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How do public policy decisions impactthe biotechnology industry?

A positive policy environment is crucial to the success of thebiotechnology industry and a negative one can be disastrous.Broadly speaking, for our companies to succeed and thrive, weneed public policies that support innovation.

Innovation is the heart of biotechnology. Our industry has astrong record of contributing to the betterment of the world. Ourproducts fight disease, feed the hungry and reduce pollution. Ourcompanies have the potential to contribute even more to improvehealth care, supply alternative fuel sources, protect the environmentand expand the world’s food supply.

But biotech companies don’t operate in a policy vacuum. Ourproducts have to compete in a global marketplace. We contend forinvestment capital in the financial markets, conduct research,develop and market products all within a framework of laws andregulations shaped by policy decisions made in Congress, infederal agencies and by state and local governments.

These decisions affect every biotechnology company, from thesmallest venture-backed start-up the largest multinationalcorporation. Policies that promote innovation help us bring thebenefits of biotech to the world. Laws and regulations that inhibitinnovation undermine our ability to do so.

What public policy decisions are likely tobe made in the near future that will eithersupport or discourage innovation?

Patent ReformStrong intellectual property protection is essential to the success,and in some instances to the survival, of biotechnology companies.Our patent system encourages the development of new medicinesand diagnostics, agricultural and environmental products, and otherinnovations produced by our industry. However, several recentpolicy proposals would weaken patent protection for biotechnologycompanies.

Last year, the U.S. Patent and Trademark Office proposedchanges in its rules that would restrict the number of claimsexamined in a single application and limit inventors’ rights to file

continuation applications. These changes would have a devastatingeffect on biotechnology companies by making it more difficult toreceive adequate patent protection. They would make patentapplication process more burdensome and expensive, and theoutcome more uncertain. BIO has detailed our concerns aboutthese proposals in comments to the USPTO and recommendedalternative means for reducing the backlog of patent applications.

Meanwhile, we expect Congress will consider patent legislationlater this year. BIO and our members recognize a need forimprovements in the current patent system. But some of thechanges being proposed would harm biotechnology innovation bymaking it cheaper and easier to challenge patents and in otherways weakening the strength and certainty of patent protection.BIO will actively encourage Congress to truly strengthen, and notweaken, the patent system that helped give birth to thebiotechnology industry and all of the beneficial innovations ourcompanies have produced.

The FDAThe Food and Drug Administration (FDA) is the main gatekeeperfor medical products and food products reaching patients andconsumers. Our companies depend upon that regulatory pathwayfunctioning well. We want a review process that is careful,transparent and predictable—that ensures product safety andefficacy and also facilitates timely patient access to novel therapies.

To maintain an environment that facilitates our companiesbringing safe, effective new life-saving therapies to patients,Congress must provide the FDA with the financial resources itneeds to do its job well. We also want to enhance publicconfidence in the FDA and in drug safety.

This year Congress will consider reauthorization of thePrescription Drug User Fee Act (PDUFA). In January, the FDArecommended improvements to PDUFA that were a result ofextensive discussion and input from industry, as well as patientorganizations, consumer groups and other stakeholders. TheFDA recommendations address a broad range of public andindustry concerns about the product review process and drugsafety.

The PDUFA proposals would fund a modernization andenhancement of FDA’s post-market surveillance system so that theagency can better monitor the benefits and risks of biotechnology

Q&A with Jim Greenwood

3aE m e r g i n g Tr e n d s i n B i o t e c h n o l o g y

Jim GreenwoodPresident & CEO, Biotechnology Industry Organization

Jim Greenwood answerssome vital questions on theimportance of a positivebusiness, policy andregulatory environment for our industry.

continued on page 5a

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products across their marketed lifetimes and adopt new scientificapproaches to surveillance.

These proposals will also establish processes to create morepredictability and efficiency in pre-market review by allowing forsufficient time in the review process for meaningful agency-sponsordiscussions of the product label and proposed post-marketingcommitments. They allow for the development of science-basedguidance to modernize drug development and would fund criticalinformation technology enhancements.

BIO will remain deeply engaged in advocating for theseimprovements in the PDUFA reauthorization. We have also joinedwith patient groups, consumer advocacy organizations and otherindustry associations to form the Coalition for a Stronger FDA tosupport increased public funding for FDA and lessen the growingreliance on user fees to fund the FDA’s activities.

What effect does the change fromRepublican to Democratic control ofCongress have on the outlook for theissues you’ve mentioned and othersaffecting the biotechnology industry?

Stem Cell ResearchThe change in party control brings both challenges andopportunities for the biotechnology industry. The Democrats aregenerally more supportive of federal funding for stem cell research.In January, the House passed H.R. 3, the Stem Cell ResearchEnhancement Act of 2007, by a vote of 253-174. This bill wouldexpand the limited number of stem cell lines currently available forfederally-funded research. I expect the Senate will also pass thislegislation. Given President Bush’s strong views on the matter, wecan expect another presidential veto, but support for embryonicstem cell research is definitely increasing on Capitol Hill.

BiofuelsAnother area of opportunity is in biofuels. Democrats generallyconsider global climate change a high priority. President Bush citedclimate change concerns as a rationale for his strong support ofrenewable fuels in his State of the Union Address in January, alongwith achieving energy independence. We have a great opportunityfor bipartisan cooperation in promoting greater production and useof biofuels and for establishing the U.S. as the world leader in theproduction of renewable and alternative energy sources throughthe use of industrial biotechnology.

Non-InterferenceOn the challenge side, we have already seen legislation passed bythe House of Representatives that is a disappointing stepbackward in public health policy. H.R. 4, the Medicare PrescriptionDrug Price Negotiation Act, strikes the language in the MedicareModernization Act which prohibits the federal government frominterfering with the negotiations between drug manufacturers,pharmacies and plan sponsors and replaces it with a requirementto interfere in this process.

