Center for Biosecurity of UPMC
The Industrialization of Biology
and Its Impact on National Security
June 8, 2012
Center for Biosecurity Project Team
Gigi Kwik Gronvall, Ph.D
Senior Associate
Ryan Morhard, JD
Legal Analyst
Kunal Rambhia, MS
Senior Analyst
Anita Cicero, JD
Chief Operating Officer and Deputy Director
Tom Inglesby, MD
Chief Executive Office and Director
The Industrialization of Biology and Its Impact on National Security
CONTENTSPAGE
Summary of Findings: The Industrialization of Biology and Its Impact on National Security
1
Purpose, Methods, and Analysis
2
Finding 1: Biology Is on the Cusp of Becoming a Pervasive Industrial Technology
4
Biological Approaches Gaining Industrial Significance
Increased Computing Power Available
Data Management Challenges
Engineering-Grade Knowledge Needed Finding 2: Industrialization and Peer Competition Are Altering the “Biotech Ecosystem”
7
Biotechnology Has Low Barriers to Entrance
Movement Toward Large Interdisciplinary Teams
Peer Competition Increasing
Shifts in Biotech Ecosystem Connected to Drug Shortages
Critical to Remain Competitive
Hidden Costs of Outsourcing
Intellectual Property Barriers
Finding 3: Biological Dangers Are Persistent
15
Options for Harm
Threats from Skilled Individuals
Agriculture Is Vulnerable
Consequential Accidents
Finding 4: Bioscience Has Untapped Potential to Empower National Security
18
Reduced Time to Protection
More Powerful and Accessible Diagnostics
Treating the Patient, Regardless of Pathogen
Drug Targets Currently Underutilized
Drug Shortages Less Likely
Medical Practice Slow to Change
Regulatory Approach Needs to Be Right, or It Could Block Progress
Regulation Being Outpaced by Technological Change
Public Engagement—A Must for Technologies to Flourish
Summary22
References23
Appendices
A: List of November 9, 2011, Biodangers Meeting Participants
B: Experts Interviewed by the Center for Biosecurity
29
31
SUMMARY OF FINDINGS
The Industrialization of Biology and Its Impact on National Security:
Summary of Findings
The Center for Biosecurity of UPMC (the Center) conducted a horizon-scanning project to provide senior
leaders from the United States and the United Kingdom with awareness and understanding of the mediumterm future of biotechnology and biological dangers, resulting strategic concerns for homeland and national
security, and possible approaches that both countries may take to address biological dangers.
Biology is on the cusp of becoming a pervasive industrial technology.
Economically and strategically important industries are increasingly relying on biological manufacturing
processes for fuel, agriculture, medicines, and products that traditionally have been made using chemistry.
The industrialization of biology, akin to the introduction of steam engines or computers in ushering in a
new technological age, has major national security implications in terms of peer competition, sources for
precursor materials, availability of critical pharmaceutical drugs, and the global accessibility of powerful
technologies. There are technical barriers, including software development and the difficulty in managing
large datasets, that could potentially limit the pace, but not the end result, of biotechnology industrialization.
As a consequence of biological industrialization, the “who, what, and where” of
bioscience—what project participants termed the biotech ecosystem—is changing.
Concerns were expressed about the need for established centers of biotechnology, including the U.S. and
U.K., to adapt to the global competitive market for bioscience. Peer country competitors, including Brazil,
China, Russia, and India, have made substantial economic gains from biotechnology and are competing
with other bioscience regions for manufacturing resources, consumer markets, and skilled workers, with
implications for national security.
Industrialization will inevitably increase the potential for misuse of biology.
The advent of powerful new technologies expands both the possibilities for nefarious use by malicious actors
and the number of potential actors who are technically able to misuse bioscience. Collectively, the global
accessibility of powerful biotechnologies, information, and training; the “de-skilling” of molecular techniques;
and the beneficent uses of biotechnology indicate that most biological dangers will be impervious to central
control or regulation on a global scale. It will also be difficult to maintain appropriate individual vaccines and
therapies for an increasing range of biological dangers, whether they stem from misuse, accident, or nature.
Biotechnologies have untapped potential to empower national security.
In this new industrial biotechnology future, national-level strategies are required to stay competitive
and to maintain domestic biotechnology capabilities for national security. Advances in the biosciences
and biotechnologies should enable the development of diagnostics, the rapid development of medical
countermeasures, and the means to evaluate the effectiveness of those countermeasures. It should also
provide positive contributions to diagnostics to aid in the rapid detection of natural or deliberate disease and
to help guide response. Shepherding these technologies requires good management and funding of science
and technology and the right regulatory approach.
Center for Biosecurity of UPMC | January 2012
Page 1 Industrialization of Biology and National Security
PURPOSE AND METHODS
The Industrialization of Biology and Its Impact on National Security
Purpose
The Center for Biosecurity of UPMC (the Center) conducted a horizon-scanning project to provide senior
leaders from the United States and the United Kingdom with an expert assessment of key bioscience
developments in a 5- to 10-year timeframe, the resulting concerns for homeland and national security, and
suggestions for what the U.S. and U.K. may do to address them. The Center also examined the drivers of
likely advances, barriers to advancement, and ways in which dangers might be mitigated.
Methods and Analysis
Interviews: The Center interviewed 46 leaders (listed in Appendix B) from the biosciences and related
fields from academia, government, and the private sector, including venture capitalists. Our goal was to
ascertain the experts’ judgments about evolving capabilities in the life sciences and the accessibility of those
capabilities.
Our discussions focused on trends in capabilities as opposed to details about specific technologies, because
technologies are interdependent, and the experts with whom we spoke often work at the interface of
categorically distinct technologies, such as synthetic biology and bioinformatics. Our analysis also captured
insights into newly emerging technologies that are not widely visible.
We asked in interviews how bioscience capabilities are likely to evolve over the next 5 to 10 years and
about the drivers that could affect the trajectory of that evolution. Such drivers include, but are not limited
to, commercial market and medical research interests, regulatory pressure, investments in education,
intersections with other technologies, government support of national industries, and the effects of the
global economic downturn. We focused on how accessible new capabilities would be to nation states, small
groups, or individuals—for entrepreneurship, or recreation (ie, do-it-yourself biology, aka DIY Bio, or citizen
science), or for malevolent purposes. We asked about potential dangers and homeland security concerns that
could emanate from these capabilities, and how such dangers or concerns could be mitigated by the U.S.,
the U.K., or through a collaborative partnership.
U.K. Synthetic Biology Workshop: The Center for Biosecurity participated in the September 29, 2011,
Synthetic Biology Workshop organized by Imperial College and the U.K. Home Office, which was a “scienceled forward look at the potential negative impacts of synthetic biology.” The participants were a diverse
group of U.K. scientists. The deliberations of this meeting informed the subsequent November 9, 2011,
Biodangers meeting at the Center for Biosecurity and this project report.
