Three Steps Toward Actualizing the White House’s Bioeconomy
May 7th, 2012
Posted by Paul Sonnier
The White House Office of Science and Technology Policy (OSTP) recently released its “National Bioeconomy Blueprint”—a detailed proposal on how advances in our knowledge of biology and biotechnology have spurred significant enough economic activity (e.g., labor, capital and resources) to create a new type of economy for the United States.
While the report focused on many areas outside of healthcare, the following three points struck me as significant for those of us who spend our time thinking about life sciences:
- We must facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences. If a national “bioeconomy” is to be successful, it must be based on a steady flow of new products and services that address the needs of American and global customers. Ensuring this steady flow will mean that policies must be developed—and taxpayer dollars used responsibly—to foster an environment that supports discovery, innovation and commercialization.
- We must integrate approaches across fields. Modern research questions have become so complex that traditional boundaries between fields of study have become permeable. Today, programs must concentrate expertise from diverse disciplines around society’s greatest challenges. The Administration should prioritize (fund) additional multidisciplinary efforts to enable biological research at the boundaries of fields, such as physics, chemistry, engineering, computer sciences, and mathematics, as well as genomics, imaging, biosensors and wireless technologies that will all support the new bioeconomy. The success of systems biology in using genetic data and other big data sets to link and thus redefine disparate diseases is an example of how these efforts are starting to pay off. The bioeconomy can borrow from cross-disciplinary approaches used in other industries like construction and defense.
- Moving forward—improved regulatory processes will help rapidly and safely achieve the promise of the future bioeconomy.
- Agencies should improve their predictability and reduce uncertainty in their regulatory processes and requirements. Part of this predictability includes coordinating efforts among agencies that hadn’t operated in the healthcare space; recently Rep. Marsha Blackburn (R-Tenn) and five other members of Congress asked the Federal Communications Commission and FDA to clarify their ongoing efforts to improve the regulatory process for development of wireless medical devices.
- To reduce costs and impediments, but without compromising safety, attention should be given to drug and device application review times, coordinating reviews by multiple agencies to allow parallel (instead of sequential) reviews, and specific guidance that should be issued in response to stakeholder needs.
- When emerging technology enters the regulatory process, agencies must have a solid framework to identify lead agency responsibilities, clarify supporting agency roles, and deliver timely, specific guidance for applicants. At the very least, these new moves should update and streamline the 1986 Coordinated Framework among federal agencies.
In future posts, we will be talking more about how the federal government is planning on aligning itself with the new bioeconomy, including initiatives in digital health and takeaways from some of our meetings with federal government representatives.
What was your key reaction to the White House’s blueprint for a bioeconomy? Are there points that you honed in on? For what other programs should the OSTP advocate? Is a future “bioeconomy” even a realistic concept? Share your thoughts with us.
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