Corrections or additions?
These articles were prepared for the March 22, 2006 issue of U.S. 1
Newspaper. All rights reserved.
The creative agencies that produce marketing materials for
pharmaceutical companies must stick to the truth, the whole truth, and
nothing but the truth. "We can never say things like `it’s the best’ –
things you see all the time in consumer advertising," says Gregory
Gross, copy supervisor at DDB Rx, a New York advertising firm that
serves the healthcare industry. "Our claims must be supported by hard
To ensure that everything said is a "defensible true claim," the
marketing process for the pharmaceutical industry is elongated,
requiring that materials jump through several hoops before entering
the marketplace. This means precision during the creative process,
with artists and writers sticking to the facts, as well as submitting
to multiple reviews – informal and formal.
Gross speaks on "Pharm Fresh: Producing Great Creative in a Regulated
Industry" at the third annual Thinking Creatively conference, a
two-day event beginning on Friday, March 24, at 9:30 a.m. at the
University Center of Kean University. The conference is co-sponsored
by Kean University’s Office of University Relations and Design Center
and by the Art Directors’ Club of New Jersey. Cost: $150. For full
details visit www.adcnj.org.
The tight control of pharmaceutical marketing materials is part of the
general regulation of the pharmaceutical industry. Although regulation
contributes to the cost of medications and lengthens the time to
market, most consumers wouldn’t have it any other way. Yet for most of
modern history, the public did not have an agency and laws to protect
it from tainted food, destructive drugs, and poorly designed medical
devices. Regulation of drugs and drug marketing came only in the wake
of three medical catastrophes.
First, in the 19th century, companies were marketing morphine as a
"soothing syrup" for teething babies and for people with persistent
coughs and other ailments. The result was widespread addiction to
cocaine and morphine. Not until the beginning of the 20th century was
there a wave of reform efforts to control these "secret-recipe" patent
medicines – medicines that could be extraordinarily dangerous. The
American Medical Association led the forces of reform, pressuring drug
makers to abide by the AMA’s "rules for ethical medicines" in drug
marketing. Eventually the Pure Food and Drug Act of 1906 codified some
of these regulations.
A second disaster occurred in 1937 when sulfanilamide, a drug whose
powder and tablet formulations had been successfully used to treat
streptococcal infections, came out in elixir form. An untested
ingredient in the solution was diethylene glycol, a chemical normally
used as antifreeze. This deadly poison killed over 100 people in 15
states, most of whom were children, and the chemist who formulated it
committed suicide. The consequence of this second tragedy was the
passage of the 1938 Food, Drug, and Cosmetic Act, which gave the Food
and Drug Administration authority over product safety.
The most recent tragedy, at its worst in the late 1950s and early
1960s, struck children whose mothers had taken thalidomide during
pregnancy to relieve morning sickness and to induce sleep. A number of
these women gave birth to children with birth defects, including
malformed or missing limbs as well as internal deformities that led to
early deaths. Gross says that the crisis was worst in Germany, where
the drug was invented, and where there were about 10,000 victims, only
half of whom survived.
At about the same time, says Gross, growing public concern with drug
companies as "profiteers" had led to an effort to tighten
restrictions. But as Senator Estes Kefauver of Tennessee pressed for
reform in the late 1950s, his efforts were considered "antibusiness,"
and he got little support. "But as soon as thalidomide hit, the
opposition evaporated," says Gross, and the Kefauver-Harrison
amendment of 1964 was supported by President Kennedy and passed
unanimously by both houses of Congress. This established FDA control
over pharmaceutical advertising and gave the FDA the responsibility to
judge the truthfulness and scientific accuracy of all promotional drug
Gross, previously an English professor at Roosevelt University in
Chicago, had started to think about changing careers because of the
improbability of finding a tenure-track position in a city where he
might want to live.
