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Integrating a wide range of biomedical data such as that rapidly emerging from the use of next-generation sequencing is expected to have a key role in identifying and qualifying new biomarkers to support precision medicine. Here, we highlight some of the challenges for biomedical data integration and approaches to address them.

Japanese clinical research and regulatory frameworks have evolved considerably in the past two decades to reduce the delay in the introduction of new drugs in Japan compared with other major markets. However, recently introduced changes related to access to unapproved drugs might have the opposite effect and might not benefit all patients.

Global collaboration in translational science promises to accelerate the discovery, development and dissemination of new medical interventions. Here, we introduce a new international collaboration of translational science organizations and highlight our initial strategy to reduce or remove bottlenecks in translation.

Understanding the basis of variability in the response of patients to the dose of a drug and a willingness to vary the dose regimen as well as the choice of drug should be one of the key pillars of precision medicine.

What could be the benefits of moving the treatment paradigm for serious neuropsychiatric disorders towards earlier intervention, and what is needed to achieve this?

Technological advances coupled with novel collaborative strategies for compound sourcing and management are poised to transform the utility of high-throughput screening.

Several types of collaboration are being pursued to identify, validate and apply new biomarkers. Here, we highlight examples of such initiatives and discuss the challenges, approaches to address these challenges and key factors for success.

The reproducibility of biomedical research on novel drug targets has become suspect. Here, we highlight how drug discovery centres embedded in academic institutions, but with a translational imperative, can help address this reproducibility crisis.

'Quick-kill' strategies in pharmaceutical research and development aim to reduce late-stage attrition by bringing project termination decisions forward, to an earlier point in the process. How can the barriers to implementing such strategies be overcome?

The Community for Open Antimicrobial Drug Discovery aims to tap into the potential of the millions of compounds distributed around laboratories globally to be a source of new antibiotic leads by offering free screening for antimicrobial properties, with no strings attached.

The treatment of tuberculosis is based on combinations of drugs that directly targetMycobacterium tuberculosis. A new global initiative is now focusing on a complementary approach of developing adjunct host-directed therapies.

The increasing availability of individual-level data from clinical trials could allow the relative efficacy of new drugs to be assessed in a robust, cost-effective and timely way.

Advancing drug development for airway diseases beyond the established mechanisms and symptomatic therapies requires redefining the classifications of airway diseases, considering systemic manifestations, developing new tools and encouraging collaborations.

The Ontario Brain Institute manages a network of partnerships among researchers, clinicians, industry representatives and patients to maximize their collective impact on developing better treatment and care for those living with brain disorders.

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we summarize the strategies of the European Medicines Agency to help address such challenges.

The Structural Genomics Consortium (SGC) and its clinical, industry and disease-foundation partners are launching open-source preclinical translational medicine studies.

Consortia have begun to establish 'mechanism-based taxonomies' for inflammatory and neurodegenerative diseases that could aid drug development and personalized therapy.

Since its launch in 2008, the Innovative Medicines Initiative has catalysed the formation of many consortia to address challenges in drug development and regulation. As it moves into its second phase, we highlight key outcomes so far and lessons learned.

Innovative partnerships among researchers, patients, regulators, payors and industry are needed to reinvigorate drug discovery for central nervous system disorders. Here, representatives of the 2013 Collegium Internationale Neuro-Psychopharmacologicum (CINP) Summit group summarize plans to achieve this goal.

The Critical Path Institute brings scientists from regulatory agencies, industry and academia together to improve drug development and regulatory processes.