Thought LeadersMichael WeingartenDirector, Small Business Innovation Research Development CenterNational Cancer Institute 

In this interview, News-Medical interviews Michael Weingarten about his work as a director of the Small Business Innovation Research Development Center, helping to fund highly-innovative technologies that are revolutionizing cancer research.

Please can you introduce yourself and tell us about your role at the National Cancer Institute?

My name is Michael Weingarten and I am the director of the National Cancer Institute's Small Business Innovation Research Program (SBIR). This program was actually started by Congress back in 1982. It is really like a seed program for small biotechs in the cancer space at the NCI.

We fund the next generation of technologies that companies are developing for detecting and treating cancer. That is a very broad-based portfolio project. At any given time we are funding 400 to 450 different projects dealing with areas such as drug development, devices, diagnostics, research tools, and other key areas in treating cancers.

Can you tell us about some of the latest projects that you were involved in as a director of the Small Business Innovation Research Development Center?

One of the things that we do at the NCI is provide funding for these startup companies, which is crucial to their existence because we are the first source of funds that allow these companies to look forward when they are first getting started. The funding is critical, but most of these companies are five people or fewer, and so they need access to a lot of other resources in addition to just the funding. We are always looking for new programs we can start that really help meet a key need.

One program that we just launched this past year is called our concept award. The whole goal behind the concept award is to fund transformative new technologies that can have a major impact in areas like pediatric and rare cancers.

This is the first type of this award that has ever been done at the NIH. It is totally based on funding highly innovative projects, not just incremental innovation. The goal is to really transform the way we treat pediatric and rare cancers, looking for out-of-the-box ideas from companies and new approaches that have not been tried before for both pediatric and rare cancers. That is just one example, but we have got a whole range of other programs like that.

As cancer cases continue to rise across the globe, why is it more important than ever to develop these new technologies to prevent, diagnose and treat cancer?

I think that the key thing here is the opportunity to detect a cancer earlier so that it does not have the opportunity to advance in the person. Then you have that much more of a chance to actually treat it and cure the cancer. The earlier we can detect, the earlier that we can treat. The NCIS mission is early detection and treatment of cancers so that we can help patients.

The SBR program is a key component to that, but so is all the rest of the work that the NCI is doing. Most of our funding goes into basic research on cancers. We fund a lot of academic research on cancers. A lot of those investments in academic research yield new technologies that are spinning out of academic laboratories.

The whole goal behind the SBIR program is to help take some of those academic innovations, spin them out into small businesses, and then fund the small business to advance the technology all the way to the patient so that the patient can then be treated. It is kind of a continuum of investments from the NCI to advance all these promising new technologies.

You are involved in many innovative projects at the NCI. What do creativity and innovation look like to you within science?

That is a multifaceted question. In terms of creativity, we are always looking at where we can have the greatest kinds of impacts, both in terms of technology development and in terms of the resources that we offer to a small business. That includes funding the next generation of technologies that can really have an impact on the field, whether that be in drug development, in diagnosing cancers earlier, or in a whole range of strategies for how we go about treating those cancers. We are always looking to fund that next innovation that is really going to have an impact on the patient.

In addition to that, creativity involves looking at the needs of all these young startup companies. That includes providing, for example, connections with investors. With the SBIR program, we provide that early-stage funding from the government where we are willing to take on risks that maybe the private sector would not take on. That is what really makes the SBIR program different and special – we fund very high-risk, early-stage research.

As the technologies in these companies advance, they need to be able to raise investor capital in order to move that technology towards commercialization. Over the last 15 years, we have developed relationships with all the major investors in cancer in the private sector. We help connect our early-stage small businesses with those investors so that our companies can then help raise the capital they need to move their promising technologies all the way to commercialization, and ultimately towards patients.

Another thing that we do is provide key access, for example, to training that the small businesses need. We run a program called I-Corps, Innovation Corps, which really teaches companies how to build a business model around the technology that they have developed. For academic innovators, that is really important because they spent all their time in the labs.

They need to learn about how you go about running a business and not just developing technology, but moving that technology all the way to the marketplace? That is what I-Corps does. It teaches them how to build a business model in order to make that happen. Those are just some examples of how we impact creativity.

One initiative that you have recently launched at the NCI is the NIH I-Corps pilot program. Could you tell us a bit more about this program and how it works?

I-Corps takes teams very soon after they have received their first funding from us. We run this program for the NIH as a whole, so as well as running it at the NCI, we run it at 23 other institutes cutting across all different disease categories.

Typically, for the participating teams in I-Corps, we require a three-person team that involves the innovator and an industry expert who really knows the industry that they are targeting. Then it involves a corporate decision-maker on the team, someone who can actually take the recommendations and the learnings from the training they receive through this program and actually go out and implement them.

I-Corps works over an eight-week program. These companies go out and conduct over a hundred different interviews with stakeholders and customers in the market that they are targeting.

By doing that, they really understand what part of the marketplace their technology can have the greatest impact in. By talking to the real stakeholders, you can really understand that there are a whole plethora of areas where you could target a technology. By talking to customers and key decision-makers in a given market, you can really understand where each technology can have a major impact.

Because they do that type of research, it helps launch them to the next stage of the company where they know how they should be investing the resources of the company and what market they should be targeting in order to have the greatest impact on patients.