A Senate bill, S. 250, would require that the federal governmentnegotiate with manufacturers for the prices of “single source drugswithout therapeutic equivalents.”

Both of these bills, if they became law, would effectively reducepatient access to therapies. We will fight hard in the comingmonths to oppose that outcome. We believe that the goal ofgovernment policy should be to promote, not discourage, the

development of breakthrough therapies that target unmet clinicalneeds and improve upon existing treatment options.

The message that BIO and biotechnology companies musttake to members of Congress is that there is a disconnectbetween celebrating the potential for new cures and treatmentsfrom breakthroughs in areas like stem cell research … and thenturning around to condemn and punish the same innovativecompanies who will make those breakthroughs and bring thosenew therapies to patients.

What is BIO’s role in creating a positivepolicy environment for biotechnology?

When the BIO board of directors hired me, I was directed tocreate a world class advocacy organization. We have doneexactly that. Our team is the best in Washington. We are workingaround the clock to make sure that when biotech companiescombine the talents of the best scientists, the best investors andthe best business managers to develop new, life-enhancingproducts, that the public policy environment in Congress, in theadministration, the states, the localities and around the world isconducive to your success.

Our team is working hard on all the issues I’ve mentioned.Intellectual property protection. PDUFA and FDA funding. We alsoare engaged in advocacy initiatives on Sarbanes-Oxley compliance,SBIR eligibility, follow-on biologics, agricultural biotechnology,funding for cellulosic ethanol research and production and on avariety of state and local initiatives. We communicate biotech’sbenefits and potential to policymakers and help them shapepolicies that enhance, rather than impede, innovation.

What role can biotechnologyprofessionals and individual biotechcompanies play in shaping the policyenvironment?

The two most important things you working in the biotech industrycan do are to educate yourself about how public policy affectsyour business and to help educate policymakers about thebenefits of biotech, the process of innovation and the effect oftheir decisions on your ability to create the products that willimprove and save lives.

The best starting point is to make sure the policymakers closestto you—your own representatives—know who you are and knowyour story. Visit your legislators. Even better, invite them to visit yourfacilities in their districts. Take that opportunity to explain what youdo and how your work benefits patients or consumers. Let themknow how many jobs you create. Help them connect the dots. Bevisible and be engaged.

BIO itself is a great resource. Through our website (www.bio.org),publications, government relations blogs and other channels, ourstaff can help you stay informed about policy developments thataffect your company and our industry. More importantly, we’re thereto listen so that we know what challenges you’re encountering andwhat policy improvements you’d like to see.

Through our board of directors and standing committees, wework closely with our members and others in the industry tocommunicate the contributions and value of biotech and to createan environment that will help our industry thrive. ■

E m e r g i n g Tr e n d s i n B i o t e c h n o l o g y 5a

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Biopharma:Beyond the First Product

Executives at fledgling biotech and specialty pharmacompanies strive to develop lead products withblockbuster potential in the hopes that soaring productrevenues will translate into years of sustained growth.

Unfortunately, the recipe for success is rarely that simple. Not onlymust companies effectively manage the commercialization of thatfirst compound, but in order to succeed, they must also develop adeep enough pipeline—either by investing in home-grown researchand development or by smartly in-licensing compounds. Thechallenge for these nascent companies comes in managing thisdifficult dance, all the while moving on a path toward profitability.

Determining what needs to happen—and when—can be adaunting task. By analyzing the lifecycles of 32 publicly tradedbiotech and specialty pharma companies, though, we haveidentified 5 factors that distinguish the ultimate winners from theunderperformers in the marketplace. Exploring these drivers ofsuccess was the topic of an article by the authors that waspublished in In Vivo: The Business & Medicine Report in June 2006.i

Any time a biopharma brings a product to market, it’s a criticalevent. But no occasion is fraught with more hand-wringing than thecommercialization of the very first compound. That’s because aproduct launch plays a key role in attracting investor attention andwill directly impact a company’s valuation. A product introductionrepresents an important opportunity for investor value accretion.Companies that succeed in commercializing a product are vieweddifferently from their development stage brethren: they belong to adifferent asset class, one that has a much lower risk profile. Crunchthe numbers and you’ll find that the 32 companies included in thisstudy had robust performance, achieving on average more than250% market capitalization appreciation, and 40% stock priceappreciation beyond the Amex Biotech Index, or BTK, in the fiveyears following the market introductions of their first drugs.

Despite the bump in market capitalization, most companiesstruggled to maintain their initial success. Sustained growthremained a constant challenge, and in fact only 19% of themconsistently outperformed the biotech industry in the 5 yearsfollowing the launch of their first products (See Exhibit 1). Basedon a careful examination of the data, we divided our 32 companiesinto three different categories: (1) sustainable performers; (2)momentum performers; and (3) underperformers.

Only six companies consistently outperformed the BTK duringthe five years that followed a first product launch. These“sustainable performers” rocketed to success, on averageoutpacing the BTK by more than 700% in market cap appreciationand 250% in stock price appreciation during the critical timeperiod. The firms now post market capitalizations in the billions.

There were eight “momentum performers” who saw a bump intheir market values following the introduction of a first therapeutic—at least initially. But these companies were unable to maintain theirperformance for more than two to three years, and the averagespike in market capitalization lasted only 20 months. Of these eight,only one had performance in excess of the market at the end of thestudy 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 theybegan marketing their first products. Five years later, the

Pierre JacquetL.E.K. Consulting


Exhibit 1

Source: Bloomberg, L.E.K. analysis

by Pierre Jacquet, L.E.K. Consulting and Jonathan Hodgson, L.E.K. Consulting

companies were consistent laggards, underperforming the BTK by40% in stock price and 70% in market capitalization.

What can a company do to ensure it ends up a sustainableperformer and not a momentum performer or underperformer? Andwhat are the key drivers for value creation beyond market launch?A closer look at the histories of these 32 companies offers someilluminating lessons for building sustainable growth beyond thecommercialization of a company’s first therapeutic.

