Corrections or additions?
These articles by Barbara Fox were published in U.S. 1 Newspaper on August 18, 1999. All rights reserved.
CROs: Hatching New Drugs
by Barbara Fox
Depending on your business, the Princeton corridor
goes by different names. Engineers call it "Video Valley,"
referring to RCA and the Sarnoff Corporation spinoffs. On the pharmaceutical
side, the corridor has been called Pharm Country, and some researchers
dub it "Carbonyl Valley," after the organic compound often
used in making drugs.
Here’s another potential moniker: "CRO Row," after the contract
research organizations that are nesting near the big pharmas. The
mission of a CRO is to help hatch the new drugs, to get them through
clinical trials. The Princeton area has at least 17 of these CROs,
and they employ more than 1,500 people. They range from the one-person
firm, PharmHealth Technologies on Carter Road, to Covance, which is
950 strong at the Carnegie Center. A newly expanded CRO is PharmaNet,
also at the Carnegie Center (see article below).
Other kinds of support companies are thriving here too — those
dedicated to providing all kinds of consulting services to the CROs
and the pharmaceuticals. Not counting the companies with a variety
of clients, 30 Princeton area companies on U.S. 1’s roster devote
themselves solely to the pharmas, and they represent about 700 jobs.
A start-up, PharmaPros, has just moved to Main Street in Lawrenceville,
two prominent consulting firms, Princeton Brand Econometrics and RWD
Technologies, have expanded at the Carnegie Center, and another is
expanding at Palmer Square (see stories below).
They share a rosy outlook. The pharmaceutical and healthcare industries
are growing at a rate of 15 percent in the United States, and with
the aging of the baby boomer generation and the frantic rate of new
product launches, this rate is expected to increase. The pharmaceutical
industry is worth more than $8 billion in New Jersey, and it has more
than 53,000 employees who make an average of just under $60,000. Says
William Healey, a representative of the big pharmas trade group, New
Brunswick-based Healthcare Institute of New Jersey, "High quality
jobs follow us."
Still, most of the really big companies do not have their headquarters
here, but are located in North Jersey. For the service companies,
nevertheless, Central Jersey has two big advantages: lower rents and
good proximity to that other hotbed of new drugs, Philadelphia. Read
between the lines of these company stories and you will find that
these firms have positioned themselves squarely on the crossroads
between the two centers.
PharmaPros is the newest "pharma helper" on
the block, and it occupies center stage in a new block. Peg Regan
— a pharmaceutical veteran and also the wife of the current director
of regulatory affairs at Bristol-Myers Squibb — established a
consulting business in 1997 and has grown it into the big time at
the "new" Main Street in the village of Lawrenceville. Her
firm helps bring drugs to market by smoothing the path for clinical
trials, doing information technology, data management, and training.
PharmaPros is not a CRO firm, but it works with CROs. Though small,
it is effective, says Regan: "Whereas large consulting companies
supplement a client’s staff, we bring in an entire team of people
to support the process, from the last phases of developing the clinical
protocol, to getting the study running, to doing technical support,
re-engineering, and reporting." She points to more than 75 years
of combined experience in the healthcare industry, direct experience
ranging from worldwide pharmaceutical companies to medical device,
biotechnology, and contract research organizations.
Regan has moved her company into the second floor of the new building
that is so central to the development of Lawrenceville’s Main Street.
This building is the home of Fedora Cafe, and is right next to Acadia
Restaurant. At 2633 Main Street, the firm has the whole floor, 3,150
feet, but hopes to sublet 850 feet.
An eight to ten-station training room is central to Regan’s business
plan. "Many companies don’t really want to do training at their
own site, because people in training are constantly being called out
— or they don’t have training facilities. Our facility is centrally
located and within driving distance, so our companies could run their
training at our facility or have us perform it," says Regan.
