Can we expect the biopharma folks to quickly find a good treatment for COVID-19? Is it time to bust up regulatory barriers holding back innovation?
In March 1997, BusinessWeek magazine, now part of Bloomberg, ran a cover story entitled “The Biotech Century.” The cover language, in part, said “Thanks to fundamental advances in genetics, biology will define scientific progress in the 21st century.”
In the subsequent 23 years, biological scientists have achieved notable scientific triumphs, including the sequencing of the human genome. HIV was tamed, HepB has been cured, and gene therapies are slowly coming onto the market. Since that cover, the private and public sectors have spent probably close to $2 trillion on health-related research and development, a truly astonishing sum.
Nevertheless, the acknowledged innovation leaders in the 21st Century have been info-tech companies like Google, Apple, and Amazon. Pharma companies like Pfizer, Gilead, and Roche have done well, both in terms of beneficial new drugs and business success. But they haven’t captured the popular imagination like the tech firms.
Unfortunately, that’s fair. Tech applications have gotten cheaper and faster across the board. Meanwhile, bio science has moved really fast, but market applications of the new science have been much slower. Moreover, the promises of faster, cheaper, more targeted drug development seem to have fallen short. Instead, drug development has been getting more expensive and riskier.
There’s no agreement, though, on why the scientific advances have not translated into lower costs and faster drug development. There are three leading hypotheses, not mutually exclusive. First, the intricacies of medicine could be a lot harder and more complicated than scientists thought. Second, regulatory barriers in bio could be slowing down innovation. Third, the profit motive could be diverting biopharma firms from truly important R&D.
Now the moment of truth for bio has arrived, along with a global pandemic that rages out of control. Tech companies can be helpful in maintaining the infotech infrastructure that allows the essential social distancing. But the real innovative responses have to be carried out by the university labs, the biopharma companies, and hospital researchers.
Some of that has started. Roche and Thermo Fisher have developed new faster tests for coronavirus, which received emergency clearance from the FDA. Companies such as Gilead and Regeneron are developing and testing new treatments at a breakneck pace. And vaccines are going through their initial round of tests.
But it’s not enough. What we can do to help: Make it clear that innovation and new ideas are encouraged, even risky ones. Legitimate researchers with new tests and new solutions should be encouraged. And unnecessary regulatory barriers that slow down drug and vaccine development should be temporarily thrust aside. This is not a time for business as usual.