The Fine Line of FDA Approval

What it takes for new drugs to be tested and reach patients, con't

What is the general time frame for a new drug to be approved by the FDA so it can be available to patients?

From beginning to end, typical clinical drug development takes around seven to 10 years. If a drug is showing remarkable activity and serves an unmet medical need, an accelerated process can go much quicker, maybe around three years after the onset of clinical trials. This is generally speaking, as every drug is unique in its own way.

What do researchers look for in a promising drug?

People may not realize that nine out of 10 Phase I trials fail. A compound may not reach the intended target or it might not be safe for patients because it is too toxic.

Once researchers show that a compound is safe and has activity against the intended target, it will be pursued further. Our goal is to develop therapeutic cancer drugs, but not further injure patients. If severe toxicity occurs during Phase I testing, the compound is unlikely to be further developed. To ensure patient safety, a Phase I study must be tightly monitored and every event must be documented.

What about drugs that go through the accelerated process for FDA approval? Are there disadvantages when drugs go through the process quickly?

As far as cancer drugs go, I believe the FDA approval process is streamlined and efficient. Even though at times it seems like the FDA is overly conservative, I feel it is a fair and well-structured process. If a compound proves to be good and there is no question about it, it moves forward quickly in the approval process.

When a drug goes through the accelerated process, it receives conditional approval from the FDA. This means that testing on the drug continues once patients are using it and the drug must meet additional milestones later, such as survival improvement.

What good things do you see in the future for the development of cancer drugs?

Cancer is now the major focus of drug development. We need new concepts and a better understanding of what targets to go after. We are just beginning the process of discovering targets and developing diagnostic tools.

One project of clinical importance we're working on in the U-M Cancer Center is the idea of precision or personalized medicine. This involves what is called next-generation sequencing, or studying a tumor's genetic makeup to identify mutations. The idea is to see what mutations can be acted upon and whether we can target them so we’ll have a large selection of compounds available to match specific mutations.

We at the Cancer Center have also developed a Phase I translational research center. We have a great team and are aiming to partner with drug companies throughout the drug development process.

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