It’s tough presenting programs on technology transfer because so much has already been said that it’s hard to find something new. However, that was not a problem this week in San Francisco at the BIO Technology Transfer Symposium.
The Symposium began with an overview of the efforts by the Obama Administration to spur innovation including funding macro and micro grants to encourage the development of regional technology clusters, and proof of concept centers to help bridge the “valley of death” between early stage research and the point where private capital will pick up development. However, a wise caution was added that the US must avoid federal micromanagement of innovation, which is deadly to entrepreneurs. The participants agreed that “valley of death” issues are intricately linked with the prospect of marketing approval and commercialization of a potential product, which are in turn linked with job creation and economic growth.
A key discussion addressed “Enhancing America’s Competitive Edge.” The US originated 62% of the top 50 drugs on the market, and between 2001- 2010 fostered 57% of new chemical entities. However, participants agreed that there is room for improvement in the R&D and collaborative process given the increased need for innovative products. Suggested areas for improvement included better and more predictable animal and disease models, a more streamlined and less burdensome federal regulatory system, and ways to ease commercial pressure that often forces companies to terminate projects earlier in the pipeline. The participants agreed that these factors, if addressed, would not only bring venture funding back into biotech, but would also encourage global uptake of biotechnology products, to the benefit of patients, farmers and other consumers.
The Symposium touched on the fact that even new drugs are viewed as “costly innovation ”– despite evidence that such drugs actually save as much as seven times in non-drug expenditures otherwise used to treat patients. It was suggested that one way to address this concern may be to involve patient groups in the review process as the interests of those with the most as stake—the patients—are commonly absent. Given that the thrust of the current system is to “do no harm”, regulators tend to shy away from risk taking. A representative from the patient community indicated that perhaps a better motto is “do some good” focusing on the need to relieve human misery in addition to insuring drug safety and efficacy. The efforts of AIDs activists in the 1980s which compelled the U.S. Food & Drug Administration to speed review times were cited as a model for how this can work.
In a lively discussion of efforts to improve the commercialization of university research, participants suggested that universities could shift the focus from licensing income to the positive impact the discovery could have on society. With 49 of the 50 states[i] encouraging the development of a biotech industry, moving research to the marketplace appears to be a key part of the economic development strategy for not only the national government, but also at the state and local level.
The Symposium wrapped up by stressing the need for increased collaborations between all stakeholders and for creative approaches in the biotech ecosystem. Participants agreed that while there is room for improvements, in particular to the regulatory review process, the licensing of inventions through university tech transfer offices in general works well. In fact, a proposal in the recently-issued report of the Jobs Council to President Obama which called for a “free agent” inventor system was quickly dismissed as being of little interest to the Administration by Paul Corson, Acting Director of the Office of Innovation and Entrepreneurship of the U.S. Department of Commerce.
[i] Currently, Alaska has no biotechnology initiative.