He managed to parlay a summer job experience in advertising and his
expertise in writing and language – he knows Latin, French, and German
– into an entry-level job with an advertising agency in Chicago, where
he grew up. He worked there on employee recruitment campaigns for
corporations. "It was a remarkably good fit," he says. "A lot of the
skills I developed in academia transferred nicely into my work in
Finding himself unemployed after massive layoffs in Chicago’s
advertising sector during the 2001 recession, he spent the summer
looking for work. Then came 9/11 and things got worse. "I was on the
cusp of getting hired," he says. "Then there was a new hiring freeze
because of the uncertainty, and it seemed that pharmaceuticals was the
one area in advertising still growing and unaffected by the
Following a lead in New York, he got a job with Cline, Davis, and Mann
in November, 2001. Just a year ago DDB Rx was spun off from Cline "to
better serve the needs of a growing client." Both companies are held
At Cline and DDB Rx Gross has done pharmaceutical marketing and
advertising, which is similar to standard product marketing, but which
differs in the review process. "What you learn when you join this
industry is that you have to have a long development timeline, with a
round of internal and external reviews," he says.
Gross describes the extended process that his materials – including
direct-to-professional materials, ads in journals, and a battery of
sales materials – undergo from creation through review:
Concepting the campaign. "The creative side is not much different from
the rest of the advertising world," says Gross. They look at product
features and benefits, consider the audience, and do the same kind of
conceptual brainstorming, "but with the caveat that it has to be a
defendable true claim." For Femara, a breast cancer drug, his team
developed a campaign that "married" hope from the patient’s
perspective and good science from the doctor’s perspective.
One central image is a woman wearing a "ribbon" – with the shape of
the familiar pink ribbon for breast cancer, but with writing on it
from a landmark cancer study in a prestigious medical journal. "For
doctors, what’s motivating is the data," he says. "What we think of in
our neck of the woods as a sexy message includes a percentage and a
study end point."
Creating the ad. The ad is the centerpiece from which all of the
marketing pieces are derived. These materials must legally have what
is termed "fair balance." Gross explains: "Whenever you make a claim
about what the drug does, you have to balance it with statements about
what it doesn’t do, so well or any adverse side effects. The materials
must include all pertinent safety information."’
Creating corollary materials. Concurrently with the ad, the creative
team must develop the primary sales tool that sales reps will take
into a doctor’s office – an 8-to-10-page booklet that tells the
complete story of the drug, including the clinical trial design and
all the data about efficacy, safety, and tolerability. "These are all
designed to work as a set," says Gross. "We want them all to be
consistent for maximum recognition."
Testing the materials with doctors. During market testing of the
materials, the creative teams goes through several iterations of
graphics and copy until they develop the most compelling message
possible. A key test is how doctors react.
Running it by the client. Pharmaceutical companies have their own
review committees, consisting of a lawyer, a medical expert, and a
regulatory expert. Each must review and revise every piece of
marketing for legality, medical accuracy, and regulatory adherence.
Submitting ads to the FDA. During this last step, the FDA "goes
through the materials with a fine-tooth comb," says Gross, and sends
out a formal letter with mandates for revision if necessary.
Despite Gross’s long detour into academe, he suggests that
pharmaceutical marketing may have always been his destiny.
"For a while I thought I wanted to go to art school," he says, "then I
decided I wanted a classic liberal arts education." He says he didn’t
have sufficient confidence in his artistic talents, even though he
"loved doing art." He ended up studying English, "because it was less
intimidating." He earned a bachelor’s degree in English from Tulane
University in 1986 and a Ph.D. in English from Brown University, with
a dissertation on 14th-century literature.
But when he was a kid and people asked him what he wanted to be, Gross
says his answer was "either a poet or an artist or a chemist."
Perhaps, then, being a copywriter in healthcare marketing combines
these two aspects of his childhood aspirations. As Gross concludes,
"So maybe it does make sense that I am doing pharmaceutical
– Michele Alperin
There is a reason why many nonprofit organizations hire grant writers
and that is because grant writing – like tax preparation or auto
repair – can be tough, nerve-racking work. But according to Joan
Hollendonner, vice president of programs at Princeton Area Community
Foundation (PACF), organizations can successfully untangle the sticky
web of grant applications by taking a do-it-yourself, step-by-step
approach into the process.
