This phase usually involves 1,000 to 5,000 patients in clinics and hospitals. Physicians monitor patients closely to confirm efficacy and identify
New Drug Application (NDA)
Following the completion of all three phases of clinical trials, a company
analyzes all of the data and files an NDA with the FDA if the data successfully demonstrate both safety and effectiveness. The NDA contains all of the
scientific information that the company has gathered. NDAs typically run
100,000 pages or more. By law, the FDA is allowed six months to review an
NDA. The average review time for new molecular entities approved in 2001
was 16. 4 months.
Once the FDA approves an NDA, the new medicine becomes available for
physicians to prescribe. A company must continue to submit periodic reports
to the FDA, including any cases of adverse reactions and appropriate quality
control records. For some medicines, the FDA requires additional trials (Phase
IV) to evaluate long-term effects.
Discovering and developing safe and effective new medicines is a long,
difficult, and expensive process. The research-based pharmaceutical industry
invested more than $30 billion in research and development in 2001.
The Drug Development
and Approval Process
THE U.S. SYSTEM OF NEW DRUG APPROVALS IS PERHAPS THE MOST RIGORous in the world. On average, it costs a company $802 million to get one
new medicine from the laboratory to U.S. patients, according to a November
2001 report by the Tufts Center for the Study of Drug Development.
It takes 10 to 15 years on average for an experimental drug to travel from
the lab to U.S. patients, according to the Tufts Center for the Study of Drug
Development, based on drugs approved from 1994 through 1998. Only 5 in
5,000 compounds that enter preclinical testing make it to human testing.
And only one of those five is approved for sale.
Once a new compound has been identified in the laboratory, medicines
are developed as follows.
A pharmaceutical company conducts laboratory and animal studies to
show biological activity of the compound against the targeted disease, and
the compound is evaluated for safety.
Investigational New Drug applications (IND)
After completing preclinical testing, a company files an IND with the U.S.
Food and Drug Administration (FDA) to begin to test the drug in people.
An IND becomes effective if the FDA does not disapprove it within 30 days.
The IND shows results of previous experiments; how, where, and by whom
the new studies will be conducted; the chemical structure of the compound;
how it is thought to work in the body; any toxic effects found in the animal
studies; and how the compound is manufactured. All clinical trials must be
reviewed and approved by the Institutional Review Board (IRB) where the
trials will be conducted. Progress reports on the clinical trials must be submitted at least annually to the FDA and the IRB.
Clinical trials, phase I
These tests involve about 20 to 100 normal, healthy volunteers. The tests
study a drug’s safety profile, including the safe dosage range. The studies
also determine how a drug is absorbed, distributed, metabolized, and excreted, as well as the duration of its action.
Clinical trials, phase II
In this phase, controlled trials of approximately 100 to 500 volunteer
patients (people with the disease) assess a drug’s effectiveness.
John kelly is senior vice president for scientific and regulatory affairs at
the Pharmaceutical Research and Manufacturers of America.
real-world experiences prior to graduation through a National
Science Foundation Research Experiences for Undergraduates
opportunity at Wellesley College. “The experience made me
confident that research is what I wanted to do,” Meekins says. “It
provided me with better understanding of work/life situations.”
Saradha Chandrasekhar points to professional opportuni-
ties that served as guideposts during her education. But, unlike
Meekins, Chandrasekhar’s real-world experience came as a result
of her graduate education. Chandrasekhar works at Novartis,
carrying out assays for formulations that are developed for differ-
ent kinds of vaccines. She has a professional science master’s in
biotechnology from Northeastern University, where she had the
opportunity to do a co-op at EMD Serono, a biopharmaceutical
company in Rockland, MA.
“When I got the offer from Novartis, I realized that I already
had experience with some of the things they were doing,” she
recalls. She also points to non-science courses offered during her
professional science master’s program as giving her a leg up at
“I took business courses at Northeastern, which I would say
have helped me look at things from a different angle,” she says.
“I don’t just know about research, I understand what else is
going on in the company.”
It takes teams of individuals from a variety of backgrounds to
successfully complete the drug development process and get a
product to market. The good news is that chemists in both tradi-
tional and non-traditional roles are an integral part of that team,
from drug discovery through approval and post-market phases.
Many exciting and interesting careers are available to chemists at
all levels from associate’s degree to Ph.D. iC
Wendy hankle is a freelance writer and communications professional who lives in Ithaca, NY.