Commercializing academic research should not be so hard: learn from Vascudyne’s journey.
Are you looking to commercialize academic research?
Whether it’s your own research or you’re a biotech or medtech industry veteran scouting the best business opportunity, you’ll pick up some pointers from this case study.
Rick Murphy, VP Operations and General Manager at Vascudyne, shares his experience licensing technology from the University of Minnesota, tips lessons learned from how it’s worked so far.
Tell us a bit about Vascudyne: what are you currently working on and where do you see the company in the next 2-3 years?
Vascudyne is an incredible company, we are at the beginnings of a new era in medical treatment and have a world leading technology developed right here at the University of Minnesota. We are expanding our operations and developing a stronger understanding of the full potential of the licensed technology.
We licensed the biologically engineered tissue technology developed in Dr. Robert Tranquillo’s laboratory at the end of 2017 and are using it to fuel our product pipeline of medical devices.
We have already conducted our first in human trial using this premium material as an arterial to venous bypass and access for patients requiring hemodialysis and have been seeing very encouraging results. We are also conducting research and development studies that are showing additional potential of this technology.
Over the next 2-3 years, Vascudyne will continue expanding operations, pursuing the TRUE™ Graft through the clinical trials necessary to support commercialization, and presenting new designs to the clinic for alternative applications that have high commercial value and significant impact to patient care and healthcare economics.
When you were evaluating different technologies for licensing, what were the top criteria you were applying?
Vascudyne had always had a mission to find the best material for implantable applications, a durable material that doesn’t elicit an immune reaction. This material was initially sought for some of the heart valve applications we had been investigating at the early stages of our company.
We explored synthetics, chemically treated xenograft tissue, as well as lab grown engineered tissue. While the lab grown tissue was perhaps the more difficult from a processing perspective, the animal results we experienced early on were clear. The only biomaterial that meets all of the technology assessment objectives is lab grown engineered tissue. Our TRUE to Nature tissues we manufacture from cells in the lab are 100% biological and proved to be a clear winner by addressing both durability and non-immunogenic reactions while maintaining their regenerative potential.
What advice would you give to academics developing technologies with commercialization potential? What are some of the things that you saw missing in your search?
I have had such positive experience working with the University of Minnesota and feel there are some aspects worth mentioning that have been paramount to the success of the transition. For example, communicate with regulatory agencies as often as you can, even at the early stages of the project. Understanding the differences between a solid research study and a pivotal product development study helps with strategy and efficiencies.
Another example is to invest in process engineering to help potential partners understand the vision for commercial production.
A third example is to clearly show the strength of the advantage the technology has over the current market trends. This needs to be clear and concise as it is what the value partners are looking for.
Some of the technologies we explored early on had some weaknesses with respect to ensuring critical component supply agreements or complicated licensing agreement stipulations. While this is sometimes expected with academic research translation, this can prevent deals from being signed.
Efficiency is key and providing a clear and quick technology transition pathway is highly valuable to companies like Vascudyne.
What do you see as the biggest challenge in commercializing regenerative medicine technologies?
Regeneration technologies have some product development and regulatory approval burdens that need to be overcome.
One of them is the lack of truly replicating a clinical scenario in pre-clinical studies. This is true for any medical product, but even more critical for regenerative therapies. One can only model so much with animals which are traditionally healthy and have different healing responses to implantable materials. We have to be very careful in reading too much into the results from animals, but also need these studies to improve our confidence in the product performance before going to clinic.
The data generated in research then needs to be balanced with the expectations of the regulatory agencies. This is a lengthy and expensive process, which is why it is so critical to choose the correct material early on in the process.
What industry trends or developments give you hope about the successful commercialization of tissue-engineered medical products?
From my perspective, engineered tissue is a premium product that is a far better choice than any other implantable material that exists in the market today.
There are so many applications needing a non-immunogenic and regenerative material. In the end, we need to show how our materials will help patients while showing some benefit to the costs of healthcare.
At the onset, this is seemingly an oxymoron, but the strength in engineered tissue technology is the ability for the patient’s body to recognize the implanted material as its own, thus not eliciting any immune reaction and providing a durable material that will last the lifetime of the patient.
How to Contact Rick: You can learn more about Vascudyne and its TRUE™ Tissue technology at vascudyne.com and reach Rick at rmurphy(at)vascudyne.com.
Disclaimer: Vascudyne is an Access Biomedical Solutions client.