While looking for space Regan met a tenant of this building who confided
that the second floor tenant had pulled out. So she took the whole
second floor and now has permanent offices for six people plus "hotel"
space for two visitors, a conference room, and the training room.
Charitable "work-training" groups may also be able to use
the training facility.
Schroeder/Perez Architects PC designed the space in a utilitarian
but ultra modern manner, with an open floor plan (to fit the ethos
of her firm, says Regan). The steel beams remain exposed, as is the
galvanized steel ceiling with drop lights and painted girders. V.J.
Scozzari & Sons, which owns the building, did the fitout. Her accountants
are D’Angelis & Higgins on Cranbury’s Main Street, and her law firm
is Miller & Mitchell on Route 206.
Regan started out working with PharmaNet, the firm that has grown
to 210 employees at the Carnegie Center. "When they had just 10
people, they were our first client, and we continue to help them build
their ClinTrial system into a PharmaNet-specific system," she
says. Other clients are SmithKline Beecham in the United Kingdom and
the United States, Schering Plough, Berlex Laboratories in California
and New Jersey, Ethicon Endo-Surgery in Cincinnati, and Ethicon Inc.
in New Jersey.
Margaret "Peg" Boyce Regan grew up in Edison;
her mother worked for Baxter Health Care Products and her father was
an electronics technician for an instrument company. One of her sisters
is an accountant for the Harbor Branch Foundation, and her brother-in-law
the controller. Her other sister is a nurse. Regan had an associate’s
degree in chemistry and worked for Bristol-Myers Squibb for 15 years,
meanwhile going to Rutgers University College for her B.S. in computer
science. Working in information systems development, she supported
clinical research and regulatory affairs. Her husband, William Regan,
has spent his 30-year career at Bristol-Myers Squibb. He is director
of regulatory affairs at the Hopewell site, and is on the board of
his wife’s company. They live in Princeton Junction and have two sons,
one an artist and the other a musician.
Before starting PharmaPros, Regan left Bristol-Myers Squibb to work
remotely for Boston-based DomainPharma Corporation, formerly known
as BBN Software Products. She has not pursued any contracts with Bristol-Myers
Squibb. "Business has been very very successful — we’re growing
rapidly," says Regan. "We have been in business for 2 1/2
years, and we are completely funded by our own revenue." In March,
1998, she hired her first two employees and now has 10. "Because
we work with so many different companies, we have two people in Maryland,
one in Massachusetts, one in Denver, and one in Pennsylvania,"
Though she considers Integrated Systems Consulting Group, based in
Somerset, to be a competitor, she prefers to partner with companies
rather than compete with them.
"We all came from the pharmaceutical or health care industries,
either in information technology or in clinical research positions,
so we provide a sweep of services, from showing how to start the first
trial, to showing how to clean up data," says Regan. "But
we are in a support position rather than doing it ourselves. Our approach
to professional services is unique to the consulting industry today.
Unlike offering individuals to supplement your staff, we offer our
entire team of professionals to provide all the required elements
to make your team a success."
The firm also does training and consulting on safety, FDA reporting,
and medical coding — anything to do with regulatory affairs —
and helps companies select a clinical system. "We understand the
third party clinical systems out there, so we study how can they improve
the business process to make the system work," says Regan. PharmaPros
has particular expertise with Domain Pharma’s Clintrial product and
also with a web-based clinical trial system put forth by Versal Technologies
Inc. "We help them understand the technology in their hands."
08648. Peg Regan, owner. 609-912-1100; fax, 609-912-1120. Home
Managers of nuclear power plants want to train their
technicians well — very well. After all, in an emergency, you
want them to act swiftly and correctly. Drug firms, though they operate
under less time pressure, also rely heavily on technicians’ accuracy.
So it would make sense that nuclear engineers would work well with
the pharmaceutical firms. They know how to focus on the end user,
the technician. Harry L. Graham, manager of the Princeton branch of
RWD Technologies, did have six years in the U.S. Navy’s nuclear program.
