Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes advocated under anticipatory and adaptive approaches by laying the groundwork for and providing valuable data to support future normative deliberations about the governance of emerging technologies.

Harnessing our very life.

The Aristotelian ideas of nature (physis) and technology (techné) are taken as a starting point for understanding what it would mean for technology to be truly living. Heidegger's critique of the conflation of scientific and technological thinking in the current era is accepted as demonstrating that humanity does not have a deep enough appreciation of the nature of life to harness its essence safely. Could the vision of harnessing life be realized, which we strongly doubt, living technology would give selected humans transforming powers that could be expected to exacerbate, rather than solve, current global problems. The source of human purposefulness, and hence of both technology and ethics, is identified in nature's emergent capability to instantiate informational representations in material forms. Ethics that are properly grounded in an appreciation of intrinsic value, especially that of life, demand that proposals to give humanity the capabilities of living technology address the social, political, economic, and environmental problems inherent in its development and potential deployment. Before any development is embarked on, steps must be taken to avoid living technology, whatever the term eventually designates, becoming available for destructive or antisocial purposes such as those that might devastate humanity or irrevocably damage the natural world.

Maintaining a relevant, up-to-date capstone design course.

Senior capstone design courses can be extremely helpful in preparing biomedical engineering students for careers in engineering and other fields. They allow students to develop communication, teamwork, and other transferable technical and nontechnical skills. They can also make students aware of the (1) legal, regulatory, economic, environmental, and social/political constraints of medical device design, (2) contemporary issues related to biomedical engineering and health care, and (3) the latest trends and tools in new product development and project management.

Bioengineered bugs, drugs and contentious issues in patenting.

Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.