National health systems have the challenge of ensuring access to new medicines and, at the same time, operating in an efficient and cost-effective way. On the other hand, while many public and private laboratories have the potential to develop innovative therapies, the biotechnology industry has been dominated by a small handful of large companies because of exorbitant research and development costs, in addition to the inherent risk of this activity.
In response to these challenges, public-private arise as a valid alternative model that allows the skills and assets of each sector (public and private) to be shared in search of new and improved therapies. As part of this partnership model, the public institutions contribute highly qualified human resources and its experience in identifying new therapeutic targets, as well as in preclinical and clinical developments, while companies contribute their capacity in industrial processes according to international quality standards, as well as economic resources, project management and marketing skills. Importantly, not only do the partners share resources, but also the risks and the potential reward if the new drug reaches the market.
This model of partnership has grown significantly in recent years around the globe. For example, in 2012 Bristol-Myers Squibb formed a public-private partnership with ten cancer research institutes – the International Immuno-Oncology Network – to “facilitate the translation of scientific research findings into clinical trials and, eventually, clinical practice, as well as advance innovation in drug discovery and development.” These types of arrangements are common in the United States and, to some extent in the EU, and Argentina is no exception either. Through its local funding agencies such as FONTAR, FonCyt, the National Cancer Institute, and others, various financial instruments have been created in the country to promote and finance public-private partnerships in the life sciences.
In line with this impulse from the State agencies, the Insud Group has been promoting the public-private cooperation for more than a decade through the R&D+i Consortium (Research, Development, and Innovation) involving more than 100 Researchers from companies and academia (universities and hospitals). Currently, Insud´s R&D+i Consortium has three main focus areas: innovative cancer therapies, technological development therapeutic monoclonal antibodies, and production of recombinant vaccines.
As in all cases where cooperation between different actors needs to be coordinated, there are certain steps in shaping and managing these public-private consortia which, at least on the basis of our experience, must be followed in order to succeed.
The first step is choosing partners carefully. Not only must the experience and skills of the public partners and the leadership and the financial capacity of the private partner be evaluated, but it is crucial that the interests of both of them are aligned. Given all the challenges that biotech developments (all the way from the laboratory to the market) present, partners will have to work hand in hand and support each other for many years. A detailed and transparent cooperation agreement should be established from the start, describing the responsibilities, risks and benefits for each partner, as well as a clearly defined method of dispute resolution. Also, before embarking on a project that will demand a lot of time, money and effort, a business plan should be drawn up that clearly describes the scope of the project, approximate development costs , market potential and the proposed capitalization alternatives (state funding only covers a small percentage of development expenses). Sometimes an idea that seems good at first glance is unprofitable or impractical when analyzed in detail. It is therefore important to identify the opportunity and the challenges from the beginning of the project. It is also desirable that the consortium has a manager who can keep the project on track throughout its different development phases. Today more than ever, a slow-moving clinical project is considered a dead end project.
Pharmaceutical public-private partnerships will not only affect the parties directly involved in it (public institutions and companies), but also the patients, the scientific-medical community, investors, and other stakeholders. Importantly, Governments that support research through public-private partnerships may also aim to explore and support other R&D+i endeavors (e.g., open innovation), thus promoting new forms of economic activity.