Monday, May 19, 2014

Treating the Unthinkable: Vaccine Development for Unknown Synthetic Viruses

Developing a vaccine against any illness is difficult and time consuming but theneed for rapid vaccine production becomes even more important against emerging infectious diseases like H1N1 flu. One of the biggest hurdles in creating an influenza vaccine has to do with the virus itself. "In conventional vaccine making you need the actual virus that causes the disease," says Phil Dormitzer, who leads a team of vaccine researchers at Novartis. "The bottleneck has been for a vaccine manufacturer to get its hands on a suitable vaccine virus." http://www.doubleexscience.org/creating-viruses-to-create-the-vaccines-against-them/  

image:www.doubleexscience.org


But what if the disease we are trying to prevent is unknown, synthetically derived and possibly created in a clandestine warfare lab? As I've previously discussed, DARPA's Blue Angel program and Medicago, have successfully overcome the production lag time issue for flue vaccine production, however, what would happen if a synthetic virus unknown at this point, were able to be either accidentally or deliberately released? While I personally remain a strong proponent of synthetic biology, and political arguments aside, are we ready to treat in a mass casualty context, synthetic illnesses? 

image: www.inovio.com
In 2010, DARPA invested 6 million in a project called 'BioDesign.'Wired and Popular Science have both written on this topic. Essentially, Bio-Design would override evolution and 'eliminate the randomness of natural evolutionary enhancement." DARPA would create molecules that bolster cell resistance to death and ultimately program cells to live indefinitely. Additionally, cells would be programmed with a kill switch. According to DARPA as stated in Wired (see: http://www.wired.com/dangerroom/2010/20/pentagon-looks-to-breed-immortal-synthetic-organisms-molecular-kill-switch-included), BioDesign could be used to "Develop strategies to create a synthetic organism 'self-destruct' option to be implemented upon nefarious removal of organism." The project comes as DARPA also plans to throw 20 Million into a new synthetic biology program, and 7.5 million into increasing several decades the speed with which we sequence, analyze and functionally edit cellular genomes." Could DARPA's synthetic biology programs develop applications for countering synthetic diseases and thus remove synthetically derived diseases from the arsenal of would-be bio terrorists or states? 
Homeland Security
 Newswire published a piece entitled: Day of Synthetic Pathogens Based Bio-Terrorism Nears' (http://www.homelandsecuritynewswire.com/day-synthetic-pathogens-based-bioterrorism-nears) their 2010 observations at the time of publication remain relevant today:

"The problem is that now you can make DNA. For a number of these, you really don't need to have access to the the sample. The genome of these pathogens are in publicly available databases," said Jean Peccoud, an associate professor at the Virginia Bioinformatics Institute at Virginia Tech. "For a few thousand dollars you can get the Ebola genome." Under the auspices of researcher and combating infectious agents, scientists in 2008 used synthetic biology to recreate SARS virus. Three years earlier, researchers successfully reconstructed the 1918 flu virus, which caused a worldwide pandemic estimated to have killed fifty million people. Eventually, it will almost certainly be possible to recreate bacterial pathogens like smallpox. We might also be able to enhance these pathogens. Some work in Australia on mousepox suggests ways of making smallpox more potent, for example. In theory, entirely new pathogens could be created.' Hastings Center Report Editor Gregory Kaebnick said in congressional testimony during a May hearing on Capital Hill."  



DARPA's Living Foundries Program certainly seems up to the challenge of developing counter-measures to synthetic disease. While we are much closer to being able to identify and possibly develop vaccines rapidly to treat unknown synthetic pathogenic agents, I believe if faced  with this scenario today, we would struggle to respond. It is therefore essential we continue to investment in bio-defence programs and maintain our focus on the horizon of synthetically produced biological warfare agents.
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Stopping a Hemorrhagic Killer: BCX4430

