Think of all the rules you need to follow, and all the steps you need to take, in order to make a successful life partnership flourish. In precision medicine, where patients get diagnostic tests to establish their suitability for a specific therapy, getting the partnership right between diagnostic and pharmaceutical companies is similarly complex and challenging. However, doing it successfully is vital, because it can maximize the number of patients being tested effectively and ultimately lead to better treatment outcomes.
The reason these partnerships are important is that the therapy and diagnostic need to be aligned to achieve the same clinical goal. Pharma are focused on developing their therapies, so the majority need to partner with one or more diagnostic companies to develop a test that will support a targeted therapy. Some pharma companies have brought diagnostics under their own roof through mergers and acquisitions – Roche is a good example of this with their acquisition of Ventana – but most will still have to partner with external companies as well.
These partnerships are especially pertinent now that regulatory bodies are encouraging a joint review of the therapy with the diagnostic. This means that both partners need to be aligned for the approval process as well as preparing for commercialization. For example, recent companion diagnostics co-developed with the therapy have had successful PMA reviews by the FDA and been approved in under six months. Pharma can only benefit from having the diagnostic test available and optimized in laboratories at launch, meaning patients can be seamlessly tested at the earliest opportunity. This is a further incentive for pharma to develop productive and clearly-defined partnerships.
There is undoubtedly a growing understanding of partnering in the space. Diaceutics has been monitoring the precision medicine marketplace for several years and we have noted a steady rise in the number of pharma-diagnostic company partnering deals. For 2016, we know around 80 partnerships were formed and in 2017, based on figures for the first six months of the year, we estimate seeing another 90. Oncology remains the main target for these deals, but as precision medicine moves into general medicine, more pharma companies are partnering in areas such as infectious disease, neuroscience, transplantation, cardiovascular disease and immunological disorders.
As in all relationships, whether they be business or personal, pharma-diagnostic company partnerships need to be built on strong foundations and nurtured, or they may face difficulties. A successful deal, therefore, requires partner engagement, cooperation, careful management and continuous dialogue. But in this environment, it does not always pay to be equal – pharmaceutical companies need to assume responsibility for the availability and quality of the diagnostic test they are promoting together with their partner. They must avoid losing sight of the fact that the quality and perception of their product can be dependent on a separate company with different objectives that may not be aligned to their own. For that reason, pharma should strive to be the architect of the overall diagnostic strategy and commercialization and not abdicate this responsibility to the diagnostic partner.
Pharma and diagnostic companies essentially share the same clinical goal but can have different priorities. Making sure that everyone agrees to the ‘pre-nup’ and sets out definite roles and responsibilities will likely prevent heartache further down the line.