Hats Off to Regulatory

This is the sixth post in our Lilly Discovery blog series that describes how Lilly employees discover and develop innovative treatments for patients. We're also highlighting many of the passionate scientists and clinicians behind Lilly’s cutting-edge discoveries.

Storyteller. Liaison. Product expert. These are just a few of the many hats Lilly’s regulatory affairs teammates wear when shepherding a drug through the U.S. Food and Drug Administration (FDA) review process. The review process is a thorough system of checks and balances to ensure patients receive safe and effective medicines. So what does it take to support the development, approval and life cycle of Lilly’s products?

We asked Lilly global regulatory affairs team members Robin Wojcieszek and Brian Wagner to weigh in on that. Watch the conversation between them about how they went from pharmacy to regulatory, and what is most rewarding about the work they do at Lilly:

It takes time … and a lot of paperwork.

“Pharmaceuticals are highly regulated, and the process for submitting information to the FDA can take five, seven, 10 years,” says Wojcieszek.

“If you think about all the information – a submission includes thousands of pages of data,” Wagner adds. “It used to literally be delivered to the FDA in a truck. And we now do this electronically, but it still takes a lot of time to ensure the drug not only works but is also safe.”

It takes a village.

“Collaboration is really important,” says Wagner. “It takes a village to pull together a drug application for submission to the FDA. You have to weave together pieces of information from several areas  – medical, statistics and manufacturing to name a few – to pull together the story of your drug.”

FDA Review Process Overview:

  1. Lilly submits an Investigational New Drug (IND) Application to the FDA based on results from preclinical testing.
  2. Lilly conducts phase 1, 2 and 3 clinical trial testing.
  3. Lilly submits a New Drug Application (NDA) to the FDA, requesting consideration for the marketing approval of a drug.
  4. The FDA reviews the drug’s safety and effectiveness, as well as the information that goes on a drug’s label.
  5. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
  6. FDA reviewers will approve the application or issue a complete response letter.

It takes the ability to adapt.

“The regulatory environment is constantly changing and as a regulatory scientist, we must be able to adapt and embrace change to bring new medications to patients,” says Wojcieszek.

It requires strong communication.

“Being open and transparent with the FDA goes a long way to help ensure the success of a new drug,” says Wagner. “We take the time to educate the FDA on our innovative approach and actively listen to its viewpoint, taking their feedback as constructive advice.”

Learn more about our scientists in Lilly Discovery chapters 1, 2, 3, 4 and 5