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By Dr. Wayne T. Harris
 The
pharmaceutical industry provides tremendous opportunities
for career development for college graduates. According to
the Pharmaceutical Research and Manufacturers of America (PhRMA),
total domestic sales for member companies have increased an
average of 11.5% per year from 1970 to 2002. It is this
stable growth in sales, which allows for growth in career
opportunities. The top areas for college recruitment by this
industry are: science, engineering, health professions,
finance, marketing and information technology. The member
companies of PhRMA include Pfizer, Novartis, Aventis, Eli
Lilly, Abbott, Glaxo Smith Kline, Bristol-Meyers, Novo
Nordisk and Astra Zeneca.
The previous growth in sales and expectations for the
future are fueled by several important trends. First of all,
an aging population has an increased need for health care,
including prescription medications. It is important to note
that development and use of new medicines have contributed
significantly to the increased life span that we now enjoy.
Secondly, developments in genomics research will result in
new approaches to treatment and prevention of disease and a
wide variety of new types of pharmaceutical agents. Thirdly,
the growing concerns regarding bioterrorism have affected
the entire world. Products of the pharmaceutical industry
are crucial for adequate response to attacks using
biological or chemical weapons.
The development of new drugs requires a substantial
investment in research and development. Knowledge of the
research and development process allows for a better
understanding of the nature of pharmaceutical industry.
The average cost of developing a new drug has increased
from $138 million in 1975 to $802 million in 2002, according
to the PhRMA. In addition to the financial costs, an average
of ten to fifteen years is required to develop a new drug
while only 1 of 5000 screened compounds is approved for use
as a new medicine. A patent is secured once a new chemical
compound is created or identified for a particular
biological effect. The United States provides a 20-year
patent term and as noted earlier, from ten to fifteen years
is required to conduct the required research and development
on any new chemical entity.
The research and development process is divided into
several stages.
- Preclinical/prehuman studies
- Phase I clinical trials
- Phase II clinical trials
- Phase III clinical trials
- Phase IV (Post-marketing Surveillance)
Preclinical studies focus on all the scientific
disciplines and are involved with appropriate laboratory
tests to assure purity, develop analytical procedures, and
assure effectiveness in laboratory models of disease and
animal models. In addition, marketing analysis and business
planning are conducted simultaneously. If this first stage
succeeds, the chemical is tested for safety in humans. This
step requires submission of an Investigational New Drug (IND)
Application to the United States Food and Drug
Administration and approval by that agency. Phase I clinical
trials focus on demonstrating safety when administered to
humans. The manufacturer sets up a research protocol
involving healthy volunteers in which doses of the
investigational new drug are administered. The purpose of
these experiments is to determine whether the drug causes
any side effects and the severity of those effects. If the
drug survives the safety study, which could take two or
three years, the manufacturer will begin Phase II trials in
which small-scale experiments in patients with the condition
to be treated are used to conduct an effectiveness study.
Once those studies are done, the manufacturer undertakes
more complicated Phase III clinical trials to determine
whether the drug will work in large groups of people with
the disease. Successful results through this process will
allow for submission of a New Drug Application to the Food
and Drug Administration. Approval of the NDA will allow the
drug to be used for sale to the general population. As you
can see, this is an escalating process and at any point a
new chemical entity can be withdrawn from further
development if experimental results are not acceptable. The
manufacturer could have as little as five years to make a
profit on the investment of hundreds of millions of dollars.
The final stage in the research and development process is
Phase IV (post-marketing surveillance). This is an ongoing
process once the FDA has approved a drug. It involves
continued clinical trials and reporting of adverse drug
reactions.
The member companies of the PhRMA are supporting these
long ranges of studies. They invest the hundreds of millions
of dollars, and if a drug gets through to the effectiveness
trial and doesn't work, the development stops and continues
to the next new chemical entity. After the patent-life of a
drug, a generic drug or copy of that drug may be produced
and sold by other companies.