We have been offering this program now since 2014, and we have had over 250 different teams that have been trained across all different disease categories. What we found is that those companies that have gone through the I-Corps program, have gone on to become quite successful. They have been able to raise a lot of private funding to continue the development of their technologies to supplement the funding that they get from the NIH.

Often new initiatives, research and technologies rely heavily upon funding. How important is funding to the advancement of fields such as cancer research?

Funding is critical. If you talk to a lot of the companies that receive funding from us, most of them will tell you that if it was not for the SBIR program, they would not actually be here. Because when they are first starting out, they are fairly risky companies and it is very difficult when you are a high-risk, small business to be able to go out and raise private capital.

The SBIR program takes that risk. We are willing to take that risk because we know that if the government takes that risk, we can help step in and advance some of these technologies to the point where we de-risk them enough and the private sector will step in.

An example of this is when we funded a company called RefleXion. They came and started talking to us back in 2009 when they just had an idea of a new technology that they wanted to develop, but they did not have a prototype at that point. We were so intrigued by the idea of the technology that we were willing to take the risk and fund its development.

As a result of that initial investment that we made at the NCI, that technology has now been approved by the FDA. It is the first biologically guided radiation therapy technology that combines what is known as pet CT with radiotherapy. That allows clinicians to locate and treat multiple tumors simultaneously while imaging those tumors. It is real-time detection and treatment of multiple tumors.

The key thing is that SBIR took that early-stage risk by investing in that technology when it was just an idea. Because we were willing to do that, they were able to advance the technology and now they are at the point where patients are able to get those treatments and the technology is saving lives.

Cancer research. Image Credit: Roman Zaiets/Shutterstock.com

One area in which we have seen increased attention too is artificial intelligence and machine learning within science. What do you believe the future of AI looks like within science and specifically cancer research? Is there any particular challenge that we need to overcome before we can see it being increasingly used?

AI is one of the hottest areas in biotech research right now. There are all kinds of fascinating studies that are coming out of AI and we are heavy investors in that area ourselves. It is very promising.

We are funding this one company called Health Mine which is developing a new treatment planning technology that uses AI. This technology is called a quantitative imaging decision support system that combines imaging data with electronic medical records, as well as radiation therapy and other clinical data points.

By using AI, the company can analyze data and provide clinicians and doctors with decision-making support systems to help them in planning the optimum treatment for a particular patient. That is just one example of a project in AI that we are currently funding.

With continued innovation within science, especially concerning clinical diagnostics, are there any particular sectors that you are looking forward to seeing evolve in the coming years?

I think one of the most promising new areas is an area known as liquid biopsy, where you can get all kinds of genomic analyses of an individual's tumors just by taking their blood. We have been actively investing in the area of liquid biopsies. An example here is a company called Cynvenio. They are developing this liquid biopsy technology that provides access to a wide range of rare cancer cells in whole blood by simultaneously analyzing DNA from circulating tumor cells and germline DNA.

I think we started investing in liquid biopsy technology about 10 years ago. When we first started, it was an emerging field and there were not a lot of key players there. The NCI SBIR program was able to step in and provide these early-stage investments. It is a really thriving community.

In fact, there is a company called Thrive that is very active in this area, and that is a company that we also invested in. Liquid biopsies are a really promising area and one that we think holds a lot of promise for cancer research and being able to help detect cancers earlier so that we can come up with the optimum treatments for those cancers.

Have you got anything else you would like to mention?

We are always thinking about the impact of this program. It is important to be able to quantify the impact of the investments that you make in all these companies and the technologies that they are developing.

Back in 2018, we did an economic impact study where we went back and interviewed all the companies that had received what we call phase two awards from our program between 1998 and 2010. Phase two awards are where companies have reached a stage of development where the company is a little bit more mature and they are moving their technology through preclinical development and towards human clinical trials. We thought it was important to take a look at those companies and actually see what came out of the investment that we made in them.

What we found was actually quite impressive. The NCI invested $787 million of government funding into those companies, and that was across a total of 690 different projects. Out of those 690 projects, 247 technologies were commercialized. Those technologies are out on the market right now and those 247 products have resulted in $9 billion in sales and a total of $26 billion in economic return to the US economy.

What that shows you is that the small investment from the NCI, $787 million, has actually had a $26 billion impact on the economy as a whole. We are getting about a 33 to one return on investment from taxpayer dollars. It just shows you that these types of investments really are worth the dollars that you put into them.

When we started the study, we did not know exactly what the numbers were going to look like. We were hopeful, but when we actually saw the hard concrete results, it was really exciting to see. It makes you want to go to work every day.

About Michael Weingarten

Michael Weingarten is the Director for the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute in Bethesda, MD. In this role, Mr. Weingarten leads a team of 12 Program Directors who manage all aspects of the NCI SBIR & STTR Programs including a portfolio of $182M in grants and contracts annually. The SBIR & STTR programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. Mr. Weingarten has implemented a set of key initiatives for optimizing the performance of the NCI SBIR Program at the NIH. These include the establishment of a new model at the NCI for managing the program – the SBIR Development Center.

Written by

Emily Henderson

During her time at AZoNetwork, Emily has interviewed over 200 leading experts in all areas of science and healthcare including the World Health Organization and the United Nations. She loves being at the forefront of exciting new research and sharing science stories with thought leaders all over the world.