

[53]  R. W. Hansen,et al.  The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.

[54]  W. Cromwell,et al.  Measurement issues related to lipoprotein heterogeneity. , 2002, The American journal of cardiology.

[55]  G. Getz,et al.  Mouse models of atherosclerosis , 2001, Current opinion in lipidology.

[56]  Nick C Fox,et al.  Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects. , 2000, Archives of neurology.

[57]  D R Shapiro,et al.  Relation between baseline and on-treatment lipid parameters and first acute major coronary events in the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS). , 2000, Circulation.

[58]  R. Levy,et al.  Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. , 1972, Clinical chemistry.

[59]  W Young,et al.  Ischemic Heart Disease, Atherosclerosis, and Longevity , 1966, Circulation.

[60]  J. Crowley,et al.  Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes. , 2013, Contemporary clinical trials.

[61]  J. Feliu,et al.  Prognostic and predictive biomarkers for epidermal growth factor receptor-targeted therapy in colorectal cancer: beyond KRAS mutations. , 2013, Critical reviews in oncology/hematology.

[62]  M. Roizen Forecasting the Future of Cardiovascular Disease in the United States: A Policy Statement From the American Heart Association , 2012 .

[63]  T. Eberlein,et al.  Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation , 2012 .

[64]  G. Moneta,et al.  Major Lipids, Apolipoproteins, and Risk of Vascular Disease , 2010 .

[65]  Robert B Livingston,et al.  Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. , 2010, The Lancet. Oncology.

[66]  N. Unwin,et al.  Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Detection, Evaluation, and Treatment of High Blood Cholesterol Education Program (NCEP) Expert Panel on Executive Summary of the Third Report of the National , 2009 .

[67]  J. Couzin,et al.  NIH budget. Boom and bust. , 2007, Science.