Landry: Regulators keep consumers safe

Denise Landry of Emergent BioSolutions, Inc., recently said that regulators enforce standards and keep consumers safe while maintaining an open dialogue with pharmaceuticals, according to a recent article in Yale Insights.

Landry, the senior vice president and chief quality officer at Emergent, said that manufacturers and regulators both have the interest of putting a safe and effective product on the market. Landry said that Emergent, which develops the only U.S. Food and Drug Administration-licensed vaccine for the prevention of anthrax disease, does not see regulators as having a negative impact.

"As industry progresses, regulations follow shortly behind," Landry said. "I think that the FDA has, in the last few years, really made great strides to have a dialog with industry so that you spend time talking to them as you develop new drugs. They become more consultants in those early phases as opposed to just telling you it's right or wrong after you've gone down the development path."

Landry said the FDA uses the concept of quality by design, which means that pharmaceutical companies and regulators are very thoughtful about how a new product is developed. This improves the outcome of the development process by ensuring pharmaceutical companies understand the biological and chemical aspects of a product and the infrastructure of how it will be manufactured.

"The FDA has embraced this in new drug applications and processes," Landry said. "Those thoughtful conversations up front and then developing and designing experiments improve the drug development process."