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Oncology outsourced: An emerging research model
August 2013
SHARING OPTIONS:
In spite of advances in biology and medicine, cancer remains
a major unmet clinical need. In the pharmaceutical and biotechnology worlds,
cancer research is focused primarily on diagnostic tool development and
target-based drug discovery. Diagnostic tests play an important role in patient
stratification for treatment and for monitoring therapeutic benefit. The
reductionist target-based drug discovery approach enables a more effective,
personalized approach to clinical treatment.
Fortunately for us, the chances for meaningful advances in
these areas are never higher than today. Over the past decade, we have
witnessed the dawn of the 'omics era and the advent of Big Data. Emerging
technologies like next-generation sequencing and innovative analytical tools
such as network analysis have improved our understanding of basic cancer
pathophysiology. What remains is translating this knowledge from the bench to
the bedside.
Although academic and government research institutions and,
increasingly, nonprofit research foundations, contribute to the search for new
diagnostics and therapeutics, the bulk of cancer research is carried out by the
pharmaceutical industry. In the past few years, however, multiple factors
including decreased productivity, higher costs and the ongoing patent cliff have
made drug research in the pharmaceutical industry unsustainable in its current
format. As a consequence, newer models of science and business are replacing
the fully integrated pharmaceutical company (FIPCO) model that is quickly
becoming a relic of the past. Evolving technology has allowed and even driven
this shift. The name of the game for drug research today is outsourcing.
Outsourcing of drug research
Pharmaceutical companies are adapting to the changing
business dynamics by moving away from a vertically integrated model where
company scientists do all of the research in company laboratories. Outsourcing
has become the key to not only efficient technology development, but also the
entire drug research process. This is true for all disciplines, but is nowhere
more evident than in oncology, drug discovery and diagnostics, where the
pharmaceutical industry has established relationships with thousands of
external research partners. These days, many companies have become fully
integrated pharmaceutical networks (FIPNets) comprised of company scientists
working hand in hand with outside experts.
What are the benefits of this networked research approach? For
one, it makes it easier to access research capabilities and experts on demand,
thereby empowering cancer researchers. Other benefits include dramatically
reduced costs, shortened development times, higher quality and improved
productivity.
External research partnerships
Pharmaceutical companies have established three types of
external research partnerships, each with its own unique benefits:
1. Pharmaceutical companies have long used the published
fruits of academic research to help them in drug research. Today,
pharmaceutical companies are actively partnering with universities. These
companies get access to cutting-edge tools and technologies and an innovation
mindset. The academics benefit from research funding and the ability to
translate their basic research into clinical studies.
2. Pharmaceutical companies are turning to small and mid-sized
biotechnology companies to access new technologies and fill their dwindling
drug pipelines. Smaller companies are often nimble and more efficient than
their larger cousins. These partnerships generate revenue for the small company
and often lead to its outright purchase, such as the acquisition of MedImmune
by AstraZeneca in 2007.
3. Pharmaceutical companies have established partnerships
with tens of thousands of research vendors, including contract research
organizations (CROs), contract manufacturing organizations (CMOs),
non-governmental organizations (NGOs) and patient-advocacy groups. The
relationships can be quite diverse, ranging from one-week, fee-for-service
partnerships to multiyear, billion-dollar deals. As an example of the latter, a
few years ago, Eli Lilly & Co. outsourced its drug safety research, in its
entirety, to a single CRO. Of the three types of partnerships, easy access to CROs is
having the biggest impact on the pharmaceutical research landscape. Having
thousands of external research providers eager to custom create research
services, products or tools is game-changing for the pharmaceutical industry.
This approach has enabled AstraZeneca to keep just 40 of 800 scientists in its
neuroscience division and shut down most internal neuroscience laboratories,
but still run the same number of neuroscience drug research programs.
Pharmaceutical companies fall into two research outsourcing
camps. One camp prefers to outsource services to preferred vendors that are preselected
in each research area, which means they routinely work with hundreds of small
and large vendors at the same time.
The other camp prefers to outsource all or most services to
a single large CRO, a so-called "full-service model." With thousands of new
research tools being created every year at an ever-accelerating pace, however,
it will become increasingly difficult for a single CRO, no matter how big, to
offer every research tool required to run multiple drug research programs. Even
companies that embrace the full-service model today will be forced to access a
range of CROs if they want access to the most innovative and cutting-edge
research technologies.
