Collaborators Against Cancer

Courtesy of Getty Images Among the most fiercely competitive corporations in the business world, pharmaceutical companies jealously guard their secret research and profitable patents. Yet an industry group is now promoting a plan to break down the walls dividing the world's major drug makers for an all-out effort against cancer. The CEO Roundtable on Cancer, which met earlier this month, is considering a proposal to create a research collaboration similar to one established by the US semiconductor industry in the 1980s. The proposed research plan would spread both the risks and rewards of drug discovery across a wide pool of companies and potentially speed treatment to patients. The plan faces significant obstacles, chiefly legal problems related to intellectual property rights and antitrust regulations. A task force exploring the idea expects it will take at least another year to come up with a solid framework for a combined research program. "This presents an interesting opportunity for possible collaboration, but we are in very early discussions," says Robert Ingram, who chairs the CEO Roundtable on Cancer and is vice chairman of pharmaceuticals at GlaxoSmithKline. "Many details are being worked on in the hopes of being able to put a real proposal on the table in the foreseeable future." PRESIDENTIAL PRIORITY The CEO Roundtable on Cancer is part of the National Dialogue on Cancer chaired by former President George H. Bush and his wife, Barbara. Their daughter Robin died of leukemia two months before her fourth birthday. The ideas being discussed represent a radical change in the way private-sector research is structured, but analysts say the concept has promise. "I think it's real. It is very expensive to develop drugs for cancer. I think it is in everybody's best interest to work together," says Michael King, an analyst with Banc of America Securities. King says the industry faces so many challenges right now, including barren product pipelines and government pressure to cap prices, that it might be ready to embrace a novel approach to research. "They're under a lot of pressure from a lot of other constituencies," says King. "They'll have to overcome their egos to get this done." The rationale behind the proposal lies in the explosion of genomics-based research in the last few years. "In the post-genomic era, ultimately we will find it may take many years and decades to benefit from the new technology," says Gabriel Leung, former oncology chief at Pharmacia and now executive vice president and president of oncology at OSI Pharmaceuticals in Melville, Long Island, NY. "If somehow we can find a way to collaborate to accelerate our learning, and approach valid drug targets in a systematic manner across the industry, it could potentially accelerate the whole process and allow us to bring new therapy for all those patients," says Leung, who is member of the CEO Roundtable's task force on collaboration. Leung says the idea of scientific collaboration is not new. The current proposal, however, would be rooted in the private sector and create collaborations that would stretch out over many years, from initial target identification through clinical trials and regulatory approvals. "What we're looking at here is more than just a one-off, project-by-project collaboration," says Leung. GENOMIC ECONOMICS Martin Murphy, an oncologist and consultant to the task force, says new genomics-based drugs or combination therapies may lead to more effective treatments for smaller, more targeted, groups of cancer patients. The problem, however, is that drug companies would need to invest as much as $800 million in a product that may have only about six or seven years of patent protection and a market of only 100,000 patients. The situation is similar to the so-called orphan drugs, which have small patient populations. "It's a formula for economic disaster," says Murphy. "Just at the time when there is so much hope with genomics ... if we don't do something courageous and venturesome, we may not be able to deploy it for good." John Niederhuber, professor of surgery and oncology at the University of Wisconsin and another member of the task force, says industry-wide collaboration would allow researchers to explore many more targets. Today, he says, leading pharmaceutical companies all tend to focus on the same few leads that have the most commercial potential. "It would allow an R&D operation to really work on everything," he says. "You wouldn't have to, as a single company, try and guess what might be the potential windfalls. You could really be very, very comprehensive in your research agenda. To me, as an academic scientist and clinician, I find that very exciting." Niederhuber says a collaboration on cancer could have another benefit for the beleaguered drug industry: "It would also be very positive for the image of drug development in this country." In Europe, similar concerns about the most effective ways to put genomics research to work led the European Union last year to propose a new four-year, £400 million cross-border collaboration. "Our investments will only bear fruit if researchers and funding agencies from across Europe work together with common goals," EU Research Commissioner Philippe Busquin said when he announced the plan last fall.1 The CEO Roundtable would be modeled in part on International Sematech (Semiconductor Manufacturing Technology), an industry group formed in 1987 by 14 technology companies. Sematech spread the risk of financing new development across its members when the semiconductor industry came under serious threat from offshore manufacturers. The US government waived antitrust rules and helped finance the group, because its products were viewed as essential for national security. Niederhuber says cancer should receive the same kind of consideration. "It is not only personally devastating, it is economically devastating to this country. The government would want to be a partner in this, too." Leung says the drug development collaboration would be more complicated than is Sematech, because the semiconductor group was focused largely on manufacturing, and was not as weighed down by the complicated issues surrounding intellectual property. "Drug development is far more complex and much more time-consuming" he says. Another idea for discussion, says Niederhuber, would consider a sliding cap on intellectual property protections, dependent on a product's market share. Niederhuber says government support in the regulatory process could be another complex area; the new generation of drugs targeted to smaller populations should prompt changes in the way clinical trials are designed, he says. "There are a lot of innovative ways to work in partnership with the government." Colleges and universities would most likely not join the consortium as business partners, but he says the task force envisions consultation with a scientific board that would include academics. Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation (WARF) and a task force participant, says the plan might also meet opposition from biotech firms that have focused on taking basic research into the early stages of applied preclinical development. "The original focus of this was the problem of addressing super-orphan conditions and conditions that are not going to be treated with a single bullet and need a complicated cocktail," he says. "I don't think the startups have the money or the horsepower to address that." Susan Warner (swarner@comcast.net) is a freelance writer in Philadelphia. 1. "EU supports creation of a European cancer research area," Sept. 19, 2002; available online at europa.eu.int/comm/research/press/2002/pr1909en.html function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

Collaborators Against Cancer

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