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UPCOMING FEATURES

Genomics: Building Clinical Models—February 24

Toxicology: Animal-free Techniques—March 2

Polymer Science: Creating Synthetic Materials—March 16

Though contract research organizations (CROs) have been around for decades, they traditionally served large pharmaceutical companies with deep pockets, providing temporary assistance for particular projects.

Now, however, even small university labs use these service companies routinely, sending out everything from simple DNA sequencing to sophisticated biochemical experiments. Indeed, some biotechnology companies now conduct entire research programs “virtually,” outsourcing all of the lab work to contrac-tors so they can focus their energies on analyzing results and designing new experiments.

The CRO industry has evolved to meet the new demands. “Years ago, there weren’t as many Ph.D.s on the CRO side,” says Nancy Gillett, corporate executive vice president at Charles

River Labs in Wilmington, Massachusetts. Gillett adds that these days, companies like hers employ many former research-ers who can provide intellectual as well as technical input for their customers’ projects. The industry has also diversifi ed, and different CROs now offer a tremendous array of services for sci-entists across numerous fi elds.

TOXICOLOGY ON TAPIn some specialized areas, the outsourcing trend is nothing new. Roy Forster, chief scientifi c offi cer of CiToxLAB in Évreux, France, explains that for several years, “there’s been a tendency for pharmaceutical companies to cut back on in-house resources and [choosing instead to] outsource toxicology.” He adds that the growth of the biotechnology industry has accelerated the trend, as small startup companies seldom have the money to set up a dedicated toxicology lab.

Toxicology-focused CROs generally offer a range of services,

from quick, relatively inexpensive predictive toxicology tests that can help a company eliminate bad drug leads, to detailed toxicity testing in nonhuman primates for late-stage translational stud-ies. At CiToxLAB, Forster and his colleagues have developed a series of toxicology screening tests that comply with good labo-ratory practice (GLP) standards, an important consideration for studies that will eventually support regulatory fi lings.

It’s not just corporate researchers who’ve seen the benefi ts of sending out such work. “We do have nice contacts and some good relationships with [academic institutions]. I think they espe-cially appreciate the capability that people like us might offer to transfer technology . . . into a GLP-compliant environment,” says Sophie Baratte, CiToxLAB’s chief executive offi cer.

For researchers shopping for a toxicology CRO, it might be tempting to aim for the lowest bidder. That approach may work well for routine, well-characterized toxicity screens, especially in cell culture systems, but more complex assays often require extensive customization. “There may be some product sectors where toxicology is a commodity,” says Forster, but he adds that for pharmaceutical and biotechnology companies, “there’s a lot of things to understand about the products, about their charac-teristics, about the way they have to be handled, about why the

As Science Accelerates,Researchers Hire HelpFor the general public, the word “outsourcing” conjures images of layoffs, overseas call centers, and politicians railing against the loss of local jobs. In biomedical research labs, though, outsourcing has become one of the hottest new trends. Both corporate and academic scientists have realized that hiring a contract research organization can help speed up routine tasks and give them easy access to techniques that are too expensive or complex to do in-house. By Alan Dove

Outsourcing gives researchers easy

access to new technologies, such as

next generation sequencing.

LIFE SCIENCE TECHNOLOGIES

OUTSOURCING LAB SERVICES

Produced by the Science/AAAS Custom Publishing Office

www.sciencemag.org/products 1155

studies have to be done in certain ways.” As a result, he advises

researchers to communicate extensively with their CROs to en-

sure that such studies are done exactly right.

Scientists should also consider the size of the CRO, as both

large and small contractors offer distinct advantages. “There are

different models around the globe of how to be a good preclini-

cal CRO, and probably everybody has their own answer,” says

Baratte. She explains that a large company can have the capacity

to handle big, standardized projects on short notice, but may be

slow to adapt to unusual needs. “Our clients, because they have

to move quickly, appreciate having a very fl exible organization as

a partner,” she says.

BIOCHEMISTRY ON A DEADLINEBasic researchers have also been jumping on the outsourc-

ing bandwagon, often sending out work that was once routine

drudgery for graduate students and postdocs. Rather than pour-

ing large acrylamide gels and setting up Sanger DNA sequencing

reactions, for example, most research labs simply call their local

sequencing contractor, have their samples picked up by a cou-

rier, then wait for the fi nished sequences to arrive in their e-mail

inboxes a few hours later. More complex studies, such as cDNA

library screening and even some biochemical studies, are also

going off-campus.