Lessons 1 and 2: Revenue Growth andAggressive Business DevelopmentThe highest performing companies posted the greatest increase inrevenue in that critical five-year window following a first productintroduction. Sustainable performers used two different strategiesto maintain growth. Some were able to boost product sales of theirfirst compound by putting it into clinical trials in multiple additionalindications, as Celgene Corp. did for its cancer drug thalidomide(Thalomid), a therapeutic initially designed to treat severe erythemanodosum leprosum (ENL) and now on the market for multiplemyeloma. Other companies were able to launch a series of newproducts in quick succession, as Gilead Sciences, Inc. did withinjectable cidofovir (Vistide) in 1996, oseltamivir phosphate(Tamiflu) in 1999, amphotericin B (AmBisome) in 2000, andtenofovir disoproxil fumarate (Viread) in 2001. Surprisingly, acompany’s change in revenue was a more meaningful indicator ofperformance than was their change in earnings.

But sustainable performers did more than boost product sales.These companies made aggressive business developmentdecisions, taking advantage of the spike in their market values toraise additional funds for future R&D, in-licensing, orcommercialization expenditures. Indeed, the companies doing themost deals—either licensing transactions or money-raising efforts—belong to the sustainable performer class. Unlike the momentumplayers or underperformers, most of them conducted at least onefollow-on public offering to raise cash after the first productcommercialization. And sustainable performers didn’t just tap theirfinancial wells more often—they were also able to raise moremoney per event, as well as cumulatively, than peers in theunderperformer or momentum performer classes.

Another key factor indicative of outperforming the BTK post-product launch: the number of business development transactionscompleted. Sustainable performers and momentum performersconducted 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 performersalso completed more significant transactions. For instance, half ofthe sustainable performers purchased a company within 24 monthsof bringing their first drug to market, including Celgene’sacquisitions of Signal Pharmaceuticals, Inc. and AnthrogenesisCorp. for R&D expertise and stem cell capabilities, respectively,Gilead’s acquisition of NeXstar Pharmaceuticals, Inc. for itsantiviral franchise, and Cephalon, Inc.’s acquisition of Anesta Corp.for its pipeline and delivery technology.

Lesson 3: Build a PipelineOur analysis revealed that sustainable performers created astronger foundation of products, as measured through theirPipeline Productivity Index (PPI), during and after the time spentcommercializing their first compound. The PPI is the sum of thenumber of products in clinical trials multiplied by the probability thatthose products will reach the market, and thus provides a measureof the scope of a company’s pipeline. At the time of a new drug

launch, sustainable performers had a marginally deeper pipelinethan momentum and underperformers based on the PPI, achievinga PPI of 2.9, compared to 2.4 for the momentum performers, andonly 2.0 for the underperformers. Three years after launching a newdrug, however, there was a much greater disparity between thePPIs of the three classes of companies: sustainable performershad an average PPI of 4.8, while momentum performers had a PPIof 3.2, and underperformers had a PPI of only 2.7. One keydifference, then, between sustainable performers and their lesssuccessful peers: these companies were more than one-hitwonders, with multiple follow-on drugs and indications at variousstages of development at the time they were commercializing theirfirst compound.

Lesson 4: The Benefits of FocusIt’s hard enough to develop a novel compound and get it on themarket. It’s much more difficult to repeat this process forcompounds that treat very different diseases because ofdifferences ranging from the markets to the clinical trials requiredfor approval. Not surprisingly, most sustainable performers adoptedfocused business development strategies, opting to build expertisein just one therapeutic area. United Therapeutics Corp., forexample, successfully managed the lifecycle of its pulmonaryhypertension lead product, treprostinil sodium (Remodulin), througha wave of worldwide approvals, post-marketing trials, andreformulations. Gilead, meanwhile, commercialized three anti-viralproducts in the five years following the launch of its AIDS-supportcytomegalovirus drug, Vistide.

Lesson 5: Delaying Time to ProfitabilityA final factor in building a sustainable company: adopting a slowand steady march toward profitability. Though it may seem counter-intuitive, many companies push to become profitable too early intheir lifecycles. If they focus heavily on generating positive earnings,companies run the risk of stretching themselves too thin from acapital standpoint. As a result, they man not have the needed cashto fund the R&D or product acquisitions that are essential for futuregrowth. Indeed, based on our analysis, 100% of the sustainableperformers ultimately became profitable, but it took, on average, 16quarters to do so. In contrast, just 50% of momentum performersmanaged to do so, even though many tried to reach this elusivegoal in just five short quarters. Just 33% of the underperformers,meanwhile, became profitable, taking at least as long as thesustainable performers to attain this goal. While it is clear that acompany must eventually turn a profit if it is to generate value forshareholders, it also seems true that rushing to become anearnings-driven company is not optimal.

About L.E.K. ConsultingL.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 expertservices, including corporate strategy, product strategy, andtransaction services, helping companies innovate, fund,develop, market, and launch ground-breaking products in ahighly dynamic marketplace. ■

i In Vivo & Windhover Information. © 2006 Windhover Information(www.windhover.com).

E m e r g i n g Tr e n d s i n B i o t e c h n o l o g y 9a

BioProcess International™ is a monthly,controlled-circulation magazine devoted to thedevelopment, scale-up, and manufacture of

biotherapeutics and biodiagnostics. Each issue provides the global industrialbiotherapeutic community with up-to-date, peer-reviewed information detailing thebusiness, politics, ethics, applications, products, and services required tosuccessfully drive biopharmaceuticals, vaccines, and biodiagnostics through thedevelopment and manufacturing process.