"Filoviruses, such as Ebola and Marburg virus, constitute serious threats to our national defense," said Colonel Erin P. Edgar, commander of USAMRIID. "Development of cost-effective and versatile treatment options to combat these agents remains an unmet medical need and a high biodefense priorityfor the U.S. Government."
See: http://www.nature.com/nature/journal/vaop/ncurrent/full/nature13027.html#sthash.6b2rLOfA.dpuf

ebola virus picture
Ebola

"Filoviruses, such as Ebola virus and Marburg virus, are extremely virulent.Case fatality rates associated with filovirus disease outbreaks are the highest reported for any infection, exceeding 90 percent. These pathogens are classified as Category A bioterrorism Agents by the Centers for DiseaseControl and Prevention. BCX4430 completely protected cynomolgus macaques from Marburg virus infection and Ebola virus infections. In addition, BCX4430 was shown to be active in vitro against a broad range of other RNA viruses, including the emerging viral pathogen Middle East Respiratory Syndrome Coronavirus (MERS-CoV)." See: http:..globenewswire.com/news-release/2014/03/03/614909/10070784/en/BioCryst-Announces-Nature-Publication-Demonstrating-Efficacy-of BCX4430-in-a-Non-Human-Primate-Model-of-Filovirus-Infection#sthash.6b2rLOfA.dpuf

Although Cruecell, a Dutch based pharmaceutical firm has been working on an Ebola vaccine candidate for several years and notes on their site that "In experiments conducted in 2004 by the VRC together with the U.S. ArmyMedical Research Institute of Infectious Diseases (USAMRIID), our vaccine candidate confirms single-dose protection of monkeys against Ebola. Our results are distinct from the earlier trials in that our vaccine is based on PER.C6® cells, makind it suitable for large scale manufacturing." (See: http://www.crucell.com/R_and_D-Clinical_Development_Ebola_Vaccine) One is not exclusive to the other and indeed a viable vaccine candidate would be a valuable addition to any national strategic stockpile. However, BCX4430 offers a novel approach with wide 

applications
.

BioCryst Pharmaceuticals, Inc. announced on March 3, 2014 in the journalNature extensive laboratory and nonclinical characterizations of BCX4430, "including efficacy results in animal models of infection with Marburg virus and Ebola virus, two highly virulent pathogens responsible for viral hemorrhagic fever diseases. The Nature publication entitled,"Protection against filovirus diseases by a novel broad-spectrum nucleoside analogue BCX4430," represents the first report of protection of non-human primates from filovirus disease by a small molecule drug, and describes efficacy results generated from an ongoing collaboration between scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and BioCryst." See: http://globenewswire.com/news-release/2014/03/03/614909/10070784/en/BioCryst-Announces-Nature-Publication-Demonstrating-Efficacy-of-BCX4430-in-a-Non-Human-Primate-Model-of-Filovirus-Infection.html#sthash.6b2rLOfA.dpuf "BCX4430, resembles the famous "A" found in DNA: adenosine. (Recall that DNA is made of Adenosine, Thymidine, Cytidine and Guanosine.) The RNA-based filoviruses also use "A" in their genomes. BCX4430, because it resembles "A", can be accidently used by the virus when it is trying to grow inside of our cells. For the virus, this is a fatal mistake. BCX4430 blocks further growth and reproduction." See: http://www.nature.com/nature/journal/vaop/ncurrent/full/nature13027.html#sthash.6b2rLOfA.dpuf

While both Crucell and BioCryst offer potentially novel ways of combating filovirus outbreaks, BCX4430 has the advantage of greater application. This is an exciting discovery, not only as a counter-measure for Ebola and other VHF, but the potential application to other highly pathogenic diseases for which we currently have no treatment or preventive medical countermeasures i.e. vaccines. For years, bio-defence drug discovery has endured a one bug one drug approach, but advanced drug discovery means our ability to counter emerging and re-emerging diseases for which their previously was low to no investment incentives, may mean research and development for orphan diseases will become more enticing. The recent outbreak of Ebola in Guinea and Liberia, serves to remind us that emergingand re-emerging diseases continue to pose a global public health threat. The emergence of MERS-CoV and the increasing mortality associated with it mean it  too will likely remain a health concern for years to come. 


