Pharma Invests in Companion Diagnostics

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.

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 investment plans of major drug companies.

Roundtable participants also noted the following:

• The importance of working with regulators early in development, as both parties benefit by jointly determining how best to validate biomarker efficacy

• Criticality to start diagnostic development early so it will be ready for use when the therapeutic launches.

• Knowledge of existing biomarkers, as well as biomarkers that have yet to be identified.

• 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.

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