Executive Spotlight: David Levison, Founder, CEO and Director of CardioDx

CardioDx is a personalized medicine company that develops and commercializes genetic based cardiac diagnostic tests. The company is currently developing several molecular diagnostics that will help physicians determine appropriate treatment for cardiovascular patients. CardioDx is using both genetics and genomics technologies to develop these unique diagnostic products. David Levison, the founder, CEO and director, who was previously a venture capitalist and CEO of a couple of start ups, including XDx and iScribe, talked with me about what it's like to run a start-up, how CardioDx is seeking a competitive edge in the cardiovascular testing market and how he thinks diagnostics might hold the key for more efficiently spending our healthcare dollars.

Q: Tell me about CardioDx, its products and what’s in the pipeline.
A: CardioDx is a four-year old genomic diagnostics company focused exclusively on cardiovascular disease. In June of this year, we launched our first product, Corus CAD, which is a gene expression test to aid in the assessment of obstructive coronary artery disease. This test is designed to help physicians identify which patients with chest pain are likely to have enough plaque in their coronary arteries that it is obstructing blood flow to their heart. This first test is intended for non-diabetics, but we are working on a product version for diabetic patients. We’re also working on prognostic applications of this product—so, say a patient’s score goes up over time, we’re looking at what that may mean in terms of disease progression. Additionally, we’re looking at multiple technology modalities; this first test is based on the expression of certain genes, but there could be applications for proteomics and/or genetics as well. In addition, CardioDx has an ongoing prospective clinical trial in arrhythmia and sudden cardiac arrest risk stratification to identify patients who would be good candidates for receiving implantable cardioverter defibrillators, or ICDs. Right now clinicians have suboptimal diagnostic tools to determine who would be ideal recipients for these sophisticated therapy devices. In fact, studies have indicated that a majority of these devices implanted in patients may never need to deliver therapy, or “fire”.

Q: How does the Corus CAD test work?
A: It’s a gene expression test that measures how the activity of certain genes in peripheral blood reflects the state of disease in the coronary arteries. It’s a central lab test (CLIA), so a blood sample is drawn by a clinician in an office or lab and shipped overnight to our lab in Palo Alto. The results, in the form of a score, which correlates to the probability that the patient has obstructive coronary disease, are sent to the clinician within two days. Clinicians should use the Corus CAD test results in conjunction with other tests in their patient assessment, and our U.S. clinical trial (PREDICT) results indicate that a low patient score reflects a low probability that obstructive coronary disease exists. And finally, Corus CAD provides a safe, noninvasive, and less restrictive means of assessing obstructive coronary disease without patient exposure to radiation or imaging agents, which many patients do not tolerate well—we think that’s pretty important, too.

Q: How is this condition currently diagnosed?
A: Currently, obstructive coronary artery disease is being assessed in numerous and varying ways: clinicians consider a patient’s personal or family history of cardiovascular disease, the type of chest pain they’re having, and numerous other clinical variables that impact the likelihood a given patient has coronary artery disease. Many times noninvasive imaging modalities are utilized, such as echocardiography or myocardial nuclear perfusion. These procedures are not entirely benign for all patients, and they are costly and time-consuming.

Q: How many people work at CardioDx and how many locations do you have?
A: We have about 70 people working in research and development, clinical and regulatory, sales and marketing, our commercial CLIA lab, and operational administration roles. Our primary location is in Palo Alto, but others are spread throughout the country working on our clinical trials and commercializing Corus CAD in our initial sales territories.

