The Rise of Chinese Biotech

On the theme of increased participation of developing countries in biological technology, Rik Wehbring pointed me to a Reuters story, "Low Cost Spearheads China Drive Into Biotech".  As I have written previously here, in addition to investment by Western companies China is putting considerable effort into developing both domestic R&D and domestic clinical expertise.

The Reuters story notes that

China already boasts more than 20 biotech parks dotted around the country and 500 biotech enterprises.  Some 300 of these companies are focused on medicine, with the balance mainly targeting agriculture.  The Chinese government and local governments have both been active in supporting the sector, with total state funding last year reaching the equivalent of 270 million euros ($325 million).

Because "the cost of biomedical research in China is only about 20 percent of the cost in Western countries", that $325 million goes quite a long ways.

We can expect drug development and biomedical research to take off in India as well.  A friend of mine with investments in the U.S., Europe, and in India cites cost figures for India identical to those for China.

So I ask you, without considerably greater investment in education and domestic R&D, how are either the U.S. or Europe going to compete?  What is it going to take for policy (politicians) to catch up to reality?

Progress on Cell-Based Therapies

Spinal cord injury and HIV are the targets of two innovative cell-based therapies, with the planned HIV treatment relying on gene-therapy to produce in vivo RNA interference (RNAi).  In a very short news piece in Nature (subscription required), "Pioneering HIV treatment would use interference and gene therapy", Erika Check writes that;

If the FDA says yes, [John Rossi and his team at  at City of Hope's Beckman Research Institute] will test the therapy on five HIV patients who have a blood cancer called lymphoma. They will treat the patients' lymphoma with aggressive chemotherapy and a bone-marrow transplant — a normal procedure. But before the transplant, they will use gene therapy to add stretches of DNA to stem cells in the bone marrow. It is hoped that molecules encoded by the added genes will trigger the cells' RNAi defences against HIV.

The trial is different from the RNAi trials already under way, because the molecules used in those studies remain in the body for only a short time. The City of Hope researchers will deliver DNA packaged into a gene-therapy vector that could persist in patients for months or even years.

The Recombinant DNA Advisory Committee is having Rossi perform additional safety tests before giving the OK for the trial.  If this works out, it will demonstrate a remarkably powerful way to alter human physiology through the permanent (?) addition of a new RNAi pathway.  The strategy pursued by Rossi, et al., would provide a pool of stem cells that produce lymphocytes immune to HIV.  Since HIV shows some tropism for neural and other tissues, the treatment may not completely rid patients of the virus, but as lymphocytes carrying HIV die out at least the patient would have a source of healthy immune cells.  As this research goes forward, we can expect significant press coverage because the technique will probably find immediate use in treating many other chronic diseases.

The work on repairing spinal cord injury through cord blood cell transplantation has received surprisingly little press.  In an article in Cytotherapy, K-S Kang et al., demonstrate that multipotent stem cells (MSC) derived from umbilical cord blood colonized the site of a spinal cord injury in a 37-year old women who had been a paraplegic for almost 20 years.  The MSCs were amplified in vitro and then surgically transplanted to the site of the injury.

Prior to treatment, the patient showed no somatosensory or motor activity in her lower body, and nerve conduction studies confirmed the extent of the damage.  After transplantation, the patient regained significant sensation within 2 weeks and could maintain an upright posture.  She was able to move her lower legs shortly thereafter.  Nerve conduction studies were used to confirm the extent of recovered electrical activity.  CT and MRI demonstrated regeneration of the spinal cord.

My neurophysiology is more than a tad rusty, which means the import of some specific things reported in the paper isn't immediately clear to me, but the overall results are enough to make anyone take notice; a previously paralyzed patient is now able to at least feel stimulation in her lower limbs, maintain an upright posture unassisted, and has regained some motion in her lower legs.

