2015 BIO World Congress on Industrial Biotechnology

I’ll be attending BIO’s World Congress on Industrial Biotechnology next week (July 19-22, 2015), and I’ll be presenting two talks at breakout sessions. One will discuss the emerging roadmap for gaining regulatory approvals for uses of genetically modified algae in industrial biotechnology; covering topics applicable to uses of any modified microorganism for fuel or chemical production. The other talk will analyze whether existing biotechnology regulatory frameworks are sufficient to cover industrial products developed using synthetic biology.  I’ll post copies of my presentations after the conference, and time permitting I’ll try to post some updates on the conference here on the blog. Please contact me with any questions or for more information about my talks.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Blog Post 100: Reflections on the State of the Bio-Based Industry

On this, the 100th post on the Advanced Biotechnology for Biofuels blog, I thought I would take this opportunity to write on a more personal note. When I started this blog in January 2010, I was pretty much an outsider to the biofuels industry – I was a veteran of several different sectors of biotechnology, with skills and prior experience that I felt were applicable to companies using advanced biotechnology for the production of fuels and chemicals. So I created the blog as an outlet to discuss things I had been learning about the industry, and to elaborate on topics where I felt I had knowledge and expertise to offer, in areas like biotechnology regulations. Now, biofuels and industrial biotechnology have been my sole or main professional focus for over three years, having worked in-house or consulted for several leading companies with exciting new technologies, participated in numerous conferences, trade association activities and other industry events, and developed a broad network of contacts within the field. So I hope I’ve earned the right to make some observations about the field and where it’s heading.

One thing that hasn’t changed is my passion for the field and my belief that developing a global bio-based economy is essential. If anything, the importance of what we’re doing is even more clear to me than before, as evidence for the severity of human-induced global climate change becomes more convincing (yet the vehemence of the “deniers” just grows and grows), and the need to move away from a fossil-based economy throughout the world becomes more evident. It will likely be a long transition, maybe requiring decades, but I’m convinced that biological methods will eventually command a significant portion of the strategies the world uses to manufacture fuels, chemicals and other products that today are petrochemically-based, and that this will be a key weapon in the ongoing struggle against climate change.

However, having seen the industry up close for these past several years, I now have a clearer understanding of just how challenging these goals will be to attain. I must admit to coming into the field with a certain amount of “biologist’s bias” – in thinking that designing and creating the production organisms was the most important part of the process. Although even then I knew that there was more to successful commercialization than just splicing a few genes and throwing the resulting bug into a fermentation vessel, working closely with several companies and their staffs have shown me just how many challenges, at so many levels, must be overcome to achieve large-scale commercial success of a novel microbially-based process. To mention but a few: production organisms, growth media and fermentation conditions must be tweaked and optimized for improved performance; engineering challenges of many kinds must be overcome to move from the lab to each successive stage of commercial proof of concept and demonstration; processes must be fine-tuned to be economically feasible and to present the most favorable carbon footprints; and large amounts of capital must be raised through financial markets or from strategic partners to build even modest-scale demonstration plants or commercial facilities. And that’s not to mention the marketplace barriers which serve to protect entrenched competing interests, issues of consumer acceptance, and those instances where innovative products or processes are singled out for excessive oversight or regulation. It’s an uphill battle, and I have the utmost respect for those companies that have successfully fought through these issues and that have gotten bio-based fuels or chemicals on the market.

At the same time, it’s clear that bio-based industries need favorable policy environments to succeed in major market countries. I won’t comment in detail here about specific policy initiatives important for the industry’s success, which I’ve done recently in a series of posts on my Biofuel Policy Watch blog, except to say that government policies (such as the U.S. Renewable Fuel Standard and the EU Renewable Energy Directive) continue to be critical to the successful growth of fledgling industries like ours, and even where favorable treatment (e.g., subsidies, tax credits) is not politically possible, the least we can ask is for a level playing field with regard to competing technologies and entrenched industries. And, as I’ve often said, even as political stalemate and climate change denial increasingly stymie chances for meaningful policy reform in the U.S., I am heartened by the reality that other regions of the world (where politicians still believe in science!) can lead the way in developing policies to encourage the growth of the industry. And I appreciate that I’ve had the opportunity to work with several excellent companies from around the world who are bringing innovative solutions to address international markets.