It is important to note that the pharmacy practice
industry is integrally related to the development and
manufacturing industry. The pharmacy practice industry
consists of independent health professionals and employees,
small and large corporations that focus on treating
patients. These companies manage drug distribution,
dispensing, counseling patients, and so forth. It too is a
huge industry because, as with manufacturing drugs, people
have more diseases to treat as they live longer – the number
of people who are using drugs is growing, as the baby
boomers become retirees and so forth. All the major
companies in this sector are looking to expand, because they
see the increased need I have described. They are creating
new stores in new markets all over the country. The major
national companies in this sector are Walgreens, Wal-Mart,
Eckerd, Rite Aid, CVS, major food chains and regional
chains. These companies are also recruiting college
graduates in the same disciplines as the research
manufacturers. Opportunities in this pharmacy practice
industry are extremely good because the demand for
pharmaceuticals is growing. The need for pharmacists is
especially acute in most major markets.
The federal government represents another important area
for career development and many of the agencies in the
federal government are directly involved with the
pharmaceutical industry from a regulatory perspective to
emergency preparedness. The agencies under the United States
Department of Health and Human Services are involved with
improving public health (Centers for Disease Control and
Prevention and the Health Resources and Services
Administration), regulation and approval of prescription
drugs (Food and Drug Administration), policy development,
and support of basic and clinical research (National
Institutes of Health). Opportunities exist for health
professionals and majors in science, engineering, business,
and information technology. The Health Resources and
Services Administration oversees a large variety of programs
including those that provide drugs to patients who can't
afford to buy them for themselves. They are usually
connected with community health centers, and pharmacists
oversee that program.
In discussing career opportunities related to the
pharmaceutical industry, I must include education of health
professionals for health services throughout the United
States as a part of the pharmaceutical industry. The Federal
Government through the Department of Health and Human
Services (HHS) established a blue print for improving the
health of society referred to as "Healthy People 2000." It
was a huge document that set forth a number of objectives
for improving the health of society by the year 2000. Those
objectives were far-reaching and focused on specific
indicators for healthy lives. Lack of physical exercise and
smoking are two specific examples. The objectives set
specific targets for those major indicators. Analysis of
performance in achieving those objectives led to development
of "Healthy People 2010," which set objectives to be
achieved by 2010. There are two main goals for "Healthy
People 2010." The first goal is to increase the number of
years of healthy life for all citizens of this country, a
very lofty goal.
The second main goal for "Healthy People 2010" is to
eliminate health disparities, these meaning differences in
prevalence, morbidity and mortality of diseases among people
of different racial and ethnic groups. One of the objectives
for eliminating health disparities is increasing the number
of minority health professionals. "Healthy People 2010" sets
specific targets for 2010. The premise for establishing
these targets is that the number of minority health
professionals and the number of minority educators who teach
in health-profession academic programs should reflect the
demographics of society. For example, approximately, five
percent of pharmacists in the United States are African
Americans while African Americans make up about thirteen
percent of the population. That's a problem and
health-professions education must be addressed if continued
progress is to be made. The Federal Government has said we
cannot achieve the goals of "Healthy People 2010" without
increasing the representation of minority health
professionals and educators. The message must be widely
disseminated about the need for minority educators in the
health- professions programs and minority health
professionals.
In conclusion, the opportunities in the pharmaceutical
industry are extraordinary. It includes the research and
development manufacturers, the practice industry, education
of health professionals, and pharmacy academic programs. The
interplay between this industry and the Federal Government
creates many opportunities in the federal sector as well.
Each has many career opportunities. If we are going to deal
with health disparities, we must deal with creating health
professionals who represent the population. That's one of
the biggest challenge we face.
Recruiter's Advice
Monica Poindexter of Genentech
The single most important advice I would give to
collegians to help them succeed in their career within the
pharmaceutical industry or with Genentech is to get an
industry internship. The landscape for New College is
extremely competitive. If you do not have skills or
experience to differentiate you from the vast sea of
competition, you're no different from the next student. Seek
out internship opportunities and pay attention to the
companies that are coming to your campus to host information
sessions or meet-the-firm night. Too many times,
African-American and other minority students are not
informed about the recruitment efforts going on their own
campus. It is critical for students to make it their
business to research companies who are in their particular
field of interest. Don't wait until the last minute to get
an internship; start as early as possible. From a personal
standpoint, I had my first internship right out of high
school through the INROADS, Inc. program. I kept my same
internship for four consecutive summers with my sponsoring
company. It is no surprise that I had a job with the very
company with which I spent four summers. So my advice: take
the time to find an internship!
Wayne T. Harris, R.Ph., Ph.D. is
Professor and Dean, College of Pharmacy, Xavier University
of LA. |
