PharmaPros

Peg Regan

RWD Technologies

Expansion: PharmaNet

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.

Top Of Page
PharmaPros

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.

Top Of Page
Peg Regan

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,"

says Regan.

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."

PharmaPros, 2633 Main Street, Suite 201, Lawrenceville

08648. Peg Regan, owner. 609-912-1100; fax, 609-912-1120. Home

page: http://www.pharmapros.com.

Top Of Page
RWD Technologies

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

Academy.

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

two children.

"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

development.

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."

RWD Technologies (RWDT), 214 Carnegie Center, Suite

101, Princeton 08540. Harry L. Graham, director, pharmaceutical center

of excellence. 609-734-0600; fax, 609-419-3780. Home page: http://www.rwd.com.

Top Of Page
Expansion: PharmaNet

PharmaNet, 504 Carnegie Center, Princeton 08543.

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."


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