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How do public policy decisions impact
the biotechnology industry?
A positive policy environment is crucial to the success of the
biotechnology industry and a negative one can be disastrous.
Broadly speaking, for our companies to succeed and thrive, we
need public policies that support innovation.
Innovation is the heart of biotechnology. Our industry has a
strong record of contributing to the betterment of the world. Our
products fight disease, feed the hungry and reduce pollution. Our
companies have the potential to contribute even more to improve
health care, supply alternative fuel sources, protect the environment
and expand the worlds food supply.
But biotech companies dont operate in a policy vacuum. Our
products have to compete in a global marketplace. We contend for
investment capital in the financial markets, conduct research,
develop and market products all within a framework of laws and
regulations shaped by policy decisions made in Congress, in
federal agencies and by state and local governments.
These decisions affect every biotechnology company, fromthe
smallest venture-backed start-up the largest multinational
corporation. Policies that promote innovation help us bring the
benefits of biotech to the world. Laws and regulations that inhibit
innovation undermine our ability to do so.
What public policy decisions are likely to
be made in the near future that will either
support or discourage innovation?
Patent Reform
Strong intellectual property protection is essential to the success,
and in some instances to the survival, of biotechnology companies.
Our patent systemencourages the development of new medicines
and diagnostics, agricultural and environmental products, and other
innovations produced by our industry. However, several recent
policy proposals would weaken patent protection for biotechnology
companies.
Last year, the U.S. Patent and Trademark Office proposed
changes in its rules that would restrict the number of claims
examined in a single application and limit inventors rights to file
continuation applications. These changes would have a devastating
effect on biotechnology companies by making it more difficult to
receive adequate patent protection. They would make patent
application process more burdensome and expensive, and the
outcome more uncertain. BIO has detailed our concerns about
these proposals in comments to the USPTO and recommended
alternative means for reducing the backlog of patent applications.
Meanwhile, we expect Congress will consider patent legislation
later this year. BIO and our members recognize a need for
improvements in the current patent system. But some of the
changes being proposed would harmbiotechnology innovation by
making it cheaper and easier to challenge patents and in other
ways weakening the strength and certainty of patent protection.
BIO will actively encourage Congress to truly strengthen, and not
weaken, the patent systemthat helped give birth to the
biotechnology industry and all of the beneficial innovations our
companies have produced.
The FDA
The Food and Drug Administration (FDA) is the main gatekeeper
for medical products and food products reaching patients and
consumers. Our companies depend upon that regulatory pathway
functioning well. We want a review process that is careful,
transparent and predictablethat ensures product safety and
efficacy and also facilitates timely patient access to novel therapies.
To maintain an environment that facilitates our companies
bringing safe, effective new life-saving therapies to patients,
Congress must provide the FDA with the financial resources it
needs to do its job well. We also want to enhance public
confidence in the FDA and in drug safety.
This year Congress will consider reauthorization of the
Prescription Drug User Fee Act (PDUFA). In January, the FDA
recommended improvements to PDUFA that were a result of
extensive discussion and input from industry, as well as patient
organizations, consumer groups and other stakeholders. The
FDA recommendations address a broad range of public and
industry concerns about the product review process and drug
safety.
The PDUFA proposals would fund a modernization and
enhancement of FDAs post-market surveillance systemso that the
agency can better monitor the benefits and risks of biotechnology
Q&A with
J im Greenwood
3a
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
Jim Greenwood
President & CEO, Biotechnology Industry Organization
J im Greenwood answers
some vital questions on the
importance of a positive
business, policy and
regulatory environment
for our industry.
continued on page 5a
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Vascular
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products across their marketed lifetimes and adopt new scientific
approaches to surveillance.
These proposals will also establish processes to create more
predictability and efficiency in pre-market review by allowing for
sufficient time in the review process for meaningful agency-sponsor
discussions of the product label and proposed post-marketing
commitments. They allow for the development of science-based
guidance to modernize drug development and would fund critical
information technology enhancements.
BIO will remain deeply engaged in advocating for these
improvements in the PDUFA reauthorization. We have also joined
with patient groups, consumer advocacy organizations and other
industry associations to formthe Coalition for a Stronger FDA to
support increased public funding for FDA and lessen the growing
reliance on user fees to fund the FDAs activities.
What effect does the change from
Republican to Democratic control of
Congress have on the outlook for the
issues youve mentioned and others
affecting the biotechnology industry?
Stem Cell Res earch
The change in party control brings both challenges and
opportunities for the biotechnology industry. The Democrats are
generally more supportive of federal funding for stemcell research.
In January, the House passed H.R. 3, the StemCell Research
Enhancement Act of 2007, by a vote of 253-174. This bill would
expand the limited number of stemcell lines currently available for
federally-funded research. I expect the Senate will also pass this
legislation. Given President Bushs strong views on the matter, we
can expect another presidential veto, but support for embryonic
stemcell research is definitely increasing on Capitol Hill.
Biofuels
Another area of opportunity is in biofuels. Democrats generally
consider global climate change a high priority. President Bush cited
climate change concerns as a rationale for his strong support of
renewable fuels in his State of the Union Address in January, along
with achieving energy independence. We have a great opportunity
for bipartisan cooperation in promoting greater production and use
of biofuels and for establishing the U.S. as the world leader in the
production of renewable and alternative energy sources through
the use of industrial biotechnology.
Non-Interference
On the challenge side, we have already seen legislation passed by
the House of Representatives that is a disappointing step
backward in public health policy. H.R. 4, the Medicare Prescription
Drug Price Negotiation Act, strikes the language in the Medicare
Modernization Act which prohibits the federal government from
interfering with the negotiations between drug manufacturers,
pharmacies and plan sponsors and replaces it with a requirement
to interfere in this process.
A Senate bill, S. 250, would require that the federal government
negotiate with manufacturers for the prices of single source drugs
without therapeutic equivalents.
Both of these bills, if they became law, would effectively reduce
patient access to therapies. We will fight hard in the coming
months to oppose that outcome. We believe that the goal of
government policy should be to promote, not discourage, the
development of breakthrough therapies that target unmet clinical
needs and improve upon existing treatment options.
The message that BIO and biotechnology companies must
take to members of Congress is that there is a disconnect
between celebrating the potential for new cures and treatments
from breakthroughs in areas like stem cell research and then
turning around to condemn and punish the same innovative
companies who will make those breakthroughs and bring those
new therapies to patients.
What is B IOs role in creating a positive
policy environment for biotechnology?
When the BIO board of directors hired me, I was directed to
create a world class advocacy organization. We have done
exactly that. Our team is the best in Washington. We are working
around the clock to make sure that when biotech companies
combine the talents of the best scientists, the best investors and
the best business managers to develop new, life-enhancing
products, that the public policy environment in Congress, in the
administration, the states, the localities and around the world is
conducive to your success.
Our teamis working hard on all the issues Ive mentioned.