"We value the nonprofit organizations in the area and we know that the
resources they need to operate with are scarce," says Hollendonner.
"That’s why we do our best to help people along with the application
process." She heads a free 90-minute grant information session on
Tuesday, March 28, at 9 a.m. at Princeton Area Community Foundation at
15 Princess Road. Call 609-219-1800 for more information, or visit
Created in 1991, PACF is a public nonprofit community foundation that
seeks to raise the level of giving in the central New Jersey area by
connecting individuals, corporations, and nonprofits to each other and
to common causes and issues. This is accomplished by managing
charitable funds, providing discretionary grants, creating
partnerships, and serving as a catalyst to help solve community
problems. "We offer grants twice a year, in the spring and fall," says
Hollendonner. The next grant application deadline is Tuesday, April
11, with awards being made in July.
Prior to coming to PACF in 2004, Hollendonner worked as a
communications and management consultant providing services to
foundation, nonprofit, and government clients. Before that she worked
with the Robert Wood Johnson Foundation in Princeton for 15 years as a
senior communications officer and program officer.
This year PACF is expected to award more than $700,000 in grants, but
competition for the money can be fierce. Last year about 40 percent of
the grant applications received funding, so it is important for an
organization to put its best grant-application foot forward. In order
to make the grant information more user-friendly, the centerpiece of
the session is a walk-through of guidelines for obtaining a grant.
In order to be eligible, organizations must have tax exempt, 501 (c) 3
status and be registered as a New Jersey charity. "We want to be there
for the entire non-profit community, so we get proposals from large
organizations with multimillion dollar budgets and a staff of hundreds
as well as from small organizations that don’t even have a $100,000-a-
year budget and have a staff of two," says Hollendonner.
All attendees to the session receive grant guidelines, application
forms, and the ever-important budget forms. Typically the sessions
attract about 20 people from a variety of organizations with a wide
range of grant-writing experience, ranging from the novice to the
seasoned professional. At the start of each session Hollendonner polls
the room and tailors the presentation to the level of experience she
finds. "It is not unusual to have nonprofit executive directors and
board members seated next to volunteers," she says, adding that the
sessions are free-flowing and everyone is encouraged to ask questions
at any time in order to ensure that each person attending gets as much
information as he or she needs.
This is followed by a review of some of the many resources available
to nonprofits in the area, such as the Foundation Center, a national
organization with a gigantic database of foundations. There is a
branch located in the state library in Trenton. "It’s a great resource
where people can learn a lot about where they can go for funding,"
says Hollendonner. "The thing is that not a lot of people know about
it." Other largely unknown resources are the many websites that offer
discounts to nonprofits for technology information and computer
A formal question and answer session is held just before the session
wraps up, after which a number of people inevitably stay behind to
have a one-on-one consultation or to network with the other nonprofit
attendees in the room. Hollendonner says that this is a particularly
valuable part of the session. "Sometimes people are not aware of what
some of their colleagues are doing and this allows them to connect
with each other," she says. "At our last grant information session
there was a woman who had worked at Princeton University before giving
birth to her child. She came to the session simply because she just
wanted to volunteer. A number of people stayed afterward and spoke
There are three different categories of funding under the Greater
Mercer Grants program.
The first is what Hollendonner calls the tried-and-true community
foundation role. "If you want us to support up to $15,000 for a grant
for a safety project, meals-on-wheels, or youth development, we will
do that under this category."
The second category – with grants of up to $20,000 – is aimed at
community organizing in low-income neighborhoods. "The focus is really
on community building," says Hollendonner. "This allows groups of
residents to organize and apply for a grant. Many people come in talk
about how they remember growing up in neighborhoods in which kids
couldn’t get away with anything because neighbors were watching and
would not hesitate to call parents if they did anything they weren’t
supposed to do. We have lost that and that this category is trying to
The third category does the same thing, though on a wider level,
within entire municipalities or across municipalities, with grants of
up to $50,000.