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Overcoming the Cold Chain Problem in Vaccine Storage and Distribution

image: CCF-technologies.com




One of the major problems faced during epidemic and pandemic outbreak of disease is overcoming the 'cold chain' issue both in the storage, as well as the distribution of vaccines. Bio-defence vaccines are no different, however, the circumstances of their distribution may increase risks associated with cold chain standards. Imagine a deliberate outbreak of smallpox in a remote village in the Congo or worse during conflict, which poses more extreme obstacles in terms of epidemiological trace-back, delivery of vaccines and ultimately vaccination. While disruptions in the cold chain protocol result in millions of lost dollars and vaccines, future biologicals are swiftly overcoming this problem. http://globalbiodefense.com/2013/05/27/soligenix-thermostable-biodefense-vaccine-technology-patent/

"Cold chain management is the process of preparing temperature-sensitive medical products for shipment utilizing standardized systems and procedures, maintaining required temperatures during all phases of distribution from the time it leaves the manufacturer until administration of the vaccine to the patient. Vaccines are sensitive biological substances that can lose their potency and effectiveness if exposed to heat, extreme cold, and or light. For example, certain vaccines lose potency when exposed to room temperature for as little as 30 minutes and freezing damages almost all refrigerated vaccines. Failure to adhere to proper storage temperatures may reduce vaccine potency, resulting in an inadequate immune response and protection against disease. Once lost, vaccine potency cannot be reversed. http://www.vaccines.mil/documents/1632_SH_Guidelines.pdf

"Roughly 1.5 million children die each year from vaccine-preventable diseases like tuberculosis. This is due in part to the sensitive nature of the vaccines themselves, which spoil if they're not kept at precise temperatures from manufacturing to use. The cold supply chain is well established in many parts of the world, but poor infrastructure and unreliable power prevent vaccines from reaching many developing countries." http://www.intellectualventures.com/inventions-patents/our-inventions/vaccine-cold-chain-device/


image:clinicrising.com

Soligenix is a pharmaceutical company manufacturing bio-defence vaccines, but its their 'thermostability technology' which caught my eye. Typically, bio-defence vaccines are vaccines developed to treat the probability of a wide spread outbreak of diseases we generally don't see in annual epidemic outbreaks. These vaccines tend to be more costly to research and develop and investiment in both the U.S. and EU has come, to a large extent, from government agencies (Bio-Shield, BARDA, NIAID). As I wrote my previous pieces on the Ebola outbreak in Guinea and theStrategic National Stockpile, I recalled my engagement some years back with WHO. Vaccine stockpiling and certainly distribution is a core activity during an outbreak of highly pathogenic diseases like we see in Guinea. In this specific case, not only has it been difficult to inspire interest to develop a vaccine candidate against VHF and Crucell (See:http://biodefenceindustryanalyst.blogspot.nl/2014/03/ebola-in-southern-guinea-vaccine.html) has been working on this for years, but the cold chain problem in storage and distribution remains a significant issue. Typically pharmaceutical firms are reluctant to launch into drug development for illness which either do not occur, occur with extremely limited frequency or used only during relatively small outbreaks. Bio-defence vaccines face a number of challenges which vaccine candidates for diseases like mumps, measles and rubella simply do not. Moreover, even in terms of force protection, many of these vaccines are not even on a Milivax schedule for our forces. Added to this, any disruption in the cold chain management of vaccines is a quite serious and significant issue.

www.downtoearth.org.in

I was quite excited when I spotted their announcement that "Recent studies have demonstrated the potential for heat-sensitive vaccines formulated using this technology to withstand temperatures exceeding 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. The underlying work has been conducted with the Company’s proprietary ricin toxin vaccine (RiVax™) as part of a continuing program to evaluate the effectiveness of protein subunit vaccines to withstand extremes of temperature and other environmental stress conditions.(See: http://www.soligenix.com/news.aspx?titleId=444) Their website states the following: "Soligenix's proprietary thermostability technology, ThermoVax™, is a novel method of rendering aluminum salt, Alum, adjuvanted vaccines stable at elevated temperatures. Alum is the most widely employed adjuvant technology in the vaccine industry. The value of ThermoVax™ lies in its potential ability to eliminate the need for cold-chain 

production
, transportation, and storage for Alum adjuvanted vaccines. This would relieve companies of the high costs of producing and maintaining vaccines under refrigerated conditions. The World Health Organization (WHO) reports that 50% of all vaccines around the world are wasted due to thermostability issues. This is due to the fact that most Alum adjuvanted vaccines need to be maintained at between 2 and 8 degrees Celsius ("C") and even brief excursions from this temperature range (especially below freezing) usually necessitates the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. The savings realized from the elimination of cold chain costs and related product losses would in turn significantly increase the profitability of vaccine products. Elimination of the cold chain would also further facilitate the use of these vaccines in the lesser developed parts of the world. On the Vaccines/BioDefense side, ThermoVax™ has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency settings."