Biotech Products Are Global

glob·al: adj. 1) of, relating to, or involving the entire world; of orrelating to a celestial body (as the moon); 2) of, relating to, orapplying to a whole (universal)

In the first days of the biotechnology industry—roughly 1975 to1985—early commercial research spanned the gamut ofpossibilities. In casual conversation once, biotech guru CynthiaRobbins-Roth told me how discussions in her lab at

Genentech would go from making biomaterials (e.g., spidersilkproteins from transgenic goat’s milk) to getting blockbusterantibody drugs from cows’ blood without any sense of irony.That’s what scientists can be likewhen they’re allowed to venture intothe realm of technologicalinnovation: no fear, no boundaries,no limitations. After all, their nascentindustry was all about futuristicconcepts that were the stuff ofscience fiction just a decade earlier.

Eventually, the realities of thebusiness world did set in. Thanks tothe famous forward-looking Asilomarconference of 1975, regulatorsweren’t playing catch-up but ratherparticipating in the process ofdefining the industry. And due to thecomplexities of regulation andmarketing, companies realized thatthey would each have to focusefforts on a particular niche.Monsanto chose agriculturalbiotechnology. Genentech led theway in making drugs through animalcell culture. Eli Lilly and NovoNordisk muscled their way into the forefront of insulin productionthrough microbial fermentation. Others ventured down riskier pathsinto industrial biotechnology and transgenics, the food and energyindustries, and even invention of brand new therapeutic areas.Gene and cell therapies, xenotransplantation, and tissueengineering are still working out the kinks in their respectivesystems. Biotechnology became not so much an industry as a

Scott visited the RoslinInstitute a few yearsago during a Scotlandpress tour and metDolly face to face.

The birth of “Dolly,” the clonedsheep, was first reported 10 years ago, on February 22, 1997,forcing the world to consider thepossibilities of cloning.

toolkit for potential use in many industries. And the membership ofthe Biotechnology Industry Organization reflects that—it’s not somuch a collection of biotech companies as of companies that usebiotechnology.

Meanwhile, the industry was spreading out from its initialclustered safety centering on important bioresearch centers (e.g.,Cambridge, MA, and the San Diego and San Francisco areas inCalifornia) 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 studyingextremophilic bacteria down there! Many countries and economic

regions are betting on biotechbusiness for their futures. And itseems as though every majoruniversity has at least one spin-outcompany in the works.

In our editorial offices atBioProcess International, we usuallyfind ourselves focusing pretty heavilyon the big biotech success story:protein therapeutics. There is theoccasional foray into gene transferor stem cells, tissue therapies andtransgenics. But like many of ourreaders, as well as the venturecapitalists and other investors, weknow where the big money is—fornow, anyway. And we have to coverthe industry we understand best,that being biotherapeutics. Even so,we can’t help admiring the work ofthose involved in the other types ofbiotechnology, both with andwithout genetic engineering. It’s not

as easy to define as many people might think, but one thing’s forsure: Biotechnology is global, both in terms of its geography andits applications.

ScienceThere are hundreds of biotherapeutic products on the worldmarket, the vast majority of them parenteral protein formulations,


Now biotech is happening in various

forms on everycontinent—and thatprobably includes

Antarctica if researchersare studying

extremophilic bacteriadown there!

by Cheryl Scott, Senior Editor, BioProcess International

I m p r o v i n g p a t i e n t o u t c ome s— t oge t h e r

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Alan and others like him are the patients who benefit 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

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With more than 100 years of experience in laboratory testing at Mayo Clinic, we deliver the reliability, speed to

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Clinically validating our laboratory testing for drugand device development is—music to Alan’s ears.

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E m e r g i n g Tr e n d s i n B i o t e c h n o l o g y

from antibodies to cytokines to growth factors and beyond.Enzymes are big, too, some of them small enough to be syntheticpeptides rather than the products of bioprocessing. Thedevelopment pipeline for these products is going strong, too, withthousands of molecules currently in preclinical and clinical testing.Quite a few of them are vaccines, a product area where cell cultureoffers great promise.

Big as it is—big enough to support several devoted tradejournals, in fact, of which we are one—that’s not the wholebiotechnology industry, however. Biotech grew out of advances inbiological science, and such advances are happening faster andtaking more impressive form as time goes on. The human genomeprojects (both commercial and government-funded approaches)have given us a map of our genome, but that’s only the beginning.Meanwhile, biodiesel and bioethanol fuels are showing up on ourhighways. I can’t go two days without a stem cell news storyshowing up on my desktop. Biocatalysis has revolutionizednumerous industries. ELISAs and other microarrays have changedhow many types of analysis are done, as well as reinvigorated thediagnostics business. And the medical device industry not onlypresents a good model for our companies to follow in riskmanagement and systems-based inspections, but it also offerssolutions to many biotech drug delivery quandaries. Biopolymershave a number of potential applications both in and out of themedical field.

The Biotech Rainbow: Many discussions about the variousapplications of biotechnology are now making use of colorfulshorthand to describe the general areas it can be found. “Redbiotechnology” refers to the health care systems we’re all familiarwith. “White” or “grey biotechnology” describes the science asapplied to industrial processes, as in the culture of microbes toproduce useful chemicals. Such processes tend to consume lessin resources than traditional means of such production. “Greenbiotechnology” is that applied to foods and agriculture, such astransgenic plants that grow under specific conditions. Its intentionis to produce more environmentally friendly solutions than can beachieved otherwise, but that possibility is under continuing debate.The term “blue biotechnology” has been used to describeaquacultural applications of biotechnology. Finally, although it hasn’tyet been ascribed a color—perhaps silver?—computational

biotechnology or bioinformatics is increasingly playing such a keyrole in so many arenas that it probably deserves a specialdesignation of its own. Genomics, proteomics, and systemsbiology are receiving such wide application, for example, that itseems every pharmaceutical company that runs such experimentsin its laboratories wants to call itself a “biotechnology” company.

