The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Last month, CSDD published a study which found that personalized medicine development is “occupying a growing role in the clinical pipelines of drug developers, and is leading companies to change their R&D paradigms, including how they make go/no-go decisions.” In fact, the study found that 12% – 50% of current clinical pipelines of the companies interviewed involve personalized medicines. The analysis, the first of its kind to measure the pharma/biotech industry’s progress in developing personalized medicines, was based on interviews and a survey of nearly two dozen companies that are leading the way in this new field.
The study was reported in the November/December Tufts CSDD Impact Report, and presented on Nov. 18 at a conference, Personalized Medicine: Impacting Healthcare, held at Harvard Medical School.
Christopher-Paul Milne, associate director at Tufts CSDD and author of the study, noted that “Early indications show that development of personalized medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry.” He further explained that “the scientific, regulatory, commercial, and practical challenges confronting developers in creating personalized medicines are significant, and, as a result, approaches taken by individual companies in the pursuit of these new medicines vary greatly.”
In particular, developers are working with academic medical centers to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities. The study also found that:
The magnitude of resources required to create personalized medicines means developers must team with multiple external partners, presenting challenges for project stewardship and intellectual property rights.
Biomarkers increasingly are used to better understand patient response, but companies still cannot use biomarker data to support approval until the regulators’ capacity to evaluate it catches up to the science
Oncology leads other therapeutic areas in the number of personalized medicines on the market as well as in the pipeline with the expectation that within the decade all oncology drugs will have a related diagnostic.
Other key therapeutic areas in which personalized medicine is making headway include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.
Oncology taking the lead in therapeutic areas is crucial because R&D in oncology relies on more biomarkers and diagnostics. As the study noted, “Company infrastructures have been changed to incorporate this approach into oncology programs, and one interviewee said he expects all oncology drugs will have a related diagnostic “within five to 10 years.” This will lead to better and newer personalized treatments to help find ways to cure cancer.
Ultimately, one of the most important findings from the study revealed that drug developers are teaming with external partners, including academic medical centers and diagnostics developers, to advance the science of personalized medicine.
What that finding demonstrates is that the process of achieving personalized medicine is dependent on industry-academia and industry-physician collaboration and relationships. It suggests that academic medical centers that are installing strict rules and guidelines preventing industry from working with staff and faculty will impair the ability of those centers from focusing on personalized medicine.
If academic medical centers truly have the best interests of patients and the public in mind, they should reconsider any stringent policies for faculty and staff they have made or are considering that make collaborating with industry difficult, since these partnerships are already showing promise in personalized medicine development.
Accordingly, as companies begin to shift their structures to implement provisions of health care reform to address health care costs, and as the government expands the role of health care and regulatory agencies, it is clear from this study that industry-academic collaboration will help bridge these goals together.