Center for Biosecurity of UPMC | January 2012
Page 2 Industrialization of Biology and National Security
PURPOSE AND METHODS
Review of published literature and previous reports: The Center analyzed and included relevant data
from available published horizon-scanning assessments of technology, which included the following: (1)
U.S. National Research Council report Globalization, Biosecurity, and the Future of the Life Sciences (2006),
which described such scientific trends as acquiring novel molecular diversity, directed design, and intentional
manipulation of biological systems; (2) commercial, medical, and industrial applications; and (3) the 2011
report Life Sciences and Related Fields: Trends Relevant to the Biological Weapons Convention, which
described the weaponization potential of bioscience capabilities.1,2
November 9, 2011, Biodangers meeting: The Center completed a preliminary analysis report that
synthesized the results of both the literature review and our expert interviews. Those findings were used
to facilitate the discussion in the November 9, 2011, Biodangers meeting at the Center for Biosecurity in
Baltimore, MD, USA. That meeting was attended by participants from U.S. and U.K. academic institutions,
private industry, the U.S. government (USG), and the U.K. Home Office, which funded the travel of the U.K.
participants. Appendix A lists all meeting participants. Senior staff and leadership from the U.K. Home Office,
the Defense Threat Reduction Agency (DTRA), the Department of Homeland Security (DHS), the Center, and
The Tauri Group participated.
The meeting served as a forum for in-depth discussion of the direction of biotechnologies, the challenges
and priorities for the USG and U.K. Home Office in promoting positive uses of biotechnologies, and
potential biosecurity needs that the U.S. and U.K. could pursue in the medium-term, either collaboratively
or separately. Diverse views were encouraged in this discussion, and while there was no requirement for
consensus, there was substantial agreement around many findings.
Final report: This final report presents the Center’s scientific and policy assessment of this issue, informed by
our expert interviews, literature review, and U.S. and U.K. meeting discussions. The views expressed do not
necessarily reflect specific views of the meeting participants or sponsors.
Offset quotes: Throughout this report, the offset quotes that appear in the text were from individual
meeting participants. They are anonymous as per agreement with the project participants.
Funding: This project was funded by the DTRA Chemical and Biological Technologies Directorate DTRA/RDCB) through The Tauri Group.
Center for Biosecurity of UPMC | January 2012
Page 3 Industrialization of Biology and National Security
Finding 1. B
iology is on the cusp of becoming a pervasive
industrial technology.
Biology is on the cusp of becoming fully industrialized. Economically and strategically important industries
increasingly rely on biological manufacturing processes for fuel, agriculture, medicines, and products that
have traditionally been made using chemistry.
This section of the report describes the growth of biotechnology industries, as well as technical barriers that
could potentially limit the pace, but not likely the end result, of biotechnology industrialization.
In the 1800s, we saw huge changes from the invention of the steam engine and the ability to
create and distribute energy. In the 1900s, we saw revolutionary changes from electronics and the
ability to manipulate information. The major change in this century will be biological control over
manufacturing. From an engineering perspective, biology is about making things—it’s a manufacturing
technology. It puts atoms precisely where they should be.
Biological Approaches Gaining Industrial
Significance
Industry is increasingly reliant on biological
approaches. Biological processes have long been
used for industrial purposes. Agriculture, biologics,
pharmaceuticals, and fermented products (such
as beer and wine) all require biological processing
steps. Yet, the industrial use of biology is extending
into areas that have traditionally required either
chemical engineering or resource-intensive
harvesting from nature. For example, artemisia
plants have been used for medicinal purposes since
at least 200 BC but on a small scale; now, a synthetic
version of artemisinin can be mass produced, so that
the World Health Organization (WHO) may use it in
sub-Saharan Africa to treat malaria patients.3
Medicines are only part of the industrialization of
biology. Analysts have forecasted that by 2015,
one-fifth of the U.S. $1.8 trillion chemical industry
could be dependent on synthetic biology.4 Over the
course of the next decade, the synthetic biology
market has the potential to grow to US$3.5 billion
based on its industrial relevance.4 This is due to
Center for Biosecurity of UPMC | January 2012
investment in biofuels and chemical processes,
such as bioisoprene to make tires traditionally
produced from natural rubber, or valencene,
an orange flavoring used in perfumes and food
products, or any number of detergents, adhesives,
and building materials. Mining is another example:
Biological organisms are currently used in gold
mining, because it is cost-effective, safer, and less
environmentally damaging compared to traditional
extracting methods using cyanide.5 In the future,
synthetic organisms may be designed for extracting
rare earth metals, essential for lasers, magnets, and
electronics. Rare earth metals are not rare in nature,
but the expense of extraction and toxic byproducts,
coupled with aggressive market strategies, has
resulted in the U.S. purchasing most rare earth
materials from China, even though there are
plentiful domestic natural resources.6
In addition to mining, there is a potentially vast
body of information relevant to other industries
that may be gained from the harvesting and study
of natural organisms. Extremophiles, for instance,
are organisms that thrive in habitats unsuitable for
most life forms. They can be found in environments
Page 4 Industrialization of Biology and National Security
FINDING 1
of high heat, dryness, or salinity, or in habitats of
low pH or high pH, or in places with high levels of
radiation—all habitats that require adaptations that
could inform industrial manufacturing processes
and environmental remediation. Further, it may not
always be necessary to harvest from the natural
environment: There is a great amount of genetic
flexibility within organisms that could be tapped in a
laboratory for industrial applications.
Increased Computing Power Available
Increased computing power is driving new
bioscience approaches and applications. In the
coming years, biological systems are expected to
become more predictable to scientists, and thus
more amenable to engineering. Increased computing
power available to scientists and engineers, along
with inexpensive DNA sequencing and synthesis
technologies, will allow many permutations of
biological systems to be synthesized and tested.
Computational biology is consequently expanding
as a field, along with its requirements for applied
mathematics, software engineering, data storage,
and algorithm development.
According to the scientists interviewed, the effects of
increased data-crunching power are only beginning
to be realized; they expect that enhanced computing
power and accessibility will lead to improvements
in drug development and diagnostic tests, as
well as improved modeling of biological systems,
interpretation of genomic datasets, and manipulation
of smart materials.
The bio community doesn’t yet understand
how much computer power will be available
and what it means.
improved management of biomedical databases,
and electronic medical and high-volume automated
image-screening technologies.8
Just as computing power stands to transform our
understanding of biological systems, biological
systems themselves may provide computational
power. Nature has evolved to use genetic material
to both store and act on information; this process is
now being put to industrial use.
Nanotechnology is about building tiny
machines, and biology worked that out a long
time ago.
There are already in existence computers that use
DNA instead of silicon to perform calculations.
These biological computers, sometimes called
matter computers, have already performed simple
calculations, such as square roots, in a test tube,9
and they may eventually contribute to the industrial
potential of self-healing plastics or point-of-care
diagnostics that do not require refrigeration. As
recently demonstrated in vitro, an RNA-based
circuit was able to distinguish cancer cells from
noncancerous cells and trigger the cancer cells to
self-destruct.10
Data Management Challenges
Managing and interpreting an explosion of data
will be a challenge. Technical challenges ahead
include that of storing massive amounts of biological
information. Right now, more than 2% of the
electricity in the U.S. is consumed by datacenters.11 It
is expected that to support the technology of today,
the equivalent of about 45 new coal plants will be
needed to power U.S. datacenters by 2015 if there
are not dramatic improvements in efficiency.
In addition to computing with petaflops in highresource settings, computing power is also more
accessible to all scientists. A 2011-era smart phone
has more processing power than all the computers in
the Apollo 11 Lunar Lander, which put 2 people on
the moon.7 Computing power may help to form new
industries around next-generation investigative tools,
which will include advanced sequencing capabilities,
In addition to the costs of storage, there are
technical challenges in manipulating such large
amounts of information. One of these challenges is
software-based. While there have been great strides
in advancing the multiprocessing capabilities of
computers, software development to take advantage
of multicore processing has lagged behind.
