U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Science and Research | Drugs
  4. Regulatory Science in Action
  5. Ashutosh Rao, Ph.D. - Transcript
  1. Regulatory Science in Action

Ashutosh Rao, Ph.D. - Transcript

Helping patients answer questions about their protein-based medicines

Dr. Rao: I realized the importance of the FDA and its mission when I was in pharmacy school. I realized the importance of consistent quality, of consistent review of providing a scientifically robust assessment of the safety and efficacy of a drug, before the public can be assured that they can take this with assurance.

Text Slide:

Ashutosh Rao, Ph.D.

Chief, Laboratory of Applied Biochemistry

Division of Biotechnology Review and Research III

Office of Pharmaceutical Quality

Office of Biotechnology Products

Dr. Rao: The office of biotechnology products is responsible for protecting public health, and specifically by way of assuring the safety, quality, efficacy of therapeutic proteins.

So these are drugs that are used in every day life by most people. Some may not realize it that these are proteins, for example, insulin, which is a protein.

Inherently proteins are not happy being outside cells, proteins are made within cells, but inherently when you take them out of cells, they’re unstable, they want to coagulate, they want to precipitate, they want to fragment themselves in order to basically be removed from the system, because that’s not where they’re supposed to be.

A change in protein oxidation will impact the way a protein behaves on the shelf and in your body and so it’s important to understand it, it’s important to characterize it, and in some instances it’s important to control for it, so you know what’s going into people.

So my lab studies how protein oxidation impacts the quality, safety, and efficacy of the drugs that we regulate.

With the advent of new technology we have developed a very quick and easy way if you will, of quantifying protein oxidation, a specific type of protein oxidation called ‘carbonilation’ And that technology was developed here at FDA.

By identifying risk factors, by identifying ways to make more stable drugs, folks are investing their time, their energy, and their money in developing drugs for the future.

What our lab does is look at how do you make a protein stronger.

Using that information, hopefully drug developers can then go back and reconstruct or engineer a protein in those factories so that when they’re actually produced they’re stronger, they’re more stable, they’re higher quality, hopefully of higher yield based on the information that we provided on how to build a protein oxidation resistant or a more stable molecule.

As a pharmacist, I used to get asked, ‘well I left my medication on the kitchen counter for about six hours, should I still take it?’ So the research that we do actually informs how those six hours of medication sitting on the kitchen counter will probably lead to protein oxidation or aggregation, or a different safety and efficacy profile. So it does provide a better scientifically robust way of answering back to a patient, ‘yes it’s probably fine,’ or ‘no, that medicine is probably not going to do what you think it does after having left it on your kitchen counter.’

I do like working here, it’s challenging. I love being able to make an impact. I love that I am able to do things which directly influence how patients get and take safe and efficacious medications.

Back to Top