With 60 percent of grant applications denied funding last year, it is
important for nonprofit organizations to present the best application
they possibly can. Hollendonner offers these tips to help tip the
Make sure you meet basic criteria. Pay attention to directions. The
Greater Mercer Grants require that organizations fit into local
geographic boundaries. "An example would be that someone who wants to
do a project at the Jersey shore will not receive funding," says
Include all important details. While the competition pool for grant
proposals varies from season-to-season and year-to-year, it pays to
make sure the quality of the application package is up to snuff.
Submit the application on time, include all the required information,
and write clearly. "It doesn’t have to be written in beautiful prose,
but we need to fully understand what it is you are asking support
for," says Hollendonner.
Use common sense. Before submitting your grant proposal, ask yourself
whether the program you want to do is logical. What is the potential
of your organization? Do you have the staff in place to do the job?
How many people will your project serve and for how long? Is the
budget reasonable? How will you assess success or failure, and what
will you do with the results?
"If someone tells you that your program was awful, what will you do
with that information?" asks Hollendonner. "Organizations need to
think of all these things in advance in order to increase the
likelihood of receiving funding."
Look around. "Sometimes in this area we will have a new organization
that doesn’t realize that there is already an organization doing what
they want to do right next door," says Hollendonner. "If a need is
being met, we usually don’t need more."
On the other hand, Hollendonner says that it is possible to do what
other organizations are doing if you are going to do it better. "If
you have a summer camp that offers a program Monday, Wednesday, and
Friday for two hours, and another camp that starts when parents have
to go to work and continues until mom or dad get back, it is easy to
see which one you are going to put your money into."
Don’t ever give up. Even if you fail, you still succeed. If not this
year, then maybe the next. One of the hot phrases for the new
millennium is "social capital," and, according to Hollendonner, the
lack of it affects individuals and organizations in similar ways.
"It has been documented that the number of connections people make
these days is declining," she says. "When you connect with others you
are in touch with shared resources and can be more successful at
taking advantage of opportunities. Connections can make a difference."
– Jack Florek
When entrepreneurs dream, they dream of money. So do the venture
capitalists who partner up and fund them. The money dreams of
entrepreneurs tend to center on receiving a funding check. The best
dollar-sign dream for a venture capitalist involves what the investors
fondly term a "liquid event." In these dreams, the plucky
entrepreneurs in whose untried ideas they have invested sell the
entire new company, selling off a production license, or, by taking
the company public, bring in billions of dollars (think Google).
Yet only one in five firms survives its first three years, let alone
becomes strong enough to make itself an attractive buy-out target. To
help entrepreneurs and venture capitalists understand the joint effort
needed to produce a gusher of a liquid event, the New Jersey
Technology Council presents "Liquidity: Everyone’s Goal" on Wednesday,
March 29, at 8:15 a.m. at the Garden State Exhibit Center in Somerset.
Cost: $50. Call 856-787-9700 or visit www.njtc.org.
Susan Roos of Pricewaterhouse Coopers moderates. Panels include
attorney Jeffery Nicholas of Fox Rothschild, based on Lenox Drive and
in Bucks County; and Nick Baughan, managing member of Marks, Baughan &
Co. in Conshohocken, Pennsylvania.
This event immediately precedes the New Jersey Technology Council’s
Venture Conference, at which 50 early/mid-stage companies will make
formal presentations. Visit www.njtc.org for registration.
Nicholas is heir apparent to the ultimate entrepreneurial path. His
father was an attorney/businessman who was kept sane by the farmer’s
daughter he met and married at Northwestern University.
"Dad was forever starting all sorts of crazy businesses," says
Nicholas. "He imported Irish wolfhounds from Ireland, and even began
his own venture fund." Not all of these efforts proved quite crazy.
