The latest innovation in oncology research is tying tumor biomarkers to specific treatments in order to improve patient outcomes. Med Ad News spoke with Gerald Messerschmidt, M.D., chief medical officer of Precision Oncology, to find out how the biomarker-treatment link will help get treatments to market, and to the right patients, faster.




Med Ad News: What is your company’s goal in oncology research?

Gerald Messerschmidt: The major goal of our organization is to get promising new drugs to cancer patients much faster. That includes widening access to the drugs while they’re still experimental, and then of course bringing them to market faster. We are doing that in several ways. What we see with oncology is that a lot of these newer therapies are very targeted, very specific. That results in higher responses in selected population and lower toxicity. So the pathway can actually be compressed into a shorter time period and smaller number of patients. That’s what we talk to our clients about – finding ways to design protocols so that FDA and EMA and the rest of the world can approve the drugs faster and get them to the cancer population.

Med Ad News: Can you tell us more about how this accelerated process works?

Gerald Messerschmidt: The process involves a profiling of the patient so that we have a specific understanding of the patient’s cancer and that includes the mutation status of the cancer, the abnormal proteins of the cancer, where it started, where it’s located and a lot of the – what’s on top of the cancer so that maybe vaccines can even be used. We profile the patient and then we set a criteria in the clinical trial, often with several different arms or baskets, where the patient will get specific treatment based on their specific profile and may get one or more drugs in the clinical trial. Because of the specificity of the selection of the patients, the response rates are often quite high. FDA has recognized this new way of speeding on patients that can get benefit with specific profiles and specific drugs, and is working with us and everyone else that they approached to try to get these products approved more rapidly. Now, a major part of all this is the biomarker.

Med Ad News: Can you explain a bit more about the link between drugs and biomarkers?

Gerald Messerschmidt:  The data is very clear regarding cancer drugs that are associated with biomarkers that can be specifically measured, so that we know from the profile what the patient has and then follow the biomarkers. Those drugs actually get approved much faster than drugs that do not have biomarkers. We believe and have seen it firsthand that the combination of smart clinical design, in association with a biomarker, leads to much more rapid approval and uptake in the market.

Med Ad News: So a potential client comes to you with a compound and says, “We want to find a biomarker that’s associated with this compound.” Is that correct? Are they coming to you with biomarkers already and asking you to seek out the potential biomarkers among potential clinical trial participants? Or are they asking you to find the biomarkers?

Gerald Messerschmidt: It can be either way. They often come with a proposed biomarker. Some do not have an idea of a biomarker and we can help them from the beginning. In either case, the goal is to get the biomarker associated and develop a companion diagnostic – to get approval of your drug and your test at the same time.

Med Ad News: Can you give us a real-world example?

Gerald Messerschmidt: There is a pharmaceutical company that is, I would say, a medium-size biotech pharmaceutical company with a new cancer drug that they want to bring to the market. They did not have a biomarker. However, in a lot of time going over data and research, recently I found a potential biomarker for them. We have been discussing performing liquid biopsy for this biomarker that is specific to the cancers that their drug is targeted to. Our plan is to get them into trials and approved relatively quickly. The biomarker will be a part of that. We proposed that to them, actually. This happens frequently. I would say that we have recommended to probably 70 percent to 80 percent of our clients that they seriously consider developing another biomarker. In the proposals that we have received over the last year, it is really an important part of the process that a lot of people are not as familiar with as we are and we have been helping.

Med Ad News: So it sounds like most of your clients are coming to you without biomarkers already?

Gerald Messerschmidt:  That is exactly right. Probably 20 percent to 30 percent come with a proposed biomarker and we propose to them most of the time that they consider a companion diagnostic with a specific biomarker, or sometimes, two and three. We may not use them all but we talk to them about the pluses and minuses of each biomarker, and then a decision is made to incorporate that in the clinical trial.

Med Ad News: You said that you were reviewing research to try to find a biomarker for a particular compound. Is this research that was done by the sponsor company? Where does this research come from?

Gerald Messerschmidt: We were asked to help them develop their plan to bring this to market. When we do that, we do in-depth research, and so I spent time reading the literature and finding other experiments done in universities and people developing similar products, and was able to discover a unique marker that’s in the blood of the patients they were thinking of targeting, which was actually described several years ago by another researcher who found the marker in the blood but really isn’t well known. It’s a real positive – I was very excited when I found this research at this research paper because it really provided a coming together of many of our programs actually. One is just a general biomarker. The other is liquid biopsies.

