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Lost in translation?
In QB3’s Anti-Medical School course, UC Berkeley and UCSF bioengineering students try to solve real-world problems that doctors face in the clinic.
Wednesday night, QB3 hosted a talk at Byers Auditorium in Genentech Hall entitled “Translational Medicine: Key to Progress or Bridge to Nowhere.” Speaking at the lecture was Andy Grove, co-founder and former CEO of the semiconductor giant Intel.
Grove spoke about the problems currently facing drug development. In terms of time and investment, he said the closest equivalent process in history to the creation of a single drug is the construction of a single pyramid in ancient Egypt. According to his estimates, a pyramid cost the equivalent of $1.5 billion US dollars and took 20 years to construct—similar to the average drug development cost and time in the US since the early 90s.
Things are only set to get worse. Grove pointed out that modern science is currently facing a new age of genetic- and cellular-based personalized medicine. The complexity of delivering such individualized drugs repeatedly and effectively will require a new way of thinking about medicine. Researchers will need to rely heavily on integrative technology and collaboration. Grove cited the implantable artificial kidney under development in the lab of Shuvo Roy at UCSF as one such approach to overcoming such problems.
But other difficulties loom. Because of the extraordinary complexity of personalized medicine, researchers have a hard time telling the truly relevant effects from everything else, said Grove. This unsettles investors, who consider biotech a “risky business at risk.” Currently, potential biotechnology seed investments are diverted to Silicon Valley social networking sites, he said.
And then he delivered the bad news.
According to Grove, the industry is not primed for the overwhelming change it will face in the coming decades. Transformation is needed, he said repeatedly. This revolution will only come if people can lower the resistance to flow of knowledge from labs and research organizations to pharmaceutical companies.
Ideally, Grove said, knowledge flows from a medical center to industry and dollars flow back. Biotech startups are the perfect transitional step between such institutions. Unfortunately, due to difficulties in integration and regulation, nothing flows either way, said Grove.
The solution for him is to do science and early research inside the industry. Grove cited his work at Intel, where he got rid of the R&D department and placed it entirely inside manufacturing, streamlining the process. Perhaps such a model could be a boon to clinical medicine, he suggested.
Regulation has also become a barrier to companies trying to develop new medicine, said Grove. Because it is so easy to file, the US patent office is overwhelmed with trivial and obvious inventions. This is threatening and kills innovation, he said. Furthermore, the agency has been slow to upgrade from paper-based technology to computers, which would greatly reduce waste and increase speed, he said.
In addition, the FDA, while trying to help, has also slowed innovation. Every year, 800,000 scientific papers related to new drugs appear in the literature, said Grove. From these, 6,000 new drugs make it to phase 3 FDA trials. But because of stringent standards, only 20 new drugs come to market each year.
Still, Grove’s talk was not all about gloom and doom. He urged scientists and doctors to get involved in trying to change the system. Ultimately, researchers need to look into doing science that’s not just for itself, Grove said. They need to produce products that help people.