The specific mechanisms behind the recovery must now be determined, including how the MSCs produce such dramatic improvement.  The authors also note that they cannot rule out the surgery as effecting some recovery.  But the demonstrated increase in electrical activity and motion is extraordinary.  And you have to imagine that the ability to maintain an upright position unassisted for the first time in 20 years is by itself an enormous gift.

This is just one patient, and just one paper, so lots of work is required before anything like this becomes standard treatment.  It is also unclear what the long term effects of the procedure and the new cells will be.  Then there is the little problem that in the U.S. working with stem cells is a tad problematic, regardless of their source.  This study notably, took place in Korea.

Nonetheless, what fantastic news.

Synthetic Biology for HIV prevention: "A live microbial microbicide for HIV"

In the latest issue of Proceedings of the National Academy of Sciences, Rao et al demonstrate a fascinating, and probably immensely useful, application of genetic modification.  They altered human commensal strain of E. coli to excrete proteins that prevent HIV from infecting immune cells.

This isn't the first time bacteria have been genetically modified to carry antigens, antibodies, or, as in the present example, peptides that directly interfere with a pathogen's mode of infection.  But it is particularly interesting because the authors chose as a delivery strain a bug that is available as an over the counter probiotic supplement used to treat irritable bowel disease, cholitis, and Crohn's Disease.  The strain, "Nissle 1917", has thus already been demonstrated safe for use in humans, and is distributed in capsules intended for oral ingestion that can be easily manufactured and then stored at room temperature.

It's important to note that while this paper shows the bacterium prevents HIV infection in cell culture, and that the bacterium survives in the intestines of mice while secreting "inhibitory concentrations of the anti-HIV peptide onto mucosal surfaces of the gastrointestinal tract", it does not actually demonstrate prevention of infection in an animal model, let alone humans.  This experiment will no doubt require considerable review by institutional committees, and perhaps by the NIH itself (which is likely, since the work took place at the National Institute of Allergy and Infectious Disease).

Nonetheless, this is a quite sophisticated application of biological technology to address human needs.  The anti-HIV peptide is itself a synthetic product, being a fusion of hemolysin-A and a fragment of gp-41, the later chosen because it binds to the protein complex on HIV that enables it to dock with and then enter human cells.  Hemolysin-A served as the "shipping tag"; it is part of a protein excretion system already present in E. coli.  Thus this work demonstrates the modification of a bacterial strain -- one already known to be well tolerated in humans -- by exploiting an extant protein export system to excrete a synthetic protein cargo that may provide significant protection against HIV.

Like Jay Keasling's work to manufacture anti-malarial drugs in E. coli, Rao et al are on the path to producing organisms that can be easily and inexpensively grown in culture, followed by harvest and packaging of therapeutic compounds or of the bugs themselves.  This production work is similar to commercial efforts in India, China, and other developing countries, and helps pave the way to distributed biological manufacturing(PDF).  There is clearly lots of work left to do before humans are given genetically modified bacteria as preventative microbicides, but the world it is achangin'.

Cheap drug and stem cell trials in China

"Leaders and laggards in the stem cell enterprise," in the 30 June 05 issue of Nature Biotechnology, describes the global distribution of policy and science of stem cell research.  The story notes that;

The wild cards in all this are China and South Korea. Both have extremely talented scientists, but both are (perhaps unfairly) singled out for lax ethical standards and an uninformed public. With fewer shackles on the momentum of ES cell research, the two countries could potentially accelerate products into clinical trials much faster than the rest of the world.

But just because progress might be made in the clinic, it isn't clear that drugs (including cell-based therapies) produced in China will find an easy time in U.S. and European markets.

In "China beckons to clinical trial sponsors", Hepeng Jia writes that;

The clinical trials market is opening up in China...Low cost and ease of access to patients are the main incentives for clinical trial outsourcing...Ying Zhang, marketing director at Beijing-based clinical trial contract research organization (CRO) Excel Medical Technology, estimates that the cost of a clinical trial for a new drug in China is only half of the amount in the United States or Western Europe owing to lower labor and infrastructure costs.

