Executive Summary

Pre-competitive collaboration is a novel research model in biopharmaceuticals, with the intention of accelerating collaboration and productivity, ultimately leading to more new medicines and therapies for patients. The research model exists in multiple forms including public-private partnerships. It aims to aggregate research prowess in the biopharmaceutical industry, establish an open culture of shared innovation & expertise, and ultimately incentivize collaboration.

Various issues such as pipeline stagnation, patent cliffs, shrinking R&D budgets, uncertainty in the regulatory space, declining investment by venture capitalists, difficulties in clinical trials, evolving business mix, and tough scientific barriers have led to rethinking of the strategic priorities in biopharma. The loss of patent exclusivity and consequent replacement of blockbuster drugs by generics has resulted in tapering margins for life sciences firms. The stifling drug approval norms (typically, one in five drugs making the cut) and rising development costs (an average outlay of ~US$2.8 billion for development, approval, and post-approval R&D of a prescription drug) are further adding to the woes of pharma firms.

This has prompted an examination of all aspects of the biopharma R&D process in recent years to try to cut costs and improve efficiency and productivity. Although this has led to mergers and reorganization in the industry, it has not resulted in the radical shift required. An approach that has become common of late (and comparable to other industries) to solve similar problems in terms of lack of productivity and innovation is to build strategies around pre-competitive collaboration and open innovation. Many large pharmaceutical companies are now getting behind this movement, which goes beyond competitive dynamics.

In light of recent heightened activity in this space, this viewpoint explores the theme along the following dimensions:

• R&D crisis in biopharma
• Clinical and R&D trends
• Existing collaborative platforms/alliances
• Successful implementation and use-case
• Challenges to adoption
• Best practices