Nancy J. Kelley
President and CEO, Nancy J. Kelley & Associates
In this video, Nancy J. Kelley, former founding executive director of the New York Genome Center, gives a presentation of the economic, social, and regulatory implications of biology.
Kirkpatrick: Next, I want to introduce Nancy Kelley, who in a former life founded the New York Genome Center. And I’m especially happy she’s going to be making the presentation here, because what she’s talking about is going to be the biggest implications for the planet, for human society, of synthetic biology and of some of these other biological innovations we’ve been hearing about today, like what does it really mean for the big picture. So Nancy, let’s hear about it.
Kelley: Okay, so I’m going to have a seat here and just kind of have a conversation with you. Really, we’ve been exploring the boundaries between synthetic and biological world for almost two hundred years. So when Friedrich Wöhler turned ammonium cyanate, which is an inorganic salt, into urea, which is a natural compound produced by the kidneys, he basically set the stage for the question of what is life and where is the boundary between an inorganic molecule and something that is alive.
We’ve been talking a lot about synthetic biology this afternoon and specific applications for what this will mean for the future of our planet. So I just wanted to talk to you a little bit about the fact that we’re living in a cultural and social and political environment. So this was Friedrich Wöhler. And we are actually living in an environment where we need to think about these things systemically and how we can make efforts like this sustainable over the long run, so that they actually have permanent change on our planet, addressing real global solutions.
And I believe that what is really at stake here is the future competitive advantage between countries, and I think we’re seeing this evolve now where the United States was in a position actually pioneering this science and developing it and proving it over the last fifteen years. And now that the promise and potential is actually being demonstrated, you’re seeing the EC and the UK and countries like China really beginning to invest in this area in ways that will surpass the efforts of the United States. And they’re really understanding what this means for employment, economies, and the creation of wealth.
So synthetic biology actually is not that old. It was first established as a field in 2000 with a handful of scientists from a small number of Universities who started working on a concept that had not yet been proven. And basically what has happened in the interim period is that it’s evolved not only into an academic exercise but also has spawned a growing industry that in 2011 by some estimates was worth about $1.6 billion, and is growing at a 45 percent compounded annual growth rate, so that by 2016 it’ll be somewhere around $11 billion. And it sits within what Rob Carlson estimates is a $350 billion dollar economy, as Drew was describing earlier, which plays a very, very important role in the United States economy now.
I think the development of this area is reflected in the rapidly growing number of registries where designed parts, devices, and chasses are actually being deposited today’s also the number of for-profit companies that are growing in this area, which basically tripled between 2009 and 2013, when they grew from about 61 to about a 192, primarily here in the United States.
And what we’re seeing is that the solutions that they’re bringing to market are really profoundly changing the way in which we live, from the energy space where Solazyme is basically creating the first consumer-ready algae-based fuel for cars, planes, and boats among other things in the chemical area, which is especially exciting. And what we’re seeing is synthetically-derived palm oils, which have just made the news recently, could reduce deforestation, and this is really important because some claim that in fifteen years 98 percent of the rainforest in Indonesia and Malaysia will be gone unless we create a sustainable way of producing palm oil.
Agriculture’s we’ve got seven billion people living on the earth today and the global population is growing exponentially, while the food supply is only growing arithmetically. And so obviously we need higher-yield crops that can be grown in areas where there’s not a lot of water and that are pest-resistant, and it’s going to be incredibly important to be able to feed the world.
And then when you get to health, medicine, and human improvement, I mean this is where you’re really spanning all of the different industry segments, as has been discussed earlier. So we see companies like Novartis working to establish real-time, geographically dispersed vaccine production for pandemic viruses, and this became especially important and was demonstrated to the world in 2009 for the H1N1 virus, which became available only after human infections had actually peaked.
And then finally for bioremediation and in the environment, we saw modular genetics engineering a microorganism that produced soy-based biodispersions, and this was important for the cleanup of the 2010 Deepwater Horizon oil spill in the Gulf.
And so as I said, the U.S. has lead in the conception, development, and commercialization over the last decade, but now other countries are really paying attention and investing, and so we need to understand what are the areas that we need to really pay attention to and address in order to keep our leadership and our strength in these areas.
So some major areas that I think we need to I be thinking about as we think about our responsibility in advancing this great promise for the world:
First, we’ve only just scratched the surface. There is a great need for new foundational and translational technologies and tools and need for fundamental research in biology in terms of how it actually works and how we understand it. And so methods, technologies, biological platforms, computational tools, and bioinformatics all of this still remains to be developed.
