Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public–private partnerships, adaptive designs and big data. Public–private partnerships come in many different forms with regard to scope, duration and type and number of participants. They range from project-specific collaborations to strategic alliances to large multi-party consortia. Each of them offers specific opportunities and faces distinct challenges. Among types of collaboration, investigator-initiated studies are becoming increasingly popular but have legal, ethical, and financial implications. Adaptive trial designs are also increasingly discussed. However, adaptive should not be used as euphemism for the repurposing of a failed trial; rather it requires carefully planning and specification before a trial starts. Adaptive licensing can be a counter-part of adaptive trial design. The use of Big Data is another opportunity to leverage existing information into knowledge useable for drug discovery and development. Respecting limitations of informed consent and privacy is a key challenge in the use of Big Data. Speakers and participants at the symposium were convinced that appropriate use of the above new options may indeed help to increase the efficiency of future drug development.
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 pharmaceutical industry is faced with significant challenges in its efforts to discover new drugs that address unmet medical needs. Safety concerns and lack of efficacy are the two main technical reasons for attrition. Improved early research tools including predictive in silico, in vitro, and in vivo models, as well as a deeper understanding of the disease biology, therefore have the potential to improve success rates. The combination of internal activities with external collaborations in line with the interests and needs of all partners is a successful approach to foster innovation and to meet the challenges. Collaboration can take place in different ways, depending on the requirements of the participants. In this review, the value of public-private partnership approaches will be discussed, using examples from the Innovative Medicines Initiative (IMI). These examples describe consortia approaches to develop tools and processes for improving target identification and validation, as well as lead identification and optimization. The project "Kinetics for Drug Discovery" (K4DD), focusing on the adoption of drug-target binding kinetics analysis in the drug discovery decision-making process, is described in more detail.
Precision medicine aims to provide the precise treatment for the patient with the right dose at the right point of time. Biomarkers (BM) are vital for the identification of patients who would benefit the most from individualized treatment. In addition, they help to enable the prediction of prognosis, the detection of early therapeutic and adverse effects, and may serve as surrogate endpoints in clinical trials. BM are becoming essential tools to increase productivity in drug discovery and impressively enhance the way medicine is practiced. However, the identification, sufficient validation and implementation of such BM are challenging. This process requires expertise from different areas and high resource investments. Collaborations of different partners may be helpful to overcome these challenges. In the past decade, collaborations between diagnostics and pharmaceutical companies as well as industrial-academic collaborations have been increasingly pursued. Moreover, public funding may offer support and open new opportunities to form such consortia. Herein we give an overview of the different types of collaborations, their opportunities and challenges, and describe experiences in forming strategic partnerships with other companies.
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