There are, however, a few challenges, including, "poor data standardization, delays in gaining trial authorization from regulators and questionable ethical standards," and a, "poor level of compliance with Western standards."

Despite the harmonization of standards at some clinical trials facilities, it remains to be seen whether the US Food and Drug Administration or European Medicines Agency will accept data obtained from clinical trials carried out in China. Already foreign organizations like Quintiles, CCBR and Canadian company MDS of Toronto, have been seeking endorsement of agencies like the American College of Pathologists to gain recognition for their work there.

Large pharmaceutical corporations are moving into the Chinese market via acquisition.  Alla Katsnelson reports (Nature Biotechnology 23, 765 (2005)) that the Israeli generic manufacturer Teva Pharmaceuticals is buying Tianjin Hualida Biotechnology Pharmaceutical Co, in part because of "regulatory purgatory" in the United States.  "By tackling less strictly regulated markets first, Teva could gain more expertise in manufacturing biogenerics and profit from those markets directly."

Writes Katznelson;

The first problem is that products made in China are arguably unlikely to be approvable in Western countries [by the FDA and EMEA].  'Standards in the US are so much higher that there's just no comparison'.
    Getting non-Western facilities up to production standards is a long and expensive process...  For example, requirements for manufacturing specific such as water purity may not be important clinically, but the FDA is likely to insist on them.

Yet Teva is evidently pursuing a long-term strategy, because while the FDA has for several years been issuing assurances that, "creating a regulatory pathway for biogenerics is a top priority...its reactionary approach has not inspired confidence in the generics industry of late;"

RA used to mean regulatory affairs, but now it means risk aversion," says Alan Liss, senior director of biotech at Duramed Research in Pennsylvania. "While we're talking, China and India will be supplying the rest of the world with products," he adds.

But the story concludes that this same sort of transition occurred in India, that Indian drug development and manufacturing efforts were "eventually folded in the Western regulatory framework," and that "in ten years, companies will use China not only as a local market but as a springboard for global opportunities -- providing talent and infrastructure at a good price."

Gong Yidong, writing in the 29 July issue of Science, notes the many motivations for operating in China;

China's growing appetite for Western drugs--the current $15 billion market is expected to quadruple by 2010, and then double again by 2020--has certainly caught the attention of every drug company. So has its cheap but skilled scientific labor force. Not only do Ph.D.s receive annual salaries of $10,000 or less, but the most expensive aspect of drug development--clinical trials--costs an estimated 30% less in China than in the United States or Europe. And then there is its growing prowess in science. "I'd say that setting up our own research lab there is only a matter of time," Novartis CEO Dan Vasella remarked this spring. "It's not so much a need as it is a hunger to take advantage of the opportunities."

With many companies opening R&D labs in country, combined with the increasing level of education and the desire to take a larger role on the world state, we're likely to see remarkable ferment developing new treatments in China.

Biotech Oases -- your gas purchases at work.

Hot on the heels of news about serious biotech investment in Kazakhstan comes an update on similar efforts in the Middle East.  In the latest Nature Biotechnology, Cormac Sheridan describes (PDF only) initiatives in Dubai, Abu Dhabi, Qatar, and Saudi Arabia to nucleate biotech business and education.

Tax incentives, government sponsored facilities and infrastructure, and multi-billion dollar endowments for training and scientific grants are all part of efforts to bootstrap local technology development.  Strong, well-funded connections are being built with western educational institutions.  The story notes that countries in this region do not have a strong history (recently, anyway) of scientific research, and that part of the challenge will be to create a culture of innovation and competition to produce new results.  Oil money is paying for all of this, and I have to say that I am not unhappy some of the profits from filling my gas tank will go to this sort of investment.

In the long run, I wonder what will be the domestic social and political impacts of encouraging inquiry and increased contact with western scientists.  It's also worth asking, given historical Arab leadership in education and scholarship, about the local mores (Islamic or otherwise) regarding cloning, stem cells, genetic modification, and cell based therapies.  Does anyone have suggestions for reading along these lines?