Intellectual property protection. PDUFA and FDA funding. We also
are engaged in advocacy initiatives on Sarbanes-Oxley compliance,
SBIR eligibility, follow-on biologics, agricultural biotechnology,
funding for cellulosic ethanol research and production and on a
variety of state and local initiatives. We communicate biotechs
benefits and potential to policymakers and help themshape
policies that enhance, rather than impede, innovation.
What role can biotechnology
professionals and individual biotech
companies play in shaping the policy
environment?
The two most important things you working in the biotech industry
can do are to educate yourself about how public policy affects
your business and to help educate policymakers about the
benefits of biotech, the process of innovation and the effect of
their decisions on your ability to create the products that will
improve and save lives.
The best starting point is to make sure the policymakers closest
to youyour own representativesknow who you are and know
your story. Visit your legislators. Even better, invite themto visit your
facilities in their districts. Take that opportunity to explain what you
do and how your work benefits patients or consumers. Let them
know how many jobs you create. Help themconnect the dots. Be
visible and be engaged.
BIO itself is a great resource. Through our website (www.bio.org),
publications, government relations blogs and other channels, our
staff can help you stay informed about policy developments that
affect your company and our industry. More importantly, were there
to listen so that we know what challenges youre encountering and
what policy improvements youd like to see.
Through our board of directors and standing committees, we
work closely with our members and others in the industry to
communicate the contributions and value of biotech and to create
an environment that will help our industry thrive.
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
5a
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7a
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
B iopharma:
B eyond the
F irst P roduct
E
xecutives at fledgling biotech and specialty pharma
companies strive to develop lead products with
blockbuster potential in the hopes that soaring product
revenues will translate into years of sustained growth.
Unfortunately, the recipe for success is rarely that simple. Not only
must companies effectively manage the commercialization of that
first compound, but in order to succeed, they must also develop a
deep enough pipelineeither by investing in home-grown research
and development or by smartly in-licensing compounds. The
challenge for these nascent companies comes in managing this
difficult dance, all the while moving on a path toward profitability.
Determining what needs to happenand whencan be a
daunting task. By analyzing the lifecycles of 32 publicly traded
biotech and specialty pharma companies, though, we have
identified 5 factors that distinguish the ultimate winners fromthe
underperformers in the marketplace. Exploring these drivers of
success was the topic of an article by the authors that was
published in In Vivo: The Business & Medicine Report in
June 2006.
i
Any time a biopharma brings a product to market, its a critical
event. But no occasion is fraught with more hand-wringing than the
commercialization of the very first compound. Thats because a
product launch plays a key role in attracting investor attention and
will directly impact a companys valuation. A product introduction
represents an important opportunity for investor value accretion.
Companies that succeed in commercializing a product are viewed
differently fromtheir development stage brethren: they belong to a
different asset class, one that has a much lower risk profile. Crunch
the numbers and youll find that the 32 companies included in this
study had robust performance, achieving on average more than
250% market capitalization appreciation, and 40% stock price
appreciation beyond the AmexBiotech Index, or BTK, in the five
years following the market introductions of their first drugs.
Despite the bump in market capitalization, most companies
struggled to maintain their initial success. Sustained growth
remained a constant challenge, and in fact only 19% of them
consistently outperformed the biotech industry in the 5 years
following the launch of their first products (See Exhibit 1). Based
on a careful examination of the data, we divided our 32 companies
into three different categories: (1) sustainable performers; (2)
momentumperformers; and (3) underperformers.
Only sixcompanies consistently outperformed the BTK during
the five years that followed a first product launch. These
sustainable performers rocketed to success, on average
outpacing the BTK by more than 700% in market cap appreciation
and 250% in stock price appreciation during the critical time
period. The firms now post market capitalizations in the billions.
There were eight momentumperformers who saw a bump in
their market values following the introduction of a first therapeutic
at least initially. But these companies were unable to maintain their
performance for more than two to three years, and the average
spike in market capitalization lasted only 20 months. Of these eight,
only one had performance in excess of the market at the end of the
study period, at a 60% discount to its best performance.
Finally, 18 of the 32 companies were underperformers,
reaching a peak in market cap appreciation around the time they
began marketing their first products. Five years later, the
Pierre Jacquet
L.E.K. Consulting
continued on page 9a
Exhibit 1
Source: Bloomberg, L.E.K. analysis
byPierre Jacquet, L.E.K. Consulting and
Jonathan Hodgson, L.E.K. Consulting
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companies were consistent laggards, underperforming the BTK by
40% in stock price and 70% in market capitalization.
What can a company do to ensure it ends up a sustainable
performer and not a momentumperformer or underperformer? And
what are the key drivers for value creation beyond market launch?
A closer look at the histories of these 32 companies offers some
illuminating lessons for building sustainable growth beyond the
commercialization of a companys first therapeutic.
Lessons 1 and 2: Revenue Growth and
Aggressive Business Development
The highest performing companies posted the greatest increase in
revenue in that critical five-year window following a first product
introduction. Sustainable performers used two different strategies
to maintain growth. Some were able to boost product sales of their
first compound by putting it into clinical trials in multiple additional
indications, as Celgene Corp. did for its cancer drug thalidomide
(Thalomid), a therapeutic initially designed to treat severe erythema
nodosumleprosum(ENL) and now on the market for multiple
myeloma. Other companies were able to launch a series of new
products in quick succession, as Gilead Sciences, Inc. did with
injectable cidofovir (Vistide) in 1996, oseltamivir phosphate
(Tamiflu) in 1999, amphotericin B (AmBisome) in 2000, and
tenofovir disoproxil fumarate (Viread) in 2001. Surprisingly, a
companys change in revenue was a more meaningful indicator of
performance than was their change in earnings.
But sustainable performers did more than boost product sales.
These companies made aggressive business development
decisions, taking advantage of the spike in their market values to
raise additional funds for future R&D, in-licensing, or
commercialization expenditures. Indeed, the companies doing the
most dealseither licensing transactions or money-raising efforts
belong to the sustainable performer class. Unlike the momentum
players or underperformers, most of themconducted at least one
follow-on public offering to raise cash after the first product
commercialization. And sustainable performers didnt just tap their
financial wells more oftenthey were also able to raise more
money per event, as well as cumulatively, than peers in the
underperformer or momentumperformer classes.
Another key factor indicative of outperforming the BTK post-
product launch: the number of business development transactions
completed. Sustainable performers and momentumperformers
conducted on average 2.5 and 2.4 product transactions,
respectively, within the first three years of marketing their first drug,
while underperformers inked just 0.6 deals. Sustainable performers
also completed more significant transactions. For instance, half of
the sustainable performers purchased a company within 24 months
of bringing their first drug to market, including Celgenes
acquisitions of Signal Pharmaceuticals, Inc. and Anthrogenesis
Corp. for R&D expertise and stemcell capabilities, respectively,
Gileads acquisition of NeXstar Pharmaceuticals, Inc. for its
antiviral franchise, and Cephalon, Inc.s acquisition of Anesta Corp.
for its pipeline and delivery technology.