To explore the wide world of biotechnological science outsidethis article, you’ll want to go to the 2007 BIO InternationalConvention and attend some of the sessions listed in the “Benchto Products Sessions” box. Here I’m focusing on some of the majorareas where innovation is happening now.

Regenerative Medicine: Biological systems have anamazing natural capacity to repair and maintain themselves—infact, that’s part of the very definition of life. And many medicalresearchers are finding ways to aid, encourage, and add tothose processes in human patients. Their “toolbox” includesvarious proteins and populations of stem cells that might beused to cure diseases, repair injuries, and even reverse someprocesses of aging.

Stem cells are receiving the most attention these days, partlybecause of their enormous potential and partly due to controversyover how they are obtained and used. Stem cell therapy couldradically change the face of health care in general, andregenerative medicine in particular. Some adult stem cell therapiesare already in use, most notably the bone marrow transplantstreating leukemia. Future uses could include treatments for cancer,Parkinson’s disease, spinal cord injuries, and muscle damage, justto name a few. First, of course, people will have to work out thesocial and scientific uncertainties.

Cell therapy research isn’t restricted, however, to stem cellsalone. Patients die every day waiting for donated organs to becomeavailable for transplantation, and cultured cells could help. Forexample, implanted liver cells have kept some patients alive longenough for a donor organ to become available. Researchers haveimplanted insulin-producing cells into diabetics, many of whomthen needed no insulin injections for years after receiving thosecells. And skeletal muscle cells have been used to repair cardiacmuscle damage from a heart attack. Using techniques such asencapsulated cells and genetic engineering, the immune-suppressing medications used in transplant patients may be anavoidable complication.

Tissue engineering is another form of regenerative medicine—and it’s made possible by advances in cell biology and materials

2007 BIO International ConventionBench to Products Sessions:

• 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 Cells—Stem Cell Biology Meets Oncology

Visit www.bio2007.org/program for complete and up-to-dateprogram information.


Biological systemshave an amazingnatural capacity torepair and maintainthemselves—in fact,

that’s part of thedefinition of life.

13a


science. Tissues and organs may be “built” in laboratories usingbiocompatible “scaffolding” materials on which living cells aregrown into correct and usable structures. This began with so-calledartificial skin and cartilage. Next come simple organs (e.g., bloodvessels and bladders) currently in development, and maybesomeday more complex tissue combinations may be possible (e.g.,hearts and kidneys).

Human bodies use an array of growth factor proteins in cellgrowth, division, and cell differentiation. These small proteins canhelp wounds heal and regenerate injured tissue as well as advancethe development of tissue engineering. Many growth factors arealready on the market as biotech products, some derived fromblood plasma and others produced by recombinant cells andorganisms. Erythropoietin, which stimulates the formation of redblood cells, was one of the first biotechnology products. Manymore are in development.

To learn more about what’s going on in this area, check out thesessions listed in the “Regenerative Medicine Sessions” box whenyou go to Boston for the 2007 BIO International Convention.

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Industrial and Environmental Biotech: Mentionbiotechnology in mixed company these days, and you may well endup in a discussion about the energy crisis. How’d that happen?Ask the folks in Brazil, the leading country in the use of biofuels.Interest in the concept is driven by skyrocketing costs anddisappearing reserves of fossil fuels. Unlike those, biofuels are arenewable energy source. And they don’t offer any of the numerousenvironmental, economic, and political complications of nuclearfission. In fact, they are biodegradable. Biofuels are derived frombiomass: e.g., cow manure, sugar cane, corn, soybeans, flaxseed,palm oil, and even garbage and sewage. Microalgae are beingstudied for their potential as an energy source, as well, withapplications being developed for producing biodiesel, ethanol,methanol, methane, and even hydrogen.

Biofuels represent an interesting “blast from the past.” Theearliest sources of energy used by humans were burning biomass:wood, peat, manure, and animal fats. The discovery of coal andpetroleum made those all seem quaintly archaic. Now moderntechnology is allowing us to look on such renewable sources froma new perspective. Global warming only became an issue afterfossil fuels took over, after all. That’s because the carbon in biofuelsis recently extracted from atmospheric carbon dioxide, so burningthem does not cause a net increase of CO2 in Earth’s atmosphere.Ancient underground reserves of fossil fuels constitute carbon“sinks,” where the greenhouse-gas-producing element is kept safelyaway from our global life cycle on the surface.

BIO is calling such industrial and environmental solutions the“third wave of biotechnology” (following therapeutics andagriculture). And biofuels are just one aspect. Biocatalysis and

A new concept that’s catching on across

industries is sustainability:that is, continuous innovation,

improvement, and use of cleaner technologies to

lower pollution levels and resource consumption.

2007 BIO International ConventionRegenerative Medicine Sessions:

• Adult Stem Cells: Current Medical and BusinessChallenges and Opportunities

• Current Affairs in U.S. Stem Cell Research• Differentiated Cell Therapies—Proven Science &

Business Model• Stem Cells: Doing Business in an Uncertain

Environment• Stems Cells as a Therapy: Barriers to

Commercialization • Tissue Engineering: A Clinician’s Challenge


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bioremediation are two other technologies that have made and aremaking a big impact. A new concept that’s catching on acrossindustries is sustainability: that is, continuous innovation,improvement, and use of cleaner technologies to lower pollutionlevels and resource consumption. Industrially sustainableprocesses should reduce or eliminate waste, improve energyefficiency, and lower the consumption of nonrenewable rawmaterials while increasing use of recyclables and renewableresources. Because life forms have had billions of years to developways to make and use chemicals, and scientists have had a fewdecades to improve on nature through technology, biologicalprocesses should be able to answer those needs better, cheaper,and faster than traditional synthetic chemistry and materials scienceever could.

The “Industrial and Environmental Sessions” box shows therange of such topics that will be addressed at the 2007 BIOInternational Convention.

