Public-Private Partnership: A New Engine for Translational Research in Neurosciences

Murphy, Declan; Goldman, Michel; Loth, Eva; Spooren, Will

doi:10.1016/j.neuron.2014.10.006

Cited by 8 publications

(4 citation statements)

References 15 publications

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“…IMI has launched projects covering a wide array of disease areas and challenges in the discovery and development of new medicines including infectious control (20), neurodegeneration (21, 22), cancer (23, 24), diabetes (25, 26), immunological disorders (27, 28), drug safety testing (11, 12), clinical trial design (29), and the use of real world evidence in drug development (30) to mention but a few. The outputs from the projects are many and varied and to date, the partners involved in IMI projects have generated 4,983 publications (with a normalized impact factor of 1.84, nearly double the EU average).…”

Section: Evolution Of the Imi Programmementioning

confidence: 99%

The Innovative Medicines Initiative −10 Years of Public-Private Collaboration

Laverty

Meulien

2019

Front. Med.

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The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Union and the European pharmaceutical industry. Born of the necessity to foster collaboration between different stakeholders in order to address growing challenges in bringing new medicines to market and the rapidly evolving healthcare landscape, IMI has successfully delivered the radical collaboration needed to address these challenges. In this article we reflect on some of the major achievements of the programme by highlighting a few of the key projects funded and the progress they have made, as well as some of the lessons learnt in delivering such an ambitious partnership. Those that drove the foundation of IMI recognized that to address these challenges required not just ambitious scientific approaches, but also an awareness of societal needs. Therefore, actors from beyond the traditional pharmaceutical research communities would be needed. One of the key successes of IMI has been to foster radical collaboration between diverse public and private partners of all types, including large pharmaceutical companies, SMEs, regulators, patient organizations and public research institutions. It has achieved this by being a neutral platform where all partners are bound by the same rights and responsibilities. Since it began there has been an evolution in the understanding of what is considered “pre-competitive,” resulting in IMI projects now addressing all of the steps within the pharmaceutical development value chain. With this expansion in the types of projects supported by IMI, different actors from beyond the traditional pharmaceutical research family have been attracted to participate, enriching further the collaboration at the heart of the programme. Finally, such a complex programme brings with it challenges, and we reflect on some of the important learnings that should be applied to future collaborative models to ensure that they are as successful as possible and deliver the expected impact.

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Section: Evolution Of the Imi Programmementioning

confidence: 99%

The Innovative Medicines Initiative −10 Years of Public-Private Collaboration

Laverty

Meulien

2019

Front. Med.

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“…The motivation of pharmaceutical companies to involve external academic researchers in preclinical research on their developmental compounds may be more complex (Kleyn and Kitney 2007). It may include the desire to tap into the academic brain pool for innovative approaches including highly specialized techniques and models (Laverty and Goldman 2014;TralauStewart et al 2009), the hope to increase productivity of their research and development (Dorsch et al 2015) or improved translational approaches (Murphy et al 2014). Based on these considerations, it is expected that such collaborations will become even more important in the future (Thomas and McKew 2014), and joint academia-industry research conferences are starting to be seen more often (Heifetz et al 2015).…”

Section: Who Published Where?mentioning

confidence: 99%

Preclinical research strategies for newly approved drugs as reflected in early publication patterns

Köster

Nölte

Michel

2015

Naunyn-Schmiedeberg's Arch Pharmacol

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The present study aimed to explore early publication patterns (i.e. up to 1 year after obtaining regulatory approval) for newly registered drugs. From the website of the US Food and Drug Administration, all newly approved drugs for 6 calendar years between 1991 and 2011 were identified. Non-clinical original publications for these compounds were retrieved from PubMed and their abstracts analysed for type of study and reported data. This yielded 170 compounds for which 1954 original non-clinical publications were identified, i.e. a median/mean of 5/11.5 publications per compound; however, number of publications per compound varied widely (0-90) and this variation exhibited a non-Gaussian distribution. The earliest non-clinical publication typically was published less than 5 years before regulatory approval and more than 5 years after filing of the primary patent, but some compounds exhibited notable deviations from this pattern. Publications most often reported on efficacy related to the target indication and on potential future indications, with fewer studies addressing mechanisms of action, potency, selectivity, pharmacokinetics and toxic effects. For most compounds, data at the cellular and in vivo level were published, with fewer reports on effects on isolated tissues and even fewer at the molecular level. The preferred species for cellular studies was human, whereas for in vivo studies, it was rats and mice. In 75 % of cases, the lead author of the publication came from an academic institution, and most studies were published in classic pharmacology journals. We conclude that number, timing and scope of early non-clinical publications on newly approved drugs exhibit major variance. Factors potentially associated with such variance are explored in a companion paper.

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“…PPP, although still relatively few in number, have increased 214% and have become a common collaborative mechanism for drug development. PPP are a means of leveraging resources, spreading the cost, and managing the risk of drug development across several sponsors and have become important financial and scientific vehicles for drug development across therapeutic areas 20–23 . The Dominantly Inherited Alzheimer Network Trials Unit (DIAN‐TU), the Alzheimer's Prevention Initiative (API), and the European Prevention of Alzheimer's Dementia (EPAD) program are examples of PPP for AD drug development 24–26 …”

Section: Discussionmentioning

confidence: 99%

Who funds Alzheimer's disease drug development?

Cummings

Bauzon

Lee

2021

A&D Transl Res & Clin Interv

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Introduction Despite the increase in Alzheimer's disease (AD) cases in the United States, no new treatments have been approved in the United States since 2003. The costs associated with drug development programs are high and serve as a significant deterrent to AD therapeutic investigations. In this study, we analyze the sponsorship data for AD clinical trials conducted since 2016 to assess the fiscal support for AD clinical trials. Methods We analyzed the funding sources of all AD trials over the past 5 years as reported on ClinicalTrials.gov. Results There were 136 trials being conducted for treatments in the US AD therapeutic pipeline on the index date of this study. Among non‐prevention trials, disease‐modifying therapies (DMT) in Phase 3 were almost entirely sponsored by the biopharmaceutical industry; Phase 2 DMT trials were split between the biopharmaceutical industry and funding from the National Institutes of Health (NIH) to academic medical centers (AMCs). The majority of prevention trials received sponsorship from public–private partnerships (PPP). Trials of symptomatic agents are equally likely to have biopharmaceutical or NIH/AMC sponsorship. Most trials with repurposed agents had NIH/AMC funding (89%). Since 2016, there has been consistent growth in the number of trials sponsored both in part and fully by NIH/AMC sources and in PPP, and there has been a reduction in biopharmaceutical company–sponsored trials. Discussion The number of trials supported by the biopharmaceutical industry has decreased over the past 5 years; trials supported from federal sources and PPP have increased. Repurposed compounds are mostly in Phase 2 trials and provide critical mechanistic information.

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Public-Private Partnership: A New Engine for Translational Research in Neurosciences

Cited by 8 publications

References 15 publications

The Innovative Medicines Initiative −10 Years of Public-Private Collaboration

The Innovative Medicines Initiative −10 Years of Public-Private Collaboration

Preclinical research strategies for newly approved drugs as reflected in early publication patterns

Who funds Alzheimer's disease drug development?

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