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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.
The Predictive Safety Testing Consortium and the Coalition Against Major Diseases, both launched by the Critical Path Institute, provide valuable examples of the outcomes and lessons learned by different types of consortia working on new drug development tools.
Without a step change in the productivity of pharmaceutical research and development, it will be difficult to tackle the public health challenges facing societies worldwide. Public–private partnerships could play a key role in achieving this step change, but they need to be well designed and led.
The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.
Improving the science of drug development and regulation is important in fulfilling the public health mission of the US Food and Drug Administration (FDA). A decade on from the launch of the Critical Path Initiative, the FDA's Center for Drug Evaluation and Research (CDER) is now participating in more than 20 science-driven consortia to achieve this goal.
TransCelerate BioPharma was formed in 2012 as a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines.
The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.
The Biomarkers Consortium is a public–private biomedical research partnership that seeks to develop and qualify biomarkers across a broad range of diseases in order to accelerate the development of new medicines and improve patient care.
Urgent action to tackle antimicrobial resistance must take account of all the scientific opportunities available, find new resources to support academia and emphasize the importance of innovation to policy-makers and to the general public.
Several changes to scientific culture and policy are needed to aid the identification of new drug targets and therapies for central nervous system disorders from the rapidly growing volume of 'big' data in neuroscience.
Establishing industry-funded grant programmes for early-stage drug research could help address the dual challenges of declining government funding and optimizing the effectiveness of industry investment.
Realizing the vision of a new class of medicines based on modulating the electrical signalling patterns of the peripheral nervous system needs a firm research foundation. Here, an interdisciplinary community puts forward a research roadmap for the next 5 years.
Decisions made by drug regulatory agencies require a high level of expertise in statistical methodologies. Without urgent efforts to enhance the level of such expertise in European regulatory agencies, there is a risk that they will not be able to meet emerging challenges such as quantitative modelling of benefit–risk profiles, wider use of innovative trial designs and greater public transparency of clinical trial data.
Information technologies already have a key role in pharmaceutical research and development (R&D), but achieving substantial advances in their use and effectiveness will depend on overcoming current challenges in sharing, integrating and jointly analysing the range of data generated at different stages of the R&D process.
Recent policy developments in the European Union and elsewhere aim to tackle some of the key issues responsible for the limited adoption of personalized medicine approaches so far.
The efficiency and effectiveness of target selection and validation could be improved with accessible, standardized and integrated biological reference data sets. Such resources should be established through precompetitive approaches.
