The Wallace H. Coulter Foundation Optimizes Academia Process

The Wallace H. Coulter Foundation will participate in OneMedForum SF 2012.  The late Wallace Coulter’s deepest passion was to improve health care and make these improvements available and affordable to everyone.  Mr. Coulter dedicated his wealth to continuing to improve health care through medical research and engineering and, prior to his death, established the Wallace H. Coulter Foundation to fund these areas. OneMedRadio will conduct a series of 4 Interviews that will be focused on the Coulter process and the success stories by interviews with Coulter representatives and CEO’s of companies selected by Coulter. Below, Elias Caro, VP of Technology there, sat down with OneMedRadio to discuss this Miami based organization and the leading universities the company is involved with that have demonstrated groundbreaking technologies.

Brett Johnson:    Welcome. This is Brett Johnson in New York City with OneMedRadio. Today, we are with Elias Caro who is the VP of technology at the Wallace H. Coulter Foundation, a Miami-based organization that’s developed a process to help universities translate medical technology and successfully bring it into the marketplace. They’ve had great success recently and will be actually participating in the OneMedForum that’s coming to San Francisco in January. Thanks for joining us today, Elias.

Elias Caro:   Good afternoon, Brett. I’m delighted to be here.

BJ:    Can you tell us a little bit about what the Wallace H. Coulter Foundation does?

EC:    In 2005, the foundation selected ten universities for a five year Coulter Translational Research Partnership in biomedical engineering. Through this partnership, the foundation has developed, refined, and taught researchers a disciplined approach to translate university innovation. Using the Coulter process, a university office of technology transfer and other key stakeholder engage in an extensive analysis of technologies, intellectual property position, risk assessment, follow-on funding, critical milestone, and clinical adoption with the goal of improving prospect for commercial success.

And the five-year outcome from the partnership I think is impressive. To date, these universities where we have funded more than 200 projects and where we have invested $40 million in gap funding have reached an impressive return. Twenty-seven startups have garnered $150 million in venture capital funding and dozens more have attracted project specific governmental grants totaling several hundred million dollars. Also, about 28 companies had been licensed by established companies like Johnson & Johnson, General Electric and others.

BJ:    So what do you attribute to the success? I mean as you’re suggesting you have, you know, 55 deals that have gotten serious funding from the universities that you’ve been working. What is the core of the process? What makes it work?

EC:   At the Coulter Foundation, we all come from the medical device industry and so basically what we did was to say: “This is the way the process works in the industry”, and ask: “Can we transfer it and optimize the process for academia? Basically, it’s the well known process that is the Stage-Gate process that is used for product development in companies. Of course, this requires a cultural change in the universities since the researchers are used to a more lax process, which is the funding that they receive from NIH and other governmental institutions when they do basic research and sometimes translational research. So they apply for grants, get the money, and write a report once a year.

In our case, it’s very different. Besides the various strict upfront analyses before funding where we look at all the different commercialization risks like whether the FDA will approve, the possibility of reimbursement, the adoption by the community, is this really going to change medical practice, what is the next stage of funding, and where that funding is going to come. Once we clear all these risks, we do a very comprehensive analysis of all these risks, then we fund the project but after that, we really manage the project using the program management approach that is used in industry. We have very clear timelines, milestones, and we define the critical experiment that if it’s successful will bring the value to the technology and make it ready for follow-on funding.

BJ:     So you essentially just take the disciplines that you find in industry and your background obviously in the medical device industry and you basically apply that into the academic setting. And obviously that apparently works well. When you discuss this idea of vetting or analyzing the ideas, is that done by the Coulter Foundation or is that done by outside groups that are connected to the different universities?

EC:     Well, what we did is we asked the universities to create an oversight committee and the oversight committee is composed of VCs, entrepreneurs, and clinicians. The functions of the oversight committee  is first, the selection of the project, second is to mentor the projects, and third is to be the oversight of the program to see if there are things that can be done better. Of course, also we added one element that didn’t exist in academia, which is what we call the Coulter Program Director. This is a program manager that really manages the projects and makes sure that the projects keep moving through the milestones and reach the desired goals.

BJ:   So now you have a number of leading universities that have now participated in the process. As I understand, ten different universities, some of the most prominent in the country have been part of the program, and as I understand it’s been a five-year in development and now they’re beginning to put these new technologies out in a more regular fashion. And so these technologies are now available as I understand. Is that correct?

