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HUMAN TEST SUB
J ECTS
WIrB copernicus, headed by cEO Donald Deieso, third from left,
provides institutional review boards to pharmas planning to test
new drugs on human subjects. Before the drug companies
can try something on you, they have to get past the IrB.
Diccon hyatt reports, page 30.
PHOTO B
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March 25, 2015
What It’s Like to Be on an
Institutional Review Board
W
hen institutional review boards meet to discuss the ethics of human subjects in studies, they
rely on the perspective of non-scientists to make
sure that the test subjects will be able to understand
what they are signing up for. Each IRB has six scientists and three non-scientist members. The main
qualification for being one of the three non-scientists is that you are not a scientist.
Tanna MacReynold frequently serves on IRBs in
addition to her role as senior director of IRB affairs
at WIRB in Washington. “It’s very exciting. The
members are quite the mix. We have physicians, pediatric oncology doctors, photographers, and engineers. I’m a non-scientist,” she says. It’s a paid job,
but no one is an IRB member as a full-time career,
since one person is usually on at most three IRBs a
week.
IRBs meet just once to approve a study or to require modifications. The members have two days to
prepare for each meeting, each of which is about
three hours long.
“The scientists are there to present the scientific
aspects of the study,” she says. “The scientists use
the meeting as an opportunity to educate the nonscientists. We have a discussion about the rights and
welfare of the subjects, and it’s one of the critical
pieces for non-scientists to view it as a layperson,
look at the consent form, make sure that we under-
stand what is going on in the research, and go away
as informed subjects.”
After the discussion, the board holds a vote about
whether to approve the study, and the majority wins.
“I’ve been on a jury, and I would say it’s kind of
similar,” MacReynold says.
A board may approve a study, turn it down, or
request changes or additional information. The researchers have an opportunity to respond, and can
request another meeting for the IRB to reconsider.
Since IRBs are supposed to be impartial, WIRB
has to be careful to avoid conflicts of interest. MacReynold says this is easier at an independent review
company like WIRB than it is at small individual
institutions such as hospitals or universities where
the people who are on IRBs often have direct ties to
the research being conducted.
Nevertheless, the for-profit IRB industry has attracted criticism because of the fear that IRBs will
try to please clients instead of worry about the welfare of human subjects. MacReynold says the business personnel and the staff who run the IRBs are
separate from one another. “Business discussions
don’t ever come up in the boards,” she says. “Even
as a staff person, I’m pretty much as removed from
the business specs as possible. We don’t want to
commingle those two things.”
For-profit IRBs are kept honest by FDA regulations in addition to the company’s scruples. Both of
WCG’s main IRB companies, Copernicus Group
and WIRB, have been awarded ISO9000 certification by an independent auditor, with WIRB earning
the certification on March 16.
— Diccon Hyatt
Forbes magazine recently dividand benefit would have to be established,” Deieso says. “And you ed 100 pharmaceutical companies’
couldn’t trust that decision to those total research budgets by the numthat had the greatest to gain, like ber of drugs approved, and found
drug companies. Third parties were that on average, across all the cominstitutionalized to study those panies, each product brought to
market accounted for $5.8 billion
clinical trials,” he says.
IRBs already existed at some in- in spending. Some companies were
stitutions but weren’t mandated by spending as much as $11 billion on
law until that point. Most organiza- research for every successful drug
tions conducting research used that went out their doors, and even
boards that were part of research the less costly drugs were north of
institutions, or independent non- $100 million. The entire industry
spends an astounding $150 billion
profit IRBs.
Western IRB — the largest com- a year on drug development.
Deieso says he chose Princeton
pany to be taken under the WCG
umbrella — started off as one of the as the headquarters of the company
latter. According to a company his- because it is near so many potential
tory, WIRB was founded in Olym- clients — with Covance, Inventiv,
pia, Washington, by Angela Bowen Bristol-Myers Squibb, Novo-Norin 1968 to oversee her endocrinol- disk and Johnson & Johnson close
ogy research. The board began by, Princeton is a good location for
companies that
overseeing other
want to cater to
scientists’ projThere is an ongoing
life
sciences
ects and incorpodebate among bioeth- companies. (It
rated in 1977.
also helps that
icists about whether
As research
the move for
regulations grew
companies like WcG
Deiso from his
more strict in the
should oversee the
previous comearly
1980s,
pany was a
ethical performance
WIRB became a
for-profit comof companies that are short one — he
was formerly in
pany and greatly
paying them.
the same buildexpanded its oping as his curerations to inrent office at a
clude international clients as well
as many large drug companies. In company called Eduneering, where
1996 the company began offering he was CEO.)