454's Microfabricated Pyrosequencer

Today, Nature published online an article entitled, "Genome sequencing in microfabricated high-density picolitre reactors," by Margulies et al.  The paper describes embedding beads coated with DNA in 1.6 million wells etched into the end of a fiber-optic slide, where the slide is produced by repeatedly folding and drawing a fiber-optic cable.  Each well serves as a reaction chamber for the sequencing-by-synthesis method known as Pyrosequencing.  The research utilized an instrument built by 454 Life Sciences.

My email is ringing off the hook today with questions about how this fits into my estimates of sequencing and synthesis productivity ("Carlson Curves").  Thanks for your interest, everyone.

A few comments.  The first thing to note about the article is that the authors state they sequenced "25 million bases, at 99% or better accuracy, in one four hour run."  So at 6.25 million bases per hour, they appear to be doing quite well compared to a Sanger-based 96-capillary instrument, which the authors assert reads out 67,000 bases per hour.

Digging into the text a bit, we find that the average length of the DNA the authors were able to read was about 100 bases, which they note is far shorter than the ~750 bases standard in Sanger sequencing.  The article also notes that prepping the DNA samples required 10 person-hours; 4 hours for fragmenting genomic DNA into bite-sized pieces and generation library from those pieces, and 6 hours to put that DNA on beads and then put the beads on the sequencing chip.

So, that's roughly 14 hours from start to getting sequence data, which puts the productivity number at about 10 million bases per person per day.  This is better than running a couple of capillary-based instruments, it's true, but there is still an enormous amount of skilled labor in that 10 hours of sample preparation.  If you have look at the supplementary information, documents s1 and s3 in particular, the processing is by no means trivial.  Actually, the enzymatic rigmarole is quite impressive.  But I wouldn't want to do it myself.  Looking ahead, I don't see any reason it can't be automated.  Given time, patience, and some effort at the microfluidics, the whole process should require only minimal human attention.  That will definitely make an impact on productivity.  No doubt 454 is planning for this eventuality.  The upshot is that this paper puts a point, more-or-less, right on my previously published curves.  It is consistent with progress made with previous technologies, but is actually a bit slower than the estimate Mostafa Ronaghi gave me in 2003.  That's life.

Here's a bit more info.  The New York Times is reporting that;

Jonathan Rothberg, board chairman of 454 Life Sciences, said the company was already able to decode DNA 400 units at a time in test machines. It was working toward sequencing a human genome for $100,000, and if costs could be further reduced to $20,000 the sequencing of individual genomes would be medically worthwhile, Dr. Rothberg said.

We'll see.  We are still a long way from the Thousand Dollar Genome, and this paper appears to be keeping the pace.  All in all, it looks promising, though I wince at the current $500,000 instrument cost.  I don't have enough information at hand to make my own estimates of per base sequencing cost, and I haven't had a chance to contact anyone at the company to suss out the productivity issues better.  I'll update this if and when such conversations take place.

UPDATE (5 Aug 05):  The $500,000 per instrument cost comes from the NYT article:

The Joint Genome Institute, a federal genome sequencing center in Walnut Creek, Calif., has ordered one of 454's $500,000 sequencing machines but has not yet installed it. Paul Richardson, the institute's head of technology development, said the new approach "looks very, very promising" and could reduce sequencing costs fourfold.

The machine's limitation is that at present it can only read DNA fragments 100 units or so in length, compared with the 800-unit read length now attained by the Sanger-based machines. The shorter read length makes it harder to reassemble all the fragments into a complete genome, Dr. Richardson said, so although microbial genomes can be assembled with the new method, mammalian genomes may be beyond its reach at present.

Dr. Fraser, director of the Institute for Genomic Research in Rockville, Md., also said that the new machine's short read lengths "limit its overall utility at this point."