Med Ad News: What are liquid biopsies?

Gerald Messerschmidt: The standard in oncology today is to biopsy the tumor and to look at it under the microscope with various different stains and different ways of looking at it to understand what the tumor is, and to test it for genetic mutations and those kinds of things. What we’re discovering, and others have also, is the potential of measuring these things not necessarily in the tumor biopsy but in the blood. What we’ve learned is that these genetic mutations and these abnormal proteins and other things that we would, that we have often measured only in the tumors, we’re also finding in the blood. Now, this is a developing area that’s only been going for a short period of time, but it’s really rapidly growing because it saves the patient, potentially a surgical procedure.

The other thing is that, sometimes, the tumor you biopsied may not represent other tumors in the body, so the liquid biopsy has the potential – if all the tumors are shedding these abnormal molecules, then the liquid biopsy has a potential to get a more complete read on the profile of the cancer and what abnormalities exist, not only in one of the tumors but the other metastatic areas. Liquid biopsies really have a potential for a much higher accuracy in the future. As of this moment, it’s still a burgeoning field, but we’re very excited to talk with our clients about this.

In the process of developing these, we also recommend traditional biopsies at the moment but we also try to develop a liquid biopsy program along with it to be able to compare and contrast the different data that we get from each side. In this one that I’ve been working on, I found that they actually did discover a very interesting biomarker in the blood of patients with this tumor type and so can be exact regarding this product target. It’s very conducive to a liquid biopsy program in their clinical trial.

Med Ad News: You’ve said that the use of biomarkers can significantly speed up the regulatory process for cancer compounds. Has that already been the case?

Gerald Messerschmidt: One of the products we worked on was approved in 18 months. These new strategies are really quite viable but you can’t just – what you’re doing is using drugs that have high specificity that you can measure with the biomarkers and in the patients, but you also have to make sure that these are – that toxicity is understood and acceptable. And it has to be done by people who really understand these newer ways of thinking through these clinical trials to lead to approval by FDA or EMA, because the numbers are so much smaller that you have to be quite specific in how you select the population and how you collect the data, and then present the data to make sure that it’s safe and effective.

Med Ad News: What about economic outcomes analysis?

Gerald Messerschmidt: We have a division called Precision Health Economics that specifically looks at economic and health outcomes for insurers, for the government, for large pharmaceutical and small pharmaceuticals. Anything that tends to decrease cost is looked on as a positive by everyone, so we take it extremely seriously, so that’s one of the reasons why we are so interested in doing things faster with smaller numbers of patients but with equal care, because that decreases the cost of the clinical trial for the company. For example, we were talking to a small biotech a week ago in the Boston area and one of their major concerns was that they’re getting ready to go into Phase II and III. We recommended putting them into one trial with a smaller number of patients because their drug looks very efficacious and very safe, so we also recommended that they consider because they’re moving towards marketing with this drug in getting approval and that’s what we’re planning for, that they seriously consider health economic outcomes also in the study.

What our health economic group does, in general, is look at studies that have already been completed for payers and others to try to figure out, “Is this therapy decreasing the overall cost of healthcare for this patient population?” or, “Is it keeping it the same?” or, “Is it increasing it?” That’s a standard health outcomes economic type of program. But what we’re trying to do is do it earlier. Part of that – one of the things that our health economics people tell me is that they are trained to look at these lines of clinical trials and put them together in this retrospective analysis, which is sometimes quite difficult. Whereas in this program, we’ve been integrating it into the clinical development program so that the parameters are more consistent, and the economic outcomes can be more directly tied to the benefit to the patient.

Med Ad News: So your studies have both clinical and economic endpoints or targets?

Gerald Messerschmidt: Yes. I’d expand it a little bit farther and say that we have clinical endpoints which are patient derived endpoints, we have laboratory endpoints like biomarker decreases or increases, and we have economic endpoints that we recommend to our clients. We recommend incorporating all three into the development plan. So as we’re analyzing the response rate or the regression pre-survival or the overall survival in the outcomes in our biomarkers, the health economic guys are analyzing the impact on the health system.