How to Navigate Clinical Trials and Fundraising Challenges

Patricia Zilliox has spent her entire career working in ophthalmology, including 30 years at American-Swiss medical company Alcon. Now she’s running a tech startup that aims to improve treatments and prognoses for some of the most common eye diseases.

In 2017, Patricia became CEO of Eyevensys, a biotech company founded nine years earlier in Paris.

Eyevensys is in the clinical stage of making a drug delivery system to inject DNA plasmids directly into the ciliary muscle with the goal of producing a consistent supply of antibodies to fight various eye diseases. The main areas of focus for the company include wet and dry age-related macular degeneration (AMD), and degenerative retinal diseases.

Patricia is working to bring Eyevensys to big pharma companies in the U.S. But first, she has to navigate some challenging regulatory hurdles.

Eyevensys’ technology has been classified as a combination biological device by the U.S. Food and Drug Administration (FDA). This means the company has to meet the agency’s requirements for selling a biologic (a type of drug) and for selling a medical device.

“That's what starts to make it more complex, because when you raise money, the first thing investors are going to ask you is, Are you a device company? Or are you a biologic?” she says. “We are a biologic, but from a device point of view, we have to follow all the rules as if you were developing a device.”

In this interview, Patricia gives advice for navigating the complicated world of regulatory affairs, the dos and don’ts of planning clinical trials, and why raising capital is the most frustrating part of her job.