A comprehensive regulatory framework to address the unmet need for new antibacterial treatments

Boucher, 2009, Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America, Clin Infect Dis, 48, 1, 10.1086/595011 Mossialos 2012 Fauci, 2012, The perpetual challenge of infectious diseases, N Engl J Med, 366, 454, 10.1056/NEJMra1108296 Bush, 2011, Tackling antibiotic resistance, Nat Rev Microbiol, 9, 894, 10.1038/nrmicro2693 Payne, 2007, Drugs for bad bugs: confronting the challenges of antibacterial discovery, Nat Rev Drug Discov, 6, 29, 10.1038/nrd2201 Echols, 2011, Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world, Ann N Y Acad Sci, 1241, 153, 10.1111/j.1749-6632.2011.06300.x Projan, 2003, Why is big Pharma getting out of antibacterial drug discovery?, Curr Opin Microbiol, 6, 427, 10.1016/j.mib.2003.08.003 Morel, 2010, Stoking the antibiotic pipeline, BMJ, 340, c2115, 10.1136/bmj.c2115 Sharma Spellberg, 2012, The critical impact of time discounting on economic incentives to overcome the antibiotic market failure, Nat Rev Drug Discov, 11, 168, 10.1038/nrd3560-c1 Woodcock, 2012, Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?, Clin Pharmacol Ther, 91, 378, 10.1038/clpt.2011.337 Sheiner, 1997, Learning versus confirming in clinical drug development, Clin Pharmacol Ther, 61, 275, 10.1016/S0009-9236(97)90160-0 Peck, 2003, Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval, Clin Pharmacol Ther, 73, 481, 10.1016/S0009-9236(03)00018-3 Sasinowski Craig, 1998, Pharmacokinetic/pharmacodynamic parameters: Rationale for antibacterial dosing of mice and men, Clin Infect Dis, 26, 1, 10.1086/516284 Ambrose, 2007, Pharmacokinetics–pharmacodynamics of antimicrobial therapy: it's not just for mice anymore, Clin Infect Dis, 44, 79, 10.1086/510079 Morgan, 2012, Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival, Drug Discov Today, 17, 419, 10.1016/j.drudis.2011.12.020 DiMasi, 2010, Trends in risks associated with new drug development: success rates for investigational drugs, Clin Pharmacol Ther, 87, 272, 10.1038/clpt.2009.295 Ambrose, 2012, Frequentist and Bayesian pharmacometric-based approaches to facilitate critically needed new antibiotic development: overcoming lies, damn lies, and statistics, Antimicrob Agents Chemother, 56, 1466, 10.1128/AAC.01743-10 2011 2000 2006 2012 Chastre, 2008, Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study, Crit Care Med, 36, 1089, 10.1097/CCM.0b013e3181691b99 Brun-Buisson, 1998, Treatment of ventilator-associated pneumonia with piperacillin-tazobactam/amikacin versus ceftazidime/amikacin: a multicenter, randomized controlled trial. VAP study group, Clin Infect Dis, 26, 346, 10.1086/516294 Wunderink, 2012, Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study, Clin Infect Dis, 54, 621, 10.1093/cid/cir895 Lord, 2006, When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?, Ann Intern Med, 144, 850, 10.7326/0003-4819-144-11-200606060-00011 Spellberg, 2010, The antibacterial pipeline: why is it drying up and what must be done about it?, 299