Dualsystems Biotech AG, in Zurich, Switzerland, is one of

the companies catering to this growing market. “We offer two

platforms to discover protein-protein interactions,” says Tobias

Dietschy, marketing and sales director at Dualsystems. Though

Dualsystems’ assays are based on standard yeast two-hybrid

and transfected mammalian cell systems, the company has de-

veloped proprietary extensions of both techniques to make them

more reliable and fl exible.

In the yeast two-hybrid screen, developed almost two decades

ago, investigators attach a protein fragment of interest to one

half of a yeast regulatory protein complex, and screen it against

a library of other protein fragments attached to the other half.

Proteins that interact will activate a reporter gene, identifying

possible binding partners. The assay has been enormously use-

ful for tracing signal transduction pathways, but it works only on

soluble cytoplasmic proteins and suffers from high rates of false-

positives. Dualsystems has developed a series of techniques to

address both of those problems.

That kind of expertise is a major reason scientists have begun

outsourcing such assays. “Today, it is much harder for a scientist

to publish their work, you need to show your results from many

different angles, and a lot of our customers are not really experts

in all the techniques that are required in order to publish. It’s a

whole bandwidth of different technologies that are attractive for

different customers to outsource,” says Dietschy.

While many researchers get all the help they need from col-

laborators, hiring a CRO has distinct advantages. “You can go for

scientifi c collaborations, which are sometimes fruitful but some-

times also very slow, . . . whereas if you outsource it to a com-

pany you sign a contract and also the timeline is very exact, and

this is great for a scientist. I know, for example, that within three

months I can expect the company to provide me with the results

I need to further explore my scientifi c problem,” says Dietschy.

SELECTING A SEQUENCING SERVICEContractors can also help researchers deal with the accelerating

pace of technical advances. That’s especially true with next gen-

eration sequencing, which allows scientists to sequence large

sections of genomes very quickly.

“Sanger sequencing is obviously an established technology,

[but] I think next-gen sequencing is slightly different in that

in some respects this is an embryonic technology, it’s

evolving rapidly, and I think it’s much more unstable as a

technology,” says Gareth Thomson, director of genomic

services at Oxford Gene Technology (OGT) in Oxford,

United Kingdom.

That instability could send a lab down a rabbit hole of beta

testing and expensive equipment upgrades, as each new next

generation sequencing platform renders the previous one ob-

solete. Even settling on a general strategy can be a problem,

with whole-exome sequencing, targeted sequencing of specifi c

regions, and different DNA library preparation methods all calling

for their own specialized gear and training. By sending the work

out, scientists can take whatever approach makes the most

sense and use the latest technology whenever they need it, let-

ting the CRO deal with the upgrades.

An outsourcing company can also provide services investi-

gators didn’t know they needed. “Something that research-

ers often overlook is the amount of resources [necessary] to

turn the terabytes of data that’s generated into meaningful

results. Once they get hold of that data, many researchers

fi nd that the internal resources they’ve got for bioinformat-

ics [are] a real bottleneck, and it really slows them down,”

says Thomson.

To address those needs, genomics CROs often offer a variety

of sequencing-related services. OGT, for example, can provide

both targeted and whole-exome next generation sequencing as

well as customized techniques. Thomson says basic researchers

often use the whole-exome service to look for genetic changes

across entire genomes. Translational teams, on the other hand,

may prefer a customized approach focusing on genes related to

a particular clinical phenotype.

The company also offers assistance with experimental design

and data analysis, and employs a bioinformatics staff that can

identify the most relevant results from a sequencing run. Thom-

son expects these additional services to expand as more sci-

entists become interested in next generation sequencing work.

“Researchers are looking for us to provide this kind of integrat-

ed, holistic view of gene characterization, and that’s an area that

we hope to focus on,” he says. continued »

FEATURED PARTICIPANTS

Beckman Coulter Genomicswww.beckmangenomics.com

Charles River Labwww.criver.com

CiToxLABwww.citoxlab.com

Dualsystems Biotech AGwww.dualsystems.com

Oxford Gene Technologywww.ogt.co.uk

LIFE SCIENCE TECHNOLOGIES

OUTSOURCING LAB SERVICES

Produced by the Science/AAAS Custom Publishing Office

www.sciencemag.org/products1156

Alan Dove is a science writer and editor based in Massachusetts.Alan Dove is a science writer and editor based in Massachusetts.

DOI: 10.1126/science.opms.p1100060

For investigators who just need help operating an existing fa-

cility, Charles River runs a service division that can provide ex-

pertise, animal breeding assistance, and staff. Meanwhile, the

company’s research models division maintains its own facilities,

so clients can simply hand over their mice, rats, or other animals

and have someone else take care of them. Pfi zer, for example,

recently hired Charles River to maintain and distribute several of

their genetically modifi ed mouse models so researchers around

the world can use them.