Like the time he bought several baby food formulas from Squibb, took
out the salt and sugar, and renamed his new product Beechnut.
Nicholas attended Williams College, graduating with a B.A. in religion
in l977. Then, following in the family footsteps, he came back to
Chicago’s Northwestern University and took his law degree. For the
last nine years, Nicholas has directed Fox Rothschild’s technology and
venture finance group.
"Somewhere on a three, five, or seven-year schedule, new companies
should plan for some sort of liquidity event," says Nicholas. "Simply,
an entrepreneur shouldn’t take capital if he doesn’t foresee
liquidity." Of course, the best way to make it a good event is to aim
for it from the outset.
VC schemes. Venture capitalists are just investors playing for bigger
stakes. As compared with the common stock shareholder, the VC is
placing an all-or-nothing gamble – with cash he cannot pull out – in
the face of those five-to-one survival odds. He naturally hopes for
At that initial stage when venture capitalist and entrepreneur are
circling around each other cautiously, the former hands the latter a
spreadsheet. When the numbers are crunched, the venture capitalist
hopes to find a high comfort zone: an early sales growth spurt of 25
percent, followed by sustained sales climbs thereafter. A picture of
profit-taking potential going from X to 6X in a five year period makes
the potential investor increasingly comfortable.
If both the entrepreneur and investor like what they see, then comes
the inevitable question: What is the value of this company before I
put my money in? Here comes the fun part. In determining this
pre-money value figure, the venture capitalist is trying to determine
just how much he will have to put in to get what percent of the
company – and reap his expected return level. So obviously he tries to
boost the power of his investment by keeping the pre-money value
Meanwhile, the entrepreneur shoots for a high estimate of his sweat
equity, and the value of the firm as it already stands. His response
is not only emotional, but fiscal. The higher he can raise the
pre-money value, the less this investor’s percentage is worth, and the
more likely he will be to pony up a larger sum. Sometimes attorneys
help in this wrangling. Sometimes they don’t.
VC dreams. The sensible venture capitalist invests in a lot more than
numbers and an enticing product line. The world’s best invention is
not necessarily destined to be the world’s best selling one. "The
venture capitalist is investing in management and people, as much as
product," says Nicholas. "Success depends on wisdom, contacts, and
skills, and they all have to be there for an investor to come on
Conversely, the entrepreneur often wants more than funds from an
investor. He seeks a capitalist who can contribute contacts, synergy,
and access to other funding markets. To satisfy both, the venture
capitalist often takes a seat on the board or has an associate – or a
hand-picked contact – take on a senior management post.
When such appointments occur, entrepreneurs often shiver, feeling they
might be shut out in the cold from the very firm they launched. VCs on
the other hand, know that their cash is stranded in this company until
liquidity, and think that they should at least have a chance to guide
it toward a good buy out. To some extent, contractual agreements can
be drawn up to prevent anyone from giving away the store. Yet in the
end it is a sense of trust that works best. If the venture capitalist
can see the entrepreneur as a vital asset to the company and its
future success, while the entrepreneur sees the VC as a seasoned
businessman and the avenue to new capital markets, each will have the
incentive to work well together.
Seductive targets. Not every firm that is bought out has a stellar
track record with sales exploding off the charts. Of course having a
company in a nice niche in an expanding growth market is certain to
make a buyer’s heart beat faster. "Sometimes a firm can secure its
position by buying up another small company," says Nicholas. This not
only expands its market share, but also shows potential investors that
it is an aggressive firm on the move.
Additionally, the targeted firm must radiate a sense of smooth
acquisition to the potential buyer. Remove all possible infringement
issues and solve all human resource problems. Sometimes a
pre-negotiated labor contract can be a selling point. While it is
always a great fear among employees, most buyers do not want come in
and face the hassle of mass firings, and then have to recruit and
train replacements. If a buyer sees a solid group working of
high-morale workers performing well under a unified management, he is
likely to pay well for this whole, trouble-free package.
