Portrait of a Leader
This story highlights several characteristics of a good leader, showcasing Dr. Richard Pazdur, the Director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration.
“I can clearly see myself sitting in my room in high school and saying to myself, that is what I want to be.” Richard Pazdur’s face lights up as he points a finger at an imaginary catalogue from Northwestern University. “Even in high school, I knew that is what I wanted to be--that Professor of Medicine shown in the brochure.” He went on to become an oncologist and eventually a Professor of Medicine at the world renowned M.D. Anderson Cancer Center in Texas. In 1999, he left his academic job to join the Division of Oncology Drug Products (DODP) at the FDA and was promoted to be Office Director of the re-organized Office of Oncology Drug Products (OODP) in 2005. The Wall Street Journal has called him FDA’s Cancer Czar.
A 2005 analysis found that, under his leadership, the short-staffed Office of Oncology Drug Products had 41% of all products approved by the Office of New Drugs (which evaluates drugs for marketing). From 2005 through 2007, the Office of Oncology approved 44 New Drug Applications (NDAs), authorizing the marketing of a new drug or an already marketed drug for a new use.
Develop a Vision
Dr. Pazdur identifies having a vision as the single most important factor
for a leader. As the Director of OODP, he wants the cancer patients to have
access to drugs that are efficacious and safe. He can empathize with patients
and their families as several members of his own family have died from cancer.
Dr. Pazdur’s father, who had diabetes and pulmonary fibrosis, endured harmful
side effects from drugs that provided him no benefit, and in fact may have
hastened his death. As a result, Dr. Pazdur developed a heightened awareness that drugs can cause
harm, and that we do need evidence that the drugs that are approved actually
work and that the FDA should not approve drugs with severe side effects and no
benefits. “People have to have confidence that the drugs are safe and
effective,” says Dr. Pazdur. “That's our primary goal.” He gives the example of
his uncle was cured of his leukemia because of a therapy that had been
well-studied.
Communicate and Reiterate the Vision
Not only does Dr. Pazdur know his vision, he makes this vision very clear
within his organization and reiterates it at different times and in different
venues. He readily admits that he is first an Oncologist and then a Regulator
and that his emphasis is the cancer patients and what is best for them. He
reiterates this vision frequently, whether he is discussing individual drugs,
drug development, or regulations in general. His team has clear priorities and
therefore can focus on their work.
Make Decisions Based on a Sound Rationale
In an environment where the end product depends on the review of highly skilled and opinionated professionals, Dr Pazdur encourages staff to make decisions based on a clear scientific rationale. He emphasizes getting the job done and getting it done well. As a result, his team has pride in their work. An obvious lack of politics within the organization makes it a good work place for the employees and with his “open door” policy, Dr. Pazdur is very accessible to his team who are all on first-name basis with him. Priorities and expectations are clear and consistent and as a result, confusion is avoided.
Deal with Change Effectively
Change is an essential part of improvement and survival in the work
place. An effective leader is able to deal with change. Dr Pazdur observed that
in the 1970s, the National Cancer Institute (NCI) developed most of the drugs.
That is in sharp contrast to today, when drugs are mostly developed by the
pharmaceutical industry. Many trials are multinational now. This is a good
change, he says, but it requires flexibility. Since joining the FDA, Dr Pazdur
has encouraged meetings with the pharmaceutical industry to improve the
efficiency of the drug development and approval process. Under his guidance, FDA
has held workshops open to the public and discussed endpoints for oncology
trials. Previously, approvals were generally made on the basis of an improvement
in survival of cancer patients, a practice which required trials to be large and
long-running. After discussions with oncology experts, now many of the cancer treatments are approved on the basis of a
delay in cancer progression and death.
Recruit Continuously and Reward Good Work
Dr. Pazdur emphasizes the need to recruit continuously due to the high
turnover of employees. He says that he showcases OODP as the unique organization
that it is. Working here allows reviewers excellent opportunities for growth,
opportunities that they might not have in other organizations. They have
exposure to and are part of the process of cutting edge developments in
oncology, and they work and interact with leading scientists and drug developers
from all over the world. The reviewers also have opportunities to publish articles in
major journals. “We are able to hire a lot of good people,” he says. Dr Pazdur
demonstrates his appreciation for the work done by his employees by rewarding
them with gifts based on the employee’s interests. In addition, he routinely
makes a point of publicly acknowledging those who have performed well.
Trust Your People
Dr. Pazdur cautions against micromanagement. “Trust the people who work
with you and they will deliver,” says Dr. Pazdur. “If they don’t, you could
question whether they have the right job, gaps in their technical knowledge, or
their personal commitment to the job,” he says.
Work Within the System—But Leverage External Resources.
One should leverage all available resources to accomplish tasks. Recognizing the
importance of FDA and availability of oncology drugs, he has attempted to build
bridges with non-government organizations. You have to work within the system,
he says. But by leveraging the academia, professional groups, patient advocacy,
and the American Society of Clinical Oncology (ASCO) and American Society of
Hematology (ASH) he has made the process of oncology approvals more open and
public. Under his guidance, workshops and Advisory Committee meetings have been
held for development of endpoints for clinical trials. Reviewers publish
articles summarizing basis of oncology drug approvals in peer-reviewed journals.
Rapid information regarding new drug approvals is sent to oncologists and
oncology nurses via “e-mail bursts” through the American Society of Clinical
Oncology (ASCO), the Oncology Nursing Society (ONS) and postings on the National
Cancer Institute (NCI website) after approval of a cancer therapy.
In an interview with the magazine “Community Oncology” he said that his goal for the oncology products division is to foster stronger interaction with the oncology community and to become a “much more integral part” of the drug development process within the cancer community. Regarding his organization, he says “I’d be very happy if, at the end of my tenure here, I could say I really helped oncologists at FDA develop their careers and that oncology drug regulation was fully understood by the community.”
Dr. Richard Pazdur's Leadership Guidelines:
- Develop a Vision
- Communicate and Reiterate the Vision
- Deal with Change Effectively
- Make Decisions Based on a Sound Rationale
- Recruit Continuously and Reward Good Work
- Work Within the System—But Leverage External Resources
- Trust Your People
©2008 GovLeaders.org