The companies that make up
its services to institutions such as
large universities. WIRB says it is WCG are also located at research
hubs throughout the country. With
the largest company of its kind.
Arsenal bought up WIRB along its broad reach, WCG now overwith North Carolina-based Coper- sees about 11,000 clinical trials a
nicus, the second-largest company year at 1,300 institutions and has
in the field, in 2012, to form WIRB- about 550 employees around the
Copernicus Group. The group soon world. Deieso says WCG compaacquired five other companies, all nies oversee IRBs at every major
of them in the field of pharmaceuti- hospital where clinical research is
done.
cal services.
“We didn’t start this from ground
zero,” Deieso says. “We put togethn December WCG signed a
er the largest and best companies
with the finest reputations.” The deal to provide regulatory and ethother companies in the group are ics reviews to Cancer Treatment
IRBNet, a web-based research Centers of America, a cancer remanagement application; Mid- search organization with hospitals
lands Review Board, a Overland in Atlanta, Chicago, Philadelphia,
Park, Kansas-based IRB company, Phoenix, and Tulsa. WCG has an
Aspire Independent Review Board, oncology division that specializes
a woman-owned IRB based in San in cancer research.
“Cancer trials are becoming
Diego; New England Independent
Review Board, a Boston-based more and more complex,” Deieso
IRB company; and ePharma Solu- says. Cancer treatments increastions, a clinical trial consulting ingly involve not just one drug, but
“cocktails” of different drugs, in
company.
The common purpose behind all addition to new immunotherapy
the WCG companies, Deieso says, treatments that turn the human imis to make drug development safer mune system against cancer cells.
and less costly. And there is no Other research is exploring the gedoubt that such a service is badly netic underpinnings of cancer. All
of this means more regulatory and
needed.
I
ethical complexity when running a
clinical trial.
New areas of ethical complexity
are arising all the time. For example, technology companies have
created new ethics battlegrounds
with their use of consumer data to
run experiments. Facebook drew
the ire of its users when it performed an experiment to see
whether it could manipulate the
emotions of its users by increasing
the proportion of positive or nega-
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Continued from preceding page
tive items in their news feeds. Although the experiment showed only a negligible effect on the 689,000
users chosen to participate, many
ethicists objected to running the
experiment without providing informed consent to the users.
“I think the digital world is
opening up a whole new frontier
that we’re all coming to grips with
and trying to understand,” Deieso
says. “What most people don’t
know is that when you register and
log on to that software, in fine print
it says that you have actually assented to letting them have your
data.” Deieso wonders if the
clicked-through but never-read user agreements truly give companies the right to experiment on users in this way. “It’s not like letting
people with syphilis die, but it is
intrusive,” he says.
Another area of debate in the
world of IRBs is “broad consent.”
Traditionally, test subjects allow
researchers to look at their data for
particular experiments. But increasingly, researchers have been
gathering DNA and other information of the people they study and
building large databases that can be
used for all kinds of research.
A more traditional quandary that
comes up in IRB deliberations is
risk versus benefit. How much risk
is acceptable in medicine? For example, Deieso says, face transplants are new and incredibly risky
procedures, and the gain is only
cosmetic. But various IRBs have
allowed several surgeons to perform face transplants on people
who were disfigured in accidents.
“IRBs have taken a position that
there were ample instances where
the individuals were so disfigured
that they chose to take their lives.
It’s interesting from an ethical
point of view because without the
surgery, there is the risk that the in-
Edited by Diccon hyatt
holding company was named Certara, which is Latin for certitude.
Later, Certara bought Simcyp.
The UK-based company, founded
in 2001, specializes in predicting
how drugs would react not in a generic human body but in specific
populations of patients.