In fact, of nine people in top management at RWD Technologies, six
have worked in nuclear engineering or are graduates of the U.S. Naval
Graham opened his outpost at Carnegie Center 105 in 1997 with 25 people
and has expanded it to 40 employees and 15,000 square feet at 214
Carnegie. Founded by Robert W. Deutsch in Columbia, Maryland, RWD
Technologies went public two years ago and now has 15 offices in the
United States, two in England, and one in Germany. It offers software
support for manufacturing and industrial applications, client/server
applications on major platforms and desktop applications, and performance
improvement in complex technical environments.
The pharmaceutical group recently partnered with DLB Systems, a Bridgewater-based
vendor of clinical trials software marketed to mid-tier pharmaceutical,
biotechnology, medical device, and diagnostic systems companies. It
just bought Merrimac, Florida, which works with E-commerce and Internet-based
training, and has offices in Maple Shade and Cocoa, Florida.
The son of AT&T’s vice president of global real estate, Graham went
to the University of Pennsylvania, Class of 1988, and was an officer
in the U.S. Navy’s nuclear program in Long Beach and in upstate New
York. He and his wife Mary, who works at Janssen Pharmaceutica, have
"I run the pharmaceutical group but have responsibility for some
of the other divisions in the company, including the group that works
with ERP software, PeopleSoft and SAP," says Graham. He has helped
11 of the big pharmaceutical companies to better use their technology
in the areas of staffing, project management, mentoring, and business
For any project, some managers start working on the solution without
a good understanding of how the project should be planned, says Graham.
"We make sure they are well grounded and have a precise and well
thought out plan to get things done."
"From my father I learned that execution is more dependent on
the preparation than most people think. Cramming the night before
is easily detected," says Graham. "If you had done good planning
up front on the Y2K, to analyze the risks and dependencies, you wouldn’t
be surprised about how long things are taking and how much things
are costing. That is something you could have foreseen."
101, Princeton 08540. Harry L. Graham, director, pharmaceutical center
of excellence. 609-734-0600; fax, 609-419-3780. Home page: http://www.rwd.com.
Jeffrey McMullen, senior vice president marketing. 609-514-9400;
fax, 609-951-6825. Home page: http://www.pharmanet-cro.com.
This CRO has expanded, adding 20,000 square feet in the adjoining
building at Carnegie 506. Robin Sheldrick, director of organizational
development, says PharmaNet has been hiring at the rate of 20 people
per month in Princeton and now has 210 employees at the Carnegie Center,
about 70 of them in the new space.
"We are expanding both in Princeton and in other parts of the
country and exceeded our expectations in growth and success of our
business," she says. PharmaNet is hiring biostatisticians, SAS
programmers, clinical research professionals, clinical research monitors,
data managers, and medical writers.
Hein Besselaar, who started what is now Covance more than 25 years
ago, organized PharmaNet with some of his former colleagues (U.S.
1, July 3, 1996). The principals include Jeffrey P. McMullen, senior
vice president of business development; James P. Burns PhD, vice president
of regulatory affairs; Jack W. Green PhD and Mary Johnson PhD, vice
presidents of biostatistics and data management; and John R. Fassnacht
CPA, vice president of finance and administration. The firm has an
global presence is in the United Kingdom, Belgium, Switzerland, and
the Netherlands. It does such typical CRO services as strategic planning,
protocol design, study monitoring, data management, report writing,
regulatory documentation and submissions, and management consulting.
"In three years we have successfully completed more than 25 projects
for a host of clients and have `major preferred provider’ agreements
with four of the clients," says Andy Malavsky, a 1985 alumnus
of Rider who is the new director of marketing. Earlier this summer
it successfully introduced an oncology division. "The need for
clinical trials is exploding."
Corrections or additions?
This page is published by PrincetonInfo.com
— the web site for U.S. 1 Newspaper in Princeton, New Jersey.