While I would generally review other pharmaceuticals competing in this technology, Soligenix in fact seems to be much further along than others and have a more promising candidate technology. For bio-defence and European/NATO Member State stockpiling, the technology is quite exciting. WHO and Medicine sans Frontiers must certainly be waiting in the wings.

Friday, May 16, 2014

Will MERS-CoV be the next SARS? Predicting Highly Pathogenic Pandemics



image:www.neatorama.com
"At the end of April, 2014,   the WHO reported that about three-fourths of new cases of MERS-CoV were 'secondary infections' spread between people, mostly doctors and nurses at hospitals treating MERS patients. The growing evidence that the virus is being transmitted between people, and not just from sick camels to people as had previously been suspected, raised fears of a possible epidemic. Even so, experts said MERS is not spreading easily between people and would have to undergo a mutation to present a grave threat to the world." While the origins of transmission appear mainly zoonotic, the human to human transmission rate is increasing. Given that Saudi Arabia is host to the Hajj usually in October, the recent jump in human to human transmission is concerning. See:http://www.huffingtonpost.com/2014/04/30/mers-virus-spread_n_5242783.html An article entitled: "Don't Panic About MERS Yet, Health Experts Say by Joshua Hersh the following insights case some doubt on the probably of the rapid evolution of MERS.



photo: www.healthrender.com

"Every case has had some direct contact with the Arabian Peninsula," said Dr. David Swerdlow, the head of the MERS monitoring team at the U.S. Centers for Disease Control and Prevention. "If the virus doesn't generally infect more than one person, it's not going to lead to sustained transmission," Swerdlow added. "We are watching carefully the situation in Saudi Arabia and the U.A.E., and we are watching for evidence of sustained transmission, which would be a very big cause of concern. Are we concerned? Yes, we are, but we've also been concerned for a year and a half." 

"Saudi and WHO officials have indicated that the recent spike in MERS cases may be related to seasonal and weather conditions. Saudi Arabia reported a similar spike in March and April of 2013. A mutation that would allow MERS to spread more easily among humans would not be unprecedented. In 2003, the SARS virus, which is closely related to MERS, made a major leap into humans in China when a key protein changed. That disease went on to kill about 800 people, and sickened several thousand." See: http://www.huffingtonpost.com/2014/04/30/mers-virus-spread_n_5242783.html

The Centers for Disease Control and Prevention provides the following definition of Coronaviruses (CoV): "Coronaviruses are common viruses that most people get some time in their life. Human coronaviruses usually cause mild to moderate upper-respiratory tract illnesses. Coronoviruses are named for the crown like spikes on their surface. There are three main sub-groupings of coronaviruses, known as alpha, beta and gamma, and a fourth provisionally assigned new group called delta coronoviruses. Human CoV were first identified in the mid 1960's. The five CoV that can infect humans are: alpha CoV229E and NL63 and beta CoV 0C43, and SARS-CoV, the coronavirus that causes severe acute respiratory syndrome. CoV may also infect animals. Most of these usually infect only one species or at most a small number of closely related species. However, SARS-CoV can infect humans and animals, including monkeys, Himalayan palm civets, raccoon dogs, cats, dogs and rodents." See:  http://www.cdc.gov/coronavirus/about/index.html

"A novel coronavirus called “Middle East Respiratory Syndrome Coronavirus” (MERS-CoV) was first reported in 2012 in Saudi Arabia. It has caused severe illness and death in people from several countries. On May 2, 2014, the first confirmed case was reported in a traveler to the United States. On May 11, 2014, a second U.S. imported case of MERS was confirmed in a traveler who also came to the U.S. from Saudi Arabia. The two cases are not linked and MERS as of 14 May 2014 is not considered a public health emergency." See: http://www.cdc.gov/coronavirus/about/index.html


