NCI-FDA Training Program Focuses on Translation
These days, however, he's spending most of his time in training sessions and meetings at the Food and Drug Administration (FDA) learning how to review applications from drug companies seeking approval to market a new drug or conduct a clinical trial of an investigational agent.
"It's a hard thing to train for," he says. "But it's just like anything else. You have to jump in and do it."
Dr. Lechleider is one of the first fellows in a novel training program developed by NCI and FDA's Interagency Oncology Task Force (IOTF). Its goal: To develop a cadre of basic and clinical researchers who also understand the legal and regulatory aspects of delivering new drugs or diagnostics to the clinic.
"It's definitely a unique program," says Dr. Jonathan Wiest, associate director for training and education in NCI's CCR. "It's especially rare to have two agencies within HHS working together on a program like this." Dr. Wiest, along with Drs. Mary Poos and David Brown of the FDA, oversee the training program.
The IOTF Joint Fellowship Program is composed of four different programs, each with curricula that are tailored somewhat differently depending on a fellow's education, training, and interest. For Dr. Lechleider, the program offered him an opportunity to move in a new direction.
"I was a basic scientist, with no clinical involvement," he says. "I wanted to be more directly involved in drug development."
The first year of Dr. Lechleider's 3-year program was dedicated to clinical training at the Bethesda Naval Medical Hospital and at the NIH Clinical Center with patients enrolled in NCI clinical trials.
Now more than a month into the regulatory training, he admits it's quite a change.
"It's a different way of thinking," he says. "The clinical training has been great because when I start to look at trial designs, having seen patients treated on clinical trials makes it easier to interpret applications and evaluate them for risk and benefit."
Another fellow in the program, Dr. M. Stacey Ricci, agrees that the program has given her a different mindset.
"Coming from a background in basic research, it has been a great way to learn what it takes to get a promising cancer drug into clinical trials," says Dr. Ricci, who came to the program after completing her postdoctoral training at the University of Pennsylvania. "Training at the FDA has provided an opportunity to understand, in great detail, what the critical safety and manufacturing issues are for successful drug development." Much of Dr. Ricci's training at the FDA has focused on biologics, particularly monoclonal antibodies.
In addition to their regulatory training, both Drs. Ricci and Lechleider will continue conducting research in FDA and NCI laboratories, respectively.
Established as a 3- to 5-year pilot, the program definitely addresses a pressing need.
"When you look at the cost of getting a drug through to the market, one of the most expensive and time-consuming aspects is meeting the requirements for gaining regulatory approval," says Dr. Wiest. "This program is about training world-class scientists who understand how to make that happen."