Leadership Series Featuring Harry Glorikian, Senior Executive, Board Director, Consultant, and Investor

Driving Diagnostics Towards its Data-Centric Future

“If the difference between evolution and revolution is the speed of change, then healthcare is now in the mode of revolutionary change.”

Internationally renowned as a leading figure of the life sciences, healthcare & healthcare IT industries, Harry Glorikian is a company founder, sought-after speaker, and author of numerous publications distributed worldwide.

In this exclusive Slone Partners interview, Harry opens up about his new diagnostics book coming out this fall, the biggest challenges & trends facing the IVD industry, and the most pressing healthcare issues of our time and why they must be overcome.

Slone Partners: We understand that you are publishing a book on diagnostics next fall. Can you tell us a little about the book and why people in diagnostics should read it?

Harry Glorikian: For years, I’ve been asked for advice on particular aspects of IVD development and commercialization. Each time, it would be about a different part of the process—sometimes it would be about commercialization and other times it would be about strategizing to get the regulatory part right. When you think about IVD development from biomarker to finished product, it’s really complex and very few people understand all the pieces that need to come together to have a successful product. I came to the realization that there’s a real need in the industry to have a reference that can put together the major components of IVD development—from product ideation and design through commercialization and reimbursement.

This book/manual sets out to accomplish just that—aggregating the necessary information, honing in on the most important parts—the basics of what you need to know, and offering suggestions to make the process as smooth as possible.

Slone Partners: How would you say the IVD industry has changed over the past several years?

Harry Glorikian: Certainly the introduction of new technology has changed substantially in the past decade or so. Just look at genetic tests—next generation sequencing has driven down the cost per human genome and led to clinical use of whole exome and whole genome sequencing. The information we are getting from tests is becoming more complex and being used for prognosis and to determine treatment. Think about a patient with breast cancer. Years ago, they would have been given the same treatment as every other patient with breast cancer and there was no way of knowing ahead of time if they would respond favorably. Now treatments are based, in part, on the expression of different genes and the predicted response to therapy. Drugs are being developed for subpopulations of patients based on their tumor subtypes. That’s a substantial change in how we treat patients and it’s being driven by the IVD industry and the data they generate.

Another big change in the industry is the need to think in terms of the value. Healthcare is moving away from a fee-for-service model towards one based on performance and/or outcome. It’s not enough to just develop your IVD and set a price based on what you think it’s worth. Getting the right clinical utility and cost-effectiveness data is crucial to convince payers, providers and those in regulation that your test is important. This means setting up the right kinds of studies from the beginning—they can’t be an afterthought if you want to collect the data you need to support your device.

Slone Partners: When you look ahead, what trends do you think are going to have the biggest impact on the IVD industry in the next 5 years?

Harry Glorikian: I think regulatory developments are going to have a significant impact on the IVD industry in the years to come. Particularly for LDTs—final guidance from FDA could be a game-changer for a lot of companies and laboratories. Another interesting development could be the use of Agency “approved” or “certified” databases that could be used for evidence supporting the use of diagnostic devices. I’ve already mentioned how evidence-based medicine is becoming even more important; creating that evidence is both time-consuming and costly. There’s already so much evidence that’s been collected for research studies. How can we access that data for clinical utility or cost-effectiveness studies? I think we’ll see more partnerships and data-sharing agreements that are mutually beneficial for companies and researchers to leverage existing data and design clinical trials with outcomes that can be used for both diagnostics and drugs.

Reimbursement is another area where what happens in the next few years could have a pretty dramatic impact on the industry. If companies can’t get reimbursed at reasonable rates, innovation, development and investment will slump. The groups that will suffer the most if we stifle innovation in the IVD industry will be providers and patients. To achieve a true value based outcomes world we will need novel diagnostic products and the analytics that go with them to help in the diagnosis of the disease as well as predict what therapy will work best.

Another big trend I’m seeing right now is the growth of digital health. I can see a great deal of potential in this space. Think about it: how many people are using Apple watches, Fitbits, or health apps on their phones? Consumers want their data and they want to be able to use it to help them stay or get healthy. There’s a lot of potential here for IVD companies to cater to this growing demographic. The only caveat I would mention is if the IVD industry doesn’t cater to this growing trend other players will.

Slone Partners:What is the top piece of advice you would give to a company looking to enter the IVD market for the first time?

Harry Glorikian:The most important piece of advice I can offer is to make sure you get the right team in place from the beginning. Everything else follows that. You have to find someone who knows the regulatory piece inside and out, someone who understands commercialization in this emerging value based environment, someone who can handle design, and so on. You can contract out for consultants who specialize in each part of the process or hire someone directly. Get a great project manager on board who can orchestrate these different pieces. There is so much complexity to IVD development and commercialization. A project manager who can make sure nothing slips through the cracks, coordinate the timing of deliverables, and communicate with all of the stakeholders, from scientists to sales and marketing, is essential. You need someone who can make sure that you have everything in place to get your product adopted, approved (if necessary), and reimbursed. Who you have on your team or the groups advising you can be the difference between a product that succeeds and one that fails.

Slone Partners:In your blog series “Moneyball Medicine” you address the unique challenges faced by the healthcare industry today. What is the most pressing issue that must be overcome and how can we achieve that?

Harry Glorikian: The most pressing issue is interoperability/transparency. We can’t emulate the baseball world unless we have the same access to data, and right now a lot of health care facilities, pharmaceutical companies and research centers are still hoarding crucial data and not sharing it. So it is difficult to make the best “data-based” decisions. New regulations and more “competition based on data” could improve that. The only way to get to a value based outcomes world is by having the data available to analyze and optimize.

Also the Moneyball series is being migrated into a book that we plan to publish next year – stay tuned!

Slone Partners:In Moneyball, The Oakland A’s identified on-base percentage and slugging percentage as the best indicators of offensive success. What performance metrics do you think we should be looking at in healthcare?

Harry Glorikian: In healthcare, it’s very clear that we need to look at safety, efficiency, and the measurement of outcomes.  What are the rates of infections and other poor outcomes? Why would you go to a hospital with high infection rates? But today, it’s hard to discern that because we’ve only begun to share this information. Also, how often are doctors at a particular facility using best practices and/or optimizing a process? We like to say that healthcare is different….

But the best institutions must be in a constant state of measuring and analyzing the data. The analysis of this data will allow us to ask different groups to set best practice treatment goals associated with better outcomes. The healthcare landscape is changing, and it is changing fast. If the difference between evolution and revolution is the speed of change, then healthcare is now in the mode of revolutionary change. Medical information that was once kept on paper, widely dispersed, and rarely shared, is now being stored digitally. As we have seen in many other industries (Media, Telecom, Retail) once digitization takes hold the status quo can be disrupted. Healthcare has always believed that it is different and therefore the barriers to change are higher, and we in the healthcare industry are less affected. But the industry is not immune and few realize how fast the change needs to happen, or how transformational it needs to be. To be clear with this statement – organizations need to think about how data and its use may change their existing business models and/or create new models that generate more value. ”

I mentioned the move to value based outcomes earlier in this interview – if there is a single factor driving much of this change it will come from the shift in how providers are compensated for better patient outcomes. This will dramatically increase the way groups will combine and analyze data to achieve better outcomes for lower cost. This will also result in a significant change in the way industry provides products and services to providers.