Lesson 3: Build a P ipeline
Our analysis revealed that sustainable performers created a
stronger foundation of products, as measured through their
Pipeline Productivity Index(PPI), during and after the time spent
commercializing their first compound. The PPI is the sumof the
number of products in clinical trials multiplied by the probability that
those products will reach the market, and thus provides a measure
of the scope of a companys pipeline. At the time of a new drug
launch, sustainable performers had a marginally deeper pipeline
than momentumand underperformers based on the PPI, achieving
a PPI of 2.9, compared to 2.4 for the momentumperformers, and
only 2.0 for the underperformers. Three years after launching a new
drug, however, there was a much greater disparity between the
PPIs of the three classes of companies: sustainable performers
had an average PPI of 4.8, while momentumperformers had a PPI
of 3.2, and underperformers had a PPI of only 2.7. One key
difference, then, between sustainable performers and their less
successful peers: these companies were more than one-hit
wonders, with multiple follow-on drugs and indications at various
stages of development at the time they were commercializing their
first compound.
Lesson 4: The Benefits of Focus
Its hard enough to develop a novel compound and get it on the
market. Its much more difficult to repeat this process for
compounds that treat very different diseases because of
differences ranging fromthe markets to the clinical trials required
for approval. Not surprisingly, most sustainable performers adopted
focused business development strategies, opting to build expertise
in just one therapeutic area. United Therapeutics Corp., for
example, successfully managed the lifecycle of its pulmonary
hypertension lead product, treprostinil sodium(Remodulin), through
a wave of worldwide approvals, post-marketing trials, and
reformulations. Gilead, meanwhile, commercialized three anti-viral
products in the five years following the launch of its AIDS-support
cytomegalovirus drug, Vistide.
Lesson 5: Delaying Time to P rofitability
A final factor in building a sustainable company: adopting a slow
and steady march toward profitability. Though it may seemcounter-
intuitive, many companies push to become profitable too early in
their lifecycles. If they focus heavily on generating positive earnings,
companies run the risk of stretching themselves too thin froma
capital standpoint. As a result, they man not have the needed cash
to fund the R&D or product acquisitions that are essential for future
growth. Indeed, based on our analysis, 100% of the sustainable
performers ultimately became profitable, but it took, on average, 16
quarters to do so. In contrast, just 50% of momentumperformers
managed to do so, even though many tried to reach this elusive
goal in just five short quarters. Just 33% of the underperformers,
meanwhile, became profitable, taking at least as long as the
sustainable performers to attain this goal. While it is clear that a
company must eventually turn a profit if it is to generate value for
shareholders, it also seems true that rushing to become an
earnings-driven company is not optimal.
About L.E.K. Cons ulting
L.E.K. Consulting was established in 1983 and today has
more than 750 consulting professionals in offices in the U.S.,
Europe, Asia, and Australia. Our Life Sciences, Medical Devices
& Biotechnology Practice provides a full array of expert
services, including corporate strategy, product strategy, and
transaction services, helping companies innovate, fund,
develop, market, and launch ground-breaking products in a
highly dynamic marketplace.
i
In Vivo &Windhover Information. 2006 Windhover Information
(www.windhover.com).
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
9a
BioProcess Internationalis a monthly,
controlled-circulation magazine devoted to the
development, scale-up, and manufacture of
biotherapeutics and biodiagnostics. Each issue provides the global industrial
biotherapeutic community with up-to-date, peer-reviewed information detailing the
business, politics, ethics, applications, products, and services required to
successfully drive biopharmaceuticals, vaccines, and biodiagnostics through the
development and manufacturing process.
11a
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
B iotech
P roducts
Are Global
global: adj. 1) of, relating to, or involving the entire world; of or
relating to a celestial body (as the moon); 2) of, relating to, or
applying to a whole (universal)
I
n the first days of the biotechnology industryroughly 1975 to
1985early commercial research spanned the gamut of
possibilities. In casual conversation once, biotech guru Cynthia
Robbins-Roth told me how discussions in her lab at
Genentech would go frommaking biomaterials (e.g., spidersilk
proteins fromtransgenic goats milk) to getting blockbuster
antibody drugs fromcows blood without any sense of irony.
Thats what scientists can be like
when theyre allowed to venture into
the realmof technological
innovation: no fear, no boundaries,
no limitations. After all, their nascent
industry was all about futuristic
concepts that were the stuff of
science fiction just a decade earlier.
Eventually, the realities of the
business world did set in. Thanks to
the famous forward-looking Asilomar
conference of 1975, regulators
werent playing catch-up but rather
participating in the process of
defining the industry. And due to the
complexities of regulation and
marketing, companies realized that
they would each have to focus
efforts on a particular niche.
Monsanto chose agricultural
biotechnology. Genentech led the
way in making drugs through animal
cell culture. Eli Lilly and Novo
Nordisk muscled their way into the forefront of insulin production
through microbial fermentation. Others ventured down riskier paths
into industrial biotechnology and transgenics, the food and energy
industries, and even invention of brand new therapeutic areas.
Gene and cell therapies, xenotransplantation, and tissue
engineering are still working out the kinks in their respective
systems. Biotechnology became not so much an industry as a
Scott visited the Roslin
Institute a few years
ago during a Scotland
press tour and met
Dolly face to face.
The birth of Dolly, the cloned
sheep, was first reported 10
years ago, on February 22, 1997,
forcing the world to consider the
possibilities of cloning.
toolkit for potential use in many industries. And the membership of
the Biotechnology Industry Organization reflects thatits not so
much a collection of biotech companies as of companies that use
biotechnology.
Meanwhile, the industry was spreading out fromits initial
clustered safety centering on important bioresearch centers (e.g.,
Cambridge, MA, and the San Diego and San Francisco areas in
California) to become a growing economic force all over the world.
Now biotech is happening in various forms on every continent
and that probably includes Antarctica if researchers are studying
extremophilic bacteria down there! Many countries and economic
regions are betting on biotech
business for their futures. And it
seems as though every major
university has at least one spin-out
company in the works.
In our editorial offices at
BioProcess International, we usually
find ourselves focusing pretty heavily
on the big biotech success story:
protein therapeutics. There is the
occasional foray into gene transfer
or stemcells, tissue therapies and
transgenics. But like many of our
readers, as well as the venture
capitalists and other investors, we
know where the big money isfor
now, anyway. And we have to cover
the industry we understand best,
that being biotherapeutics. Even so,
we cant help admiring the work of
those involved in the other types of
biotechnology, both with and
without genetic engineering. Its not
as easy to define as many people might think, but one things for
sure: Biotechnology is global, both in terms of its geography and
its applications.
