Public-private partnerships (PPPs) are at the forefront of a changing paradigm in the approach to successfully developing new medicines. Those partnerships or consortia are part of an effort to transform the expensive, time-consuming, high-risk and complicated process that eventually leads to new treatment options.

Those consortia involve a number of stakeholders, including pharmaceutical companies, academic institutions, patient organizations and regulatory agencies and payer organizations. Each has their own perspectives and the challenge is to ensure that each consortium understands its mandate in order to achieve its goal effectively.

"That is one of things we have learned since this model got its start a few years back," Martha Brumfield, president and CEO of Arizona-based Critical Path Institute (C-Path), told BioWorld Insight. "One size certainly does not fit all."

Since C-Path was formed about 10 years ago there has been a rapid acceleration in the number of medical research and health-related consortia and medically focused initiatives that have been created.

PROLIFERATION OF CONSORTIA

According to Consortia-pedia, a new project of the nonprofit group Fastercures, there has been an increase in the number of consortia specifically created to "accelerate biomedical research." The group identified 2012 as a landmark year with the launch of 51 new consortia.

Fastercures, in fact, has been able to identify no less than 387 consortia that have been launched between the years 1995 and 2014. Half of that total they identify as focused on specific disease areas, with Alzheimer's disease, oncology, rare diseases and diabetes at the top of the list. The group defined consortia as groupings of people who don't usually work together but have a shared pain point, coming together temporarily to share resources and effort for a common objective. (See BioWorld Today, May 30, 2014.)

C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science. It is no stranger in forming collaborations itself, establishing seven global, PPPs that currently include more than 1,000 scientists from government and regulatory agencies, academia, patient advocacy organizations and a host of major pharmaceutical companies.

There is strong agreement that with so many ongoing collaborative efforts dedicated to medical research it is important to understand what each is doing so there is not duplication of effort, Brumfield explained.

Sharing collective experiences and lessons learned on a regular basis should be a key component in the operation of those groups. That is why back in early December C-Path, along with the Innovative Medicines Initiative, organized an international group of thought leaders to find new ways to collaborate and achieve common goals that will help serve to better support efficient and productive medical product development.

Last year there were several high-profile consortia that were conceived. In February 2014, the Accelerating Medicines Partnership (AMP) was unveiled. AMP is a consortium of institutions that have joined a PPP for precompetitive drug discovery. It includes leaders from NIH, 10 of the largest biopharma companies, the FDA and eight nonprofit agencies, including both industry groups such as Pharmaceutical Research and Manufacturers of America and patient advocacy groups such as the American Diabetes Association and the Lupus Foundation. (See BioWorld Today, Feb. 5, 2014.)

The project has $230 million to work with, split about evenly between the NIH and the biopharma industry. It is focusing on three pilot projects of three to five years. One of those projects will focus on Alzheimer's disease, one is looking at type 2 diabetes and one is focused on the autoimmune disorders rheumatoid arthritis and lupus.

The enthusiasm that all parties are embracing such collaborations will surely spawn more of these type of arrangements.

1+1=3?

The question remains whether the consortia are actually making an impact in medical research and leveraging the collective skills of participants so that tangible results accrue.

Brumfield said she believes that these PPs have gotten better, but the consensus from the December meeting is that there is still room for improvement. The equation is currently "one plus one equals two and a half," she said. "We have gotten better but are not quite at our peak performance yet, but at least the path is clearer on how to get there."

C-Path certainly is making strides with the output from its collaborations. Brumfield pointed to the success of its Predictive Safety Testing Consortium (PSTC). In October, the FDA issued a first-of-its kind Biomarker Letter of Support for two essential kidney safety biomarkers identified and evaluated by PSTC's Nephrotoxicity Working Group.

The biomarkers, osteopontin and neutrophil gelatinase-associated lipocalin, are proteins that can be measured in urine with higher levels indicative of kidney damage. The FDA letter provides momentum to determine if they have clinical utility.

Last month, the EMA followed the FDA lead, issuing its own kind of Biomarker Letter of Support for those biomarkers.

There is no doubt that the collective output from the many working consortia, both large and small will impact medical discovery going forward.