Food and Agriculture were the first areas where humansused biotechnology. It began with animal husbandry, plantbreeding, and the fermentation of food and beverages. Imagine aworld without dogs, cows, and llamas (species created throughdomestication); tangelos, peppermint, and wheat (plant hybridsdeveloped through agriculture); not to mention beer, wine, yogurt,and bread (all products of fermentation). Modern technology andgenetics have allowed researchers to manipulate organisms fasterthan traditional breeding practices could ever manage throughguided mutation alone. When it comes to feeding the fast-increasing human population (more than six billion people now, with10 billion expected by 2030), this may be the best solution.Biotechnology can increase crop yields while lowering necessaryinputs such as water and fertilizer and providing new options forweed and pest control.

On the whole, people in industrialized nations don’t knowhunger. We can thank the Green Revolution for that. But mostpeople—over two-thirds of that six billion—live in developingcountries and grow their own food. The Green Revolution touched

them only lightly, and it’s done little to alleviate the cycles of feastand famine they have to live through. Consequently, developingnations are more interested in what crop biotechnology can do forthem. People in the industrialized world have the luxury of askingethical questions because they’re not spending a large amount oftime and energy wondering where the next meal is going to comefrom. This is not to say that ethical questions shouldn’t be asked.But it does show that there are two sides to the story. Agriculturalbiotechnology is not just about Monsanto selling more Round-Upbrand weed killer; it’s 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 findingways to sustain themselves without periodic reliance on charityfrom the outside.

Animals, plants, and aquaculture all are subjects of agriculturalbiotechnology. Research is improving animal health, enhancinganimal products with biotechnology, and making animal husbandrya more sustainable practice. Genomics, transgenics, and cloningare applied to livestock, poultry, fish, insects, laboratory animals,and even pets. Biotech even offers approaches to endangeredspecies conservation. As for plants, it’s not all food crops. Agrowing application of biotechnology can be found in forestry, withscientists addressing issues of productivity as well as wood-processing methods.

The 2007 BIO International Convention will of course addressmany of the latest issues in this area. See the “Food andAgriculture Sessions” box for a listing of topics.

Drugs and Diagnostics: The success of Genentech’sHerceptin treatment for certain breast-cancer patients hasspotlighted a new concept in health care: personalized medicine.That product works very well in a specific subpopulation ofpatients, those expressing the HER2 gene. The study of


2007 BIO International ConventionIndustrial and Environmental Sessions:

• 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 Biotechnology—Where Is the

Value?• Environmental Biotechnology: Systems Biology,

Bioremediation and Microbial Fuel Cells• Energy Crops for Biofuels• A Cellulosic Biorefinery Incorporating Dedicated Energy

Crops


2007 BIO International Convention Food and Agriculture Sessions:

• The Road (and Potholes!) to Commercializing BiotechAnimals

• How Developing and Transitional Economies View andAffect Plant Biotechnology

• Yours, Mine or Ours? Who Owns the World’s GeneticResources?

• 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


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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.



pharmacogenetics and pharmacogenomics—examining therelationships between drugs and genetics—is widely believed tohave the potential for revolutionizing the pharmaceutical industry.Proponents say personalized medicine will use detailed geneticinformation with a patient’s clinical data to select drugs that areparticularly suited. It could supplant the blockbuster model thatcharacterizes so much of the pharmaceutical industry now. Onething will be critical to its success: more intimate relations betweentherapeutics and diagnostics. The lines between what are now twoseparate industries will blur.

DNA sequences known as genetic markers can be identified bysimple assays to study the relationship between, for example,inherited diseases and their genetic causes. Because genes thatlie near each other on chromosomes tend to be inherited together,genetic markers can be used to determine precise inheritancepatterns for genes that have yet to be localized precisely. Usingthese and other pharmacogenomics tools, companies coulddevelop rational means to optimize drug therapies to genotypes,thus ensuring maximum efficacy with minimal adverse effects.

These technologies could enable more efficient drugdevelopment processes based on sound genetic information thatcould shorten times to market. Drugs would be marketed alongwith their companion diagnostic tests, which may well improveconsumer confidence in an industry facing some public relationstrouble. With a low growth rate, the traditional diagnostics industryhas not been as successful as the pharmaceutical industry infundraising. The advent of molecular diagnostic tests opens newopportunities for partnerships.

2007 BIO International Convention Devices and Diagnostics Sessions:

• Emerging Opportunities in Molecular Imaging: SharperImages and Improving Outcomes

• Proving Genomics: What Do Payers and ProvidersNeed?

• The View From the Trenches: Personalized MedicineGetting 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


Collaboration is the name of the game when it comes tobiotechnology and medical devices as well. For more information,look for related discussions at the 2007 BIO InternationalConvention. The “Devices and Diagnostics Sessions” box tells youwhere you’ll find them.

Biopreparedness: In the wake of 2001’s very conspicuousattacks by terrorists on New York City’s twin towers, thebiodefense leapt to the forefront of national politics—and not only

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Proud Sponsors of BIO 2007

ALZA CorporationCentocor, Inc.Centocor Research & Development, Inc.Global Biologics Supply Chain, L.L.CThe Janssen-Cilag CompaniesJanssen, L.P.Johnson & Johnson Development Corporation (JJDC)Johnson & Johnson • Merck Consumer

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a Division of McNeil-PPC, Inc.Ortho Biotech Products, L.P.Ortho-McNeil Neurologics, Inc.Ortho Women's Health & Urology Division of

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McNeil-PPC, Inc.THERAKOS, Inc.Tibotec Pharmaceuticals LimitedTibotec Therapeutics, a Division of

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in the United States. Not only have biotechnology and relatedscience provided tools to help humanity, but unfortunately, like anytechnology, they can be turned to evil ends as well. Luckily, the“good guys” are working toward countermeasures before the “badguys” 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 topeople in an area affected by a biohazard or major health issue(e.g., a disease outbreak). Protection of water and food suppliesare part of it. And because of the newly identified possibility ofbiological terrorism, biopreparedness adds the modern twist ofprevention to these efforts. Additionally, there is the real possibilityof a natural pandemic outbreak of infectious disease.

