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Research Universities and Big Pharma’s Wicked Problem

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A few years ago BP awarded a consortium of universities led by Berkeley the largest grant in University of California history: $500 million over ten years to develop biofuels. Despite BP’s well-publicized travails, their commitment to the Energy Biosciences Institute remains firmly in place.

BP is a huge company with a wealth of resources at its disposal. Why did it choose to turn to universities for help? Graham Fleming, now vice-chancellor for research at UC Berkeley, but earlier one of the architects of the EBI consortium, explains it this way:

Manufacture of biofuels is a “wicked” problem, defined conventionally as a problem that is almost insoluble because it requires the expertise of many stakeholders with disparate backgrounds and non-overlapping goals to work well together to address an important society problem. Manufacturing biofuels requires economists to verify a market; chemical engineers to design refineries; industrial microbiologists to optimize enzymes to break down biomass; botanists to select the optimum biomass; agronomists to define the crop locations; and hydrologists to ensure adequate irrigation. Even a company with the resource base of BP does not have quality expertise in all these fields. In contrast, universities DO have the requisite talent, but the trick is to network them together into a team. The Berkeley leadership skillfully assembled a “biofuel ecosystem” and so deservedly won the BP competition.

This example demonstrates that, with inspired leadership, universities CAN assemble teams to address wicked problems. An obvious challenge is whether creation of an analogous “bio-innovation ecosystem” might help address the current troubles in the pharmaceutical industry.

Insight into how a bio-innovation ecosystem might solve certain difficulties faced by the pharmaceutical industry can be garnered by examining the aviation industry. The pharmaceutical and the aircraft industry both invest huge amounts in creating new products. Aeronautical engineers may not understand completely the physics of wing lift, but they can predict what will fly with remarkable accuracy. A plane is designed by engineers, built to their specifications, is rolled out on to a runway and takes off perfectly. We have such trust in our aviation knowledge and our engineers that we are not surprised.

In contrast, many drugs fail completely to do any good when put into patients. If manufacturing new aircraft were like designing new drugs, nine out of every ten newly designed planes would crash on take-off. The key issue is that we are far from having biological knowledge at anywhere close to the precision that we have engineering knowledge. We cannot generate a blueprint specifying how the human body works.

How do we know if a drug is doing any good? An airplane cockpit is crammed with indicators that monitor the status of almost every important function. If something begins to go wrong, it is quickly detected and the pilot can know whether corrective actions are indeed working. The pharmaceutical industry usually lacks good measures of the efficacy of its interventions. How do we know if a drug for Alzheimer’s or schizophrenia or cancer is having an effect? Lacking quantitative biomarkers that reflect the progress of a disease makes it a huge challenge to measure drug efficacy. We cannot fix what we cannot measure.

We also lack a theory of drug efficacy. We may scoff at the old theories from Galen’s time of balancing the humors by medical intervention, but in truth we are not much more sophisticated now. Drugs are essentially poisons. We treat a disease by poisoning the patient. To continue the airplane analogy: it is like repairing a defect in an airplane by breaking something else. Yet drugs do often succeed in improving the quality of life for patients. The explanation of this paradox is emerging, albeit slowly, as we move from reductionism to look at the human body as a set of interlocking systems. Aircraft engineers have followed a systems approach for decades.

Comparison with the aviation industry dramatizes for us the wicked problem. The pharmaceutical industry needs a much more precise blueprint for the human body; greater knowledge of its interlocking regulatory systems; and accurate monitors of functional defects. It needs clinical doctors working with research scientists and bioengineers.

There is a win-win solution. A great research university, given the incentive of a deal like the BP-Berkeley arrangement, may be able to pull together the bio-innovation ecosystem necessary to solve the pharmaceutical industry’s wicked problem.

Source: California Institute for Quantitative Biosciences