In business the old maxim of grow or die still holds true. If a firm
succeeds, eventually it will expand beyond one ownership and one
source of funding. Even if the liquidity is only selling pieces of
your the company as pubic stock offerings, it will mean a substantial
change, with a lot more horses pulling the wagon. The owner can gather
all the new reins himself, or he can hand them over to someone else
and go retire to a sprawling beach home in Aruba. Either way, working
toward liquidity is a vital a part of today’s business planning,
requiring as much attention as the current sales figures.
– Bart Jackson
This year everyone gets a tax break. April 15 falls on a Saturday, so
everyone has an extra two days to file. Not that the IRS encourages
procrastination, not at all. In fact, the revenue-gathering
organization has already put out its "last minute" tax tips.
The list begins with IRS spokesperson Gregg Semanick asking: "Looking
for ways to avoid the last-minute rush for doing your taxes? The IRS
offers some stress relieving ideas to help those that have not yet
"Historically," Semanick continues, in a prepared statement, "over 35
percent of the tax returns are filed during April."
But, he continues, "there is no need to be in line at the Post Office
at the eleventh hour on April 17. Our best advice: E-file now; pay
later. You can electronically file your return now and schedule a
payment via an electronic funds withdrawal from a bank account on
April 17. If due a refund, E-filing and requesting direct deposit of a
refund into a bank account, you can receive your money in as little as
two weeks even if e-filing a tax return during the last days of the
The IRS offers these additional tips:
Don’t procrastinate and organize your tax records. Resist the
temptation to put off your taxes until the last minute. Your haste to
meet the filing deadline may cause you to overlook potential sources
of tax savings and will likely increase your risk of making an error.
Tax preparation time can be significantly reduced if you develop a
system for organizing your records and receipts. Start with the
income, deduction, or tax credit items that were on last year’s
Visit the IRS online at IRS.gov. Millions of taxpayers visited the IRS
Web site, www.irs.gov, in calendar year 2005, downloading forms,
publications, and a variety of topic-oriented tax information. Anyone
with Internet access can also find tax law information and answers to
frequently asked tax questions.
Access "1040 Central" for your tax information needs. Taxpayers with
an adjusted gross income of $50,000 or less can file their tax returns
for free and online using the Free File Program at IRS.gov. The
popularity of IRS.gov is reflected in the fact that there were more
than 176 million visits to the Web site and 1.2 billion page views
File your return electronically. Through mid-March, over 1 million New
Jerseyans have already filed using the E-file program. Aside from ease
of filing, IRS E-file is the fastest and most accurate way to file a
tax return. If you’re due a refund, the waiting time for E-filers is
half that of paper filers. Taxpayers may use IRS E-file through their
tax preparer, over-the-counter software, or Internet programs as well
as the Free File program at IRS.gov. The Free File program can be used
by taxpayers with an adjusted gross income of $50,000 or less.
Seek free tax return preparation through volunteer programs. Free tax
help is available through the Volunteer Income Tax Assistance (VITA)
or Tax Counseling for the Elderly (TCE) sites. The free VITA program
services are available to taxpayers with incomes of $38,000 or less,
non-English speaking, and the disabled. The free TCE program services
are available to taxpayers 60 years of age or older. To obtain the
location, dates, and hours of the VITA or TCE volunteer site closest
to you, call the IRS toll-free Tax Help Line for Individuals at
1-800-829-1040 or call AARP at 1-888-227-7669.
Choose your tax preparer wisely. While most preparers provide
excellent service to their clients, the IRS urges taxpayers to be very
careful when choosing a tax preparer. You should be as careful as you
would in choosing a doctor or a lawyer. It is important to know that
even if someone else prepares your return, you are legally and
ultimately responsible for all the information on the tax return.
Taxpayers needing Form 4868 or any other federal tax form should act
soon to be sure they have the form in time. Forms are available on the
IRS Web site, www.irs.gov, or by calling toll-free 800-829-3676.
Corrections or additions?
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