Gillett says interest in this type of outsourcing is on the rise,

particularly among cash-strapped pharmaceutical companies.

“Pharma has to fi gure out how to produce new drugs, because

that’s their revenue model, . . . without just throwing more mon-

ey at it. That’s what I think is the primary driver behind looking at

outsourcing very differently,” she says.

Besides operating more effi ciently, CROs can also help compa-

nies handle the boom-and-bust funding cycle that typifi es mod-

ern corporate research. Rather than layoff full-time staff when-

ever another blockbuster’s patent expires, companies can simply

choose not to renew their outsourcing contracts.

The CRO business has had its own booms and busts over

the years, but researchers in the industry sense that a more

profound change is afoot this time. “I think things have fun-

damentally shifted and can’t go back the other way,” says Gil-

lett, adding that “once companies make the decision that

they are going to trust partners to have this expertise in cer-

tain areas, I don’t see them going out and trying to recapture

that expertise.”

ONE-STOP SHOPPINGNext generation sequencing has also become a standard offering

for larger CROs. Beckman Coulter Genomics, headquartered in

Danvers, Massachusetts, now offers researchers an extensive

menu of services. “We do a whole variety of types of sequenc-

ing, we do genotyping work on the various platforms that are

available, [and] we also do gene expression analysis,” says Doug

Smith, the company’s director of global bioinformatics and tech-

nology. For large pharmaceutical companies, Beckman provides

a biologics testing service as well, which performs the detailed

cell culture characterization required for regulatory approval of

biologically produced drugs.

The company has also introduced a novel multiplex polymerase

chain reaction (PCR) primer-design service for high throughput

gene expression studies. That type of work has become a staple

of modern drug development. “In the pharmaceutical compa-

nies, they are very interested in looking at toxicity using different

organisms, for example mouse, rat, monkey, they would like to

have different sets of [PCR primer] panels to look at the toxicity

genes . . . and determine the effi cacy of their drugs and the me-

tabolism of these drugs,” explains Handy Yowanto, global prod-

uct manager for Beckman Coulter’s West Coast facility in Brea,

California. Optimizing a set of primers for these types of studies

requires special expertise, and many companies fi nd it easier to

hire help than do it themselves.

While Yowanto’s primer-design team works mainly with big

pharma, some of Beckman’s other offerings also appeal to sci-

entists working at universities. “It’s across the whole range, and

depends a little bit on what type of analysis it is, but we have

quite a number of academic clients, and in the past we’ve actu-

ally done work with government-funded grant projects as well as

from pharmaceutical companies,” says Smith.

Like other service providers, Smith reiterates that research-

ers should talk to different CROs about their needs before set-

tling on a particular service. Labs with plenty of bioinformati-

cians on staff, for example, may just want the raw data from a

high throughput procedure, while those with limited experience

analyzing such results should fi nd a company that provides

more handholding.

Regardless of a lab’s internal expertise, it usually makes sense

to outsource sequencing and other routine genomic techniques,

particularly for translational projects that will eventually face

regulatory scrutiny. “That involves implementation of a rigorous

quality system, which again adds more cost and more things to

manage,” says Smith.

MOUSE HOUSE FOR RENTMany scientists are also anxious to dispense with the chores

of animal care. As any researcher who’s worked with laboratory

animals knows, maintaining colonies is expensive and time-con-

suming. Some CROs are happy to do it for them.

While toxicology CROs such as CiToxLAB may handle particu-

lar model organisms for their specialized tests, other outsourc-

ing companies take a more general approach, maintaining large

collections of research animals for a wide range of experiments.

“Charles River [is] known for animal care, that’s very much what

we do. We’re focused on in vivo biology,” says Gillett. Indeed, her

company has become a dominant player in veterinary outsourc-

ing, operating in 16 countries and catering to a long client list of

pharmaceutical and translational scientists.

“There’s been a tendency for

pharmaceutical companies to cut back on

in-house resources and [choosing instead

to] outsource toxicology.”

LIFE SCIENCE TECHNOLOGIES

OUTSOURCING LAB SERVICES

Produced by the Science/AAAS Custom Publishing Office

www.sciencemag.org/products 1157

Newly offered instrumentation, apparatus, and laboratory materials of interest to researchers in all disciplines in academic, industrial, and governmental organizations are

featured in this space. Emphasis is given to purpose, chief characteristics, and availability of products and materials. Endorsement by Science or AAAS of any products or

materials mentioned is not implied. Additional information may be obtained from the manufacturer or supplier.

