Corrections or additions?
This article by Barbara Figge Fox was prepared for the May 25, 2005
issue of U.S. 1 Newspaper. All rights reserved.
Route 1 Hosts Another CRO
Because of its critical mass of pharmaceutical firms, New Jersey might
be called the pill bottle for the world, and in addition to the big
pharmas it hosts a bevy of smaller companies that dance to the
pharmas’ tune. Many of them are clinical research organizations, known
as CROs. They help get the finished drug through the Food and Drug
Administration’s approval process. No fewer than 24 CROs make their
home in central New Jersey, ranging from the very big, such as
Covance, to the very small and those in between.
Advanced Biomedical Research has grown from very small to medium-sized
in the past 12 years, and earlier this spring CEO Michael Willett
expanded the firm, moving from Hopewell to 15,000 square feet of Class
A space on Alexander Road, opposite the Hyatt.
ABR does clinical study management, monitoring, biostatistics, data
management, medical writing, regulatory affairs, and submissions. It
focuses on cardiovascular, central nervous system, and urology
therapies. With 24 people in this office, it also has a clinic in
Hackensack that hosts patients who are taking drugs for clinical
trials.
“When we moved to Princeton in 1999, there wasn’t as much real estate
available, and we kept getting muscled out of small space,” says
Willett. “We took some small space at 600 Alexander and then bought a
property in Pennington. Now we think the timing was good to come back
into Princeton.” Campus Drive at University Square, he says, was more
responsive than the other Class A parks he was considering. Bill
Barish of Commercial Property Network located the upgraded space that
was formerly occupied by Deloitte.
Running clinical trials is a long process regulated by the Food and
Drug Administration, which must balance the public’s need for a drug
with its need for safe drugs. Before the drug is given to humans, it
goes through preclinical testing to determine if it works for animals.
A Phase I clinical trial is a “do no harm” operation in which
pharmaceutical companies give the new drug to healthy human volunteers
and then monitor them, sometimes overnight, to assess the effects.
Most of the pharmaceutical companies don’t have their own beds, and a
minority of CROs have their own beds, says Willett. The big ones, such
as Covance, tend to locate their clinics in the midwest.
Succeeding tests are conducted at hospital sites around the country.
Phase II testing is done on “early patient populations” to prove
efficacy and dosage, and Phase III testing, sometimes called pivotal,
is intended to reveal efficacy, safety, and dosage. Sometimes Phase IV
trials are conducted to calibrate childrens’ dosages.
ABR’s clinic in Hackensack might process as many as 1,500 test
volunteers a year. “We’ve bucked conventional wisdom in having our own
beds here, right in pharma’s back yard.” says Willett. Centers with
120 to 150 beds are not uncommon and big CROs have centers with 800 to
1,200 beds. “We haven’t tried to build a hospital palace, but 72 beds
is a pretty respectable size.”
One reason to have the clinic in Hackensack is to tap that area’s
ethnic mix. “I think we supplement a lot of people’s incomes in that
area,” says Willett.
Of all the ABR employees, one third (24) of the workers work at the
Princeton headquarters, one-third in Hackensack, and the rest monitor
Phase II to IV tests at regional sites around the country.
Willett, the son of a Bell Labs electrical engineer, grew up in the
Chicago area and was an early user of computers. He graduated in 1984
from a five-year program at the University of Illinois and has his
doctor of pharmacy degree from there as well.
Training to be a clinical pharmacist in the hospital environment, he
did a residency in adult internal medicine at the Truman Medical
Center of the University of Missouri in Kansas City. “In the more
progressive hospitals, pharmacists do a lot of consulting with
physicians to help them rationally prescribe the best drug,” says
Willett. “I was involved in a few cases where we discovered
drug-induced arrhythmias and helped the patient to be managed without
toxicity.”
Then he took a position as a monitor at Merion Laboratories, working
with investigators to help get several drugs on the market. When that
company merged, he came to Bristol-Myers Squibb to work post-approval
projects – working with opinion leaders and experts.
In 1992 he worked for a small CRO that was acquired by a Boston firm.
“I was able to negotiate with them to spin off the Hackensack research
site into ABR,” says Willett, “and with my good relationships, I built
up the CRO business on my own.”
“The site keeps us in touch with the cutting edge, and with the
compounds that come along. It is also a good training ground for the
monitors,” he says.