The almost 4,000 U.S. preclinical CROs are distributed
widely across the country with CRO clusters in the expected pharma/biotech hot
spots. For example, a 2010 study shows almost 150 CROs in the greater San Diego
area alone that are collaborating with local drug research companies.
Research from virtual
laboratories
Since it is no longer necessary to maintain expensive
laboratories to run a drug research program, groundbreaking drug research is no
longer restricted to the few big, wealthy organizations. Any talented
individual with a computer and basic knowledge of spreadsheets, biology and
statistics can run a drug research program or develop clinical diagnostic
tests.
Take the example of Dr. Purvesh Khatri, a computer scientist
working with Dr. Atul Butte at Stanford University. Purvesh accessed public
genetic data on tumor samples from an online repository and used his knowledge
of statistics and free online software to identify genes that were overexpressed
in tumors compared to normal samples (a case/control study). He next used a CRO
to obtain blood samples from 10 cancer patients and 10 healthy individuals, and
then shipped the blood samples to yet another CRO for testing by ELISA. Using
this virtual research approach, Purvesh identified biomarkers for three
different cancer types within one year—without ever setting foot in a
laboratory!
Purvesh's example is an encouraging step forward for
do-it-yourself biologists with limited resources, but an unlimited drive and
ideas waiting to be tested. As Butte says, "we say, 'outsource everything
except the genius.'" Virtual research may represent a paradigm shift enabling
highly efficient use of limited finances and manpower.
Outsourcing makes our
scientific world flat; a citizen scientist with limited resources can now do
projects previously restricted to a large pharmaceutical company with enormous
resources.
Empowering citizen scientists
It's been more than 40 years since Richard Nixon first declared
the "war on cancer." We have made progress, but with more than 7 million people
dying every year from cancer, we still have a long way to go. Although
troubling to some, it may be time for scientists to embrace the idea that we
alone can't solve this problem fast enough. We may need help from our less
well-trained brethren: the citizen scientist.
ClicktoCure is an excellent example of citizen science
attacking the challenge of cancer. Created
by Cancer Research UK, a charity dedicated to the cure of cancer through basic
and translational research, ClicktoCure recruits citizen "soldiers" who examine
colored sections of tumor images and analyze data using prompts provided on the
website. Automated techniques can generate thousands upon thousands of images
of tumor biopsies. The bottleneck is not having sufficient researchers to
examine each and every image. The ClicktoCure program leverages the power of
citizen scientists, asking volunteers to undertake the front line analysis of
thousands of images of biopsy slides. Those that are flagged by volunteers are reviewed
by experts. This crowdsourced project makes excellent use of citizen scientists
eager to participate in meaningful research with tangible results. Cancer
Research UK says it firmly believes it "will change the face of cancer research."
Citizen scientists are also important for the study of rare
and orphan diseases, often neglected by the pharmaceutical industry because of
small market size and low expected financial returns. Now that it is possible
for a single highly talented person to use outsourcing to run an entire drug
research program from a laptop computer, it is likely that there soon will be
numerous examples of personalized drug discoveries carried out by patient
advocates or even by patients themselves. With enough basic knowledge and
resourcefulness, citizen scientists will be able to leverage outsourcing to
develop specific, more effective drugs and diagnostic tests for rare cancers and
other rare diseases.
The way we develop oncology diagnostics and therapeutics is
changing rapidly. Though the shift to an outsourcing research model is being
intensely debated within pharmaceutical and biotechnology companies, it is
revolutionizing how virtual laboratories run by professional or citizen
scientists can function. Empowering all scientists and lowering barriers to
research innovation is the essence of this new research model.
Dr. Kevin Lustig is the
co-founder and CEO of Assay Depot, an online marketplace that gives scientists
the ability to access 8,000 global vendors to any research skill or service
they need for their drug research project. In 2001, Lustig founded Kalypsys, a
drug discovery company that raised more than $170 million in venture capital
and put five drug candidates into human clinical trials. Prior to Kalypsys,
Lustig directed lead discovery at Tularik, a biopharmaceutical company
purchased by Amgen in 2004 for $2.5 billion. Kevin has an M.S. degree in
biochemistry from the University of Missouri-Columbia and an A.B. degree in
molecular and cell biology from Cornell University. He carried out postdoctoral
work in cell biology at Harvard Medical School after receiving a Ph.D. degree
in biochemistry from the University of California, San Francisco (UCSF). His
research discoveries have been published in Science, Nature and other leading
scientific journals, and he has been awarded eight technology patents.
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