image:www.delhidaily.news.com

While MERS-CoV is not yet considered highly pathogenic and remains primarily zoonotic (passing from camels to humans), the history of virus evolution does not bode well for the eveolution of MERS-CoV into a more highly pathogenic strain. When we look at the evolution of viruses several events come into play. "Pathogenicity is the potential capacity of certain species of microbes or viruses to cause a disease. It is characterized by complex pathogenic properties which evolve during their struggle for existence. Pathogens are characterized by specific actions. Each species is able to give rise to different infectious processes. It is often used interchangeably with the term 'virulence', although virulence is used more specifically to describe the relative degree of damage done by a pathogen, or the degree of pathogenicity caused by an organism. A pathogen is described partly through its virulence by its ability to produce toxins, enter tissue,colonize, hijack nutrients, and its ability to immunosuppress the host.  Pathogenicity is only one factor however and coronavirus are likely to evolve. Discussing Avian flu H5N1, Georgii Bazvkin of the faculty of Bioengineering and Bioinformatics of the Moscow State University in collaboration with the Central Research Institute for Information Transmission Problems of the Russian Academy of Sciences (IITP) and Professor Alexy Kondrashov published a paper on the evolution of Avian influenza: 

"A reassortment may produce a highly virulent strain because strong genetic shift makes it "unfamiliar" to the immune system of most humans. which allows the virus to spread efficiently throughout the population. This evolutionary scenario  is known as antigenic shift. Another path, knowns as antigenic drift is a process of gradual accumulation of smaller mutations. These mutations cause changes in the viral antigenic proteins, primarily the surface antigens hemagglutinin (HA) and the neuraminidase (NA). The genes coding for these proteins evolve rapidly in the course of the arms race between the virus and immune system. The seasonal flu outbreaks are primarily caused by this antigenic drift, — explains Georgii Bazykin. — Hence every year many of us catch a flu caused by a new strain of the constantly evolving virus.”Both processes are due to changes in the viral genome, but of a different degree. The differences in the seasonal flu usually result from point mutations in the influenza virus genes, while major pandemics are often connected to profound genetic shifts known as reassortments." See: http://globalbiodefense.com/2014/01/13/prediction-of-the-future-flu-virus/#sthash.rAogNrOn.dpuf When we consider antigenic shift and pandemics, MERS may be more concerning. "Drs. David Morens and Anthony Fauci warn in a new paper: 

While it has become possible to eradicate certain infectious diseases [smallpox and the veterinary disease rinderpest], and to significantly control many others [dracunculiasis, measles, and polio, among others], it seems unlikely that we will eliminate most emerging infectious diseases in the foreseeable future. Pathogenic microorganisms can undergo rapid genetic changes, leading to new phenotypic properties that take advantage of changing host and environmental opportunities. Influenza viruses serve as a good example of emerging and re-emerging infectious agents in their ability to rapidly evolve in response to changing host and environmental circumstances via multiple genetic mechanisms. New ‘founder’ influenza viruses appear periodically, cause a pandemic, raise widespread population immunity, and then, in response to human immune pressures, evolve and persist for decades using multiple genetic evolutionary mechanisms to sustain continual immune escape. The 1918 influenza pandemic virus is one example: over the past 95 years, its descendants have evolved continually by antigenic drift, intrasubtypic reassortment, and antigenic shift, the latter producing new pandemics in 1957 and 1968. Even the genetically complex 2009 pandemic H1N1 influenza virus is a descendant of the 1918 virus. Such continuous genetic hyperevolution forces us to develop new influenza vaccines containing new antigens on an annual basis." See:http://science.time.com/2013/07/10/from-aids-to-sars-to-mers-emerging-infectious-diseases-remain-a-dire-threat/ 

Catching MERS-CoV before it evolves is critical to prevention. Novavax announced it has developed a vaccine which successfully stopped MERS infections in laboratory based trials with applications for both humans and animals (camels are suspected to be the primary host). http://basicsmedia.com/novavax-inc-nasdaqnvax-taking-mers-by-the-horns-9412 Although the vaccine is considered highly experimental it will be interesting to see the evolution of MERS and Novovax research and drug development efforts to control this. When we consider pandemics, literature on MERS would seem to suggest that the risk of MERS becoming a pandemic remain rather low, however, as we encounter emerging diseases of the future, we must pay close attention to the potential of pandemic diseases. 
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Wednesday, May 14, 2014