Science
There are hundreds of biotherapeutic products on the world
market, the vast majority of themparenteral protein formulations,
continued on page 13a
Now biotech is
happening in various
forms on every
continentand that
probably includes
Antarctica if researchers
are studying
extremophilic bacteria
down there!
byCheryl Scott, Senior Editor,
BioProcess International
I mp r o v i ng p a t i e n t o u t c o me s t oge t h e r
www.mayocts.com or call 800-541-5815 or outside the U.S. + 1 507 538 0600
Alan and others like him are the patients who beneft from the clinical laboratory testing we do to further the
development of drugs and devices in our central and core laboratories.
Unlike other central laboratories that stop at analytical validation, at Mayo Clinical Trial Services, we also
clinically validate our assays with patients. And in our core laboratories, which include Imaging, ECG, and Bone
Histomorphometry, our physicians see patients every day.
With more than 100 years of experience in laboratory testing at Mayo Clinic, we deliver the reliability, speed to
start up, and excellent client service that is synonymous with our name. And that spells hope for the patients
we can helpwhen we work together.
Clinically validating our laboratory testing for drug
and device development ismusic to Alans ears.
[ ]
hope
8.25x10.75_MCTS_Ad_v2.indd 1 1/16/07 11:23:18 AM
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
fromantibodies to cytokines to growth factors and beyond.
Enzymes are big, too, some of themsmall enough to be synthetic
peptides rather than the products of bioprocessing. The
development pipeline for these products is going strong, too, with
thousands of molecules currently in preclinical and clinical testing.
Quite a few of themare vaccines, a product area where cell culture
offers great promise.
Big as it isbig enough to support several devoted trade
journals, in fact, of which we are onethats not the whole
biotechnology industry, however. Biotech grew out of advances in
biological science, and such advances are happening faster and
taking more impressive formas time goes on. The human genome
projects (both commercial and government-funded approaches)
have given us a map of our genome, but thats only the beginning.
Meanwhile, biodiesel and bioethanol fuels are showing up on our
highways. I cant go two days without a stemcell news story
showing up on my desktop. Biocatalysis has revolutionized
numerous industries. ELISAs and other microarrays have changed
how many types of analysis are done, as well as reinvigorated the
diagnostics business. And the medical device industry not only
presents a good model for our companies to follow in risk
management and systems-based inspections, but it also offers
solutions to many biotech drug delivery quandaries. Biopolymers
have a number of potential applications both in and out of the
medical field.
The Biotech Rainbow: Many discussions about the various
applications of biotechnology are now making use of colorful
shorthand to describe the general areas it can be found. Red
biotechnology refers to the health care systems were all familiar
with. White or grey biotechnology describes the science as
applied to industrial processes, as in the culture of microbes to
produce useful chemicals. Such processes tend to consume less
in resources than traditional means of such production. Green
biotechnology is that applied to foods and agriculture, such as
transgenic plants that grow under specific conditions. Its intention
is to produce more environmentally friendly solutions than can be
achieved otherwise, but that possibility is under continuing debate.
The termblue biotechnology has been used to describe
aquacultural applications of biotechnology. Finally, although it hasnt
yet been ascribed a colorperhaps silver?computational
biotechnology or bioinformatics is increasingly playing such a key
role in so many arenas that it probably deserves a special
designation of its own. Genomics, proteomics, and systems
biology are receiving such wide application, for example, that it
seems every pharmaceutical company that runs such experiments
in its laboratories wants to call itself a biotechnology company.
To explore the wide world of biotechnological science outside
this article, youll want to go to the 2007 BIO International
Convention and attend some of the sessions listed in the Bench
to Products Sessions box. Here Imfocusing on some of the major
areas where innovation is happening now.
Regenerative Medicine: Biological systems have an
amazing natural capacity to repair and maintain themselvesin
fact, thats part of the very definition of life. And many medical
researchers are finding ways to aid, encourage, and add to
those processes in human patients. Their toolbox includes
various proteins and populations of stem cells that might be
used to cure diseases, repair injuries, and even reverse some
processes of aging.
Stemcells are receiving the most attention these days, partly
because of their enormous potential and partly due to controversy
over how they are obtained and used. Stemcell therapy could
radically change the face of health care in general, and
regenerative medicine in particular. Some adult stemcell therapies
are already in use, most notably the bone marrow transplants
treating leukemia. Future uses could include treatments for cancer,
Parkinsons disease, spinal cord injuries, and muscle damage, just
to name a few. First, of course, people will have to work out the
social and scientific uncertainties.
Cell therapy research isnt restricted, however, to stemcells
alone. Patients die every day waiting for donated organs to become
available for transplantation, and cultured cells could help. For
example, implanted liver cells have kept some patients alive long
enough for a donor organ to become available. Researchers have
implanted insulin-producing cells into diabetics, many of whom
then needed no insulin injections for years after receiving those
cells. And skeletal muscle cells have been used to repair cardiac
muscle damage froma heart attack. Using techniques such as
encapsulated cells and genetic engineering, the immune-
suppressing medications used in transplant patients may be an
avoidable complication.
Tissue engineering is another formof regenerative medicine
and its made possible by advances in cell biology and materials
2007 BIO International Convention
Bench to Products Ses s ions :
Ion Channels in the Post-Genomic Era: Exploring
Non-Voltage Gated Channels as Drug Targets
Deliver the Promise of Stem Cell Therapeutics?
Cancer Nanotechnology for Early Diagnosis and
Therapy
Proteomics: A Strategy for Translating Discoveries to
the Cancer Clinic
Around They Go, and Where They Stop, Only the
Inhibitors Know
Cancer Stem CellsStem Cell Biology Meets Oncology
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
continued on page 15a
Biological systems
have an amazing
natural capacity to
repair and maintain
themselvesin fact,
thats part of the
definition of life.
13a


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E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
science. Tissues and organs may be built in laboratories using
biocompatible scaffolding materials on which living cells are
grown into correct and usable structures. This began with so-called
artificial skin and cartilage. Next come simple organs (e.g., blood
vessels and bladders) currently in development, and maybe
someday more complextissue combinations may be possible (e.g.,
hearts and kidneys).
Human bodies use an array of growth factor proteins in cell
growth, division, and cell differentiation. These small proteins can
help wounds heal and regenerate injured tissue as well as advance
the development of tissue engineering. Many growth factors are
already on the market as biotech products, some derived from
blood plasma and others produced by recombinant cells and
organisms. Erythropoietin, which stimulates the formation of red
blood cells, was one of the first biotechnology products. Many
more are in development.
To learn more about whats going on in this area, check out the
sessions listed in the Regenerative Medicine Sessions boxwhen
you go to Boston for the 2007 BIO International Convention.