His father-in-law, a former salesperson for a company that sold Topps
bubblegum, helped provide seed capital for the new firm. Willett met
his wife, Judy, in high school in Chicago, and, with her background in
finance, she is the corporate secretary. They have three school-aged
children, the oldest a college freshman.
Willett’s father, now retired from his Bell Labs career, works with
ABR’s data management system, Oracle Clinical, “which is pretty
sophisticated for a company our size,” says Willett.
Willett says his father taught him that personal and business ethics
should be the same, and that “things are neither as bad or as good as
you think. Not to rest on your laurels, but if you are having a bad
day, tomorrow would be better.”
The low point in the CRO world came the year after 9/11 when projects
were being canceled, trips were being postponed, and even the mail
(because of the anthrax scare) wasn’t getting through. “We diversified
our basic clients, and things perked up,” he says.
Willett must contend with the perception that his company is too
small. “It’s more that we are quite nimble and give personalized
attention,” he says. “The smaller to medium-size pharmaceutical
companies think of us as full service. And we have managed some
pivotal phase III studies to get important CNS drugs approved.”
Pivotal is industry jargon for a phase III studies with as many as
1,000 subjects, followed for multiple years.
Says Willett: “We are also customizing software for submissions to the
FDA and other regulatory authorities. And we are putting effort into
pharmaco-vigilance, reporting serious events, to let the regulatory
authorities know early.”
Advanced Biomedical Research Inc., 117 Campus Drive, University
Square, Princeton 08540. Michael Willett Pharm.D, president and CEO.
609-818-1800; fax, 609-818-0026. Home page: www.abr-pharma.com
Top Of PageMore Princeton CROs
Bradstreet Clinical Research Associates, 1588 Route 130 North, New
Brunswick 08902. Patricia W. Bradstreet, CEO. 732-821-0800; fax,
732-422-9044. Www.bradstreetcra.com Clinical development services and
regulatory affairs. Staff size at this location: 20.
Covance Inc. (CVD), 206 Carnegie Center, Princeton 08540-6681. Joe
Herring, COO. 609-452-8550; fax, 609-452-9375. Home page:
Corporate headquarters for comprehensive drug development service
company, including clinical trials management, with operations in 18
countries, 6,900 employees worldwide, also at 210 Carnegie. Staff size
at this location: 691.
Covance is currently dealing with a 253-page complaint issued by an
activist group, the People for the Ethical Treatment of Animals,
regarding a preclinical trial lab it owns in Virginia. A PETA member
worked under cover there and filmed a video of primates undergoing
tests.
In a statement, Covance said PETA’s covert action was illegal and
urged media “not to leap to conclusions about the truthfulness of
these allegations, or the authenticity of any videotape and what PETA
alleges that it depicts.”
Esoterix Inc., 20 Lake Drive, East Windsor 08520. Anthony G. Busa,
president of clinical trials services. 609-443-2600; fax,
512-225-1273. Home page: www.esoterix.com Clinical trial center for
new drug testing, based in Austin, Texas. Staff size at this location:
50.
Odyssey International, 300 Alexander Park, Suite 206, Princeton 08540.
Zehra Ahson MD, office supervisor. 609-452-7666; fax, 609-452-9799.
Home page: www.odysseyresearch.org Management of clinical trials, with
offices in North Dakota. Staff size at this location: 5.
Orion Clinical Services, 600 Alexander Road, Third Floor, Princeton
08540. Chris Ellis, national director. 609-452-7887; fax,
609-452-7888. Home page: www.orioncro.com Contract research
organization with offices in London, Paris, Montreal, and Melbourne.
Staff size at this location: 35.
Pharmaceutical Profiles, 116 Village Boulevard, Suite 200, Princeton
08540. Steve Matheson. 609-951-2205; fax, 609-520-1702.
Www.pharmprofiles.com Contract research organization doing Phase I
clinical studies with gamma scintigraphy, particularly in the areas of
cardiovascular and pulmonary diseases and cystic fibrosis. It also has
site specific drug delivery tools to study regional drug absorption.
PharmaNet, 504 Carnegie Center, Princeton 08540-6242. Jeffrey
McMullen, president and CEO. 609-951-6800; fax, 609-514-0390. Home
page: www.pharmanet.net Consulting and contract clinical research,
with 900 people worldwide. Staff size at this location: 300.
Princeton Medical Institute, 256 Bunn Drive, Suite 6, Princeton 08540.
