More Princeton CROs

MedAvante Expands

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 Page
More 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:

www.covance.com

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.

Top Of Page
MedAvante Expands

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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