Janet Woodcock, M.D.—Director, Center for Drug Evaluation and Research (CDER)
A public/private partnership or consortium is a collaborative group that is convened to address an identified problem. In our case, it would be an identified scientific gap in drug development or drug regulation. And participants usually include academic researchers and institutions; pharmaceutical, biotechnology, or device companies; foundations; nonprofit institutions; patient advocacy groups; and health care organizations, along with the government.
And usually these include at least one nonprofit or 501(c)(3) organization that can act as a convener in at least one for-profit organization.
And so we engage in these scientific collaborations to enhance our knowledge and improve our ability to review drugs.
These consortia and public/private partnerships bring together expertise from all these different groups to solve these challenges, because no one entity is really in charge of fixing these problems, but as a community, we can come together to do it.
For example, the Coalition Against Major Diseases pulls and analyzes clinical trial data, and they’ve been able to generate a disease progression and trial simulation model to inform trial designs for Alzheimer’s disease. This consortium is also developing biomarkers for patient enrichment in Alzheimer’s disease clinical trials.
We often don’t take into account how a patient feels when he or she is treated with medications, and so to address this gap, the Patient-Reported Outcome Consortium is developing patient-reported outcome measures and instruments that can capture the patient’s perspective of what’s happening with the treatment.
Additional public/private partnerships include the Biomarkers Consortium and the Predictive Safety Testing Consortium. One of the projects these folks are working on is developing and validating safety biomarkers that can provide early warning signs for drug-related injury. Having such biomarkers, having very sensitive ones, is important for assessing patient safety during development of investigational drugs.
The National Institute for Pharmaceutical Technology and Education, or NIPTE, Consortium is engaged in modernizing and improving drug manufacturing methods. And this would have a great impact on the cost of producing drugs in my opinion.
Now a consortium called SmartTots is evaluating the concerns regarding anesthetics and their long-term effects in young children who require surgery.
So you can see the diversity of these type of consortia and the different types of scientific questions that they’re addressing.
Ten years ago, we started the Critical Path Initiative to lay out the path for streamlining drug development through tools, standards, methods, and approaches development, and some of these drug development–related public/private partnerships and consortia are a result of the Critical Path Initiative.
We believe that it really takes a community—the scientific community, the medical community, the patient community—to develop and deliver these advances in how to evaluate drugs, and we’re really humbled and appreciative of all the efforts that people have been putting in.