Pfizer Inc. believes its $85 million partnership with the University of California, San Francisco, which creates the first of 8 planned Global Centers for Therapeutic Innovation and brings company scientists to academic medical centers, is the right formula to take early stage biologics research from bench to bedside.

Although the partnership is reminiscent of many industry-
academia alliances in the way projects are to be funded, Pfizer is going a step further by opening a center at UCSF's Mission Bay campus whose explicit goal is to support translational research.

A joint steering committee made up of Pfizer and university representatives will solicit applications from investigators and will select projects that have translational potential and a pathway to establishing a clear proof of mechanism in the clinic. Pfizer will provide funding for 1-3 postdoctoral researchers per project, with up to 10 projects being funded per institution.

S. Claiborne Johnston, associate vice chancellor of research and director of the Clinical and Translational Science Institute at UCSF, suggested that this money would help projects that might not be funded by the NIH. "While the NIH seems to be more interested in translational medicine right now, it's expensive and time consuming, and grant review panels may not be as willing to fund a drug discovery project which could be seen as a fishing expedition," he told SciBX.

Pfizer thinks a key differentiator in its UCSF deal-and other planned Global Centers-will be the direct interactions between the pharma and the university. Pfizer will open, fund and staff labs in close proximity to its university partners and is finalizing the terms of a lease agreement for such a space at the UCSF Mission Bay campus.

The space will have capacity for 40 researchers, half of whom are expected to be company employees. The goal is to provide a physical base of technical and administrative support that will be freely accessible to academic collaborators.

"What makes this partnership different is that we are not just employing Pfizer funding, or staff, at each institution-we are also deploying Pfizer's technologies. For example, we can aid in drug discovery by employing antibody technologies including phage display or by generating needed cell lines. And we can provide the right expertise to understand toxicology or regulatory issues," Anthony Coyle, head of Pfizer's Global Centers for Therapeutic Innovation, told SciBX.

Johnston said the technology and expertise is key to motivating faculty who otherwise might not push their research into the translational space. "Energy of activation is a huge motivator here, as highly successful investigators are extremely busy and may not have the experience in their own lab to develop an idea to its full therapeutic potential. That's where Pfizer's resources can help," he said.

Lost in translation

According to Coyle, a physical presence at a medical center is critical to the translational process.

"Translational medicine is not about developing drugs and then asking if they work afterward. We believe that by working closely with institutions, we can participate hand in hand in the development of the therapeutic and, at the same time, identify the right biomarkers and molecular signatures that ensure we ask the right questions in the clinic," he said.

John Reed, CEO of the not-for-profit Sanford-Burnham Medical Research Institute, agreed. "In the past, institutions have served up licensing opportunities or occasionally sold broad right-of-first-refusal options to a pharma partner. But there wasn't much interaction along the way. What we are seeing now is a shift to a model where nonprofits and academic centers are engaging in truly collaborative research with the pharmaceutical industry," he said.

Last year, Sanford-Burnham hired Michael Jackson, former SVP of drug discovery at Johnson & Johnson, as its VP of drug discovery and development.

Although Reed said the collaborative research strategy employed by Pfizer is a step forward, he thinks the future of translational deals will be in specific, well-defined therapeutic areas. "Departments in pharma are often isolated. For example the oncology division may act independently from the neurology division or the immunology division. The model we think is most productive is to have our team of experts in direct contact with their team of experts in a given therapeutic area. A broad collaboration may suffer from inefficiencies when a promising discovery resulting from collaborative research lacks an internal champion on the pharma side to pull it through for clinical development," he said.

Show me the money

Pfizer expects to open seven more Centers for Therapeutic Innovation by the end of 2011. This year, Coyle said the company plans to announce two centers: one in Boston and one in New York. By the end of 2011 he hopes to have centers open in North America, Asia, Australia and Europe.

The terms of the UCSF deal should provide a blueprint. The university and Pfizer will jointly own any therapeutic candidates that are developed from the collaboration. The pharma will have an exclusive commercial option to the compounds once they move into the clinic. If the option is exercised, UCSF would receive a milestone payment. If Pfizer does not exercise its option, UCSF will be free to negotiate with other partners.

The Pfizer-UCSF team also will allocate two flexible funds to the partnered programs. Access to the funds will be at the discretion of the joint steering committee and could be authorized at two points.

The first fund could be accessed when a compound has been declared a candidate drug but still needs additional studies to prepare for an IND submission. The money from fund one could be used for drug material production, toxicology studies and regulatory work.

The second fund would be accessed to move a candidate from an IND application to a proof-of-mechanism study in the clinic.

Although researchers will have access to Pfizer resources, they will not be restricted from publishing their work. "We knew if we wanted to attract the smartest and most talented researchers, we would have to have a rapid turnaround on being able to publish the research," Coyle told SciBX.

With additional reporting from Tracey Baas, Senior Editor.

Cain, C. SciBX 3(46); doi:10.1038/scibx.2010.1371
Published online Dec. 2, 2010


      Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J.

      National Institutes of Health, Bethesda, Md.

      Pfizer Inc. (NYSE:PFE), New York, N.Y.

      Sanford-Burnham Medical Research Institute, La Jolla, Calif.

      University of California, San Francisco, Calif.