Emerging Technologies: Bio-hacking and the future of bio-terrorism




For some time concern has been raised over 3D and 4D technologies, (withsynthetic biology the emerging technological forerunner of these concerns and the NSABB playing watchdog), with regard to how inherent de-skilling may reduce the technical threshold which inhibits most would-be weaponeers from developing and deploying a weaponized biological agent capable of mass destruction. At the somewhat more extreme end, bio-hacking could reduce barriers which are perhaps better left in place.  Bio-hacking  was put on the map in 2013 when molecular biologist Ellen Jorgensen delivered a TED talk about Genespace, the DIY science lab she opened in New Yorkin late 2010. See: http://new.ted.com/talks/ellen_jorgensen_biohacking_you_can_do_it_too  


Picture-2.jpg
(Image: Mac Cowell/FutureLabCamp)
The lab Jorgensen oversees is one of approximately 45 DIY international sciencegroups,of  more than twenty in the US. While some of these labs are rather extreme in their goals, emerging technology such as 3D bioprinting could theoretically reduce the knowledge needed to develop synthetic weapons. So far several of the bio-hacking groups seem to be content with using themselves in experiments and implanting magnets but coding life for the masses and or the non-scientific community, could become a lot easier in a relatively short period of time. 

makerfaire.com
"But we don't smuggle plutonium. We don't supplychemical weapons. We don't build rockets. Instead we have a hobby that the FBI believes could be so dangerous that they have come up with a special programme to make sense of it. That hobby is to play with genes, proteins and bacteria in our spare time in a homemade lab we constructed from scratch. We are part of a rapidly growing community of amateur geneticists, who are often labelled biopunks, or outlaw biologists. Or, better still, in an analogy to the computer programming enthusiasts of a generation ago, some call us bio-hackers. But instead of software code, we try to tinker with DNA, the code of life. The FBI has set up the Biological Countermeasures Unit ( ) one of their goals in preventing acts of terrorism is to reach out to leading names in the field to quiz them about what they do." See: http://www.bbc.com/future/story/20130122-how-we-became-biohackers-part-1

This surely must be cutting edge bio-security, however, how close are bio-hackers to actually crossing what was considered the technological threshold to creating what might even be considered synthetic biological weapons? After 911 and the US anthrax attacks, I advised governments that mass casualty bio-terrorism was not as simple as it was being touted. In fact I, and several other scientists, focused on state warfare laboratories, considering bio-terrorism not of real world interest. Emerging technology which results in de-skilling however, may make the life of the would be bioweaponeer far easier and reduce what was always considered to be rather insurmountable technical barriers, certainly in the deployment of a mass casualty weapon. 

biohackspace.org 

What is the current view of life sciences deskilling, given the increase in DIY science? Johnathan B.Tucker, a former long time colleague, presented an excellent analysis of the issue in his paper, "Could Terrorists Exploit Synthetic Biology? published in The New Atlantis, see: http://www.thenewatlantis.com/publications/could-terrorists-exploit-synthetic-biology, although notably before bio-hacker movement emerged more openly into the media with a cohesive defined goal and group structure. Tucker, in his analysis states: 

"Member of this second school point to a contradictory trend in biotechnological development that they claim will ultimately prove stronger. They note that the evolution of many emerging technologies involves a process of de-skilling that, over time, reduces the amount of tacit knowledge required for their use. Chris Chyba of Princeton, for example, contends that as whole-genome synthesis is automated, commercialized, and 'black-boxed,' it will become more accessible to individuals with only basic scientific skills, including terrorists and other malicious actors (16).De-skilling has already occurred in several genetic-engineering techniques that have been around for more than twenty years, including gene cloning (copying foreign genes in bacteria), transfection (introducing foreign genetic material into a cell), ligation (stitching fragments of DNA together), and the polymerase chane reaction, or PCR (which makes it possible to copy any particular DNA sequence several million fold). Although one must have access to natural genetic material to use these techniques, the associated skill sets have diffused widely across the international scientific community. In fact, a few standard genetic-engineering techniques have been de-skilled to the point that they are now accessible to undergraduates and even advanced high school 
students
, and could therefore be appropriated fairly easily by terrorist groups." See:
http://www.thenewatlantis.com/publications/could-terrorists-exploit-synthetic-biology   

