Make It New - Pharmaceutical Executive


Make It New
To fix pharma's business model, nothing less than big, bold, and risky fits the bill. Two radical new visions focus on getting back to the roots of innovation—and letting a thousand flowers bloom.

Pharmaceutical Executive

Creating a new model from scratch, rather than merely tweaking the old, is what Munos has in mind. "I started with the question, Where does innovation come from?" he says. "But when I asked around pharma, none of these very smart people seemed to know. For an industry that spends so much on innovation, that was disturbing."Munos researched the history of biomedical breakthroughs and concluded that innovation derives from diversity—not what the buzzword typically means, he is quick to clarify, "but everything else—differences in styles of problem solving, professional training, specialization, language, all the way to how your brain is wired."

The research institutes with the highest number of Nobel Prizes—Rockefeller University, Cal Tech, the Pasteur Institute—also have the most diverse group of scientists working on the same problem. "The bottom line is that most conceptual or theoretical problems in any field that, once solved, would lead to a breakthrough have been solved already in another field," Munos says. Maximizing the diversity of problem-solving techniques can increase the speed of innovation. Needless to say, this contrasts starkly with the traditional pharma model, in which chemists, biologists, toxocologists—not to mention marketers—work in separate silos, cut off from competing approaches.

The search for diversity-driving models led Munos to the freshly minted concept of"open source," a collaborative process born in the software industry: A program with basic functionalities is posted on a Web site—"and then you invite the world to join in, contributing their own expertise and enhancements," Munos says. "You do not control who works on it or what they do. You only control what gets included in the final program." Wikipedia, the Web-based encyclopedia written (and revised in a never-ending fashion) by millions of volunteers, is an example.

In an effort to solve pharma's high costs/low productivity conundrum, Munos was inspired to apply open source to the discovery stage of R&D. "Tapping the insights and skills of clever scientists around the world, including those outside of traditional drug R&D—physicists, mathematicians, artificial-intelligence specialists, economists—and allowing them to cross-pollinate over the Internet, may generate breakthroughs," he says. "You post research challenges viewed as intractable and offer a bounty to the person who can solve it. Intellectual property is not an issue, because most ideas discussed on open source do not meet the legal requirements of innovation as defined by patent law." Commercialization comes after this global "scientific conversation."

Outsourcing, in Munos' radical redesign, is to drug development what open-sourcing is to drug discovery. "At any moment there is lots of infrastructure around the world sitting idle that can do clinical trials now—rather than two years from now," he says. Outsourcing is one solution to the blockbuster model's bedeviled cost structure—and the fact that even the biggest companies can no longer pay $1.7 billion to make a new drug. "Clinical research in the United States is famously wasteful," Munos says. "It's run by a legacy system of provisions that once served us but no longer provide security, quality, or efficiency."

But what about the values of quality and safety essential to pharma's mission? "Open-source organizations use reputation, due diligence, and audits as a means of preventing or uncovering problems," says Munos. "In the future, codes of good practice or even ISO standards could be developed to safeguard the process."

In fact, the open source/outsource pharma model already exists among a new breed of public-private partnerships (PPPs). Nonprofit initiatives such as the Drugs for Neglected Diseases Initiative are "systems cobbled together as cheaply as possible to help people who are desperate," says Munos. "They put out an open call for scientists to submit research projects for malaria, HIV, TB. They assemble a scientific advisory board to decide which merit funding. And then they outsource the work for development through a network of hundreds of researchers and doctors."


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