Jeffrey T. Apter MD, president. 609-921-3555; fax, 609-921-3620.
Clinical investigative research company that is hired by the CROs or
drug companies to manage clinical trials, particularly in the field of
the central nervous system. Also in Toms River, Philadelphia, New
Orleans, and Brooklyn. Staff size: 10 employees.
Radpharm, 103 Carnegie Center, Suite 300 A, Princeton 08540.
609-936-2600; fax, 609-936-2602. Home page: www.radpharm.com
Clinical trial services for medical imaging.
Russian Clinical Trials (RCT Global LLC), 256 Bunn Drive, Woodlands
Professional Building, Suite 6, Princeton 08540. Richard Leach, head
of business development. 609-731-2225; fax, 609-921-3620. Promotion of
clinical trials in St. Petersburg, Russia, sharing
offices with Princeton Medical Institute. Staff size at this location:
2.
Theradex Systems Inc., 14 Washington Road, CN 5257, Princeton
08543-5257. M. Valnoski, president. 609-799-7580; fax, 609-799-4148.
Www.theradex.com Monitoring of pharmaceutical clinical research trials
in oncology, pharmaceutical, and device development. It has offices in
Chicago, Dallas, Salt Lake City, London, Paris, Tokyo, and Sidney.
Staff size at this location: 100.
XenoBiotic Laboratories Inc., 107 Morgan Lane, Plainsboro 08536. Jinn
Wu PHD, president. 609-799-2295; fax, 609-799-7497. Home page:
www.XBL.com Pharmaceutical, biotech, and agrichemical contract
research and regulatory consultation. Staff size at this location: 45.
If you suffer from depression or some other central nervous system
disorder, it may be hard to tell your symptoms to a therapist who
lives in your own small town. You may feel more comfortable talking,
via videoconference, to a therapist who is far away. And that remote
therapist — who reviews hundreds of cases like yours — is more
likely to come up with an accurate assessment than a therapist who
reviews only a few.
At least that’s the thinking at MedAvante, which plans to cut costs
and increase accuracy by using videoconferencing for clinical trials
for central nervous system (CNS) drugs. MedAvante, which has a
3,500-foot office in Research Park, expanded by adding a 2,500
square-foot space on Bear Tavern Road.
CNS clinical trials are notoriously time intensive; it takes an
estimated $800 million to bring a CNS drug to market. Sometimes a
clinical trial fails even though everyone involved believes the drug
will work, says Paul Gilbert, executive vice president of marketing
and strategy. An economics major at Bowdoin, Class of ’86, he has an
MBA from Harvard, and he has worked at Booz Allen, Johnson & Johnson,
Church & Dwight, and Princeton E-com.
By centralizing the diagnostic operation, Gilbert believes MedAvante
can eliminate bias and save money. “We are taking one small element of
the clinical trial, asking whether a patient belongs in the study and
evaluating her progress as she goes through the study,” he says. “We
take that one element, and centralize that assessment to drive
smaller, faster, clinical trials.”
Where traditional methods might use 100 research sites and 200 raters,
MedAvante would run the same study with one seventh the number of
raters. “We enable pharmas to run smaller, faster, more successful
clinical health trials,” says Gilbert. “We take the assessments of the
patients out of the hands of overly subjective coordinators at the
traditional research sites. We centralize those assessments by using
state of the art videoconferencing in the hands of our own expert
centralized clinician.”
MedAvante is not, in itself, a CRO like Covance. “We don’t do the
monitoring, enrolling, or clinical practice,” says Gilbert. “All we do
is deliver expert high quality mental health assessments, wherever,
whenever.” He cites early funding support from Pfizer, Bristol-Myers
Squibb, Eli Lilly, Astra Zeneca, and Organon, “and we are working
closely with GlaxoSmithKline.”
At this young company, founded in 2002, the CEO’s duties are now being
shared by Amy Ellis (executive vice president of operations),
Livingston Johnson (CIO), and Gilbert, who emphasizes that 17 of the
20 employees have graduate degrees, and that the firm is backed by
“world class scientific and business advisory boards” plus strategic
investors. “We are saving the CEO slot for a world class candidate
once we get to the next stage of our development.”
MedAvante, 850 Bear Tavern Road, Ewing 08628,
609-883-1260 also 139 Wall Street, Research Park, Princeton 08540.
Paul Gilbert, EVP. Home page: www.medavante.net
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