FDA to Provide Guidance on 'Exploratory' IND Process

The FDA is preparing to release a draft guidance that will contain details about a new investigational new drug (IND) application process that it hopes will enhance postdiscovery drug development, according to a top agency official.

The guidance, which could be out as soon as this month, will propose the use of an "exploratory" IND application specifically designed for early drug development activities, said Janet Woodcock, the FDA's acting deputy commissioner of operations. The new IND process will enable drugmakers to conduct various exploratory studies -- also referred to as "Phase 0" studies -- without being limited by Phase I trial rules, which typically restrict sponsors to focusing on one research path.

"This guidance will allow sponsors to do clinical trials for different reasons depending on where they want to go with their drug," an FDA spokesperson said. For instance, instead of being limited to studying a single molecular entity, which is what is required during Phase I studies, sponsors will be able to choose between multiple molecular entities based on how the studied compound reacts in humans.

This approach should allow for faster, more efficient drug development, said Woodcock, because it will provide early information about pharmacokinetics, as well as data about a drug's absorption, distribution, metabolism and excretion characteristics. This data will help drugmakers identify promising drug candidates before committing to investment in traditional Phase I clinical development.

The guidance is one of several actions the agency intends to take to improve applied scientific research in an effort to speed the development process after a drug is discovered, said Woodcock, who noted postdiscovery drug development is an area sorely lacking in resources.