By Eric Bolesh,
Director of Research
When we spoke with teams to complete our recent examination of companion diagnostics (CDx) development, we heard a lot about the difficulties of the partnering process. It’s a difficult road for all parties, as choosing the right ally for the development of a companion diagnostic has far-reaching consequences. Companies prepare for the challenge by first thinking about which functions should be involved in the selection process, what attributes make up a great partner, and what processes should be in place once a partner is chosen.
At the pharmaceutical companies we surveyed, CDx partner selection is handled by committees whose composition varies on a company-by-company basis. The members represent any number of different internal functions, and they solicit further input from other relevant groups. The larger the company, of course, the more functions you see sitting on the selection committees. Still, nearly all organizations include some combination of business development, R&D (including key scientists) and commercialization representatives in the decision-making process.
Often, these selection committees will maintain an evolving list of criteria for choosing CDx partners. Some of the main criteria reported by companies include diagnostic companies’ technological know-how, level of scientific knowledge and capabilities across a range of specific factors, such as commercial expertise and regulatory experience. When it comes to actual test attributes, the characteristics that most concern drug companies will come as no surprise: accuracy, reliability, development speed and development cost, in that order. The success of an entire companion diagnostic program (and often the drug itself) hinges on the test’s ability to accurately and reliably select patients who will respond to a drug. Development speed and cost are business concerns that nonetheless have a outsized impact on clinical decision making.
Using all of these criteria, selection committees will narrow their focus to a small number of partnership opportunities. Ultimately, the process includes joint meetings, due diligence, negotiations and other familiar elements of partnering. Once an alliance is in place, clear objectives and regular communication help to keep the relationship on track through the ups and downs of clinical development.
One major pitfall loomed over all of the others. Executives at diagnostics companies expressed one key frustration with their biopharmaceutical brethren: a misunderstanding of the demands of diagnostic development. Diagnostic teams reported that their drug industry counterparts have a habit of assuming, incorrectly, that development around biomarkers and diagnostic tools is a fast undertaking — often one that can be completed in a matter of months. Regulatory demands, not to mention the caprices of development, mean that this is not the case for development timelines. Drug makers who enter the relationship with unrealistic expectations are bound for disappointment; companion diagnostic development is not a short-term process, and both partners must have a clear understanding of the timeline that lies before them.