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Page 5 Industrialization of Biology and National Security
FINDING 1
The cloud includes almost limitless data
storage and processing, but the software
infrastructure isn’t there to harness parallel
processing capability.
Further, information for bioinformatics analysis has
to be in a computable form, but often it is not.
Scientists have to be able to generate data in a form
that is accessible for others to compute if potential
benefits for medical diagnostics, health records,
genetic analysis, and environmental monitoring are
to be realized.
There are also many areas of biological science that
require resource-intensive efforts, such as gene
characterization, which won’t be substantially sped
up through reductions in the costs associated with
sequencing or by enhanced computing power. True
understanding of biological systems may be slowed
by the time it takes to understand these biological
systems at the detailed level needed for engineering.
What can I do with 10, 20, 50 genes? It comes
down to knowing what each part does, and
too few scientists are doing the hard work to
figure that out.
Engineering-Grade Knowledge Needed
Engineering-grade knowledge of biological systems
is needed. To be able to use DNA and other
biological molecules for engineering and industrial
purposes, their functions must be understood at the
smallest scale, which is a new requirement.
One scientist noted that when inexpensive DNA
sequencing became available to researchers in 1996,
a large number of scientists adopted sequencing
as “the thing to do.” While sequencing studies are
valuable, too few scientists are engaging in the timeintensive work of learning how individual proteins
function and how complexes of proteins interact.
Center for Biosecurity of UPMC | January 2012
Page 6 Industrialization of Biology and National Security
Finding 2: Industrialization and peer competition are altering the
“biotech ecosystem.”
The “who, what, and where” of bioscience industries—what project participants termed the biotech
ecosystem—is changing. Several project participants were concerned that not enough is being done in some
established centers of biotechnology to adapt to the changing biotech ecosystem and remain competitive.12
In contrast to other industries that require substantial natural resources, such as arable land, oil, or natural
gas, biotechnology has few barriers to entrance, and emerging markets can become competitive quickly.
This section of the report describes how the biotech ecosystem is changing, and how peer country
competitors have made substantial economic gains from biotechnology in a short period of time and are
competing with established bioscience regions for manufacturing resources, consumer markets, and skilled
workers—actions that all have implications for national security.
The center of gravity is going to change dramatically where biology is practiced, and that will catch
people by surprise. We’re going to see a tremendous shift to the developing countries, to the growing
economies, and less and less attractiveness of biology in the industrialized world. It’s going to surprise
people how quickly that future is going to come.
Biotechnology Has Low Barriers to Entrance
Entry barriers to bioscience and biotechnologies
are low. While bioscience research practice
has recently trended toward use of large,
multidisciplinary teams, the field is still open to
individuals or small groups. Due to increasing
accessibility of biological techniques (referred
to as “de-skilling”), scientific experimentation is
increasingly open to and practiced by amateurs.
Citizen science, or DIY Bio, has gained popularity
in recent years and has led to the creation of
community laboratories in Brooklyn, San Francisco,13
and Manchester, England.14
Some analysts have predicted that these laboratories
will result in innovative new biotechnologies, but
most scientists interviewed for this analysis had more
modest expectations.15 They observed that more
DIY Bio enthusiasts are working on such projects as
DNA barcoding, a taxonomic method to determine
species that is useful for detecting intentionally
mislabeled fish,16 or on mining personal genetic data.
Center for Biosecurity of UPMC | January 2012
Another example of amateur involvement in
biotechnology is iGEM, the International Genetically
Engineered Machine Competition. This is a
competition in which undergraduates from around
the world build simple synthetic biological systems
from standard, interchangeable parts, called
BioBricks, and operate them in living cells. iGEM
grew from 5 teams in 2004 to 165 teams in 2011,
with 8 to 12 students per team. A Slovenian team
won in 2010 for designing a DNA-guided assembly
line. The 2011 winner was a team from the University
of Washington for its project called Make It or Break
It: Diesel Production and Gluten Destruction, the
Synthetic Biology Way.17 Though iGEM projects are
carried out by students, many of them entirely new to
bioscience, the projects have been sophisticated, and
they demonstrate the accessibility of biotechnology
techniques to interested, dedicated groups.
The ability of small groups to accomplish meaningful
biological projects has implications for the
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FINDING 2
FIGURE 1: Number of Biotech Articles Published by Region.
Peng W. Trends in biotech literature 2009-2010. Nature Biotechnol. 2011;29:781. Adapted with permission.
geographic location of bioindustries.
No matter where I am in the world, I have
access to almost the same tools that you have
inside the Venter Institute. They might not
have the concentration of minds who do lots
of different things who are brought together
under a common vision. But there are a lot
of really smart people out there who will do
amazing things or do horrible things.
The 2010 iGEM win of the team from Slovenia,
which is not among the top 10 countries in science
and engineering, demonstrates that a few people
performing at a high level can outdo groups with
more resources.18
Movement Toward Large Interdisciplinary
Teams
statisticians, computer scientists, biophysicists,
mathematicians, material scientists, and researchers
from other disciplines, working together in large
teams. One example of this shift was the Venter
synthetic cell project, which took 20 people 10 years
to complete, at a cost of US$40 million.19 Another
example of big biology is the Human Microbiome
Project. Launched in 2008 by the U.S. National
Institutes of Health, it is a 5-year, US$157 million
effort to understand the complexity and diversity of
microbes that live in or on the human body.20,21
Multidisciplinary biological studies that incorporate
mathematicians and engineers may now be
considered the substrate for biotechnology
industrialization, but this is a radically different
organizational approach than has been used in
the past, which focused on supporting individual
scientific investigators.
High-resource laboratories are moving toward
large, interdisciplinary teams that span expertise in
biological systems and applied mathematics. Work
in the biological sciences is increasingly international
and interdisciplinary. Major advancements in
biotechnology are increasingly being accomplished
by teams of biologists, engineers, chemists,
Funding sources may not appreciate the value
or might not be able to properly evaluate
Center for Biosecurity of UPMC | January 2012
Page 8 Universities and government agencies, at
least in the U.S., have real difficulties in
nurturing and managing multidisciplinary
teams.
Industrialization of Biology and National Security
FINDING 2
FIGURE 2: U.S. Drug Sales by Volume.
Beyond Borders Global Biotechnology Report 2011. Ernst and Young. http://www.ey.com/GL/en/Industries/LifeSciences/Beyond-borders--global-biotechnology-report-2011. Accessed January 5, 2012. Adapted with permission.
interdisciplinary work. It is also a challenge to
educate professionals from the biological sciences
and from engineering so they are able to participate
and engage in multidisciplinary work and can
understand the technical terms, perspectives, and
constructs of other fields. New models of operating,
educating, funding, and collaborating will have to be
developed to maintain competitiveness.22
Peer Competition Increasing
Peer competition is changing the biotech
ecosystem. Project participants agreed that peer
competitor countries are making substantial strategic
investments and taking risks to promote innovation
in the biosciences, and they are gaining from these
strategies.