STR PROFILING SERVICEThe Short Tandem Repeat (STR) Profi ling Service offers investiga-

tors an easy and sure solution for verifying the identity of their hu-

man cell lines. Researchers simply apply cells to an FTA card fol-

lowing the instructions provided with the FTA Sample Collection Kit,

eliminating the need to ship samples on dry ice. ATCC will amplify

the DNA using the Promega PowerPlex 16 HS System and analyze

the results. Investigators can expect results via e-mail within fi ve

days from receipt of their sample. Two levels of service are offered:

Basic and Verifi ed. The Basic STR Profi ling Service (135-X) includes

a signed Cell Line Authentication Report containing an easy-to-un-

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includes everything in the Basic service, plus known reference profi l-

ing against the ATCC STR Profi le Database, and a comprehensive

interpretation of the results.

ATCC

For info: 800-638-6597 www.atcc.org/STRprofi ling

UBIQUITINPROFILER SERVICES The UbiquitinProfi ler Services determine the potency and selectivity

of compounds targeting ubiquitin ligases, key enzymes in a pathway

linked to many serious diseases. Through this service, compounds

are assessed via a panel of validated assays for their ability to enhance

or inhibit the ubiquitination pathway. With a central role in traffi cking

proteins for degradation, the ubiquitin pathway is an attractive target

for drug discovery efforts in many areas including neurodegenera-

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however, the complexity of the ubiquitin cascade has presented a

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Services, the ways in which potential drug compounds impact the

ubiquitin pathway can be more rapidly and effectively assessed. Pre-

viously, researchers had to develop and optimize all the necessary

reagents and assays themselves.

EMD Millipore

For info: 800-645-5476 www.millipore.com/ubiquitinprofi ler

RGS PROTEIN SCREENING A new high throughput screening (HTS) assay is available for

screening the “Regulators of G-protein Signaling” (RGS) proteins

that infl uence signaling of G Protein-Coupled Receptors (GPCRs).

Offered as an assay development service, the RGScreen Assay

Service opens up new therapeutic strategies for modulating GPCR

pathways, including the potential to fi ne-tune the effects of existing

GPCR ligands. RGS proteins attenuate GPCR signals by increasing

the GTPase activity of associated G� proteins. Though RGS

proteins have been the focus of intense investigation as potential

drug targets, the lack of suitable HTS assay methods has prevented

large-scale screening efforts. BellBrook overcame this technical

hurdle by developing proprietary G� variant proteins that enable

direct detection of RGS catalytic activity using their Transcreener

HTS Assay platform. The RGScreen Assay Service provides custom

assay development to produce and validate desired RGS protein

targets followed by ongoing reagent supply, including RGS proteins,

variant G� proteins, and Transcreener GDP Assay components, to

support large-scale RGS protein screening programs.

BellBrook

For info: 866-313-7881 www.bellbrooklabs.com

PROTEIN VARIANT SCREENING The SURE Variant Screening Service accelerates and improves out-

comes in display library screening campaigns by reducing the num-

ber of steps and increasing the total productivity of the system. This

service utilizes the proprietary Selexis SUREtechnology Platform and

the Selexis SURECHO-M cell line to generate variant panels ranging

from several to >100 stably-expressing protein variant cell lines, with

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LIFE SCIENCE TECHNOLOGIES

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Webinar sponsored byBrought to you by the Science/AAAS Custom Publishing Office

A major advantage of in vivo imaging by fluorescence tomography is that it

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Determining the Impact of NewTherapeutic Approaches

Advancing Imaging in Animals

December 7, 201112 noon Eastern, 9 am Pacific, 5 pm GMT

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Matthias Nahrendorf, M.D., Ph.D.Harvard Medical School

Boston, MA

Patrick McConville, Ph.D.Molecular Imaging, Inc.

Ann Arbor, MI

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Matthiias Nahrendorf, M.D., Ph.D.Harvardd Medical School

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Patrickk McConville, Ph.D.Molecuular Imaging, Inc.

Ann Arbbor, MI

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TOP IMAGE: Heterochromatin is characterized by a repressive, tight packaging of nucleosomes, whichimpedes transcription factors from gaining access to regulatory sites on the DNA. Methylation of cytosinebases in regions called CpG islands, found in many gene promoters, leads to formation of transcription-ally repressed heterochromatin. Methylation of cytosine bases by DNA methyltransferases (DNMTs)facilitates recruitment of Methyl-CpG-binding Protein 2 (MeCP2), which brings along other associatedproteins, including histone deacetylases (HDACs), histone methyltransferases (HMTs), and Hetero-chromatin Protein 1 (HP1). These proteins then facilitate the deacetylation and methylation of histoneproteins, resulting in the formation and maintenance of the repressive state of heterochromatin. To viewour epigenetics digital animation movie and for more information, please visit www.cellsignal.com.

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Input

HoxA2 α Satellite

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