B i o t e c h n o l o g y
a n d G e n o m i c s
LL.M. (Master of Laws) in
Intellectual Property
Biotechnology
Genomics and Genetic Testing
Forensic DNA Evidence
Personalized Medicine
Privacy
www.law.asu.edu/biotechllm
Email: lawadmissions.graduate@asu.edu
480.965.1474
Accepting applications for the United States first graduate
law program in biotechnology and genomics.
The Center for the Study of Law, Science, & Technology offers
qualied applicants the opportunity to study with more than
25 nationally recognized scholars from both legal and scientic
disciplines. Full time (nine months) or part time.
APPLY TODAY
continued on page 17a
Indus trial and Environmental Biotech: Mention
biotechnology in mixed company these days, and you may well end
up in a discussion about the energy crisis. Howd that happen?
Ask the folks in Brazil, the leading country in the use of biofuels.
Interest in the concept is driven by skyrocketing costs and
disappearing reserves of fossil fuels. Unlike those, biofuels are a
renewable energy source. And they dont offer any of the numerous
environmental, economic, and political complications of nuclear
fission. In fact, they are biodegradable. Biofuels are derived from
biomass: e.g., cow manure, sugar cane, corn, soybeans, flaxseed,
palmoil, and even garbage and sewage. Microalgae are being
studied for their potential as an energy source, as well, with
applications being developed for producing biodiesel, ethanol,
methanol, methane, and even hydrogen.
Biofuels represent an interesting blast fromthe past. The
earliest sources of energy used by humans were burning biomass:
wood, peat, manure, and animal fats. The discovery of coal and
petroleummade those all seemquaintly archaic. Now modern
technology is allowing us to look on such renewable sources from
a new perspective. Global warming only became an issue after
fossil fuels took over, after all. Thats because the carbon in biofuels
is recently extracted fromatmospheric carbon dioxide, so burning
themdoes not cause a net increase of CO2 in Earths atmosphere.
Ancient underground reserves of fossil fuels constitute carbon
sinks, where the greenhouse-gas-producing element is kept safely
away fromour global life cycle on the surface.
BIO is calling such industrial and environmental solutions the
third wave of biotechnology (following therapeutics and
agriculture). And biofuels are just one aspect. Biocatalysis and
A new concept thats
catching on across
industries is s us ta ina bility:
that is, continuous innovation,
improvement, and use of
cleaner technologies to
lower pollution levels
and resource consumption.
2007 BIO International Convention
Regenerative Medicine Ses s ions :
Adult Stem Cells: Current Medical and Business
Challenges and Opportunities
Current Affairs in U.S. Stem Cell Research
Differentiated Cell TherapiesProven Science &
Business Model
Stem Cells: Doing Business in an Uncertain
Environment
Stems Cells as a Therapy: Barriers to
Commercialization
Tissue Engineering: A Clinicians Challenge
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
15a
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www.novonordIsk.com/rd
Novo Nordisk is dedicaled lo delivering lhe nexl
generalion o coagulalion and immunolherapies or
lrealmenl o unmel medical needs wilhin hemophilia,
olher coagulalion disorders, auloimmune and chronic
inlammalory diseases.
To lhis end we leverage our.
LxpertIse wIthIn hemostasIs and ImmunoIogy
and our
WorId-cIass competence wIthIn recombInant pro-
teIn technoIogy
o A leader wilhin insulin lherapies or diabeles
o Selling new direclions wilhin GlP1 and modern
insulin analogs
o 0iscoverer o novel hemoslalic agenls
o lirsl lo markel dedicaled pen syslem conlaining
liquid, premixed human growlh hormone
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
bioremediation are two other technologies that have made and are
making a big impact. A new concept thats catching on across
industries is sustainability: that is, continuous innovation,
improvement, and use of cleaner technologies to lower pollution
levels and resource consumption. Industrially sustainable
processes should reduce or eliminate waste, improve energy
efficiency, and lower the consumption of nonrenewable raw
materials while increasing use of recyclables and renewable
resources. Because life forms have had billions of years to develop
ways to make and use chemicals, and scientists have had a few
decades to improve on nature through technology, biological
processes should be able to answer those needs better, cheaper,
and faster than traditional synthetic chemistry and materials science
ever could.
The Industrial and Environmental Sessions boxshows the
range of such topics that will be addressed at the 2007 BIO
International Convention.
Food and Agriculture were the first areas where humans
used biotechnology. It began with animal husbandry, plant
breeding, and the fermentation of food and beverages. Imagine a
world without dogs, cows, and llamas (species created through
domestication); tangelos, peppermint, and wheat (plant hybrids
developed through agriculture); not to mention beer, wine, yogurt,
and bread (all products of fermentation). Modern technology and
genetics have allowed researchers to manipulate organisms faster
than traditional breeding practices could ever manage through
guided mutation alone. When it comes to feeding the fast-
increasing human population (more than sixbillion people now, with
10 billion expected by 2030), this may be the best solution.
Biotechnology can increase crop yields while lowering necessary
inputs such as water and fertilizer and providing new options for
weed and pest control.
On the whole, people in industrialized nations dont know
hunger. We can thank the Green Revolution for that. But most
peopleover two-thirds of that sixbillionlive in developing
countries and grow their own food. The Green Revolution touched
themonly lightly, and its done little to alleviate the cycles of feast
and famine they have to live through. Consequently, developing
nations are more interested in what crop biotechnology can do for
them. People in the industrialized world have the luxury of asking
ethical questions because theyre not spending a large amount of
time and energy wondering where the next meal is going to come
from. This is not to say that ethical questions shouldnt be asked.
But it does show that there are two sides to the story. Agricultural
biotechnology is not just about Monsanto selling more Round-Up
brand weed killer; its also about millions of people in Brazil, China,
Egypt, India, Indonesia, Kenya, Malaysia, Mexico, Pakistan, Taiwan,
Thailand, Uganda, Venezuela, and other parts of the world finding
ways to sustain themselves without periodic reliance on charity
fromthe outside.
Animals, plants, and aquaculture all are subjects of agricultural
biotechnology. Research is improving animal health, enhancing
animal products with biotechnology, and making animal husbandry
a more sustainable practice. Genomics, transgenics, and cloning
are applied to livestock, poultry, fish, insects, laboratory animals,
and even pets. Biotech even offers approaches to endangered
species conservation. As for plants, its not all food crops. A
growing application of biotechnology can be found in forestry, with
scientists addressing issues of productivity as well as wood-
processing methods.
The 2007 BIO International Convention will of course address
many of the latest issues in this area. See the Food and
Agriculture Sessions boxfor a listing of topics.
Drugs and Diagnos tics : The success of Genentechs
Herceptin treatment for certain breast-cancer patients has
spotlighted a new concept in health care: personalized medicine.
That product works very well in a specific subpopulation of
patients, those expressing the HER2 gene. The study of
continued on page 19a
2007 BIO International Convention
Indus trial and Environmental Ses s ions :
Energy Crops for Biofuels
Forest Biorefineries: The Future of Industrial Forestry
Biotech?