Biosimulation is the intersection
of two disciplines: genetics and
computing. With the knowledge of
the human genome, makers of biosimulation software try to use computers to simulate how chemicals
certara, the owner of
three companies in
the biosimulation
business, is expanding to 100 Overlook
center.
would react with the human body.
“The integration of those two relatively different disciplines harnesses synergistic power of both sciences that together explain how the
human body works and how drugs
work,” Muniz says.
Tripos has been in the biosimulation business since 1979, when
computer-aided drug discovery
was just getting started. Today biosimulation is becoming a major
part of drug development, with analysts predicting the biosimulation
market to reach $1.7 billion by the
end of 2017, compared to the overdividuals would terminate their
lives, and that offsets some of the
risks of the procedure.”
The dilemma goes back to the
roots of scientific medicine. Paracelsus observed in the 1400s that
even medicine can be toxic in large
enough amounts, famously saying
“The dose makes the poison.” Deieso says ever since, pharmacology
has been a balancing act to find the
fine line between the two. “The
The companies that
make up WcG are located at research
hubs throughout the
country. WcG now
oversees about 11,000
clinical trials a year.
whole point of science is to determine that point,” Deieso says.
The idea of a for-profit company
being hired to provide an independent IRB is not without its critics.
There is an ongoing debate among
bioethicists about whether companies like WCG should oversee the
ethical performance of companies
that are paying them. Professors
Trudo Lemmens and Carl Elliot
have argued that commercial IRBs
have “a fundamental conflict of interest” because their clients have a
direct financial interest in obtaining drug approvals.
B
ut Ezekiel J. Emanuel, a
bioethicist and Penn professor (and
an advisor on Obamacare), says
there is no evidence that for-profit
IRBs perform poorly compared to
their nonprofit counterparts. He
notes that WIRB was the first organization to achieve the highest level of accreditation from the Association for the Accreditation of Human Research Protection Programs. He also says for-profit IRBs
are subject to the same regulations
all $68 billion drug research market. Biosimulation is used in addition to real-world clinical trials to
predict the effects of drugs being
researched in an effort to prevent
costly failures of drugs late in the
approval process.
“If you can use the biosimulation to avoid doing a costly study,
of course this work is encouraged
by the regulators as long as science
deems it appropriate,” Muniz says.
“Doing a clinical study could be
harmful to patients.”
Muniz says Certara recently had
a client that had a central nervous
system drug that was in late stage
development and about to be approved by the FDA. But first, the
company had to conduct several
studies of potential drug-drug interactions, each of which would
have cost millions of dollars. Instead of testing the drugs on real
patients, the company received approval to use computer simulations, and then provided the resulting data to the FDA.
Biosimulation also provides a
way around the mathematical reality that there are almost infinite potential drug combinations, and testing each one in a clinical trial would
be impossible, Muniz says. “In a
way, biosimulation is one of the
most cost-effective ways of conducting clinical development, not
only in terms of time, but in cost,
and in terms of harming patients.
When you conduct drug-drug interaction trials, you have to actually expose patients to potentially
and oversight as nonprofit IRBs.
But overall, the strategy of WCG
is to deepen, rather than broaden its
reach. Deieso says he has no plans
to corner the market by buying
more IRBs. “We’re happy with our
growth,” he says. “We are much
more focused now on expanding
our services so our clients can benefit from more of a single solution
that can accomplish more and more
of what they do.”
WCG is now “looking at ways to
help researchers be administratively more efficient,” Deieso says. “In
a drug trial there are hundreds and
thousands of hands involved,” he
says. “They may have hundreds of
trial sites and can be conducted by
100 or more individual physicians
and 100 or more staff, and thousands of subjects. Can you imagine
how much paper is created?”
One of WCG’s emerging services is to replace that massive paper trail with electronic records.
WCG’s recent acquisition, Plymouth, Pennsylvania-based ePharma
Solutions, is in the trial management arena. “We are very interested
in moving clinical trials into the
digital world,” Deieso says.
Another area of expansion is
WCG’s biosafety division. In July
the company bought Alliance Biosciences, a Richmond, Virginiabased company that specializes in
overseeing safety, the handling of
dangerous materials, regulatory
compliance, and lab design.