Global Distribution of Commercial DNA Foundries

(UPDATE, 22 November 05: Wired Magazine has now published a version of this map.)

Given recent discussions in the press and at the NSABB meeting concerning licensing DNA synthesis instruments and related professional skills, it seems like a good idea to make an estimate of how big the problem is by assessing the distribution of the technology.  Prompted by Jerry Epstein at the Center for Strategic and International Studies, I headed out on the web to make a list of Commercial DNA Foundries.  Here is a map we came up with to represent access to commercially synthesized oligos.

(UPDATE, 19 July 05: I've replaced the .gif with a higher resolution .jpg.)  (UPDATE: Note that these are Foundries -- that is, the building where DNA actually gets synthesized -- and that the associated distribution/marketing networks are actually considerably more widespread.)

This is just a first pass, though given how many companies there are I don't know if we will spend a lot of time trying to be encyclopedic.  A few notes:  there are no academic foundries on here, save the Zelinsky Institute in Moscow (which I included because it is quite interesting that a government facility in Russia is operating commercially -- fascinating implications for proliferation).  The number of academic foundries suggests that both instrumentation and skills are quite widely distributed.  The companies are numerous enough.  I gave up trying to fit more companies into the maps of US and Western Europe -- if I left out your company, my apologies.  Perhaps if we figure out a more clever way to keep track of, and represent, all the data, we can include all comers.  I suspect there are more companies in Russian and China, but the language barrier defeats my first pass with Google.

So now, a couple of thoughts.  The net capacity of all these foundries looks to be pretty impressive (though I have yet to add it all up).  Who is ordering all this DNA?  The estimates I've heard for the size of the synthesis market are in the low tens of millions of dollars annually.  Either many companies are ekeing out existence on wee small pieces of the total, or the market is much bigger than people think.  How is it split between short oligos, perhaps primarily used as PCR primers, and larger constructs used to build genes for recombinant proteins?  Does it make a difference, even now?  If so, given the increasing capability demonstrated in assembling short pieces of DNA, is it worth trying to distinguish between short and long oligos?  That is, will regulation of either short or long pieces of DNA be feasible and will it increase security?

Finally, I haven't yet charted the cost per base of synthesis as a function of geography, but I'm sure the results will be provocative.  I was surprised to see that the biotechnology industry in India is supporting at least three commercial synthesis foundries, and I'll bet those companies are charging less than I recently paid for gene synthesis domestically.  How soon are North American and European DNA foundries going to have to compete against Indian labor and FedEx?

More to come as I ponder this.  Comments and suggestions?

Kazakh Biotech Empire

The 24 June issue of Science contains a story (subscription required) by Richard Stone describing efforts to build up biotech in Kazakhstan.  They aren't thinking small; "The government has approved plans and is now reviewing financing for a $50 million Life Science and Biotech Center of Excellence, supported in part by the World Bank."

I think this is interesting for a couple of reasons.  The first is that the article describes U.S. Department of State hopes that the endeavor will keep former bioweapons scientists engaged in less threatening activities.  The second is that the World Bank is helping finance what could be at minimum a regional biotech power.  Given a few years to build up the infrastructure, combined with the expertise developed at Stepnogorsk in manipulating and manufacturing biologicals, they could be a global technological and economic power.

The Challenges of International Regulatory Regimes for Biological Technologies

Arriving in my mailbox this morning was a story from the Washington Times Post (Thanks, Oliver), dated 18 June 05, "Bird Flu Drug Rendered Useless: Chinese Chickens Given Medication Made for Humans", by Alan Sipress.  Chinese farmers, encouraged by the government, have since the late 1990's been feeding the antiviral drug amantadine to chickens infected with H5N1.  (Update: Recent news stories in Science and Nature carry claims from the Chinese gov't that this usage was most certainly not officially sanctioned or  encouraged.)  The story notes that this usage is in violation of international agreements on the treatment of livestock with drugs, and that the resulting long term selective pressure is the reason amantadine is no longer effective in treating the influenza strain currently causing concerns about a pandemic.  This sets up China (and due to growing economic interdependence, the rest of the industrialized world) for serious woe, amplified by the fact that the most populous country on the planet is not prepared for a pandemic. 

