cellcycleanalysisonthebdfacsverse system · mbl proproteinconvertase9/pcsk9 periostin/osf-2...
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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
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STR PROFILING SERVICEThe Short Tandem Repeat (STR) Profi ling Service offers investiga-
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For info: 800-638-6597 www.atcc.org/STRprofi ling
UBIQUITINPROFILER SERVICES The UbiquitinProfi ler Services determine the potency and selectivity
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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
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proteins have been the focus of intense investigation as potential
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PROTEIN VARIANT SCREENING The SURE Variant Screening Service accelerates and improves out-
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LIFE SCIENCE TECHNOLOGIES
NEW PRODUCTS: OUTSOURCING LAB SERVICES
Produced by the Science/AAAS Custom Publishing Office
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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natural state. Within a preclinical setting, such imaging allows disease states
to be observed and measured noninvasively within the whole animal, bridging
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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
Particcipants
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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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HoxA2 α Satellite
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A
BEzh2 (D2C9) XP® Rabbit mAb #5246:
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