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.
[Editor’s Note: This editorial is also being posted on the QB3 website.]
Author: Regis Kelly
Regis Kelly is the director of the The California Institute for Quantitative Biosciences (QB3) at the University of California. QB3 is one of four California Institutes for Science and Innovation, created by the California Legislature to strengthen the academic foundation of its technology-based industries. QB3 is the only one of the four devoted exclusively to biology and to the life science industries. It is an innovation center made up of over 200 quantitative biologists at three northern California campuses (UC Berkeley, UC Santa Cruz & UC San Francisco) working at the interface of the physical and biological sciences and a team of professionals converting its discoveries into practical benefits for society.
From 2000 to 2004, Dr. Kelly served as Executive Vice Chancellor at the University of California in San Francisco, where his major responsibility was the new Mission Bay campus. This campus, whose development over the next 10 years will double UCSF’s research space, is the center of a planned 300 acre public/private biomedical research park in San Francisco.
From 1995 to 2000, Dr. Kelly served as Chair of the Department of Biochemistry and Biophysics at UCSF; from 1988 to 1995, he was the Director of UCSF’s Cell Biology Graduate Program; and from 1992 to 2000, he was the Director of the Hormone Research Institute at UCSF. He has published extensively in the areas of cell and neurobiology.
Dr. Kelly received his undergraduate degree in Physics from the University of Edinburgh in Scotland in 1961 and his Ph.D. in Biophysics from the California Institute of Technology in 1967. Following a post-doctoral fellowship at Stanford, Dr. Kelly was an instructor in the Department of Neurobiology at Harvard. He has served as Chairman of the Bay Area Scientific Innovation Consortium (BASIC) and on the Boards of the Malaysian Biotechnology Industry Advisory Board, the Scleroderma Foundation, the Immune Tolerance Network, Bridge Pharmaceuticals, and the San Francisco Mayor’s Biotechnology Advisory Group, among others. He is also a General Partner of Mission Bay Capital venture fund.
View all posts by Regis Kelly