“Our division has experts who
specialize in the proper care and
management of hazardous organisms — not just smallpox but Anthrax and the H1N1 flu.” While
such samples are dangerous, Deieso says, they are also necessary to
keep around in order to study or
even to “weaponize” against diseases. Deieso says modified viruses could prove to be an extremely
effective drug delivery mechanism. “Viruses are magnificent machines,” Deieso says. “They are
able to mutate quickly. To capture
that capability of a virus and turn it
March 25, 2015
harmful drug-drug interactions.
Obviously, if you had to do it, it
would be for the good of humankind, but you would nevertheless
have to expose patients to risk.”
Doing the whole thing by number crunching would be preferable
— so long as the simulation was accurate. Achieving accuracy requires not only immense computing power, but the expertise of
staff. “One pharmo-kinetic model
may have 10 to 20,000 lines of
code,” Muniz says.
currently Certara has about
10 people working in the recentlycreated Princeton headquarters,
and about 350 worldwide. About
100 of those employees are scientists and medical doctors with advanced degrees. The company has
only had a presence in Princeton
since mid-2014.
“This is a pharmaceutical corridor, and the concentration of pharmaceutical companies and biotech
businesses is significant here,”
Muniz says. “Being close to our
clients would create significant interactions and easy communication.”
Together, the companies that
make up Certara have had a hand in
developing hundreds of drugs over
the years. Muniz says their clients
have had 20 drugs approved in the
last 18 months.
Design with the aid of massive
computing power has already revolutionized the aerospace industry,
defense, and weather prediction.
into good is a goal of clinical research.”
Genetic research also poses lab
safety challenges, Deieso says. Researchers must be careful not to release modified DNA into the environment. “This segment of the
market is growing in a quite dramatic way,” Deieso says.
Deieso’s background didn’t
seem likely to point him for a career in biotech. He grew up in Elizabeth, and studied engineering at
Manhattan College (and later environmental engineering for a doctorate at Rutgers) and music at Juilliard. He had always had an interest
in engineering, going back to his
father, who was an engineer. But he
describes music as the true love of
his life. He was an avid trumpet
player in college and later served
on the board of the New Jersey
Symphony. “One of my greatest
joys is just playing for myself and
perfecting my skill,” he says.
Deieso is married and lives in
Princeton. His daughter Cara
works at WCG as a senior vice
president of marketing.
Although he is still a lover of
classical music, Deieso says he has
discovered a passion for his work
in drug research. “One thing that’s
a shared trait at this company is the
desire to make a contribution,” he
says. “Everyone here, if you ask
them what they do and why they
are here, will say they want to
transform healthcare. Most people
here have stories about family
members who have had healthcare
adversity, or diseases they have
succumbed to. This is one of those
unique opportunities where you
can use your energy to make a difference. That’s what drove me.
I’ve become devoted to public
health.”
WIrB copernicus Group, 202
Carnegie Center, Suite 107,
Princeton 08540; 609-9450101. Fax, 609-799-2216.
Donald A. Deieso, CEO.
www.wcgclinical.com.
Simulation Game:
Edmundo Muniz’s
company integrates
genetics and computing to assess how
drugs could interact
with the human body.
Muniz hopes to bring healthcare, a
relative latecomer to the game, into
the same realm.
Muniz grew up in the Dominican Republic. “That means I have
to know how to dance, salsa and
merengue very well, and I should
know how to play baseball very
well,” Muniz says. He is the son of
an Exxon executive and a homemaker. Muniz recalls that by age 7,
he knew he wanted to be in medicine.
“I dissected all kinds of animals
everywhere, which my mother
would find under the bed and in the
bathroom. It was a fantastic time. I
fell in love with biology, which led
me to choose medicine as a career.
He earned a medical degree
from the Autonomous University
of Santo Domingo, and a Ph.D. in
population planning and international health and a master’s in population planning from the University of Michigan’s school of public
U.S. 1
33
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13 Roszel Road, Princeton, NJ
health. After that, he completed a
residency in epidemic intelligence
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Muniz then joined Eli Lilly,
where he worked for 11 years
working in various senior executive roles including head of worldwide pharmacovigilance and epidemiology, the cardiovascular
business unit leader, and vice president of oncology and clinical development.
He later became president of Kirax Corporation and served there
until 2014, when he became CEO
of Certara and began to oversee its
expansion.
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