China’s government is spurring investments in
biotechnology, and the sector is seen as a key source
of economic development for the future. During its
twelfth 5-year plan period, the Chinese government
will spend 20 billion yuan (US$3.15 billion) on
innovation in medicine, cultivation of genetically
modified organisms, and prevention and control of
infectious diseases, according to the China National
Center for Biotechnology Development. The goal
Center for Biosecurity of UPMC | January 2012
is to have biotechnology account for 15% of the
nation’s GDP by 2020. Currently, it accounts for 3%
of China’s GDP.23
China’s investments to date were not appraised
uniformly by those we interviewed: One government
expert classified the Chinese biotechnology
enterprise as “lavish and fast-moving” and
emphasized that the U.S. is lagging behind. Other
experts interviewed were more sanguine, predicting
that the U.S. will maintain an edge due to its patent
and venture capital systems.
One tangible and successful example of China’s
commitment to a biotechnology future is the Beijing
Genomics Institute (BGI), which boasts 128 Illumina
HiSeq 2000 sequences, or 3 times the number
that most sequencing centers have. They have
more than 4,000 employees, including more than
1,000 bioinformaticians, and they have tremendous
government support, as evidenced by a 2009
government loan equal to US$1.5 billion.
BGI was a key player in the analysis of the 2011
E. coli O104:H4 outbreak, and its scientists have
analyzed more than 50,000 samples, including tens
of thousands of whole human genomes and exomes.
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FINDING 2
FIGURE 3:
1
Venture Capital Investment in Life Sciences.
VC investment in China life science climbs 300%, tops
$1 billion. ChinaBio Today. February 4,2011. http://www.
chinabiotoday.com/articles/20110204_1. Accessed January 5,
2012. Adapted with permission.
They are currently able to sequence the equivalent
of 2,000 full human genomes in a single day.23
While China’s gains in biotechnology are impressive,
venture capitalists and biotechnology industrialists
emphasized that China is not the only competitor.
China is the 800 pound gorilla, but even if
we focus on the 800 pound gorilla, we can’t
lose focus on the 600 pound gorillas, which
include Russia, Brazil, and India.
Russia is planning to have a 5% share in the global
biotechnology market by 2020.24 The experts we
interviewed found those predictions to be credible,
based on Russia’s past technology investments.
A venture capital industry expert contrasted the
deliberate, focused strategies of other countries
with those of the U.S., noting that his firm funded a
biofuels company “that could one day produce oil at
$20 a barrel,” but was turned down for investment
by the U.S. Department of Energy. They have since
moved operations into Russia and the Middle East.
Brazil, Russia, India, and China, in addition to
being centers of innovation, have growing markets
Center for Biosecurity of UPMC | January 2012
National Venture Capital Association.
Stats and Research. http://www.nvca.org. Accessed
January 5, 2012. Adapted with permission.
2
for biotechnology and pharmaceutical products,
which will draw increased attention from private
companies. Brazil, Russia, and India are expected
to add US$5 billion to US$15 billion to the
pharmaceuticals market through 2013, and all 3
countries have had double-digit pharmaceutical
growth over the past few years.25,26
Shifts in Biotech Ecosystem Connected
to Drug Shortages
Pharmaceutical drug shortages are a growing
problem. As a consequence of the shifting biotech
ecosystem, most pharmaceutical drugs are imported.
and thus may not be available in an emergency. U.S.
and U.K. dependence on foreign manufacturing
capability has already been a factor in drug
shortages, especially for cancer therapies. In an
October 31, 2011, executive order, President Barack
Obama stated that “[s]hortages of pharmaceutical
drugs pose a serious and growing threat to public
health,” and he gave the U.S. Food and Drug
Administration (FDA) broadened powers to require
additional reporting to predict shortages and
expedited regulatory reviews of substitutes.27
Critical ingredients for most antibiotics are now
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FINDING 2
FIGURE 4: Many Chinese Scientists Are Looking to Split Time Between U.S. and China.
George Baeder and Michael Zielenziger, “The Life Sciences Leader of 2020.” Monitor Group, 2010, http://www.monitor.
com/tabid/67/ctl/ArticleDetail/mid/691/CID/20101611134152307/CTID/1/L/en-US/Default.aspx. Accessed January 5, 2012.
Adapted with permission.
made almost exclusively in China and India, as is
prednisone (steroid), metformin (for diabetes 2), and
amlodipine (antihypertensive). Indian companies
currently hold 22% of the world generic drug market.
If there is a serious dislocation of international
supply chains, conventional pharmaceuticals
would not be available. We’d see panic
in society. Major hospitals receive 2 to 3
deliveries a day to minimize shelf inventory.
Critical to Remain Competitive
The U.S. and the U.K. must prepare for a changing
ecosystem while remaining competitive. Among
those interviewed, there was a great deal of concern
that the U.S. and U.K. are not doing enough to
remain competitive in a biological future, and that
future industries would be formed by and cater to
other markets. This issue is also highlighted in the
recent U.K. government life sciences strategy.28
Meeting participants suggested a potential synthetic
biology solution to this problem: First, identify those
critical industrial chemicals that if in short supply
would create shortages of critical drugs; then, apply
biological processes and techniques to synthesize
those chemicals; finally, stockpile the organisms
that produce those critical chemicals rather than the
chemicals themselves.
Project participants were concerned that the U.S.
and the U.K. did not have the workforce required for
a biological future.
An attractive aspect of funding such an approach is
that the regulatory requirements that have to be met
to establish a particular level of purity for an organic
product created through a synthetic biology process
are not as stringent as those required when replacing
entire drugs and drug pathways.
Many scientists interviewed thought that U.S. and
U.K. training is not producing enough people geared
toward the engineering, math, and biotechnology
professions. There were also concerns that
continuing education for professional scientists is not
effective, and there is a need for training biologists
to take advantage of the large datasets that are
available to them.
Center for Biosecurity of UPMC | January 2012
Nearly all applicants to my company arrive
from outside the country—mostly from China
and Russia. Where is all the training going on?
It doesn’t seem to be here in the U.S.
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FINDING 2
FIGURE 5: Top-10 Pharmaceutical Markets.
George Baeder and Michael Zielenziger, “The Life Sciences Leader of 2020.”
Monitor Group, 2010. http://www.monitor.com/tabid/67/ctl/ArticleDetail/mid/691/
CID/20101611134152307/CTID/1/L/en-US/Default.aspx. Accessed January 5, 2012.
Adapted with permission.
In the Biodangers meeting, some scientists
complained that U.S. immigration policy makes
it overly difficult for U.S. companies to retain
highly skilled foreign talent. Once postdocs are
trained, they may have to return to their home
countries regardless of their wishes or their levels
of training. Current U.S. law allows for the award
of approximately 120,000 employment-based visas
per fiscal year, of which no more than 7% can be
awarded to any single country, regardless of that
country’s population. Thus, highly skilled workers
from such populous countries as India or China could
end up waiting indefinitely for a U.S. visa. In fact,
the waiting time for permanent resident visas for
educated workers from India is now 70 years.29
Other data, however, indicate that the decline of the
U.S. economy and the rise of emerging economies,
rather than U.S. immigration policy, are to blame
for the loss of foreign talent. A survey of Chinese
and Indian immigrants who studied or worked in the
U.S. for at least 1 year before returning home found
that the majority—86.8% of Chinese and 79% of
Indians—were motivated to leave the U.S. by career
opportunities in their home countries.30
Regardless of cause, failure to retain highly educated
Center for Biosecurity of UPMC | January 2012
and skilled talent is a boon to other economies. For
the U.S., in 2006, foreign nationals were named in
25.6% of all patent applications filed in the U.S., in
65% of Merck’s patent applications, and in 60% of
Cisco’s.31
Hidden Costs of Outsourcing
Is biotechnology outsourcing damaging the
biotech ecosystem? While BGI has been a huge
success for China, its success in sequencing has
raised concerns among the scientists we interviewed
about the consequences of outsourced sequencing.
