A 200:1 Return

September 30, 2010 at 3:18 pm Leave a comment

Mike Cassidy is President and CEO of the Georgia Research Alliance.  Lee Herron is GRA’s Vice President of Commercialization.  The GRA VentureLab program fosters the commercialization of university research.

From: Prausnitz, Mark R
Sent: Thursday, September 30, 2010 2:58 PM
To: Mike Cassidy; Lee Herron
Subject: VentureLab grant with a 200-to-1 return on investment

Dear Mike and Lee,

I am writing to let you know how a Phase I VentureLab grant has directly enabled us to receive a $10 million grant from NIH [the National Institutes of Health].  During 2009, we received Phase 1a and Phase 1b support from VentureLab, which we used mostly to generate product development, manufacturing and regulatory strategies for a microneedle patch for influenza vaccination. We also obtained quotes for GMP manufacturing, GLP toxicology studies, regulatory guidance through an IND and other work.

When NIH announced a new major funding opportunity last fall to support development of a novel biomedical technology through a Phase I clinical trial, we were ready to respond. Because we had already done much of the groundwork preparing for commercialization through a clinical trial, we were able to put together a high quality proposal within the few-month timeframe before the due date. We were only able to do this because of the advance work enabled by the VentureLab funding. We would not have been able to respond to the solicitation if we had not already done that work.

The result is that the NIH has awarded us $10 million over five years to develop a novel dissolving microneedle patch, manufacture it under GMP and obtain IND approval from the FDA, and carry out a Phase I clinical trial on influenza vaccination at Emory’s Hope Clinic. It is no exaggeration to say that we could not have even applied, let alone received, this award without the VentureLab funding to prime the pump. (Moreover, if the Global Center for Medical Innovation has suitable capabilities within our timeframe, we may do the GMP manufacturing there.)

We are leveraging this understanding of the pathways to commercialization and to the clinic in other ways too. We recently responded to a significant funding opportunity from the Russian government to develop a microneedle patch for diagnostic purposes through clinical trial and toward forming a company around the technology (in Russia…). We are finalizing a proposal with colleagues at Southern Research Institute that includes commercial scale up of a microneedle vaccine for a clinical trial. We are also in late stages of preparing a proposal with a Korean company for a microneedle device. We are also in on-going discussion with a California collaborator to start a new venture around dissolving microneedles for delivery of a biotherapeutic. We may still even start a company of our own! Our ability to respond to these opportunities has been significantly enhanced by the understanding developed through the VentureLab grants, because they all have commercial manufacturing and regulatory components that most academics do not understand. We now stand out not only as leaders in microneedles research, but also as knowledgeable collaborators on microneedles commercialization.

I thought you might be interested in these developments, and to know that VentureLab’s $50,000 investment directly enabled a $10,000,000 grant award, and we hope will enable even more. Thank you for making this possible.

Mark

Mark R. Prausnitz, PhD
Professor of Chemical and Biomedical Engineering
Cherry L. Emerson Faculty Fellow
Director of the Center for Drug Design, Development and Delivery
School of Chemical and Biomolecular Engineering
Georgia Institute of Technology

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