Q: Which companies do you view as your main competitors and what are your main competitive advantages?
A: Well, our competitors can also be our greatest collaborators. Certainly we would count the large labs like Quest and LabCorp, both of whom have product menus into which we would strategically fit. We’ve also been monitoring how successful Celera has been in terms of its introduction of the Berkeley HeartLab product line. We are unique in terms of our genomic diagnostics focus on cardiovascular disease, but there are certainly other companies out there that also serve cardiologists. I believe our product development cycle is a key differentiator for CardioDx—because we spend a tremendous amount of time to understand what clinicians need day to day, and we create detailed product specifications before investing heavily on R&D. We’ve also created competitive advantage through a multifaceted team of people from the device, pharmaceutical and diagnostic worlds with extensive experience in cardiovascular product commercialization. Lastly, we have proven our ability to drive multicenter, prospective clinical trials like PREDICT and DISCERN, which is our arrhythmia trial. Developing a product like Corus CAD requires that you rigorously control large, well annotated patient sample collections and the clinical data collection associated with them. It’s an expensive and time-consuming undertaking, but you must have high quality data in order to develop high quality products.

Q: What changes can we expect in your industry in the coming years?
A: The last 20 years have seen tremendous progress in the development of effective new drugs and medical devices to treat a wide variety of diseases. The diagnostics tools that are necessary to determine which patients should receive these new therapies have not kept pace with the new drugs and devices. As an industry, we must now apply the same rigor to the development of diagnostics that can appropriately direct these new technologies to the patients who need them. Right now it seems the diagnostics world is playing catch-up to the therapeutic world, and there appears to be a real disconnect—for example, only 3 percent of healthcare dollars are spent on diagnostics, but that cost drives another 70 percent of the cost of healthcare. There’s a tremendous opportunity to improve diagnostics to more efficiently deploy our therapeutic dollars, and we believe that genomics has given us an incredible tool with which to do this. I expect that the diagnostics industry will be a key component to improving the delivery of healthcare.

Q: What segment of your business do you see as the primary growth driver this year and next?
A: Corus CAD and its follow-on products will be the key drivers for CardioDx over the next couple of years.

Q: What do you hear from your customers about your products?
A: Both cardiologists and primary care physicians tell us that their traditional tools don’t allow them to do as good a job with assessing coronary artery disease as they’d like. Physicians looking for a new way to assess their patients with chest pain are embracing Corus CAD—they understand that the new era of genomics has brought them unique, objective biological insight that adds to their clinical capabilities today. As far as patients are concerned, the idea of a convenient blood-based test that assesses their coronary disease likelihood without radiation exposure strongly resonates. Payers love the idea of more efficiently directing the right patients into the healthcare system to ensure they get the procedures they need.

Q: What keeps you up at night?
A: Besides my five children aged 7 to 17…I ask myself if we are doing all we can to develop these tests and get them to the market as soon as possible. We’ve launched in only nine states. We wanted to be sure we knew how physicians were going to integrate the test into practice and make sure we have all the tools in place for them before launching nationwide.

Q: What do you do to relax?
A: I spend as much time with my wife and kids as possible. Relaxation isn’t always the first word that comes to mind.

Q: If your house were on fire, what would you grab?
A: The hard drive with all the family photos.

Q: When you were young, what did you aspire to be as an adult?
A: I always thought that being involved in small companies would be fun. My early career experience is actually more in information technology, but I’m delighted that I’ve moved to the healthcare side. It’s so gratifying to do well and do good at the same time.

Q: Do you have any regrets?
A: Not as relates to CardioDx. One of the real advantages is learning from those who’ve come before us. We’ve been able to learn from the mistakes and successes of other molecular diagnostic companies. We’ve certainly made our own mistakes, but we try to learn from them and not make the same mistakes over again.

Q: How do you want people to remember you?
A: I think I’m most proud of meeting the challenges of building companies that improve the lives of patients every day.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Ed Manicka, President, CEO of Corventis

Executive Spotlight: Ed Manicka, President, CEO of Corventis
Corventis launched its AVIVO Mobile Patient Management System in April of this year. CEO Ed Manicka was brought on at Corventis after working at Guidant Corp. and Boston Scientific Corp. and believes its cardiac monitor, the size of a bandage, has the potential to reduce treatment and hospitalization costs in combating one of the nation’s most expensive ailments—heart disease.

Q: How do you feel wireless technologies such as yours will contribute to improving healthcare?
A: Even though Corventis is in the genre of wireless healthcare, there’s a lot more to this company than just that. I view wireless technology as an enabler of something much bigger going on in medicine right now. If you think about how medicine is practiced now, a physician calls upon knowledge gained in medical school and in his years of practicing medicine and makes a judgment call. A lot of that can actually be automated.

