FINAL THOUGHTS
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Roger L. Lundblad, PhD, is an independent consultant located in Chapel Hill, NC. He can be reached at lundbladr@
bellsouth.net. |
A sense of frustration has emerged in the world of biomarkers. There is a perceived lack of progress in this area considering the hype that came with the start of the biomarker hunt. The term biomarker originally described organic compounds found in crude oil, which could identify the geographical source. The term now describes the Holy Grail for IVDs. Legions of scientists mounted their mass spectrometers and roared off in pursuit of definitive markers. While the results have been interesting, the return on investment has not been what had been expected. It appears as if the ability to analyze has outstripped the ability to design useful tests.
Perceived Productivity
A colleague once pointed out two sure ways to get famous in the biological sciences field: discovering a technique that is used and cited extensively (e.g., a protein analytical procedure), or naming a process or concept (e.g., proteomics, biomarkers, allosterism). I had these observations in mind as I attended two professional meetings this year. One meeting was concerned with biosimilars in biotechnology, and the other was a large multidisciplinary conference. The first meeting examined how biotechnology, like the motion picture industry, is stuck in a creativity crisis and is developing sequels rather than new productions.
At the second meeting, a lecture discussed the role of serendipity in the evolution of medicine. The speaker observed that even though computer-guided combinatorial chemistry has increased the ability to screen potential drug candidates, it is not clear whether it has improved creativity in developing new medical device technologies. The speaker also noted that while text-mining for literature searches has enhanced the ability to screen the growing volume of literature, it has stripped out the context. A colleague has similarly suggested that although electronic journals enable researchers and scientists to do their scholarly reading in their pajamas while drinking a glass of wine, they have narrowed the literature coverage. Even though researchers have boosted their perceived productivity, it is not clear whether they have improved their creativity.
Creativity and Innovation
The literature is full of articles and books on creativity and innovation in medical device technology development, although they sometimes do not distinguish between the two activities. While it can be argued that separating the two activities is like splitting hairs, there is a difference. For example, the development of the cordless phone was an innovation, and the development of the cellular phone required creativity. I have been involved in discussions on improving and teaching innovation and creativity, and creating the impression that innovation and creativity can be structured and that centers for innovation can be built.
Two articles have recently added to my focus on the issues of biomarkers, innovation, creativity, and the future of biotechnology. Professor Markus Pohmann of Ruprecht-Karls University (Heidelberg, Germany) published a thoughtful paper on the evolution of innovations. In his article, he noted that while there are no general rules for sustaining innovation, institutions can take actions that stifle innovation. The other article was written by Professor John Frangioni of Beth Israel Deaconess Medical Center at Harvard Medical School (Boston). This article made the case for a paradigm shift in the development of new medical technologies from profit-making companies to academic medical centers.
For the moment, I will ignore the fact that academic medical centers have their own problems with profit motives. Nonetheless, I am fortunate that I still retain a relationship with a medical center, and I try to attend the various grand rounds presentations. Such attendance has confirmed for me that future clinical advances in diagnostics and therapeutics will come from observations made by clever clinicians and not from computer-driven synthetic or analytical programs. Frangioni was correct in urging the shift from a focus on monetary gain to “effect size.” Such progress in identifying clinically useful biomarkers will proceed faster with more thought and less instrumentation, more focus on “effect size,” and more consideration of the older literature.