Some say we should do cheap sequencing in
China and do “added value” in the U.K. But
if we give up basic skills, we’re giving up the
foundation of our work. It is not a concern
because it is China, but because they have a
monopoly.
Many agreed that wholesale outsourcing could be
detrimental to the entire biotechnology ecosystem
and could lead to such unintended consequences
as the loss of competent workers who gravitate to
places where the work is being performed. One
meeting attendee described how his company
Page 12 Industrialization of Biology and National Security
FINDING 2
FIGURE 6: U.S. Patents Filed by BRIC Countries.
United States Patent and Trademark Office. Extended Year Set—Patents by Country, State, and Year All
Patent Types. December 2010. http://www.uspto.gov/web/offices/ac/ido/oeip/taf/cst_allh.htm. Accessed
January 5, 2012.
outsourced their regulatory studies to save money,
but found that by doing so, the company lost
substantial training opportunities for their staff. If
not planned carefully, outsourcing may lead to the
loss of key precursor materials and the knowledge
and capability to develop products.32 For capabilities
and products important to national security, this is a
concern.
Intellectual Property Barriers
Innovation and industrialization are affected by
intellectual property issues. Both the scientists
we interviewed and the meeting participants
raised concerns about intellectual property and
patents. They voiced a worry that current patent
structuring does not encourage the collaboration
and cross-licensing that has proven successful in the
electronics industry. There have also been delays
in getting patents: In 2010, the U.S. Patent and
Trademark Office reported a backlog of more than
750,000 patent applications, an accumulation that
had doubled over the previous decade.33 Delays in
granting patent rights resulting from this backlog
could ultimately cost the U.S. economy billions of
dollars annually in foregone innovation.34
Center for Biosecurity of UPMC | January 2012
The Biotechnology Industry Organization (BIO),
the world’s largest biotechnology organization,
maintains that patents often are the “most important
and sometimes only asset of a biotech company.”35
Complicating the issue, however, is an ongoing
debate over the patentability of genes and DNA,
a capability said by biotechnology experts to
be “essential for encouraging innovation,” but
condemned by others as not only costly, but
unethical.36,37
Multiple project participants expressed strong
concerns that the U.S. patent system is not
adequately fostering U.S. biotechnology innovation
and that China is now poised to surpass the U.S. and
lead the world in patent application filings.38,39
The U.S. will lead the way on biotechnology
innovation; there is a strong venture capital
system and a robust, entrepreneur-friendly
patent system. They just need to make sure
they don’t lose ground.
Recently enacted patent reform legislation in the U.S.
may mitigate these trends. The Leahy-Smith America
Invents Act, which was signed into law in September
2011, provides perhaps the most significant changes
Page 13 Industrialization of Biology and National Security
FINDING 2
FIGURE 7: Shares of World Researchers and Per Million Inhabitants (2007).
Kumar N, Asheulova N. Comparative analysis of scientific output of BRIC countries. Annals of Library and
Information Studies. September 2011;58:228. Adapted with permission.
to the U.S. patent system since the 19th century.40
The legislation introduces a first-inventor-to-file
priority rule, prevents patents from claiming or
encompassing human organisms, and reforms
administrative patent challenge proceedings at the
U.S. Patent and Trademark Office. BIO applauded
the passage of the patent reform legislation, as did
many leading manufacturers, scientists, researchers,
Center for Biosecurity of UPMC | January 2012
academic institutions, and businesses small and
large.41 Only time will tell whether these reforms
are sufficient to enable biotechnology innovators to
compete globally.
Page 14 Industrialization of Biology and National Security
Finding 3: Biological dangers are persistent.
Biological industrialization is not going to diminish the potential for misuse of biology. Rather, the reverse
is true. The advent of powerful new technologies expands both the possibilities that could be explored for
nefarious use by malicious actors and the number of potential actors who are technically able to misuse
bioscience.
The angles of the attack are almost infinite and very difficult to anticipate.
Collectively, the global accessibility of powerful biotechnologies, information, and training, along with the
“de-skilling” of molecular techniques and the almost entirely beneficent use of biotechnology, suggest that
most biological dangers will be impervious to central control or regulation on a global scale. It will also be
difficult to maintain appropriate individual vaccines and therapies for an increasing diversity of biological
dangers, whether they stem from misuse, accident, or nature.
This section of the report describes how project participants assessed the technical requirements of doing
harm with new biological techniques.
What we are dealing with is the globalization and commoditization of knowledge. Even if you start
with the most sophisticated, cutting-edge research that requires major investments and state actors,
this migrates eventually into the community. Almost anybody nowadays can pick up textbooks on
methods or read current papers on methods and techniques that 10 years ago were the stuff of Nobel
prizes. The knowledge is becoming commoditized.
Options For Harm
Well-resourced groups have many technical
options for harm. Without the addition of any
new biotechnologies, well-resourced people with
scientific training could do a great deal of damage,
according to those we interviewed. In the scientific
literature spanning the past decade or more, there
are many examples of legitimate scientific work that
could be misused in order to make pathogens more
effective as biological weapons. Indeed, it is well
known that the published literature of the past 10 to
15 years includes descriptions of making antibiotic
resistant bacteria;42,43 of engineering viruses that
can escape vaccines, as occurred in the well-known
mousepox/IL-4 experiments of 2001;44 and for
manipulating the genetics of the causative agent
of anthrax disease, Bacillus anthracis, in a way that
allows the organism to escape its vaccine.45
Center for Biosecurity of UPMC | January 2012
Extinct pathogens, such as 1918 pandemic influenza
virus, have already been resurrected.46 It also is
thought that variola major, the causative agent of
smallpox, which has been eradicated from nature,
could similarly be synthetically created, though it
would be a complicated endeavor.47 Smallpox and
influenza, of course, have caused infections in living
memory. In contrast, the scientists working in the
emerging field of paleovirology have been able to
resurrect extinct retroviruses that are millions of
years old and then demonstrate their ability to infect
human cells in vitro.48 The consequences of human
infection with a previously extinct virus are not
known.
The experts interviewed for this project had more
specific concerns about how biotechnology could
Page 15 Industrialization of Biology and National Security
FINDING 3
be misused by skilled scientists and engineers if
funding was plentiful and there was tolerance for
experimentation. They were especially concerned
about food crops, bioengineering novel systemic
disruptions, the expansion of the host range of
animal viruses, and the use of organisms to attack
physical infrastructure, including silicon or rubber.
Another concern raised was a cyber-attack with
biological consequences, as would occur if
biological data used for industrial, pharmaceutical,
or surveillance purposes was tampered with in
such a way as to derail decisions and compromise
production through application of incorrect data.
Threats from Skilled Individuals
The threats posed by individuals depend on
their skill level. Though there are many technically
possible misuses of biology, most of the scientists we
interviewed thought it unlikely that either individuals
or small groups would adopt such approaches.
“Old bugs,” such as anthrax, tularemia, and footand-mouth disease (FMD), were the biggest worries
among those interviewed. In general, they think
there are enough relatively simple paths to making a
biological weapon to render more technically difficult
approaches unattractive and, therefore, less likely to
be pursued.
The bad guys aren’t going to waste their time
with sophisticated pie-in-the sky stuff.