Vaccines, of course, play a large and integral part inbiopreparedness efforts. The US Department of Defense hasfocused for years on the development and application of vaccine-based biodefenses for troops in the field. Critical toxins andpathogens being targeted include anthrax, smallpox, plague,tularemia, botulinum, ricin, and equine encephalitis. Meanwhile, aparade of potentially pandemic organisms have marched across thenews, from West Nile fever to SARS to the Asian bird flu H5N1. And antibiotic resistance mutations could revive diseases such astuberculosis that have been previously regarded as beaten. Ofcourse, HIV is already certified as a global pandemic, and severalbiopharmaceutical companies are working to fight it already.

Others are betting on potential hazards and ways to identify actsof bioterrorism before they have a chance to spread too widely. TheUS government instituted Project BioShield in 2004, which

In the wake of 2001’svery conspicuous

attacks by terrorists onNew York City’s twintowers, biodefense

leapt to the forefront ofnational politics—and

not only in the United States.

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As any discussion of product areas will show, the so-called “firstworld” is not the only market for biotechnology’s products.However, the markets are not all the same; each presents its ownimportant issues and needs. Also, different countries have different



2007 BIO International ConventionInternational Sessions:

• Taiwan: Your Biotech Partner and the Stepping-stone toAsia Pacific

• China: Heading to a Bio-economy• Biotech “Made in Germany”: From Start-up to Grown-up• The UK Drug Pipeline: Leading the World’s 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 Tomorrow’s 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• Israel’s 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


pumped some needed money into promising vaccine anddiagnostic companies working on these ideas. However, somehave questioned its effectiveness. As BioExecutive Internationalmanaging editor Lorna McLeod wrote in her October 2006editorial, “The issue, of course, is political fodder. The ProjectBioShield budget is $5.6 billion, none of which appears to bemonitored closely. There have been few federal audits of anybiological warfare vaccine maker despite huge increases inspending since 2001. It’s a lot of money, to put it mildly, and manyplayers would like some of it. . . . And still the question remains: Arewe safer?”

For answers to that and other related questions, check out the“Biopreparedness Sessions” box, and attend those discussions atBIO’s 2007 International Convention.

Doing Business GloballyOver the years, biotechnology has grown not only in scope butalso economically and geographically. Arguably, the industry beganin the United States, and the modern science it came from isessentially a product of the so-called western world (primarilyEurope and North America)—although the Japanese expertise infermentation has been well known for decades. Over the firstquarter-century of biotechnology as an industry, those were theonly locales where anything substantive was going on. But this isno longer the case.

As the number of approved biopharmaceutical products hasincreased and manufacturing operations have expanded to meetmarket needs, more attention is being paid to increasingoperational efficiencies. Until now, most biotech manufacturingefforts have been toward production of clinical trial materials, sospeed was more important than efficiency. But the maturation ofthe industry—and the imminence of biosimilar products—has ledcompanies both large and small to look at ways they can maketheir products better, faster, and cheaper.

One important solution in many other industries has beenoutsourcing—and now the bioprocessing world is discovering ittoo. From making products to managing clinical trials to regulatoryaffairs and product sales forces, contract service providers arehelping biotech companies get things done. Some organizationsare even “virtual,” their small staffs consisting mainly of decisionmakers who direct the work of contract research andmanufacturing. Countries that have been traditionally associatedwith outsourcing are seeking and finding ways to becomedestinations for the biotech version, too. Others are seeing theadvantages of a knowledge-based economy and hoping to develophome-grown biotech sectors of their own. See the “InternationalSeminars” box for a list of those you can find out more about at the2007 BIO International Convention.

2007 BIO International ConventionBiopreparedness Sessions:

• Manufacturing for Biodefense and Pandemic Response• Public-Private Partnerships: Driving Product

Development in Global Vaccines and Biodefense• Biodefense and Pandemic Preparedness—Progress &

Opportunities


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laws regarding importation/exportation, product labeling,manufacturing practices, and intellectual property. Language andcultural differences are not to be taken lightly. And although thebusiness world does run on a 24-hour clock, it’s not alwayspossible to respond immediately to problems that occur on theother side of the world. Doing business globally is a dauntingprospect for many companies, especially the smallerentrepreneurial biotech organizations.

Vaccines make an interesting case study. The value of the globalmarket for vaccines may be $5 billion. But the economics ofvaccines are not as simple as supply and demand. Markets aremeasured in terms of potential revenue. Although the global needfor vaccines is very large, actual demand is much smaller becausethose who most need vaccines are often least able to pay for them.So the actual market is decided by governments and internationalhealth organizations, which purchase vaccines at a set price perdose. The disparity between need and demand means thatvaccines needed in the developing world are often an underfunded,lower-priority for commercial manufacturers. In fact, the vastmajority (85–90%) of global vaccine market revenue comes fromvaccine sales in the developed world, and 50% of vaccine revenueis tied to proprietary vaccines tailored to industrialized markets.

Four companies lead the vaccines market, accounting for nearly80% of worldwide vaccine sales: Aventis Pasteur,GlaxoSmithKline, Merck & Co., and Wyeth-Inc. Geneticengineering has opened new doors for vaccine manufacturers,allowing them to improve existing products, develop new ones, andreceive better patent protection than before. This change hasbrought profit potential back into the market, leading to newcompanies entering the scene. New potential also arose forvaccines to treat cancer, autoimmune diseases, and infectiousdiseases. In 2001, more than 100 US companies had vaccines invarious stages of development.

Global health and business issues will be addressed in detail atthe 2007 BIO International Convention. The “Global HealthSessions” and “Doing Business Globally Sessions” boxes listgeneral topic areas.