Gerald Epstein, of the Center for Science, Technology and Security Policy, write that whole-genome synthesis 'appears to be following a trajectory familiar to other useful techniques: Originally accessible only to a handful of top research groups working at state of the art facilities, synthesis techniques are becoming more widely available as they are refined, simplified, and improved by skilled technicians and craftsmen. Indeed, they are increasingly becoming 'commoditized,' as kits, processes, reagents, and services become available for individuals with basic lab training." (17). In 2007 Epstein and three co-authors predicted that 'ten years from now, it may be easier to synthesize almost any pathogenic virus than to obtain it through other means," although they did not imply that individuals with only basic scientific training will be among the first to acquire this capability.(18)" See:http://www.thenewatlantis.com/publications/could-terrorists-exploit-synthetic-biology 

"To date, the de-skilling of synthetic genomics has affected only a few elements of what is actually a complex, multi-step process. Practitioners of de novo viral synthesis note that the most challenging steps do not involve the synthesis of DNA fragments, which can be ordered from commercial suppliers, but the assembly of these fragments into a functional genome and the expression of the viral proteins. According to a report by the U.S. National Science Advisory Board for Biosecurity, a federal advisory committee, "The technology for synthesizing DNA is rapidly accessible, straightforward and a fundamental tool used in current biological research. In contrast, the science of constructing and expressing viruses in the laboratory is more complex and somewhat of an art. It is the laboratory procedures downstream from the actual synthesis of DNA that are the limiting steps in recovering viruses from genetic material." (19)" See: http://www.thenewatlantis.com/publications/could-terrorists-exploit-synthetic-biology 

As technology emerges which contributes to deskilling and with the advent of DIY science, we may witness rather rapid advancements which overcome the long time presumed threshold. The bio-hacking community has emerged because techniques used in molecular biology have been de-skilled and the cost has dropped. 



"A couple of decades ago, it took three years to learn how to clone and sequence a gene, and you earned a PhD in the process. Now, thanks to ready made kits you can do the same in less than three days. Specialized materials and second hand equipment are much more affordable, not to mention more available. Machines for amplifying DNA can now be purchased online, whilst enzymes and chemicals for creating, manipulating and sticking together DNA an be ordered off the shelf. The cost of sequencing DNA has plummeted , from about 100,000 for reading a million letters or base pairs, of DNA code in 2001, to around 10 cents today. See:http://www.bbc.com/future/story/20130122-how-we-became-biohackers-part-1 full review: 

Jill Bellamy is an internationally recognized expert on biological warfare and defence. She has formerly advised NATO and for the past seventeen years has represented a number of bio-pharmaceutical and government clients working on procurement strategy between NATO MS and Washington DC. Her articles have appeared in the National Review, The Wall Street Journal, The Washington Post, The Sunday Times of London, Le Temps, Le Monde and the Jerusalem Post among other publications. She is a CBRN SME with the U.S. Department of Defence, Chemical, Biological, Radiological and Nuclear Defence Information Analysis Center and CEO of Warfare Technology Analytics, a private consultancy based in the Netherlands. She is an Associate Fellow with the Henry Jackson Society, UK.

Medical Intelligence and Bio-Defence: Countering Emerging Threats of Deliberate Disease

photo:www.ascenion..de

"Medical intelligence, defined by the U.S. Department of Defence is 'a category of intelligence resulting from collection, evaluation, analysis, and interpretation of foreign medical, bio-scientific, and environmental information this is of interest to strategic planning and to military medical planning and operations for the conservation of the fighting strength of friendly forces and the formulation of assessments of foreign medical capabilities in both military and civilian sectors. Also called MEDINT.(1). See:http://en.wikipedia.org/wiki/National_Center_for_Medical_Intelligence