The rise of DIY Bio has caused concerns in the media
and among policymakers about bioweapons.49,50 Yet,
most of the scientists we interviewed are not worried
about DIY Bio’s potential for harm.
People like to equate them to hackers. But
you take a hacker and hook them up to the
Internet, they have the power of the Internet.
DIY people do not have the power of biology.
However, there was a great deal more concern about
an expert with the intent to harm—that is, a “bio”
Unabomber.
Center for Biosecurity of UPMC | January 2012
While one person might not be able to accomplish
the same biotechnological feats as an experienced
team in the same amount of time, new techniques
and falling prices for services provide skilled
individuals with shortcuts. This potential threat
should not be discounted.
Agriculture Is Vulnerable
Agriculture is vulnerable to engineered or natural
threats. Agriculture is vulnerable to nonengineered
pathogens, engineered pathogens, and introduction
of alien species. In our interviews, a great deal of
concern was expressed about biological warfare
affecting crops or livestock.
There are many known agricultural threats. The
U.S. Department of Agriculture (USDA) oversees
more than 33 of the 80+ select agents and toxins,
including the now-eradicated rinderpest virus,
bovine spongiform encephalopathy (BSE, or mad
cow disease), and peste des petits ruminants virus.
In addition to those known threats, new strains and
variants occur regularly in nature. Without adequate
fielding of diagnostics, they are often not detected
until entire herds or fields are infected.
The archetypal concern for agricultural threats is
FMD. FMD is endemic in many parts of the world
and is a relatively hardy organism that can survive
transport.
Foot-and-mouth disease is the one I worry
about in terms of bringing a country to its
knees.
The economic damage of an FMD attack could
be considerable: The 2001 U.K. outbreak that
was caused by a natural, nonengineered FMD
virus resulted in US$10 billion in losses and the
slaughter of more than 4 million animals. The costs
of a similar outbreak in the U.S. could run as high
as US$24 billion plus the lives of approximately 13
million slaughtered animals. An outbreak could be
extremely difficult to stop: The USDA calculated that
an FMD outbreak could spread to 25 states in just 5
days.51
Page 16 Industrialization of Biology and National Security
FINDING 3
In addition to engineered pathogens, alien species
could be introduced to a new environment, causing
tremendous food and economic loss.
A recent example of a natural occurrence illustrates
this phenomenon: Megacopta cribaria, or stink bugs,
were accidentally introduced into the U.S. about
15 years ago and are now present throughout the
U.S. and are killing off soybean plants.52-54 Naturally
spreading plant pathogens could also be introduced
expeditiously through a deliberate act, though
one current worry—wheat stem rust Ug99, now
spreading in Africa, Asia, and the Middle East—is
likely to arrive in Europe and the U.S. relatively soon
without assistance. A combination of chemicals can
currently kill the fungus, and there is intense work
going into making genetically resistant seeds, but
the clock is ticking.
engineering for biological containment. However,
vigilance and training to prevent accidents are still
required, especially as biosafety standards are still
not uniform worldwide.
Some meeting attendees were concerned that
the risk of a laboratory accident increases with
interdisciplinary work, which also speaks to the need
for additional biosafety training. People entering the
field of biology from other disciplines may not have
had the training or experience to be safe and take
adequate biosafety precautions.
In summary, while biotechnology has the potential
to offer exciting new industries, therapies, and
products, if misused, the advances merely expand
the range of threats. Biological dangers will persist.
The effects of agricultural disease, through natural
occurrence or intentional introduction, are not bound
by borders, as illustrated by the case of naturally
occurring South American Leaf Blight (Microcyclus),
which is the reason rubber is not produced in the
western hemisphere, where the rubber tree was
originally cultivated. This fungus is currently a threat
to Malaysia and Thailand, where rubber production is
a major part of their economies.55
Consequential Accidents
Biological accidents could be consequential.
Powerful biotechnologies could also result in
powerful accidents. Perhaps the most consequential
known biological accident occurred in 1977. The
seasonal outbreak of influenza that year was caused
by an H1N1 strain that was identical to a 1950
influenza strain that had clearly escaped from the
laboratory. 56-58 Other consequential accidents
occurred with SARS virus in Taiwan, China, and
Singapore in 2003-04, but while the escaped virus
caused harm, it did not spread around the globe.59-63
Fortunately, biosafety training and awareness have
increased dramatically since 1977, and modern
biosafety laboratories have greatly enhanced
Center for Biosecurity of UPMC | January 2012
Page 17 Industrialization of Biology and National Security
Finding 4: B
iotechnology has untapped potential to empower
national security.
Through peer competition and increasingly accessible and powerful technologies, biological industrialization
may have negative effects on national security. However, if advances in biotechnology are accompanied by
a national strategy that ensures competitiveness and maintains domestic capabilities, then national security
stands to benefit from the growing industrialization of bioscience.
In this section, we describe how advances in bioscience could improve national security by, for instance,
enabling the rapid development of diagnostics and medical countermeasures that will be more effective in
countering biothreats than what we have now. Also necessary to our ability to reap the benefits of bioscience
industrialization will be effective approaches to public engagement, increased and improved scientific
education, and regulatory approaches that encourage innovation.
If you had a dangerous technology and were afraid of what could happen as it gets widely known
about and released, there are 2 approaches you could take. One would be to try to lock it up and
make sure that nobody found out about it. And the other approach is to run like hell [to stay ahead].
And I think the approach here has to be that we run like hell. There’s no way that we’re going to keep
the things that we’re talking about secret. We just have to be better at it than anybody else. And we’d
just better get on with it.
Reduced Time To Protection
The time to develop drugs, vaccines, and
therapies will be reduced. New bioscience
knowledge and greater computing power is
expected to reduce the time required for all stages
of medical countermeasure development, which
will concomitantly reduce the risk and financial
burden of producing vaccines and drugs. From the
beginning of the drug development process, drug
target selection will be aided by systems biology
approaches.64 Animal models, which now have great
limitations in reproducing the human condition, will
be more predictive due to improved humanization
of receptors and biological processes. Increasingly,
human stem cells will also be used as an in vitro
model, offering a better predictor of toxicity.
burdensome, as batch testing of individual product
lots may no longer be necessary and the process may
be more akin to the process for chemicals.65
Also, clinical trials may be enrolled increasingly
through online communities, which should speed
enrollment and produce greater statistical power to
obtain results quickly. An example of such an online
community is the for-profit company PatientsLikeMe
(www.patientslikeme.com), which has 118,003
participants with more than 500 disease conditions.
The company sells voluntarily collected patient
information to many of the Top 20 pharmaceutical
companies and engages its members in industry- and
government-sponsored clinical trials.66-68
More Powerful and Accessible Diagnostics
For manufacturing, an advance already taking hold
is the cell-free manufacturing of biologics. This
approach should make the regulatory process less
Diagnostic tests will become more powerful
and accessible. Scientists involved in this project
believe that advances in diagnostic tests will
supply both healthcare providers and patients with
Center for Biosecurity of UPMC | January 2012
Page 18 Industrialization of Biology and National Security
FINDING 4
more information and may produce unexpected
diagnoses. Such advances will also enable rapid
detection in the event of a disease outbreak and will,
therefore, facilitate rapid response.
For diagnostics in the future, it’s not going
to be a guessing game. It’ll be [a matter of],
“Tell me what’s there, and I’ll figure out if it’s
significant.”