What we are trying to do is allow a physician to manage the routine care of patients through computers, which can do what no physician can do, and that’s watch a patient 24/7. This technology allows the physician to focus on those patients who truly do need that care. The patient ultimately gets better care and the physician is more efficient at no cost to the system.

We have engineered a solution for heart failure first, the number one most expensive problem for Americans, a huge burden on taxpayer dollars. This paradigm shift in patient management offers physicians a way to focus on those few patients who need immediate care and to detect those whose status may be degrading and need some preventive care to avoid readmission.

The device, called PiiX, looks like a bandage and measures various cardiac parameters–it’s completely waterproof and lasts for a week. It easily blends into the lifestyle of the patient and transfers data back to the caregiver in real time, 24/7. The product received FDA approval four months ago and should be available widely in the U.S. starting in October.

Q: What is the largest hurdle this new technology faces?
A: Everyone wants better care at a lower cost—to do more with less. The only way to do that is with new technology—a technology shock to the system. As long as you follow the logic of how physicians adopt new technology, and that’s with sound proof, like what we are doing with Dr. Topol at the West Wireless Health Institute, there shouldn’t be a barrier to adoption. We are setting out to prove a hypothesis that we can change the way patients are managed.

Q: Are there other applications for the technology?
A: Within cardiology I think there are a lot of potential applications, with heart attack, or acute myocardial infarction (AMI), for instance. This is a very expensive and complex problem for society. The use of this technology may enable physicians to understand when a heart attack is going to come and either prepare the patient or prepare the medical facility to provide proper care. This technology could also have applications for cardiac arrest and stroke.

Q: What keeps you up at night?
A: As with any startup, Corventis keeps me up at night! We’re trying to get a lot of work done with limited resources. The environment for funding right now is risk-averse so when we’re out there trying to get funding there’s a lot of work to get someone to write a check. We have to make sure this technology gets backing.

Q: What do you do to relax?
A: I work out a lot, I also play chess and read.

Q: If your house were on fire, what would you grab?
A: Videos of my kids when they were babies – they’re eight and seven now.

Q: When you were young, what did you aspire to be as an adult?
A: I always thought that I would be an engineer/scientist and that’s where I started my career. I thought it might be better for me to be a physician, but I know enough about cardiology where I can hold conversations with leading cardiologists. I learned all that in the course of my career, though. I’ve been able to marry my engineering and scientific background with business and that is a good outcome for me.

Q: How do you want people remember you?
A: If I can help create this shift in medical care to computational medicine, that would be a very nice legacy for me.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Melinda Richter, Executive Director, San Jose BioCenter

Recently I had the chance to meet Melinda Richter, the executive director of the San Jose BioCenter, co-founder and director of the University of California at Berkeley’s BioExec Program, co-founded and director of InnovateMD. Richter currently sits on the governing board of the National Business Incubation Association and the boards of University of California Berkeley’s Haas School of Business BioExecutive Institute and San Jose State University’s Masters of Biotechnology Program. Read below to learn more about her work at the San Jose BioCenter and why their model of innovation should be replicated to bring cures and therapies to the patients who need them most.

Q: What does the San Jose BioCenter offer?
A: The BioCenter was created in 2004 to fill a need—small companies provided opportunities to fill the gap in large companies’ pipelines, but these small companies were failing because they didn’t have the resources like large companies had to prove out their technologies. The BioCenter model provides big company infrastructure, such as specialized facilities, capital, equipment, laboratory and business staff, for small companies. The BioCenter is a 40,000 sq. ft. facility with half of that space devoted to common research and business areas that we manage for our clients. The other half is comprised of self-contained individual wet-lab suites ranging from 300 to 5,000 sq. ft. From the time a company comes in to the BioCenter, we set up and manage the day-to-day operations of a typical biotech company, from managing hazmat handling/training, permits and regulatory support to providing bulk discounts, legal advice and other support services. We’ve created a very efficient model of innovation that allows small companies to prove out their science quickly and efficiently, cutting down on up-front capital costs and minimizing the risk of operations.