What I find to be a continuing frustration is the recurring criticism of certain biofuel strategies from groups with whom the industry shares common goals. By this I mean those NGOs or other environmental activist groups, who by all accounts are equally passionate in their desire to phase out use of fossil fuels, but who continually snipe at products like corn-based ethanol as not meeting their lofty standards. Now, virtually no one in the biofuels industry seriously believes that corn ethanol or other food-derived fuels are the best and ultimate answer to all our problems, and I believe most observers consider products like these to be transitional towards advanced generation fuels (more on that in a moment). And I acknowledge that some of the traditional methods of producing ethanol from corn, or biodiesel from palm oil, or other food-based fuels, may not have particularly favorable carbon footprints. But come on, how could a responsible environmentalist possibly think that producing fuels from renewable biological sources is worse for the environment than extracting messy mixes of chemicals from oil or other fossil sources and unleashing into the atmosphere carbon that has remained underground for eons? This criticism of the industry, and of scientists and companies that are working diligently and in good faith for society’s benefit, creates confusion and ill-will in the public’s perception of the biofuel and bio-based industries, causing significant and completely unnecessary blowback to the industry’s progress, which frankly is really a disservice to the global efforts to combat climate change.

It’s clear that some of these concerns from the environmental community and others have been triggered, or at least exacerbated, by the delays in development of those second or third generation biofuels for which food-based fuels were supposed to pave the way. In particular, progress on cellulosic ethanol has been frustrating, since so many companies have been at work on these technologies for so long. In retrospect, the challenges that were encountered on the road to commercialization should not have been surprising. In addition to all the generic challenges facing biofuel production that I mentioned above (particularly the enormous amounts of capital and long time frames needed to design and build commercial-scale plants), most observers underestimated the technological challenges. After all, woody plants evolved the ability to synthesize and use cellulose over millions of years precisely to provide physical and chemical stability and resistance to degradation, so it should not have been surprising that it would be so hard to devise quick, economical and energy-efficient ways to break down cellulosic materials into fermentable sugars. But that being said, it does appear that 2014 will finally be the year that sees a significant number of cellulosic ethanol plants coming on line, and significant volumes of cellulosic fuels produced, with a healthy pipeline of many other commercial projects expected to follow in the very near future.

It is gratifying to see success with advanced biofuels like cellulosics coming at last. To me, the next frontier, and the one having the most long-term promise of microbiological methods to reduce carbon emissions, will be the development of photosynthetic processes where microorganisms such as algae or cyanobacteria can be used to synthesize fuels or chemicals directly from sunlight and carbon dioxide. This too has been an endeavor which has long been talked about, particularly for algae, and where numerous technological and economic challenges have been, and continue to be, faced. Having some familiarity with this sector of the industry (see my disclaimer below), I can see the magnitude of the biological and engineering challenges standing in the way of economical, large-scale use of such technologies. But again, I see an imperative here in the climate change battles – just as the world needs to increasingly turn to solar and wind power to create electricity or heating energy, the transport sector too must find ways to make use of the most abundant renewable resource available to mankind – solar energy – to manufacture the fuels needed for the world’s growing population. Furthermore, photosynthetic fuels offer the added promise of being able to utilize industrial carbon dioxide wastestreams that would otherwise be released into the atmosphere, potentially adding an additional weapon to the arsenal against climate change. I don’t pretend that development of photosynthetic fuels and chemicals will be quick, but I feel it is imperative and inevitable.

I’m also pleased to see the increased willingness of companies and academic researchers all around the world to explore or develop the use of genetically modified microorganisms and plants for fuel or chemical production. There has certainly been reluctance to use GMOs commercially in most industry sectors other than pharmaceuticals, because of the perception that excessive government regulation and intense public opposition would make such uses impossible or extremely difficult. Although this remains true in some regions of the world,  it is far from universally true. Having cut my teeth in the world of agricultural biotechnology at the time the public debates about environmental impacts of GMOs were most intense, and having successfully obtained early government approvals for GMO field tests at the time they were most difficult and controversial, it’s been one of my missions to convince people that, where industrial uses of a modified microorganism or plant are justified for business reasons, regulatory approvals are achievable with proper planning and management.

At this time, I think it’s fair to say that most industrial biotech companies have accepted or even embraced the possibility of using genetically engineered microorganisms in manufacturing, and that few are consciously avoiding GMOs. There’s also been increasing (albeit cautious) interest in GMOs within the algae community, where the prevalence of open-pond reactors creates a more challenging path to regulatory approval that has discouraged research using modified strains (although I’ve argued in a recent post that the regulatory system can accommodate stepwise reviews and approvals of outdoor uses of GMOs moving from small to larger scale outdoor uses). I can’t take any credit for changes in the prevailing attitude (in spite of my self-appointed position as “missionary”), but it is true that many companies are using, or planning to use, modified microorganisms and that regulatory approvals for these uses are possible and in some cases fairly easy, at least in most industrialized countries.