Certainly, there will be more diagnostic platforms
available, including mass spectrometry, microfluidics,
paper-based or cell phone–integrated tests, and
multi-analyte and host-side tests. For high-resource
settings, the low costs of sequencing could result in
routine whole-pathogen sequencing for diagnosis.
Human SNP (single nucleotide polymorphisms)
analysis and perhaps even whole-genome
sequencing of patients may be performed more
commonly to aid in diagnosis and preventive care.69
Costs for the human genome have decreased 10fold over the past 10 years and are expected to
decrease another 10-fold in the next 10 years. The
recent announcement of a combined Venter/X Prize
of US$10 million for more accurate medical-grade
whole-human genome sequencing could shorten this
timeline.70 There is already notable consumer interest
in this type of data: Testament to that is the success
of 23andMe, a company that, for $99, will mail out a
saliva collection kit to people who wish to have their
SNPs analyzed in a CLIA-certified laboratory in order
to learn about their personal disease risks. Since it
was formed in 2007, the company has analyzed the
DNA of 100,000 customers.71
Focus on the Patient, Regardless of
Pathogen
Focus on the host, not the pathogen. Efforts are
under way to better understand the host reaction
to disease, with the goal of modulating individual
immunological responses to disease. If that can
be done, then genetic modulation of individuals’
immune systems may increase resistance to disease
Center for Biosecurity of UPMC | January 2012
or reduce morbidity. This line of investigation has the
potential to shift the focus of medical response away
from the approach of fighting a pathogen with drugs
tailored specifically to that purpose to an approach
based on host immune response more generically.
It will allow the medical treatment of the “unknown,
unknown,” which is critical to national security in the
face of myriad possible variations of the biological
threat.
Drug Targets Currently Underutilized
Important drug targets may already be discovered
and waiting for development. Finding new drug
candidates may not require additional discovery.
Discussion in the Biodangers meeting suggested
that some biotech and pharmaceutical companies
now have in their possession libraries of millions of
compounds, many of which have not been tested
against pharmaceutical targets or not developed.
Governmental pressure to open up pharmaceutical
collections for neglected diseases could yield
promising candidates.
Drug Shortages Less Likely
Manufacturing can be distributed, which will make
shortages less likely. The industrial base is moving
toward a dose-on-demand approach to manufacture
of pharmaceutical drugs, which could mean
that manufacturing will be more geographically
distributed and will allow for production of smaller,
targeted doses. The vision is to develop an agile
capacity to manufacture a variety of batches of drugs
that could respond to specific market needs. As a
result of this trend, current national strategies for
stockpiling medical countermeasures may become
outmoded with advances in technologies.
We should be investing in an ability to
manufacture countermeasures. And the
good news is that biology is going to be the
enabling technology that’s going to let us do
that.
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FINDING 4
Medical Practice Slow To Change
Medical practice may not change as quickly
as progress is made in the biological sciences.
Technological change is likely to be much easier
than adoption. Extensive documentation of the
slow pace of change in medical practice indicates,
for instance, that even when information about new
developments is readily available, translation to
practice can take as long as 17 years.
As an example: Spine surgery for pain relief has
demonstrated no added benefit over other, less
invasive interventions, yet 600,000 of those surgeries
are still performed each year.72 For patients with
cardiac stents, the news is bleaker: 3 years after the
end of the COURAGE study, a well-publicized clinical
trial studying heart patients, the important changes
to recommended medical practice derived from
the study’s results have resulted in only negligible
changes to the care delivered to patients.73
Regulatory Approach Needs To Be Right, or
it Could Block Progress
The wrong regulatory approach could limit
advances in bioscience. Project participants
expressed a great deal of concern about application
of inappropriate regulation that could limit the
potential for bioscience advances, and they noted
that the right regulatory approach that promotes
innovation will be essential if bioscience benefits are
to be realized.
There is a tendency for regulators to focus on
stopping the risk rather than coping with the
risk.
Many of the scientists we interviewed believe that
current regulations are short-sighted or ill-informed.
The example cited most often was the prohibition
against genetically modified organisms (GMOs) in
the EU, a regulatory decision that has direct costs: If
GMOs were allowed, it has been estimated that the
profit margins of European farmers would increase
by US$443 million to US$929 million each year.74
Center for Biosecurity of UPMC | January 2012
Regulation Being Outpaced by
Technological Change
Technology is outpacing the ability to regulate.
The resources currently required for evaluating and
regulating biotechnologies and products are not
sufficient, which does not bode well for the future,
as more technologies emerge. In the U.S., FDAregulated products account for approximately 25
cents of every dollar spent by American consumers
each year, but the FDA mandate is considerably
more expansive than its budget.75
Confounding the problem, new technologies and
products may be dramatically different from old
models, a problem already apparent with diagnostic
tests. Instead of one diagnostic test for one disease,
diagnostic tests that detect thousands of pathogens
are now possible, but testing and validating them is a
new challenge.
Protection of individually identifiable information
will also present challenges. Genetic information
will become more important to diagnosis and drug
development, but as identification gets easier,
genetic privacy will be more difficult to control or
protect.
Public Engagement—A Must for
Technologies to Flourish
Engaging the public is a must. Without public
support, emerging biotechnologies may not be
allowed to develop or could be banned entirely,
as evidenced by prohibitions against GMOs in
the EU and bans on stem cell research in the U.S.
Clearly, public action can be a powerful impediment
to technological advancement. Many project
participants were concerned that not enough was
being done to engage the public about the future
direction of bioscience research and industrialization
and the potential benefits to society.
As scientists, we need to get smarter about
dealing with the public.
Page 20 Industrialization of Biology and National Security
FINDING 4
For national security, it is important to make the case
for continued scientific research into new ways to
diagnose infectious diseases and to prevent or treat
Center for Biosecurity of UPMC | January 2012
using new medical countermeasures. These benefits
will not be realized without ongoing commitment to
bioscience advances.
Page 21 Industrialization of Biology and National Security
Summary
Big teams do not have exclusive rights on the future of biotechnology. Individuals and smaller groups can
do the same thing as big life sciences teams on a small scale.
This report is an expert assessment of where bioscience, biotechnology, and the industrial use of
biotechnologies are heading in 5-10 years and the resulting concerns and opportunities for national security.
The “Age of Biology”—a moniker perhaps first applied at the start of the Human Genome Project in 1990—now
is a reality with substantial governmental and private industry support. Industries that traditionally relied on
chemical engineering are increasingly reliant on biological approaches, and new industries are being formed as
the availability of computational power intersects with the biosciences.
According to the experts we talked to, biological approaches are transforming manufacturing and other
industries akin to the way that steam engines or computers transformed nationally important industries. As
history has shown in previous industrial revolutions, the center of economic gravity can shift precipitously
along with these technological changes, and this is also occurring with biology industrialization. The global
biotech ecosystem of available scientific talent, investment, and education is shifting. Peer competitors
have been able to leapfrog into established markets with safer and cheaper biotechnologies. Established
centers of biotechnology, including the U.S. and the U.K., must adapt in order to remain part of this new
industrial revolution, not only with scientific contributions, but by realistically assessing the risks and rewards
of the technologies to the public, and with regulatory changes that encourage innovation and private sector
investment.
