Personalized Medicine Is Playing a Growing Role in Biopharmaceutical Development Pipelines

A new report from the Tufts Center for the Study of Drug Development finds that biopharmaceutical companies are committed to researching and developing personalized medicines.¹ The data show, for the first time, the extent to which companies are embracing this new research.

Personalized medicine is defined in the survey as the tailoring of medical treatment and delivery of health care to the individual characteristics of each patient—including their genetic, molecular, imaging and other personal determinants. Using this approach has the potential to speed accurate diagnosis, decrease side effects, and increase the likelihood that a medicine will work for an individual patient.

The authors conclude, "The industry as a whole is committed to pushing strongly ahead," and "early indications show that development of personalized medicines is commanding more resources and fomenting more corresponding organization change than is generally appreciated outside the industry."

• Of the companies surveyed, 94% said they are investing in personalized medicine research.
• In many instances, companies' investment is translating to development of therapies that have a companion diagnostic. Companies report that within their development pipelines, 12%-50% of compounds are personalized medicines.
• In the last 5 years, companies report that they have seen a roughly 75% increase in personalied medicine investment. What’s more, they expect an additional 53% increase in the next five years.
• Personalized medicine is changing the way biopharmaceutical companies research new medicines. One hundred percent of companies surveyed said that they are using biomarkers in the discovery stage of research to help learn more about a compound. Biomarkers are molecular, biological or physical characteristics that can help identify risk for disease, make a diagnosis, or guide treatment, and they are a key component of personalized medicine.
• Integrating personalized medicine into the R&D process requires significant investments in accompanying technologies. The approach represents a paradigm shift in the R&D process, changing how companies make decisions and increasing partnerships with external organizations.
• Personalized medicine research now appears to be expanding into new therapeutic areas, according to the report. Oncology is on the leading edge and personalized medicine is integrated into most new programs. Personalized medicine is “making headway” in areas including cardiovascular, central nervous system, and immunologic therapies. In areas including virology, metabolic and respiratory therapies, personalized medicine is now beginning to develop.
• Many of the most promising personalized medicines are still the early stages of research. Among treatments in preclinical development nearly 60% rely on biomarker data. In early clinical research that proportion is close to 50% and in late clinical development about 30% use biomarkers.

¹ Tufts Center for the Study of Drug Development, “Personalized Medicine Is Playing a Growing Role in Development Pipelines,” Impact Report, 12 (November/December 2010): 6. Available at: http://csdd.tufts.edu/reports/description/ir_summaries.