With interest in personalized medicines growing, drug and diagnostics companies are investing in the development of companion diagnostics that can show that their use in conjunction with personalized therapeutics will lead to positive health outcomes, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development (CSDD).

The issue is critical as drugs that have companion diagnostics, which identify biomarkers to help differentiate between responders and non-responders to a particular drug, and those at risk for adverse events, are more likely to be prescribed and reimbursed.

According to Tufts CSDD, 20% of new drugs winning approval in the U.S. last year were considered personalized medicines, a number that is expected to grow based on the investment plans of major drug companies.

“Drug and diagnostic companies have very different cultures, and their products have different timelines, procedures and regulatory pathways,” said Joshua Cohen, associate professor at Tufts CSDD. “A central question for drug sponsors is whether to team with independent diagnostics firms and acquire those companies or build their own capability.”

Just as important, roundtable participants agreed, is working with regulators early in development, as both parties benefit by jointly determining how best to validate biomarker efficacy, which remains a key hurdle.

Other points made by participants in the Tufts CSDD Executive Forum, which involved senior leaders from drug and diagnostics companies and an official from the FDA, summarized in the “August Tufts CSDD R&D Management Report,” included:

• Since it often is not clear if a diagnostic will be needed until phase II, or later, in the development of the therapeutic it will support, it is critical to start development early so it will be ready for use when the therapeutic launches.
• Knowledge of existing biomarkers is important, but personalized treatments also will depend on which biomarkers have yet to be identified as key factors in producing differential responses to therapeutics.
• Because co-development and co-approval of drugs and companion diagnostics require coordination across multiple regulatory agencies, each with different regulations and timelines, internal and external coordination and communication are paramount.

The next Executive Forum is set for Sept. 17 on novel approaches to overhauling the clinical development process.