I do need to point out a disturbing trend on the regulatory front, and that is the elevation of “synthetic biology”, especially as it being applied in industrial biotechnology, to be the new bogeyman of some environmental groups or academic scientists. In particular, many groups or individuals are alleging that regulatory systems in the U.S. and elsewhere in the world are somehow inadequate to provide proper oversight over commercial uses of synthetic biology. And in doing so, I hear the same tired arguments about potential adverse environmental impacts and the supposed gaps in the regulatory system being recycled from the 1980s. I’ve always said that legitimate questions must be addressed in risk assessments of industrial uses of modified organisms. And, I would agree that, carried to extremes, i.e. the theoretical ability to completely remake a microorganism’s phenotype or biological characteristics, synthetic biology is a potentially powerful tool. But in the eyes of government laws or regulations, there’s no difference between an organism carrying a small number of heterologous or modified genes and an organism containing dozens of foreign or synthetic coding sequences – the same laws can apply, and the same principles of risk assessment would be used in the latter case as has been done for decades for the former.

This focus on synthetic biology is troubling because of the “slippery slope” – if new regulations are indeed adopted, how many genes must be manipulated before you call it “synthetic biology” and subject a project to such greater regulatory scrutiny? But this also ignores real world considerations. I would argue that there little commercial need today to go to significant lengths to make wholesale synthetic changes to a microorganism to accomplish a desired industrial purpose. And even when such a need arises, companies will get there incrementally by a series of sequential changes to a known production organism, with regulatory oversight and risk assessment taking place as each incremental step reaches commercial use. I would be very surprised to see a proposed industrial use of a completely synthetic organism arise out of nowhere. But again, there is no reason to allege that there is something special about synthetic biology, however it is defined, such that regulatory regimes around the world are suddenly inadequate to deal with it.

So, I remain optimistic about the prospects for the biofuel and bio-based chemical industries, in spite of the challenges I’ve discussed here. No doubt these and other obstacles will continue to be faced as the companies in the industry move forward, but I’m sure that there will be significant commercial successes in the very near future. I look forward to continuing to work with my colleagues in the industry, to contribute to this success in whatever small ways I can.

As always, please note that the views expressed in this blog are my own, and do not represent the views of any of the companies or other institutions for whom I have consulted or are otherwise affiliated. In the interests of full disclosure, I have current or past consulting relationships with several companies in the industry that are or might be affected by the policies I’ve discussed in this post, and I have a financial interest in Joule Unlimited Technologies, one of the companies developing photosynthetic routes for the production of fuels and chemicals.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Upcoming Plenary Talk at Algae Bioproducts Meeting

I’ll be giving a talk later this week at the The 4th International Conference on Algal Biomass, Biofuels and Bioproducts in Santa Fe, NM. The conference, which begins today, June 16, will cover all areas of emerging technologies in algal biology, biomass production, cultivation, harvesting, extraction, biorefinery, conversion, bioproducts, and econometrics, and is expected to draw attendees from academia, government and industry. I’ll be giving one of the plenary talks this Wednesday, June 18, on regulatory and scientific issues relating to the use of genetically modified algae for the production of fuels and chemicals. My talk will provide an overview of the U.S. regulatory framework that may affect such uses of modified algae, and will also cover the scientific issues that underlie the risk assessments that would take place under such regulatory programs.

I hope to convey the message that the regulatory framework is manageable with proper planning, and in fact provides a reasonable mechanism for stepwise outdoor testing of modified algae under an appropriate level of regulatory oversight. I’ll also address the role that industry, academic and government researchers can play in developing a research database to support regulatory risk assessments.

I’ll be posting my slides online after the conference, and I may also be able to report here on he blog about any relevant sessions at the conference.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

 

Upcoming Conferences

I’ve been invited to speak at the Sixth Annual Biofuels Law and Regulation Conference in Champaign, Illinois on May 2, 2014. I’ll be part of a panel addressing legal and policy issues affecting the commercial development of biofuels. The conference is sponsored by the Energy Biosciences Institute, and the conference is intended to focus on “exploring new ways that biofuel policies can be re-imagined in order to continue promoting growth in the developing biofuel industry.” The conference aims to involve leading academic, scientific, government, and industry experts, with opportunities for in-depth discussion between and among speakers and audience members, and the organizers expect the program will appeal to a variety of stakeholders, from various industry sectors. You can find more information and links for registration at http://www.biofuellawconference.org.

Later in May, I’ll be attending BIO’s World Congress on Industrial Biotechnology, May 12-15, 2014 in Philadelphia. I’ll be presenting a poster on “International Regulation of Industrial Biotechnology”. The BIO World Congress is billed as the world’s largest industrial biotechnology event for business leaders, investors, and policy makers in biofuels, biobased products, and renewable chemicals. If you’re attending the conference and would like to meet, please let me know.

