Thursday, January 20, 2011

Pfizer (the biggest drug dealer in the world) reaches out to academia—again (to make drugs and money off the public’s dime)

Pfizer (the biggest drug dealer in the world) reaches out to academia—again (to make drugs and money off the public’s dime)

Pfizer is using public resources at Universities to make drugs and make money.  See story below

Nature Biotechnology, doi:10.1038/nbt0111-3

Pfizer is rolling out a grand plan to draw out drug-development-ready research from academia through a series of collaborations with leading medical centers worldwide. The first collaboration, announced in November, is with the University of California, San Francisco (UCSF), to which the pharma giant will commit $85 million. Coincidentally, London-based GlaxoSmithKline, is launching a similar outreach program, but with a very different approach. Like Pfizer, it wants to access leading academic researchers with targets ripe for translation into the clinic. Its scope, however, is more modest and targeted, focused on individual scientists.

For Pfizer, the overall aim in setting up these Global Centers for Therapeutic Innovation (CTIs) is to move novel bio-therapeutics rapidly into human clinical trials—each project will aim to deliver a drug through phase 1 testing in five years. Pfizer expects five such initiatives to be up and running in 2011 in the United States, Europe and Asia. Assuming eight projects per CTI, this could bring dozens of differentiated biologics against new targets into the clinical pipeline.

The New York–based pharma will set up shop on each campus, contributing proprietary phage display libraries, peptide libraries and associated technologies for rapidly generating antibodies to be used as probes against the novel targets flagged by university researchers. Each CTI will be staffed with 20–25 Pfizer employees with expertise in cell-line generation, protein characterization and purification—the skill sets needed to rapidly identify and advance molecules into the clinic. All decision making, from the initial acceptance of proposals through the determination to start clinical testing, will be made by a joint steering committee. “The concept is to make a transition away from the vertically integrated R&D model into smaller, decentralized groups of a truly global nature,” says Pfizer's Anthony Coyle, who is heading up the program out of the company's Cambridge, Massachusetts, facilities.

As important, the CTI model creates a 50-50 joint relationship where the goals of the investigators and the company are aligned and both sides are empowered to succeed. “There has got to be a change in the mindset from 'We own this, you do this for us,'” says Coyle. The CTIs will seek out investigators who have already developed a hypothesis around a novel disease mechanism and are keen to translate their discoveries into drugs. “These will be projects where we can articulate very clearly at the beginning what the first-in-man study will be,” says Coyle. The strategy will be to define the mechanism of action and in parallel develop the appropriate drug to hit the target and also determine the right patient population to target with it.

The model “allows us to leverage all of the drug discovery capability in our organization—the ability to make clinical grade material, the finances to perform the right enabling toxicology studies, and the regulatory support to allow the investigator to realize the ambition and see the concept translated,” says Coyle. He also hopes to bypass animal modeling. “What's becoming clear to me is that the time you spend on in vivo validation has zero impact, in most cases, on whether you will be successful going into the clinic. Here we propose to define the mechanism based on a human in vitro system, very quickly, which is again aided by having our phage library right there with the individuals doing the research.”

Funding for CTI initiatives will follow a pre-negotiated template Pfizer will put down at each institution. The company will pay for one to three post docs for each participating laboratory and the steering committee will have access to a flexible fund used either for additional biology or to allow the joint project team to move a compound into trials. There will be two clinical milestone payments, at proof of mechanism and successful proof of concept. All joint inventions will be jointly owned, with Pfizer holding an exclusive option to license a drug after proof of mechanism. In the event Pfizer exercises its option, any jointly developed enabling intellectual property (IP) would be licensed from the institution. If Pfizer declines, IP and other joint assets revert to the institution, which could then partner with someone else.

“There's going to be less of an establishment of value going into this, and more of it saved for the negotiation about the IP, which is downstream,” says S. Claiborne Johnston, director of the UCSF Clinical and Translational Science Institute.

In the past, most collaborations, however, have failed to lead to new drugs. “I think they generally have failed because of the misalignment of the interests of the academic investigators and the industrial partners,” says David Mack of the venture firm Alta Partners, in San Francisco, either because the academics were driven by other basic research questions or because of a lack of appreciation for the cost, risk and time that drug development takes. “They see that they've created an asset that is worth a lot, but actually it's not worth a lot because all of the risk is ahead of us—investment capital, development, technical risk.”

But as grant funding proves ever harder to find, it's an opportune time for exploring new models. Plus, the venture capital industry is contracting significantly and is also shifting its focus, where possible, to more late-stage, downstream investments. The absence of an initial public offering market has made some of the investigators more realistic. “It's the right time for that kind of approach—getting them involved on a risk-sharing basis and setting some realistic near- to midterm milestones to achieve some value creation, even if it means then passing it on to Pfizer in exchange for a royalty,” says Mack. The ability to hit the group running with a program and have immediate access to Pfizer's development resources may also be attractive to academics who are either uncomfortable or impatient with the venture capital process, where initial fund-raising could take years.

But more experienced academic entrepreneurs might not want to trade control or more potential upside in exchange for expediency. Paul Schimmel of the Scripps Research Institute in La Jolla, California, believes that “To preserve their freedom and work in an academic-like way, they'll probably want to turn to do that in the venture community and startups rather than the pharmaceutical industry, where it can get buried and disappear.”

A tendency for people within companies to move is another ongoing issue. Regis Kelly, director of the California Institute for Quantitative Biosciences (QB3), a nonprofit institute spanning three University of California campuses in the San Francisco Bay Area, points to pharma's frequent management changes as a potential snag in making the partnerships thrive. For instance, in 2008, soon after Pfizer merged with Wyeth, it dissolved the Bio-therapeutics and Bio-innovation Center (BBC) on UCSF's Mission Bay campus—set up in 2007 as a hybrid between academia and industry, to work on translational projects (Nat. Biotechnol. 27, 308, 2009). For about a year, Kelly recalls, “there was a hiatus, where we couldn't start any new programs together.”

Even as Pfizer focuses on decentralizing industry-academic partnerships, London-based GlaxoSmithKline (GSK) will soon adopt a virtual approach. GSK aims to create up to ten relationships with individual researchers throughout the world, forming a virtual project team with each of them in order to, like Pfizer, provide immediate access to GSK resources. “We're not talking about giving lots of money across to academia,” says GSK's Patrick Vallance, who is leading the program. An experienced drug discoverer will work in tandem with the research group. “At the beginning it's very focused, with access to the whole of GSK's expertise,” he says.

GSK is set to announce the first of its collaborations under the program, with Mark Pepys at University College, London (UCL), and Pepys' UCL spinout, Pentraxin Therapeutics, for the development of a small molecule to treat amyloidosis. GSK and Pentraxin are already working together to develop an antibody to treat the disease.

To some extent, Pfizer's CTI programs echo the spirit of Eli Lilly's Chorus initiative, started in 2007, in which a venture firm supplies the Indianapolis-based pharma with compounds for Lilly to rapidly advance through phase 1. But whereas both emphasize speed to the clinic from a similar preclinical starting point, the CTIs will also explore the biology around its targets in depth, at greater cost, but also presumably to its benefit. Indeed, although Pfizer is aware of the importance of targeted therapeutics and personalized medicine, “It's not an area we have invested a significant amount of time in,” says Coyle. By focusing on translational medicine up front, “We're going to have a broader impact in the organization,” he says.

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