The global industrialization of biology holds additional dangers: the accessibility of new, powerful
biotechnologies and information will inevitably increase the potential for misuse of biology. While experts had
few concerns about people unskilled in the biosciences using this technology for harm, they were concerned
about malevolent use by skilled individuals, especially if they had significant resources. To counter this danger,
the only option they foresaw was to tap the potential of biology industrialization to increase protections
against misuse. Abstaining from biotechnology development increases national security vulnerabilities, such
as diminished medical countermeasures and the loss of economically important industries, but investments in
biotechnology, such as in development of medical countermeasures, diagnostic tests, and medical treatments,
are not only economically beneficial but also yield national security dividends.
Center for Biosecurity of UPMC | January 2012
Page 22 Industrialization of Biology and National Security
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Page 28 Industrialization of Biology and National Security
APPENDIX A
Appendix A
November 9, 2011, Biodangers Meeting Participants
Parney Albright Ph.D, Laboratory Director,
Lawrence Livermore National Laboratory
Thomas Inglesby, MD, Chief Executive Officer and
Director, Center for Biosecurity of UPMC
Rainer Breitling Ph.D, Professor, University of
Glasgow
Tom Knight, Ph.D, Senior Research Scientist,
Massachusetts Institute of Technology
Mark Buller Ph.D, Professor, Saint Louis University
Susan Coller Monarez, Threat Characterization and
Attribution Branch Chief (Acting), Chemical and
Biological Defense Division, Science and Technology
Directorate, Department of Homeland Security
Anita Cicero, JD, Chief Operating Officer and
Deputy Director, Center for Biosecurity of UPMC
Bernard Courtney, Chief Scientist, The Tauri Group
Jamie Davies, Ph.D, Professor, University of
Edinburgh
Cos DiMaggio, Managing Partner, The Tauri Group
Doug Drabkowski, Transition Branch Chief and
Acting Deputy Director, Chemical and Biological
Defense Division, Science and Technology
Directorate, Department of Homeland Security
Ray Elliott, Ph.D, Senior Scientific Advisor, Syngenta
John Glass, Ph.D, Senior Scientist, JCVI Synthetic
Biology Group
Michael Goldblatt, JD, Ph.D, President and CEO,
Functional Genetics
Richard K. Gordon, Office of the Assistant to the
Secretary of Defense for Nuclear and Chemical and
Biological Defense Programs
Gigi Kwik Gronvall, Ph.D, Senior Associate, Center
for Biosecurity of UPMC
D. A. Henderson, MD, Distinguished Scholar, Center
for Biosecurity of UPMC
Center for Biosecurity of UPMC | January 2012
Ryan Morhard, JD, Legal Analyst, Center for
Biosecurity of UPMC
Stephanie Okimoto, Science and Technology Liaison
to the United Kingdom, Department of Homeland
Security
Tara O’Toole, MD, MPH, Under Secretary for
Science and Technology, Department of Homeland
Security
Jason Paragas, Ph.D, Special Advisor to the
Director, Chem Bio Division, Defense Threat
Reduction Agency
George Poste, Ph.D, Chief Scientist, Complex
Adaptive Systems Initiative, Arizona State University
Kunal Rambhia, MS, Senior Analyst, Center for
Biosecurity of UPMC
Alan Rudolph, Ph.D, MBA, Director for Chemical
and Biological Technologies Directorate, Defense
Threat Reduction Agency
Ari Schuler, Senior Policy Analyst/Acting Special
Assistant to the Undersecretary for Science and
Technology, Office of the Under Secretary, Science
and Technology Directorate, Department of
Homeland Security
Page 29 Industrialization of Biology and National Security
APPENDIX A
David Shepherd, Project Manager, Biological
Information and Analysis Program, Department of
Homeland Security Science and Technology ChemBio Defense Division
Bernard Silverman, Ph.D, Chief Scientific Adviser,
Home Office, United Kingdom
Seamus Tucker, Head of CBRNE Office of Security
and Counter-Terrorism, Home Office, United
Kingdom
Iain Williams, Head of Science Secretariat, Home
Office, United Kingdom
Joyce Tait, Ph.D, Science Advisor, Innogen Centre,
University of Edinburgh
Center for Biosecurity of UPMC | January 2012
Page 30 Industrialization of Biology and National Security
APPENDIX A
Appendix B
List of Experts Interviewed by the Center for Biosecurity
Parney Albright, Ph.D, Laboratory Director, Lawrence
Livermore National Laboratory
John Glass, Ph.D, Senior Scientist, JCVI Synthetic
Biology Group
Sameer Bade, Microsoft Research
David Gilbert, Ph.D, Brunel University
Les Baillie, Ph.D, Cardiff University
Michael Goldblatt, JD, Ph.D, President and CEO,
Functional Genetics
David Berry MD, Ph.D, Flagship Ventures
Chris Hankin Ph.D, Imperial College London
Mark Buller, Ph.D Professor, Saint Louis University
Richard Jackson, Ph.D, University of Sheffield
Rainer Breitling, Ph.D Professor, University of
Glasgow
Stephen Johnston, Ph.D, The Biodesign Institute
Mario Caccamo, Ph.D, Genome Analysis Centre
Ellen Jorgensen, Ph.D, GenSpace
Michael Callahan, MD, Defense Advanced Research
Projects Agency
Jim Karkanias, Microsoft Research
Jane Calvert, Ph.D, Innogen School of Social Science
and Political Science
Robert Carlson, Ph.D, Biodesic
Tony Cass, Ph.D, Imperial College London
Jean-Claude Kihn, Ph.D, Goodyear Tire and Rubber
Company
Tom Knight, Ph.D, Senior Research Scientist,
Massachusetts Institute of Technology
Michael Kurilla, MD, Ph.D, National Institute of
Allergy and Infectious Disease
Faye Davis, Ph.D National Defense University
Paul-Jean Letournaeu, Wolfram-Alpha
Ian Dobson, BP BioFuels
Chris Lowe, Ph.D, University of Cambridge
Andrew Ellington, Ph.D, University of Texas
Thomas Monath, MD, Kleiner Perkins Caufield Byers
Ray Elliott, Ph.D, Senior Scientific Advisor, Syngenta
Philip New, BP Biofuels
Yali Friedman Ph.D, Journal of Commercial
Biotechnology
Danny O’Hare, Ph.D, Imperial College London
Emma Frow, Genomics Forum
Center for Biosecurity of UPMC | January 2012
Page 31 Industrialization of Biology and National Security
APPENDIX B
Tara O’Toole, MD, MPH, Under Secretary for
Science and Technology, Department of Homeland
Security
Bernard Silverman, Ph.D, Chief Scientific Adviser,
Home Office, United Kingdom
Willem ‘Pim’ Stemmer, Ph.D, Amunix, Inc.
Jason Paragas, Ph.D, Special Advisor to the
Director, Chem Bio Division, Defense Threat
Reduction Agency
Martin Storksdieck, Ph.D, Director, Board on
Science Education, National Research Council
Joseph Perpich, MD, JD, JGPerpich, LLC
David Studholme, Ph.D, University of Exeter
George Poste, Ph.D, Chief Scientist, Complex
Adaptive Systems Initiative, Arizona State University
Joyce Tait, Ph.D, Science Advisor, Innogen Centre,
University of Edinburgh
David Rejeski, Wilson International Center for
Scholar
Iain Williams, Ph.D, Head of Science Secretariat,
Home Office, United Kingdom
David Relman, Ph.D, Stanford University
Alan Rudolph, Ph.D, MBA, Director for Chemical
and Biological Technologies Directorate, Defense
Threat Reduction Agency
Center for Biosecurity of UPMC | January 2012
Page 32 Industrialization of Biology and National Security
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