Q: Do you believe your model could be replicated in other regions?
A: Absolutely. Venture capital firms like to work with us because the first half of their investment usually goes to setting up the infrastructure, buying up equipment, signing leases and ramping up the operations. In our model, the venture capitalist can either choose to put all that money directly toward research or limit their up front investment until the company reaches critical milestones that increases their probability of success.

Q: What has been the greatest achievement of the center to date?
A: We have recently won two international awards for the BioCenter as a novel yet efficient, common sense model for innovation. We were able to create the model by listening to our market: the small companies, the big companies, the VCs. Because of that, we were able to create the type of infrastructure to help our companies fulfill their potential. For example, Tacere Therapeutics came in with very little money and a year after entering the BioCenter, they signed a $145 million deal with Pfizer and a $60 million deal with Oncolyst. Many innovators come in with little and suddenly they become mature, stable biotechs focused on the research. In fact, we’ve been 100 percent occupied with a wait list for the past three years.

Q: Which types of collaborations do you seek?
A: The number one collaboration for the BioCenter is with what I call the “buyer.” In this market there is no such thing as an IPO. There are only mergers and acquisitions, partnerships, and licensing or development deals coming from big biopharma. The big companies ultimately are going to benefit from the research being done here so we spend a lot of time getting to know them, finding out what their strategic needs are, what they need to fill their pipeline, etc. Collaborations in other areas include service providers and industry organizations. We are very focused on establishing the right partnerships to help our member companies succeed.

Q: What do you see as the biggest threat or challenge to biomedical innovation?
A: Lack of early-stage capital. Many great companies with exciting technology will be paralyzed without capital. That being said, I think better companies will rise to the top, but many with potential will disappear. We may see the effects of this in a few years, when we won’t see as much innovation being commercialized.

Q: What keeps you up at night?
A: I think we’ve hit upon a model that changes the probability of success of innovation but I don’t think we’re replicating it enough. It’s the only way to make the process of innovation faster, less expensive, less risky, and more likely to succeed. This model allows for more innovations in the pipeline; for companies to prove out their technology faster and to bet on the things that win.

Q: As a child, what did you aspire to be as an adult?
A: I actually wanted to be a foreign correspondent. I wanted to live around the world and report the “real stories,” the politics behind the story. My dad and my grandparents escaped from Prague during World War II. As a kid, my dad always said to us, “I don’t blame Hitler. I blame everyone else who sat around and watched…who didn’t take the time to get educated on what was going on. So your job in life is to be educated on what’s going on in the world.” So I started in journalism in college and loved the intellectual cultivation, but I also grew up in a very poor family and so I wanted to make money as well…I learned that wasn’t in the cards for a foreign correspondent, so I transferred to business and lived all over the world with Corporate America.

Q: Any regrets?
A: I have lived in many countries and I’m glad I experienced so many different cultures. Then, I nearly died when I lived in China…and that changed my life. I loved that I had the courage to explore and to live life. But after that experience, I knew it was time to give back…to bring my talents to the field of life sciences to help people who may not be as lucky as I was to walk out alive. I know I could be more effective in the field if I had a science background. I work with “street science” right now…kind of fun but I wish I had more to bring to the table.

Q: How do you want people to remember you?
A: In the first part of my life, I had a motto: Live always, always. And I did that. I explored life. Now in the second half of my life, I want to take the things I have learned and did well and put them to good use. I want to make a difference in this industry. I want to say that because we created this new model, more companies have brought technologies and cures to market so more people have access to life-saving technologies.

Q: What are you currently reading?
A: Well, this is going to sound odd. I’m reading a book called Flyte because I have a book club with my nine-year old godson. He gives me books to read and then we get together and talk about them…I’m trying to keep him interested in reading. It certainly isn’t War and Peace, but it certainly is meaningful for the two of us.

CHI-Advancing California biomedical research and innovation