Details are also being finalized for another invited talk at a biofuels conference later this spring — I’ll report on that when everything has been worked out. I’ll be reporting on any newsworthy developments or interesting discussions that take place at these meetings, and I’ll certainly be posting my slides and a copy of my poster after each conference.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Presenting a regulatory case study at BIO Pacific Rim Conference

Next week, I’ll be speaking and moderating a panel at the BIO Pacific Rim Conference on Industrial Biotechnology and Bioenergy in San Diego.  The panel is entitled “Overcoming Challenges in Regulation and Intellectual Property”, and I’ll be presenting an overview of U.S. and international regulations affecting industrial biotechnology along with a case study of my work for Joule Unlimited in its recent successful interactions with the EPA for review of a Microbial Commercial Activity Notice (MCAN) for a modified cyanobacterium for ethanol production.

The other speakers on the panel will be Kevin Wenger of Mascoma, speaking about his company’s experience in gaining regulatory approval for genetically modified yeast strains for ethanol production and use as animal feed ingredients, Konrad Sechley, of the Canadian patent law firm Gowling Lafleur Henderson, LLP, who will discuss the scope of patent protection available for biotechnology in view of recent legal developments, and Kathleen Roberts, of Bergeson & Campbell Consortia Management, LLC, who will discuss the impact of the Toxic Substances Control Act on the manufacture of bio-based chemicals.

The conference is taking place December 8-11, 2013, and you can find more information on the conference website. This is the 8th annual Pacific Rim Summit organized by the Biotechnology Industry Organization, and is the original conference dedicated solely to the growth of the industrial biotechnology and bioenergy sectors in North America and the Asia-Pacific region. In addition to four plenary sessions, the meeting will feature 30 breakout panels covering topics including algae, advanced biofuels, bioplastics, dedicated energy crops, renewable chemicals, marine bio-resources and synthetic biology.

Please let me know if you’re attending the conference and would like to meet, or if you’d like a copy of my presentation, which I expect to make available after the meeting. I also hope to blog about the conference and some of the sessions I attend, time permitting.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Ethanol News Update Posted on Biofuel Policy Watch

Just a quick note to mention that I’ve just posted the first of what I expect will be a series of news updates on my Biofuel Policy Watch blog. Today’s posting reports on news items and other developments during the last few months of 2012 and early 2013 that are relevant to the use and market acceptance of E15 ethanol and other higher blends of ethanol such as E85. This includes updates of legislative and regulatory developments at the federal and state levels, and other developments in the states promoting or otherwise affecting market acceptance of these ethanol blends. Increased consumer use of such blends, E15 in particular, is viewed as a critical step for the ethanol and renewable fuels industry to overcome the ethanol “blend wall” so that sufficient volumes of ethanol are sold in the U.S. to meet RFS volume mandates in the coming years.

You can access this update here.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ government and regulatory consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

The “Advanced Biotechnology for Biofuels” Blog is Back!

I’m happy to report that, after a hiatus of about a year and a half, I’m reviving the “Advanced Biotechnology for Biofuels” blog. Although I’ve not been blogging over those 18 months, it has been a time when I’ve been able to devote all of my professional attention to the renewable fuels industry, and to broaden my areas of expertise to include many aspects of the biofuels business, particularly including regulatory requirements for the certification of new motor vehicle and aviation fuels, and for establishing sustainability of fuel manufacture for compliance with the U.S. Renewable Fuel Standard (RFS) and similar programs. In the weeks to come, I expect to be writing about topics such as the following.

  • Updates on developments in industrial biotechnology regulation, including descriptions of new regulatory filings in the biofuel and bio-based chemical space since my last blog entries in the spring of 2011. I’ll probably also be able to discuss the regulatory structures for industrial biotechnology that are in place in countries around the world, beyond those I have already discussed in the blog.
  • Descriptions of programs such as the U.S. RFS, the California Low Carbon Fuel Standard (and similar laws proposed in other states), the European Union Renewable Energy Directive, and discussion and analysis of recent developments and controversies relating to these programs.
  • More mini-profiles of biofuel companies utilizing advanced biotechnology approaches, focusing on newer companies that have arisen or come into prominence in the last year or two.
  • Descriptions of new inventions and other technology developments arising from universities and other non-profit institutions that may be available for licensing.

I also plan to include discussion and analysis of important public policy developments and controversies, in the U.S. and elsewhere, affecting the biofuels industry, including real time comments about significant industry news of general interest to the renewable fuels sector. For this purpose, I’ve begun a new blog, “Biofuel Policy Watch”, which will focus exclusively on legislative, regulatory and other public policy issues, although there will likely be some (hopefully complementary) overlap between posts on the two blogs.

As always, I’m happy to respond to comments or questions from those of you who are following these blog posts. I look forward to continuing the dialogue on the prospects of this exciting and promising industry.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation,  are available at www.slideshare.net/djglass99 and  at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.