I think we really need to look at the leadership problem and question. The U.S., despite its early entry into this area, currently lacks a coordinated, integrated, and strategic approach to leadership on a global level. And although some roadmap activities are beginning to take place now—I think there was one that was published last week on ecology by the Wilson Center and others and there’s another that’s underway for specialty chemicals—these do not address the strategic needs of the United States’ research and commercialization field as a whole and the EU and the UK have published roadmaps of their own, China has a roadmap of their own and they are mobilizing to put funding, education, and infrastructure investments behind these roadmaps. And we need to really think about where the strategic leadership in this country is going to come from today.
We talked about funding and we’ve talked about the fact that this is a multidisciplinary field. Funding needs to come from a number areas, it can no longer just come from the federal government. But unfortunately, that is where the scientific community is really looking for the next round of funding. Federal funding is not integrated, the agencies have not come up with an idea of what they’re going to fund, how they’re going to fund, how they’re going to coordinate it. And so I think what we need is a non-governmental approach, which basically allows the foundations, academia, commercial entities, and government to come together in a way that will really put funding behind some of the larger multidisciplinary projects that we need.
We’ve got a very complex regulatory structure right now, and if some of you have been following synthetic biology, you know that it is not prime time for overseeing the introduction of some of these new products into the marketplace, and in particular we had the Venter Institute just last week—or two weeks ago—releasing an analysis of the regulatory structure for plants and engineered microbes and really pointing out that there were some serious gaps that needed to be filled here. And at a meeting that was sponsored by the National Academy of Sciences in the U.S. last year, the U.S. agencies themselves acknowledged that they weren’t ready to begin regulating in many areas in connection with synthetic biology, and they cited a lack of expertise and knowledge amongst regulators and program managers who actually can no longer keep up with the science themselves. And they are suggesting the need for more education and much closer collaboration between government regulators and the private sectors and academia, in order to really allow regulation to move forward so that it will not become a bottleneck as new companies begin to produce products.
Public awareness and acceptance: There’s been a lot a discussion here this afternoon about that and obviously we all know, as we’ve been discussing amongst ourselves, the opportunities and the benefits that this exciting new science will bring to us. But it’s really pretty scary to a public that doesn’t understand it. And so we’re facing a skeptical public and I think that this is illustrated just this week by the calls for labeling and regulatory review of an ingredient in Ecover natural laundry liquid that is designed to replace palm oil. And if we go down that route, we’re going to go down the route of GMOs and how it was regulated in Europe and that’s going to be a real problem. It will be a real way that this industry will be prevented from moving forward in the way that it should. And so in the absence of a legitimate mobilizing responsible voice, the opposition is educating the public and we just can’t let that happen.
So how can we get there? Somebody asked that earlier this afternoon and I think that one of the ways that we can get there is by thinking creatively about how to engage the public on the questions that this kind of science raises. One of the best examples I’ve seen of that is the exhibition on the human genome project that actually was launched at the Smithsonian last spring and which raised many of the questions in connection with medical genomics that the public will need to grapple with. And they actually encouraged individuals walking through the exhibit to grapple with those questions themselves and then gave them responses of where they stood or where their responses lay in terms of public opinion in the United States.
There’s been a lot of talk about infrastructure and I have kind of a set of items within what I call the bio-commons infrastructure that is currently lacking in terms of access to the entire syn-bio community, and these are tools, kind of laboratories that can be used by both academic and industry to bridge the Valley of Death between the laboratory and commercial adoption. And they include registries, repositories, software tools, biofab, standards. It would include adequate approaches to intellectual property that would preserve our ability to commercialize technologies while maintaining open-source environments for researchers to use and build on. And there’s ways that we can do that but we need to build it into the infrastructure.
So how do we manage these issues? In short, I think we need a bold vision to support where we need to go while tying it to the present. What does that mean? I think we need an organizing force, a coordinating entity that can support the community, grow its leaders, serve as a mobilizer of researchers, industry, government, and philanthropy. We need a research community that continues to lead in the development of both foundational tools and applications. We need new funding. We need another generation of researchers and advocates. We need a research community, which includes citizen researchers, that is trained and committed to responsible innovation, public engagement, a shared vision with roadmaps, a bio-commons infrastructure. And all of this will lead to a growing portfolio of commercial successes and industrial collaborations.
But I think it really boils down to the bottom line: What do we need today? Additional research with money to support growth, contributed by institutions that believe in the syn-bio vision and led by champions with passion. Syn-bio has the ability to solve many global problems today and now is the time to engineer the future for the U.S. in this important field and for the entire global syn-bio community. Thank you.