Leading Pretreatment Technologies With Corn Stover
and Poplar Wood
White Biotechnology: From Partnership to Product
Biofeedstock Development for the Emerging Cellulosic
Ethanol Industry
Fuel for the Future: Biodiesel Facts and Fiction
Investing in Industrial BiotechnologyWhere Is the
Value?
Environmental Biotechnology: Systems Biology,
Bioremediation and Microbial Fuel Cells
Energy Crops for Biofuels
A Cellulosic Biorefinery Incorporating Dedicated Energy
Crops
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
2007 BIO International Convention
Food and Agriculture Ses s ions :
The Road (and Potholes!) to Commercializing Biotech
Animals
How Developing and Transitional Economies View and
Affect Plant Biotechnology
Yours, Mine or Ours? Who Owns the Worlds Genetic
Resources?
Genomic Markers . . . Worth Their Weight in Gold?
Health and Wellness Strategies in Companion Animals
Prevention and Cure: Contributions of Plant
Biotechnology to Human Health
Farm-Level Economic and Nonpecuniary Impacts of
Cultivating Biotech Crops
Nutrigenomics, Nutritional Systems Biology and
Personalized Nutrition- Truth or Sci-Fi?
Aquaculture: How Biotech Advances Can Feed the
World Sustainably
Having It All: Producing Enough Grain for Both Food
and Fuel
Answers from Agbiotech: Beyond Transgenics
Energy Crops for Biofuels
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
17a
BUSINESS CLIMATE
Grow your Life Sciences company in Syracuse, the heart of New York, where our life
sciences workforce has built a dynamic biotech foundation. With 6 nearby world-class
universities and 5 community colleges offering bioengineering degrees and programs,
we graduate 2,000 minds a year in life science, engineering and related fields. And the
New York State Center for Bioprocess Engineering Education is right here, too.
For a detailed report on the life sciences industry in Central New York go to
www.SyracuseCentral.com/LifeScienceReport.
Or contact Greg Hitchin, Syracuse Economic Growth Council,
at (877) 797-8222.
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
continued on page 21a
pharmacogenetics and pharmacogenomicsexamining the
relationships between drugs and geneticsis widely believed to
have the potential for revolutionizing the pharmaceutical industry.
Proponents say personalized medicine will use detailed genetic
information with a patients clinical data to select drugs that are
particularly suited. It could supplant the blockbuster model that
characterizes so much of the pharmaceutical industry now. One
thing will be critical to its success: more intimate relations between
therapeutics and diagnostics. The lines between what are now two
separate industries will blur.
DNA sequences known as genetic markers can be identified by
simple assays to study the relationship between, for example,
inherited diseases and their genetic causes. Because genes that
lie near each other on chromosomes tend to be inherited together,
genetic markers can be used to determine precise inheritance
patterns for genes that have yet to be localized precisely. Using
these and other pharmacogenomics tools, companies could
develop rational means to optimize drug therapies to genotypes,
thus ensuring maximumefficacy with minimal adverse effects.
These technologies could enable more efficient drug
development processes based on sound genetic information that
could shorten times to market. Drugs would be marketed along
with their companion diagnostic tests, which may well improve
consumer confidence in an industry facing some public relations
trouble. With a low growth rate, the traditional diagnostics industry
has not been as successful as the pharmaceutical industry in
fundraising. The advent of molecular diagnostic tests opens new
opportunities for partnerships.
2007 BIO International Convention
Devices and Diagnos tics Ses s ions :
Emerging Opportunities in Molecular Imaging: Sharper
Images and Improving Outcomes
Proving Genomics: What Do Payers and Providers
Need?
The View From the Trenches: Personalized Medicine
Getting Real
Personalized Medicine in Japan: Moving Into High Gear
Twinning Strategies: The Business of Companion
Diagnostics and Targeted Therapies
Next Generation in Diagnostics
Biotechnology Devices: Where Man Meets Machine
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
Collaboration is the name of the game when it comes to
biotechnology and medical devices as well. For more information,
look for related discussions at the 2007 BIO International
Convention. The Devices and Diagnostics Sessions boxtells you
where youll find them.
Biopreparednes s : In the wake of 2001s very conspicuous
attacks by terrorists on New York Citys twin towers, the
biodefense leapt to the forefront of national politicsand not only
19a
Proud Sponsors of BIO 2007
ALZA Corporation
Centocor, Inc.
Centocor Research & Development, Inc.
Global Biologics Supply Chain, L.L.C
The Janssen-Cilag Companies
Janssen, L.P.
Johnson & Johnson Development Corporation (JJDC)
Johnson & Johnson Merck Consumer
Pharmaceuticals Co.
Johnson & Johnson Pharmaceutical
Research & Development, L.L.C.
McNeil Consumer & Specialty Pharmaceuticals,
a Division of McNeil-PPC, Inc.
Ortho Biotech Products, L.P.
Ortho-McNeil Neurologics, Inc.
Ortho Women's Health & Urology Division of
Ortho-McNeil Pharmaceutical, Inc.
PriCara, Unit of Ortho-McNeil, Inc.
Scios Inc.
Specialty Pharmaceuticals Division of
McNeil-PPC, Inc.
THERAKOS, Inc.
Tibotec Pharmaceuticals Limited
Tibotec Therapeutics, a Division of
Ortho Biotech Products, L.P.
TransForm Pharmaceuticals, Inc.
2007, Centocor, Inc.
FROM GREAT IDEAS...
TO POWERFUL PARTNERSHIPS
Come grow with us
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
continued on page 23a
in the United States. Not only have biotechnology and related
science provided tools to help humanity, but unfortunately, like any
technology, they can be turned to evil ends as well. Luckily, the
good guys are working toward countermeasures before the bad
guys have a chance to catch us all unawares.
The concept of biodefense has traditionally referred to short-
term, local, government-driven measures to restore security to
people in an area affected by a biohazard or major health issue
(e.g., a disease outbreak). Protection of water and food supplies
are part of it. And because of the newly identified possibility of
biological terrorism, biopreparedness adds the modern twist of
prevention to these efforts. Additionally, there is the real possibility
of a natural pandemic outbreak of infectious disease.
Vaccines, of course, play a large and integral part in
biopreparedness efforts. The US Department of Defense has
focused for years on the development and application of vaccine-
based biodefenses for troops in the field. Critical toxins and
pathogens being targeted include anthrax, smallpox, plague,
tularemia, botulinum, ricin, and equine encephalitis. Meanwhile, a
parade of potentially pandemic organisms have marched across the
news, fromWest Nile fever to SARS to the Asian bird flu H5N1.
And antibiotic resistance mutations could revive diseases such as
tuberculosis that have been previously regarded as beaten. Of
course, HIV is already certified as a global pandemic, and several
biopharmaceutical companies are working to fight it already.
