Demystifying the path to regulatory approval with Rui Jing Jiang of Avisi
In honor of World Glaucoma Day, we spoke to Rui Jing Jiang, CEO and Co-Founder of Avisi Technologies. Avisi is a University of Pennsylvania spinout company developing a nanoscale, ocular implant called VisiPlate to stop blindness in patients with glaucoma, the leading cause of irreversible blindness worldwide. To date, Avisi has been funded by the National Science Foundation, Ben Franklin Technology Partners, the University of Pennsylvania, and others. Avisi is a Johnson & Johnson JLABS incubated company, a MedTech Innovator Accelerator company, and a UCSF Rosenman Innovator. Avisi has been recognized as one of ten most promising Philadelphia tech companies of the decade in Technical.ly’s RealLIST Startups 2020, a Watchlist venture in Wharton Magazine, and a finalist at the 2019 SXSW Innovation Awards for Health, Med, and Biotech. Rui Jing co-founded Avisi while completing her degree at the Wharton School at the University of Pennsylvania, where she graduated cum laude with a B.S. in Economics, Finance, and Strategic Management.
Here are some of the highlights of our conversation:
Did you know you can just go into the Tech Transfer Office at your school and request to the patents?
“These are awesome technologies and innovations that don’t have an application, and the university wants you to go and do something with it, because that’s how they’re going to get a return on investing in that particular professor, so you know, if anyone wants to do this kind of stuff, it’s possible,” Rui Jing explains.
In fact, that is how Rui Jing began her journey to develop a better solution to the world’s leading cause of irreversible blindness. Avisi licensed a material technology invented by a professor at University of Pennsylvania, and is now using the material to as a novel eye implant to prevent glaucoma progression.
Rui Jing also gave us insight on how licensing patents work with universities:
“When anyone goes to a university to license out a patent, the university will generally negotiate some stake in the company, percentage equity stake, and the biggest thing that they care about is royalties on future sales. When the patent that the university has protected is open for licensing that means they’ve already invested a great deal in getting that patent to that stage. Tens of thousands of dollars, for example, and they generally want you to pay it back, so you have to negotiate how much of it you’re going to pay back, in what time schedule are you going to pay it back, and all of that kind of revolves around your pitch to them.”
Demystifying the FDA
“So I think that everyone thinks the FDA is really scary, but they’re actually really awesome people, and they’re really nice, so we did the Q-sub process, and had an informational meeting. It was a lot of work leading up to it I would say because you’re putting together a package and you have to submit it a certain way, they require you to burn CD’s, believe it or not, they do not take electronic submissions, so you burn the CD and you send it all in and they say yes! We’re happy to meet you on this day, and you just hop on a train; well we were in Philadelphia so we just hopped on a train, went to Silver Spring, Maryland, walked into the building, only US citizens can enter the building, so that’s something I didn’t know about, and after you go through security you wait in this lobby and then your lead reviewer comes out and gets you.”
Rui Jing also provided some tips:
- Communicate as frequently and as often as you feel comfortable doing with experts at FDA. It can only help you, really. They’re there to help you. I think the FDA’s intentions are aligned with your intentions, which is to get a safe, effective and life-changing application out to patients who need it, so you shouldn’t be afraid, in any sense.
- Determine which FDA pathway is most appropriate for your innovation
- Work with a regulatory professional, I think that can help alleviate any worry, and those also exist as consultants.
- Use your school’s alumni database to find people that have done this before or who in regulatory that can give some advice
“Bring your own computer. Oh my gosh, no one told me to bring my own computer, we thought we could just give our presentation on a thumb drive, and that is like a big cybersecurity red flag, so bring your own computer.,” she adds.
Want to hear our conversation with Rui Jing? Check out our podcast Spotlight on Women in Health Ventures on Spotify and Anchor!
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Story written by Luiza Perez and Priya Kumar.
