Mark Prausnitz holding microneedle vaccine patch

Mark Prausnitz is among five Georgia Tech professors named to the new distinction of Regents’ Entrepreneur by the University System of Georgia (USG) Board of Regents.

Prausnitz is a Regents’ Professor and the J. Erskine Love Jr. Chair of Georgia Tech’s School of Chemical and Biomolecular Engineering (ChBE). His recent designation as a Regents’ Entrepreneur recognizes his reputation as a successful innovator who has taken his research into a commercial setting. He is the only faculty member at Georgia Tech recognized as both a Regents’ Professor and Regents’ Entrepreneur.

Prausnitz has co-founded seven start-up companies based on the commercialization of microneedle technologies developed in his lab at Georgia Tech. Together, these companies have raised nearly $350 million. Three of the companies have products for sale, including an FDA-approved treatment of ocular inflammation. His technologies have been studied in more than 20 human clinical trials.

"Mark is not only one of the most accomplished entrepreneurs in the College of Engineering and at Georgia Tech, but he stands out nationally and internationally for the progress and impact he is making to bring exciting advances out of the laboratory and into medical practice to benefit the health and wellbeing of people around the world," said Professor Christopher W. Jones, the John F. Brock III School Chair of ChBE.

Creating Novel Technologies at Georgia Tech

The basis for most of Prausnitz’s entrepreneurial activity involves the development of microneedle technologies. Microneedles are solid or hollow structures that measure microns in dimensions and can be used to administer drugs into tissues in the body without the limitations of hypodermic needles. Solid microneedle patches contain drug within the microneedles that is released into the body upon pressing the patch onto the skin. Hollow microneedles infuse drug solutions into tissues in a minimally invasive way.

"In terms of broader impact, Dr. Prausnitz’s microneedle patches offer a painless option for simplifying vaccinations with huge potential to impact global human health. With Gates Foundation funding, clinical trials involving measles and rubella vaccination are underway in West Africa," said College of Engineering Dean Raheem A. Beyah, Southern Company Chair. "This technology also enables self-administered vaccination, including those for the common flu. By translating microneedles technology into the clinic, Mark’s aim is to make vaccination programs, including in developing countries, more effective."

Since Prausnitz started his research lab at Georgia Tech in 1995, he has supervised 48 PhD thesis students; 80 postdoctoral researchers, research scientists and visiting researchers; and almost 200 undergraduate and high school students. His work has produced 317 journal articles that have garnered more than 50,000 citations (h-index of 110), more than 350 conference abstracts, and more than 275 invited lectures at conferences, universities, and industry. He has served as principal investigator or investigator on more than 100 research grants totaling almost $50 million.

A microneedle used to inject glaucoma medications into the eye is shown next to a conventional hypodermic needle.

Licensing Intellectual Property

Prausnitz is an inventor on 83 invention disclosures filed with Georgia Tech. These inventions have generated 71 U.S. patent filings, yielding 29 issued US patents, and 39 pending US patents. Among those, 54 patents (79%) have been licensed by companies (i.e., mostly companies founded by Prausnitz). In addition to the U.S. patents, Prausnitz is also inventor on 93 international patent filings. In recognition of the impact of his inventions, Prausnitz was elected as a Fellow of the National Academy of Inventors.

A patch containing 100 dissolving microneedles is shown on a U.S. penny coin.

Founding Start-up companies

All seven of the companies founded by Prausnitz have been based on microdevices utilizing microneedle technologies for medical and other applications. These companies are in various stages of commercialization, ranging from performing pre-clinical technology development to conducting clinical trials to having an FDA-approved product.

The companies include:

• Redeon. When Prausnitz published the first paper on microneedles for drug delivery in 1998, its press release received more press coverage than any prior Georgia Tech press release not about sports. Prausnitz was approached by a serial entrepreneur from Boston (IJ Gujral), which led to their forming Redeon, along with Mark Allen (a former Georgia Tech faculty member), to develop microneedle patch technology for drug delivery. After a first round of venture capital financing, they sold Redeon to a larger company (BioValve) that continued to develop the technology.
• Microneedle Systems. To address the need for microneedles in research, Prausnitz and former student Vladimir Zarnitsyn founded Microneedle Systems, which was the first company to make microneedles available off-the-shelf to research labs in academia and industry. The company sold microneedles for about a decade, until the field matured and microneedle technology eventually became more widely available.
• Clearside Biomedical. Collaborating with Emory University, Prausnitz developed hollow microneedles for targeted injection in the eye, especially into the suprachoroidal space. Along with Henry Edelhauser at Emory and Samir Patel and Vladimir Zarnitsyn at Georgia Tech, Prausnitz founded Clearside Biomedical in 2011 to commercialize the technology, where he served on the Board of Directors. The company had an IPO in 2016, received FDA approval of its first product in 2021, and will begin sales of the product in 2022. Through venture capital financing, followed by stock offerings listed on the NASDAQ, Clearside has raised nearly $300 million to support its commercialization programs.
• Micron Biomedical. Leveraging results from a successful Phase 1 clinical trial of influenza vaccination by microneedle patch by Georgia Tech and Emory, Prausnitz founded Micron Biomedical with Sebastien Henry and Devin McAllister in 2012. With Prausnitz serving on the Board of Directors and as the company's chief scientific officer, Micron has raised about $20 million in non-dilutive financing from Gates Foundation, pharmaceutical companies and others to support technology and product development, including conducting multiple on-going and planned Phase 1 and 2 clinical trials. Micron is currently in the final stage of a major venture capital financing round.
• Aldena Therapeutics, Vimela Therapeutics, Microstar Biotech. The most recent manifestation of microneedle technology is STAR particles, which can be rubbed on the skin to increase drug absorption. Prausnitz has founded three companies based on this technology. Aldena Therapeutics raised $30 million in venture capital to advance the technology as a platform in dermatology. Vimela Therapeutics raised $11 million in venture capital to develop STAR particles for a specific high-value application in dermatology. Microstar Biotech is adapting the technology for cosmetic applications.

STAR particles shown on a fingertip

Consulting and Advising Other Companies

Prausnitz has served as a consultant to 50 companies and other institutions, including Genentech, GSK, Becton Dickinson, Merck, Kimberly Clark, Estee Lauder, and others.

He has served on the scientific advisory board of 10 companies, on the Board of Directors of six companies, and as an expert witness in more than 60 legal cases.

Regent’s Entrepreneur Creation

The board approved the Regents’ Entrepreneur designation in their February 2022 meeting to recognize and support faculty entrepreneurship and innovation. The Regents’ Entrepreneur designation may be granted by the Board of Regents to an outstanding full-time tenured faculty member who has an established reputation as a successful innovator and who has taken their research into a commercial setting. The Regents’ Entrepreneur designation is bestowed by the board only upon the unanimous recommendation of the USG institution president, the chief academic officer, and the chancellor, and upon the approval of the Committee on Academic Affairs.