Others are betting on potential hazards and ways to identify acts
of bioterrorismbefore they have a chance to spread too widely. The
US government instituted Project BioShield in 2004, which
!3%26)#%/&
In the wake of 2001s
very conspicuous
attacks by terrorists on
New York Citys twin
towers, biodefense
leapt to the forefront of
national politicsand
not only in the
United States.
21a
As any discussion of product areas will show, the so-called first
world is not the only market for biotechnologys products.
However, the markets are not all the same; each presents its own
important issues and needs. Also, different countries have different
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
continued on page 25a
2007 BIO International Convention
International Ses s ions :
Taiwan: Your Biotech Partner and the Stepping-stone to
Asia Pacific
China: Heading to a Bio-economy
Biotech Made in Germany: From Start-up to Grown-up
The UK Drug Pipeline: Leading the Worlds Drug
Innovation
Chile: Trends and Opportunities for Partnering, R&D and
Clinical Trials
Getting Connected: Global Partnerships From the True
South
Italian Biotech Industry: Assets and Opportunities for
Italian-U.S. Collaboration
Partnering With Japanese Biotech
Agricultural R&D in Biomass Conversion for Renewable
Energy
The Rise of Biotechnology in Russia
Modern Biotechnology for Europe
International Cooperation in EU Research Programs
EC-U.S. Task Force on Biotechnology Research: Looking
for Sustainable Development
Growing the Australian Biobased Economy Through
Science and Innovation
Australian Biotech Solutions to Global Problems
Austria: Cutting Edge Biotech Pioneer Spearheading the
Way Into Tomorrows Markets
Naturally Occurring Substances and the Positive Impacts
for Human Health
Canada: Your Partner for Global Health Innovation
Chile: Leveraging Biotechnology to Strengthen Leadership
in Global Industrial Markets
The Promising Future of Biotechnology in the Czech
Republic
Biotechnology and Life Sciences in the EU: Current
Developments
Indian Agri-Biotechnology: The Growth Potential
India: Leveraging Opportunities in Biotechnology
Israels Interdisciplinary BioMed Industry: Looking Globally
Life Sciences and Health in the Netherlands
New Zealand Innovation: Future Farming for Better Health
Biotechnology in Spain: High-Growth Industry
Promoting Agricultural Biotechnology in Taiwan:
Innovations, Collaborations and Business Opportunities
Thailand: Investment and Collaboration in Agricultural
Development and Medical Innovation
Biotechnology in Mexico: Regional Leadership and Cross-
Border Collaborations
Achieving Wellness from Natural Substances: Capacity
Building and Its Challenges
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
pumped some needed money into promising vaccine and
diagnostic companies working on these ideas. However, some
have questioned its effectiveness. As BioExecutive International
managing editor Lorna McLeod wrote in her October 2006
editorial, The issue, of course, is political fodder. The Project
BioShield budget is $5.6 billion, none of which appears to be
monitored closely. There have been few federal audits of any
biological warfare vaccine maker despite huge increases in
spending since 2001. Its a lot of money, to put it mildly, and many
players would like some of it. . . . And still the question remains: Are
we safer?
For answers to that and other related questions, check out the
Biopreparedness Sessions box, and attend those discussions at
BIOs 2007 International Convention.
Doing Bus ines s Globally
Over the years, biotechnology has grown not only in scope but
also economically and geographically. Arguably, the industry began
in the United States, and the modern science it came fromis
essentially a product of the so-called western world (primarily
Europe and North America)although the Japanese expertise in
fermentation has been well known for decades. Over the first
quarter-century of biotechnology as an industry, those were the
only locales where anything substantive was going on. But this is
no longer the case.
As the number of approved biopharmaceutical products has
increased and manufacturing operations have expanded to meet
market needs, more attention is being paid to increasing
operational efficiencies. Until now, most biotech manufacturing
efforts have been toward production of clinical trial materials, so
speed was more important than efficiency. But the maturation of
the industryand the imminence of biosimilar productshas led
companies both large and small to look at ways they can make
their products better, faster, and cheaper.
One important solution in many other industries has been
outsourcingand now the bioprocessing world is discovering it
too. Frommaking products to managing clinical trials to regulatory
affairs and product sales forces, contract service providers are
helping biotech companies get things done. Some organizations
are even virtual, their small staffs consisting mainly of decision
makers who direct the work of contract research and
manufacturing. Countries that have been traditionally associated
with outsourcing are seeking and finding ways to become
destinations for the biotech version, too. Others are seeing the
advantages of a knowledge-based economy and hoping to develop
home-grown biotech sectors of their own. See the International
Seminars boxfor a list of those you can find out more about at the
2007 BIO International Convention.
2007 BIO International Convention
Biopreparednes s Ses s ions :
Manufacturing for Biodefense and Pandemic Response
Public-Private Partnerships: Driving Product
Development in Global Vaccines and Biodefense
Biodefense and Pandemic PreparednessProgress &
Opportunities
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
23a
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
continued on page 26a
laws regarding importation/exportation, product labeling,
manufacturing practices, and intellectual property. Language and
cultural differences are not to be taken lightly. And although the
business world does run on a 24-hour clock, its not always
possible to respond immediately to problems that occur on the
other side of the world. Doing business globally is a daunting
prospect for many companies, especially the smaller
entrepreneurial biotech organizations.
Vaccines make an interesting case study. The value of the global
market for vaccines may be $5 billion. But the economics of
vaccines are not as simple as supply and demand. Markets are
measured in terms of potential revenue. Although the global need
for vaccines is very large, actual demand is much smaller because
those who most need vaccines are often least able to pay for them.
So the actual market is decided by governments and international
health organizations, which purchase vaccines at a set price per
dose. The disparity between need and demand means that
vaccines needed in the developing world are often an underfunded,
lower-priority for commercial manufacturers. In fact, the vast
majority (8590%) of global vaccine market revenue comes from
vaccine sales in the developed world, and 50% of vaccine revenue
is tied to proprietary vaccines tailored to industrialized markets.
Four companies lead the vaccines market, accounting for nearly
80% of worldwide vaccine sales: Aventis Pasteur,
GlaxoSmithKline, Merck & Co., and Wyeth-Inc. Genetic
engineering has opened new doors for vaccine manufacturers,
allowing themto improve existing products, develop new ones, and
receive better patent protection than before. This change has
brought profit potential back into the market, leading to new
companies entering the scene. New potential also arose for
vaccines to treat cancer, autoimmune diseases, and infectious
diseases. In 2001, more than 100 US companies had vaccines in
various stages of development.
Global health and business issues will be addressed in detail at
the 2007 BIO International Convention. The Global Health
Sessions and Doing Business Globally Sessions boxes list
general topic areas.
