The new report states that academics, industry giants, regulators and patients’ organizations must work together in collaborative research projects in order for modern medicine to flourish.
Over the past decade, the number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved by the US Food and Drug Administration (FDA) has fallen steadily, despite ever-increasing R&D expenditure. This gap between investment and success has led the pharmaceutical industry to rethink its business strategies, with industry professionals now working together in order to explore improved pathways for drug discovery and development.
Collaboration and open innovation through Public-Private Partnerships (PPPs) enables research that would not be possible for companies to undertake individually. The consortia tackle precompetitive research – fields of activity in which large companies agree to collaborate and invest in jointly, despite their rivalry in the drug market. Most companies agree that disease biology is a precompetitive science, but that once disease targets are identified, research becomes competitive. These projects aim to eliminate duplication of research, which would waste funding and resources, and also develop competition for samples and clinical trial participation within a single patient population.
The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a huge PPP, funded by the National Institutes of Health as well as private contributions from pharmaceutical partners through the Foundations for National Institutes of Health. Alzheimer’s disease is difficult to target, as it can progress for many years before symptoms become evident. The path of disease progression is unclear, and clinical trials for any new drug have to be very lengthy, and the failure of a drug to demonstrate efficacy represents both a huge loss of investments for pharma companies, and an ongoing lack of treatment options for patients.
The initiative has produced results which have fundamentally challenged the way in which clinical trials in Alzheimer’s disease should be conducted. Previously, the length of time over which the disease can progress without symptoms was not fully appreciated, and it has become clear that anti-amyloid treatments under investigation may prove far more effective in patients with the disease at an earlier stage than those currently included in clinical trials.
The ADNI represents one of the earliest large PPPs of its type, and stakeholders worked together to decide how to manage data and intellectual property. The decision to place all data into the public domain ensured there were no intellectual property issues, and opened the newly discovered research up to the world. Though is it still uncertain how commercial companies will deal with public access to their research, increased data leveraging undoubtedly makes more sense in the eyes of a scientist or patient.
The ADNI PPP has created a sense of shared responsibility in understanding Alzheimer’s disease and has improved the landscape for clinical research in the future. This could represent a major change to the way in which pharmaceuticals are researched and value created, setting the stage for future collaborations.