Assessing biological threats both natural and deliberate is often considered a multi-agency and multi-national endeavor. Indeed, global health agencies such as the World Health organization have developed sophisticated disease surveillance architectures. For example, in October of 1995, a new unit was established at WHO as the Division of Emerging Viral and Bacterial Disease Surveillance and Control (EMC). (WHO 1995b), to be later renamed successively as the Department of Communicable Diseases Surveillance and Response (CSR) and the Department of Epidemic and Pandemic Alert and Response (EPR). In 2000, under the operational support of CSR team members, a Global Outbreak Alert and Response Network (GOARN) was created to coordinate technical resources involved worldwide in combating outbreak-prone diseases (Enserink 2004). The apparent success of GOARN and collaborating technical partners in limiting the international spread of SARS in 2003 (Heymann and Rodier 2004) has vindicated efforts led by WHO to put the control of emerging or re-emerging diseases high on the global health agenda. See: http://heapol.oxfordjournals.org/content/22/1/2.long


image: www.fanpop.com

While international networks for surveillance of emerging and reemerging disease serves a vital function in identification and prevention of the spread of disease, among other things, it is but one aspect of biological defence. The United States has one of the more advanced MEDINT infrastructures in the world.  Few people are aware of how medical intelligence is collected and the critical aspect this serves, specifically in terms of forecasting. In an online U.S. Department of Defence publication, by Cheryl Pellerin entitled, "Medical Intelligence Center Monitors Health Threats," she offers interesting insights into how NCMI functions, it's targets and products. Pellerin's article states: 


"The Defence Intelligence Agency's National Center for Medical Intelligence, known as NCMI, is an intelligence organization, not a public health organization. The center's intelligence targets are medical and scientific issues. Its products, like those of the rest of the intelligence community are predictive analysis and products for warning, produced in four divisions who's experts follow developments in infectious disease, environmental health, global health systems and medical science and technology. [ ] "In the infectious Disease Division, the baseline requirement is to understand the risk of every type of [endemic] infectious disease in every country. You can imagine why, Rizzo says. "If an outbreak of mystery disease occurs in a country, we need to be able to say that we know int hat country that Ebola, malaria and dengue are very common, so my people can look at the symptoms of mystery disease and know" the most likely suspects. Rizzo said. "If mystery disease doesn't fit the things that are most likely," he added, "then we have to start looking really differently.""

"At NCMI, every division also has a baseline product in addition to alerts and threat forecasts. In the Infectious Disease Division, it's the Infectious Disease Risk Assessment, a predictive product, Rizzo noted, "that says if you go to a place unprotected, we predict these are the diseases your people will get, and ....these are the numbers of cases." "Every federal organization that sends Americans overseas uses this product, along with baseline products from the other divisions." Also at NCMI is a cross-divisional pandemic warning team that spends all its time monitoring highly pathogenic h5N1 avian influenza and other potential pandemic diseases. In April 2009, two months before the World Health Organization and the U.S. Centers for Disease Control and Prevention officially declared the global outbreak of H1N1 influenza pandemic, NCMI published an intelligence product for senior U.S. policy makers that predicted H1N1 would be a pandemic. "That does not make us better than [CDC]," Rizzo said, "What it does do is make us different, because [CDC] has to be right. We in the intelligence community love to be right, but we also know that in order to provide timely warning, warning in time for the customer to take action to mitigate what we've predicted, we have to be early. And the earlier we predict....the less certainty we have." The NCMI Science and Technology Division is responsible for understanding every nation’s medical defense capabilities against chemical, biological, radiological and nuclear weapons. “If you understand a country’s medical defense capabilities, that can very much help you understand what their other capabilities might be and what their intent is,” Rizzo said. “People plan medical defense based on what they think is going to happen to them or what they think they can do.” For full article see: http://www.defense.gov/news/newsarticle.aspx?id=118163

In contrast to NCMI, the European Commission operates an integrated system of  number of surveillance and epidemic intelligence collection. Below is a diagram from DG Public Health 'Medical Intelligence in Europe: 
http://ec.europa.eu/health/preparedness_response/generic_preparedness/planning/medical_intelligence_en.htm

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Medical intelligence in Europe is closely associated with real time disease outbreaks, monitoring and surveillance and data collection within this domain. In addition it covers 'epidemic intelligence on communicable disease but also chemical, radiological and nuclear information, it reviews the latest developments in health, as for instance the progress in science, in medicine, vaccines and covers the preparedness and response activities. See: http://ec.europa.eu/health/preparedness_response/generic_preparedness/planning/medical_intelligence_en.htm

Medical intelligence plays a vital role not only in national security but public health security. The challenge today is to bring aspects of this integrated network to areas of the world with more limited infrastructures: Africa, Asia and the Middle East, particularly those aspects which related to monitoring and disease surveillance. 
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