For many years, the most common solution for biotech companies
in need of funding or expertise and doing business both locally and
globally has been to find a partner. Sometimes this means licensing
your product to a bigger pharmaceutical company. Sometimes it
means partnering with big pharma to explore a disease area or
type of product. Sometimes it means teaming up with another
small company with capabilities that happen to be compatible with
your own. The biggest issue here is finding the money to keep on
going when it can take several years and hundreds of millions of
dollars to bring a single biopharmaceutical product to market.
Meanwhile, companies must weather the periodic storms of public
and investor relations, wade through the confusion of bioethics and
intellectual property, and tread carefully among the landmines of
regulatory requirements. Its a risky businessbut as most of the
people involved will tell you, well worth the trouble.
2007 BIO International Convention
Global Health Ses s ions :
Partnerships for Global Health: Going From Bench to
Bedside
Antibacterial Treatments: The Need Is Now, Can
Research Deliver?
Controlling HIV/ AIDS, TB and Malaria Through Vaccines
Bugs to Drugs: The Next Generation of Antiviral
Therapeutics
Biobanks: Building Capacity, Building Understanding,
Building Business
Demand Forecasting for Global Health Products
Innovative Approaches to Expand Market Value in
Underdeveloped Markets
No More White Elephants Creating Sustainable
Diagnostic Solutions for the Developing World
Harnessing Biotech Innovation to Improve the Global
Health Pipeline
Vaccine Innovation: Sustaining Innovation to Improve
Public Health
Eliminating the Gaps: Ensuring Access to New Vaccines
in Developing Countries
Developing a Sustainable Global Business Model for
the Vaccine Industry
Meeting Industry Needs and Access Criteria in
Developing Drugs for Neglected Diseases
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
2007 BIO International Convention
Doing Bus ines s Globally Ses s ions :
Future Directions of Biologics in China
Labeling and International Trade Agreements:
Considering a New Paradigm
Coming to America: Establishing a Business Presence
in the United States
Turning Naturally Occurring Products into Approved
Pharmaceuticals
Visit www.bio2007.org/ programfor complete and up-to-date
programinformation.
One important
solution in many other
industries has been
outsourcing
and now the
bioprocessing world
is discovering it too.
25a
26a
E m e r g i n g T r e n d s i n B i o t e c h n o l o g y
For Further Reading
Booth R. Extending Your Enterprise with Outsourcing. BioProcess
International 1(10) 2003: 1418.
Darroch S. The Road Ahead for Vaccines. BioProcess International May
2005: 1416.
Dougherty E, Robinson E. International Relocations: What You Need to
Know to Make Your Move Successful. BioProcess International 2(6) 2004:
1618.
Finnegan S, Pinto K. Offshoring: The Globalization of Outsourced
Biomanufacturing. BioProcess International 4(8, supplement): 5662.
Gin BS. Singapore: Biotech Mecca. BioProcess International January
2006: 4446.
Howarth B. Down Under Deals: US Companies Sign Lucrative Contracts
with Australian Biotech Sector. BioProcess International June 2005:
3638.
IsomE. Requirements for Outsourced Cold Chain Storage and Logistics in
Biopharmaceutical Development. BioProcess International 4(8,
supplement) 2006: 4850.
Jones SD, Levine H. Biotech Emerges in India: A Changing Business and
Legal Environment Drives the Expansion. BioProcess International May
2005: 5053.
Jones SD, Levine H. You Can Outsource Manufacturing But Not
Responsibility. BioProcess International March 2005: 4650.
Koberstein W, Robinson K. Can Europe Catch Up? Biotech on the
Continent. BioProcess International May 2005: 5867.
Kostrubanic JA. Putting Together a Successful Strategic Alliance: Avoiding
Pitfalls. BioProcess International September 2006: 4447.
LennoxP. Building a Biotech Sector. BioProcess International June 2006:
4447.
Matsumoto H. Japan Makes a Home for Biotechnology. BioProcess
International December 2005: 3033.
Montgomery SA, Rosin LJ, Scott C. Contract Service Providers: Your
Partners for Success. BioProcess International 4(8, supplement): 48.
Montgomery SA, Rosin LJ, Scott C. The Future of Bio-Outsourcing.
BioProcess International 4(8, supplement): 4447.
Montgomery SA, Rosin LJ, Scott C. The Many Roles of Service Providers.
BioProcess International 4(8, supplement): 2225.
Muddyman G. Conquering International Biopharmaceutical Markets: The
Challenge of China. BioProcess International May 2006: 3639.
Niazi SK, Flynn TL. A Practical Model for Outsourced Biomanufacturing.
BioProcess International 4(8, supplement): 1016.
Noffke TJ. Smooth Sailing for Pharma-Biotech Alliances: Skilled Project
Management Can Navigate Stormy Seas. BioProcess International
December 2005.
Palermo RJ. The Expanding Role of Biologics in the Pharmaceutical
Industry. BioProcess International 4(10) 2006: 80.
Peterson R. Creative Financing: Moving Beyond Venture Capitalist Funding
for Biotech Start-Ups. BioProcess International 1(8) 2003: 1824.
Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 1:
The Basics. BioProcess International 3(8) 2005: 2830.
Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 2:
Main Elements of a Biotechnology Licensing Agreement. BioProcess
International 3(9) 2005: 2628.
Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 1:
Licensing Strategies. BioProcess International 3(11) 2005: 1214.
Robinson K. Genzymes View of Europe: EU Ideals Versus Member-Nation
Needs. BioProcess International June 2005: 2022.
Rosin LJ. Are Pharmaceutical Prices Just: A Discussion of Business, Values,
and Ethics. BioProcess International 2(2) 2004: 1820.
Singh M, Dai D. Clinical Supplies Excellence: Are You Set Up to Succeed?
BioProcess International 4(1) 2006: 1216.
Steffy CP, Rosin LJ. Chapter Five: The Two Global Markets Vaccines for
the Developed and Developing Worlds. BioProcess International 2(4,
supplement) 2004: 4857.
Steffy CP. Chapter Six: A Multitude of Fears Why the Public Objects to
Transgenics and What You Can Do About It. BioProcess International 2(6,
supplement) 2004: 6267.
Van Yoder S. Moving Upstreamin Chinese Pharma Industry. BioProcess
International September 2006: 5254.
Wheelwright SM. Bioprocessing in Asia: Now and the Next Five Years.
BioProcess International 3(9) 2005: 2023.
Williams D. Top 10 Principles of Successful Manufacturing Partnerships.
BioProcess International October 2006: 3033.
Zhou Y. Opportunities in Biopharmaceutical Outsourcing to China.
BioProcess International 5(1) 2007: 1623.
For an additional article written
by C heryl Scott on, Managing
Biotherapeutic P rocess
P ipelines, visit the free stuff
area at www.bio2007.org.
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GE Healthcare Bio-Sciences AB, a General Electric Company.
GE Healthcare Bio-Sciences AB, Bjrkgatan 30, 751 84 Uppsala,
Sweden 2007 General Electric Company - All rights reserved.
GE01-07. First printed 01/2007.