EC:   The program started five years ago and of course the first two years it was a little bit trial and error for all the stakeholders to really understand what we were trying to do, but really after the third year, this came really into focus. So far, as I’ve explained 55 of the technologies had been licensed out but there are still more than a hundred projects that continue to move forward at these universities that some are ready to be licensed out as well.

BJ:     Okay. So there are upwards of 100 well developed technologies available at this point from these different universities.

EC:    That’s correct. And really these are all technologies that are addressing unmet clinical needs and all of them had been screened and validated from all the areas of commercial risk and approved by this oversight committee that as I said has the leading VC, entrepreneurs, and clinicians that form these oversight committees.

BJ:    Tremendous. So essentially there’s a hundred very solid ideas that meet a clinical need that have really been developed that are now available for commercialization. How do people learn about these technologies?

EC:    On our website, we have the names of the universities and if somebody wants to see what projects are available in the universities, they can contact directly the Office of Technology of those universities.

BJ:    Okay. Terrific. And that website is

EC:   Yes.

BJ: So Wallace H. Coulter Foundation, the acronym for that Okay. Well that’s exceptional. Now another component that you have talked about is gap funding. Can you tell us about that and that’s actually providing some additional capital to help move these things along?

EC:    Yes. So we provided to each university a million dollars a year and that money includes about $200,000 to do commercialization, IP analysis, etc. and the rest was used to fund projects, about $100,000 per project per year. And what was surprising for us coming from the industry were, it would require several millions to move projects forward. In the universities in most of the projects that have been successful had been successful with only $200,000 to $300,000 of funding, so basically two to maximum three years of funding. So really, the oversight committee decides how much money to give to each project and how long to fund it before they are ready to be licensed out.

BJ:  So it’s interesting that your experience has been more capitalization or actually required less money within the university setting than it has been in your experience in the private sector.

EC:     Yes, in most of the cases, we get to large animals, efficacy and safety and in some cases, even to first in humans. So yes, actually it’s very cost efficient. The universities, all the instrumentation is available and second they have very inexpensive labor with all the PhDs and the students they have.

BJ:  Interesting. So it’s a unique combination. You’re taking sort of the best management ideas from the industry and you’re marrying them with the good platform or the efficient, cost efficient platform of academia and you’re putting them together to get a win-win kind of sort of best of both approach.

 EC:    Yes. And also you have to remember that all these technologies had been previously funded by NIH, NSF, and all the governmental institutions so there are millions of dollars behind these technologies. But what we added was risk capital to move it from a basic research and a technology that existed to a product that solved an unmet clinical need.

BJ:   Can you tell us a little bit about your background and the Coulter origins of the business and how all this came to be?

EC:   So Wallace Coulter, our benefactor, invented the Coulter principle in 1947, created a Coulter Corporation in 1957. He was at the head of the corporation. For 40 years, the company remained private and in ’97, the company was sold to Beckman and became Beckman-Coulter. Wallace passed away in ’98 and that day the foundation was formed. Something that is unique about our foundation is that we all come from the industry where in most of the foundations that support medical research the leadership comes from academia. So our focus is really to apply the same processes that we have in industry.

My background, I was in charge of several international units of Coulter from ’85 to ’97 when the company was acquired, in Latin America, Europe, and Japan. And in Beckman, I was in charge of product development for all the diagnostics after that I was the president of one of the two divisions, the life science division. Finally, I was in charge of the commercial operations worldwide and in 2006, I retired from Beckman and joined the Coulter Foundation.

BJ:  So if you had to sort of like paint your vision of the Coulter Foundation as related to this translational process, what’s your vision of where you hope to take this?

EC:   Well, I think that now we have ten universities that understand how to do translational research and in partnership with us, had put the funds to continue the program as we call it in perpetuity. So now we have ten that we can consider powerhouses in translational research. Some of those universities are expanding our programs to other areas of technology and science because they felt that this process can be implemented in other areas of engineering and science. This group of ten universities is what we call our phase 1. Now we are starting a phase 2 where we invited six more universities and they will start the five-year program and that will start next year.

BJ:   Terrific. Well it sounds like you’ve really built a great process there and made a great contribution to translational medicine so congratulations on that and thank you very much for joining us today.

EC:   Thank you very much.

BJ:    So that is Elias Caro who is the VP of technology at the Wallace H. Coulter Foundation, a Miami group that’s developed a tremendous success story here on bringing technologies from the university setting into the marketplace. This is Brett Johnson signing off for OneMedRadio in New York City. Have a great day.

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