In summary, an important tool in dealing with a potential pandemic outbreak in humans has been rendered useless despite an international agreement aimed specifically at preventing that sort of occurrence.  Writes Sipress;

The Chinese Agriculture Ministry approved the production and sale of the drug for use in chickens, according to officials from the Chinese pharmaceutical industry and the government, although such use is barred in the United States and many other countries. Local government veterinary stations instructed Chinese farmers on how to use the drug and at times supplied it, animal health experts said.

Amantadine is one of two types of medication for treating human influenza. But researchers determined last year that the H5N1 bird flu strain circulating in Vietnam and Thailand, the two countries hardest hit by the virus, had become resistant, leaving only an alternative drug that is difficult to produce in large amounts and much less affordable, especially for developing countries in Southeast Asia.

The scientific evidence that using antivirals in poultry is a bad idea has been around for quite some time, and international policies regarding veterinary application of the drugs is based on clear evidence: "In 1987, researchers at a U.S. Department of Agriculture laboratory demonstrated that bird flu viruses developed drug resistance within a matter of days when infected chickens received amantadine."

So we have a situation where scientific, technical, and policy components were all directed towards a particular regulatory goal, and all were ignored.  There is one more key piece to this story, and that is the number of years it has taken to confirm the information.  Sipress, again;

Health experts outside China previously said they suspected the virus's resistance to the medicine was linked to drug use at poultry farms but were unable to confirm the practice inside the country. Influenza researchers at the U.S. Centers for Disease Control and Prevention, in particular, have collected information about amantadine use from Chinese Web sites but have been frustrated in their efforts to learn more on the ground.

This is truly the crux of our challenge over the coming decades.  Despite efforts determine the extent of veterinary use of amantadine within China, even widespread government sanctioned (recommended, according to the story!) use that violated explicit international agreements continued unabated.  Even if the relevant intelligence had been confirmed, it isn't clear that the Chinese government would have changed its policies.  Regulation failed in this case, and because information was hard to come by our response to the problem is further impaired.  (Update:  Regardless of the involvement of the government, my point about the importance of good information stands.)

This is why I have been arguing so strenuously that open and distributed networks of people using and developing biological technologies are strongly preferable to closed ones. In my recent essay "Synthetic Biology 1.0", I discussed the effect of regulation on preparedness for natural and artificial biological threats, in part with conditions in China in mind.  Though many states and organizations will be pushing biological technologies in the coming years, China is front and center because of its growing economic might and educated population.  It is clear they are going their own way, developing and, more importantly, using technology as they see fit.

In the year 2000, Jiang Zhemin, the former President (Premier? I can never remember which) of China, said in no uncertain terms that in order to deal with their health care crisis they would use all tools at their disposal.  He specifically mentioned genetically engineering the population (this story is now finally on the record in Gerald Epstein's recent report from CSIS, "Global Evolution of Dual-Use Biotechnology").  Such efforts will explicitly require sophisticated biological technologies, in particular those related to DNA synthesis and sequencing.  Countries throughout Asia are already pushing the technology without much, if any, concern for what we decide to do here in the states.  Creating and enforcing regulatory regimes for this sort of thing would require an international effort that historically doesn't work so very well for just about anything else.  Witness the amantadine problem.