For many years, the most common solution for biotech companiesin need of funding or expertise and doing business both locally andglobally has been to find a partner. Sometimes this means licensingyour product to a bigger pharmaceutical company. Sometimes itmeans partnering with “big pharma” to explore a disease area ortype of product. Sometimes it means teaming up with anothersmall company with capabilities that happen to be compatible withyour own. The biggest issue here is finding the money to keep ongoing when it can take several years and hundreds of millions ofdollars to bring a single biopharmaceutical product to market.Meanwhile, companies must weather the periodic storms of publicand investor relations, wade through the confusion of bioethics andintellectual property, and tread carefully among the landmines ofregulatory requirements. It’s a risky business—but as most of thepeople involved will tell you, well worth the trouble.

2007 BIO International Convention Global Health Sessions:

• Partnerships for Global Health: Going From Bench toBedside

• Antibacterial Treatments: The Need Is Now, CanResearch 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


2007 BIO International Convention Doing Business Globally Sessions:

• 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


One important solution in many otherindustries has been

outsourcing—and now the

bioprocessing world is discovering it too.

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26a E m e r g i n g Tr 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. BioProcessInternational 1(10) 2003: 14–18.

Darroch S. The Road Ahead for Vaccines. BioProcess International May2005: 14–16.

Dougherty E, Robinson E. International Relocations: What You Need toKnow to Make Your Move Successful. BioProcess International 2(6) 2004:16–18.

Finnegan S, Pinto K. Offshoring: The Globalization of OutsourcedBiomanufacturing. BioProcess International 4(8, supplement): 56–62.

Gin BS. Singapore: Biotech Mecca. BioProcess International January2006: 44–46.

Howarth B. Down Under Deals: US Companies Sign Lucrative Contractswith Australian Biotech Sector. BioProcess International June 2005:36–38.

Isom E. Requirements for Outsourced Cold Chain Storage and Logistics inBiopharmaceutical Development. BioProcess International 4(8,supplement) 2006: 48–50.

Jones SD, Levine H. Biotech Emerges in India: A Changing Business andLegal Environment Drives the Expansion. BioProcess International May2005: 50–53.

Jones SD, Levine H. You Can Outsource Manufacturing But NotResponsibility. BioProcess International March 2005: 46–50.

Koberstein W, Robinson K. Can Europe Catch Up? Biotech on theContinent. BioProcess International May 2005: 58–67.

Kostrubanic JA. Putting Together a Successful Strategic Alliance: AvoidingPitfalls. BioProcess International September 2006: 44–47.

Lennox P. Building a Biotech Sector. BioProcess International June 2006:44–47.

Matsumoto H. Japan Makes a Home for Biotechnology. BioProcessInternational December 2005: 30–33.

Montgomery SA, Rosin LJ, Scott C. Contract Service Providers: YourPartners for Success. BioProcess International 4(8, supplement): 4–8.

Montgomery SA, Rosin LJ, Scott C. The Future of Bio-Outsourcing.BioProcess International 4(8, supplement): 44–47.

Montgomery SA, Rosin LJ, Scott C. The Many Roles of Service Providers.BioProcess International 4(8, supplement): 22–25.

Muddyman G. Conquering International Biopharmaceutical Markets: TheChallenge of China. BioProcess International May 2006: 36–39.

Niazi SK, Flynn TL. A Practical Model for Outsourced Biomanufacturing.BioProcess International 4(8, supplement): 10–16.

Noffke TJ. Smooth Sailing for Pharma-Biotech Alliances: Skilled ProjectManagement Can Navigate Stormy Seas. BioProcess InternationalDecember 2005.

Palermo RJ. The Expanding Role of Biologics in the PharmaceuticalIndustry. BioProcess International 4(10) 2006: 80.

Peterson R. Creative Financing: Moving Beyond Venture Capitalist Fundingfor Biotech Start-Ups. BioProcess International 1(8) 2003: 18–24.

Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 1:The Basics. BioProcess International 3(8) 2005: 28–30.

Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 2:Main Elements of a Biotechnology Licensing Agreement. BioProcessInternational 3(9) 2005: 26–28.

Restaino LG. Perspectives on Successful Biotechnology Licensing, Part 1:Licensing Strategies. BioProcess International 3(11) 2005: 12–14.

Robinson K. Genzyme’s View of Europe: EU Ideals Versus Member-NationNeeds. BioProcess International June 2005: 20–22.

Rosin LJ. Are Pharmaceutical Prices Just: A Discussion of Business, Values,and Ethics. BioProcess International 2(2) 2004: 18–20.

Singh M, Dai D. Clinical Supplies Excellence: Are You Set Up to Succeed?BioProcess International 4(1) 2006: 12–16.

Steffy CP, Rosin LJ. Chapter Five: The Two Global Markets — Vaccines forthe Developed and Developing Worlds. BioProcess International 2(4,supplement) 2004: 48–57.

Steffy CP. Chapter Six: A Multitude of Fears — Why the Public Objects toTransgenics and What You Can Do About It. BioProcess International 2(6,supplement) 2004: 62–67.

Van Yoder S. Moving Upstream in Chinese Pharma Industry. BioProcessInternational September 2006: 52–54.

Wheelwright SM. Bioprocessing in Asia: Now and the Next Five Years.BioProcess International 3(9) 2005: 20–23.

Williams D. Top 10 Principles of Successful Manufacturing Partnerships.BioProcess International October 2006: 30–33.

Zhou Y. Opportunities in Biopharmaceutical Outsourcing to China.BioProcess International 5(1) 2007: 16–23. ■

For an additional article writtenby Cheryl Scott on, “ManagingBiotherapeutic ProcessPipelines,” 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, Björkgatan 30, 751 84 Uppsala,Sweden © 2007 General Electric Company - All rights reserved.

GE01-07. First printed 01/2007.

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