Then there is the problem that the technology and skills do not respect borders.  Synthetic genes can be ordered from companies in Seattle, San Francisco, throughout western Europe and Russia, Dalian, Tehran; the list goes on.  How do we monitor the flow of Epindorf tubes full of lyophilized DNA around the globe?  Used synthesis instruments are not only available worldwide, but the parts for a new 192 channel instrument (styled after ABI or Gene Machines) can be had for about $10,000.  The plans and process specs were published long ago.  Yes, it requires some skill to assemble the instrument, and yes, it requires some skill to write the software, but most people with undergraduate degrees in engineering or physics have this skill or can fumble their way to it in a relatively short period of time.  Reagents are available worldwide, and I don't understand how we can track those reagents any better than we do it now for industrial chemicals or drugs.  The grey and black markets for everything from drugs to fluorocarbon coolants are thriving around the world.  I don't understand how reagents, short oligos, genes, or even synthetic genomes can be controlled any better.

This raises two main issues.  The first is that I suspect regulation will only slow down scientific and technological progress here in the US.  Other countries (and organizations) are likely to explore the relevant fields a their own pace.  This resulting technology gap constitutes the second issue, which is that we will be unprepared for surprises.  Given the history of technology from the last century, I do not believe we can control the pace of development of biological technologies.  If we, here in the US, are not in the lead, somebody else is.  And we will thus experience surprise on a regular basis.  Our choices about developing biological technologies will determine whether we are willing to let potential adversaries be in the lead.

The above arguments are primarily directed at our physical security, but I am equally concerned about our economic security.  It is clear that China and India are pushing ahead with biological technology.  The sheer numbers of talented and smart students in these countries is to me mind boggling.  I am not sure that we can maintain our economic vitality even if we keep going at the current rate, but I am certain we will lose out if we decide to slow down.  We absolutely require increased government investment in technology and increased numbers of skilled people.  If you don't believe me, then the interviews Bio-ERA has been doing for our DOE-funded Synthetic Biology project clearly indicate that our global competitiveness is already at risk.  There is absolutely no reason European or Asian scientists and businesses should order synthetic genes from the US.  More specifically, my experience at a Global Business Network meeting a few weeks ago indicates that even though China is likely to experience some internal disruption over the coming decade or two, they are pushing hard not just to be competitive, but to take the lead.  In everything.

In summary, given my historical study of other technologies and my experience developing new biological technologies, I do not believe that regulation will result in improved security.  On the contrary, I believe it will impair our preparedness, reduce our security, and reduce our economic competitiveness.  Independently from these issues, I do not see how international regulatory regimes for biological technologies are workable, even if agreements are reached and are implemented -- by no means trivial efforts in themselves.

Finally, I would observe that no regulatory regime is perfect, and regulation is in actuality more a problem of managing barriers (to entry and use) that are inherently leaky.  Implementation of regulations always seeds resistance.  Given the power of biological technologies how many surprises can afford?

Synthetic Biology 1.0

I have a new essay, "Synthetic Biology 1.0", just published on Future Brief.  Here are the first few 'graphs:

Open development of biological technology is crucial to US domestic security and to the health of our economy.

Misuse of this technology in bioterrorism is a clear threat. Our first response to recent domestic bioterror attacks, and to evidence of bioweapon programs abroad, has been to pursue safety in regulation. However, it is already clear that action to limit domestic access to materials and methods will produce only illusory safety. Reagents required for genetic manipulation are available from manufacturers outside the U.S. Synthetic genes can be ordered with equal ease from fabrication labs in Seattle and Tehran .

Beyond access to the infrastructure of sequencing and synthesis, which enables attempts at state-of-the-art genetic manipulation, the practical knowledge required to assemble objects and processes in cellular and molecular systems is proliferating globally. Moreover, biological technologies are being developed globally, and they will be as useful worldwide in developing new crops, drugs, and industrial products as they will be in producing weapons. These factors considerably expand the scope of our security problem.

Ensuring domestic physical security and economic competitiveness requires a long-term plan to integrate public and private sector interests. Serious consideration should be given to the role of government in establishing the design and production infrastructure for biological engineering. In particular, investing in engineering tools as a goal of federal research policy will enable safer and more rapid progress in all areas of biology...

Follow the link to Future Brief for a PDF.  The link only just went live today, and there is already some nice commentary over at WorldChanging.