Wednesday, August 24, 2011

Executive Spotlight: Daniel Laser, CEO and President, Wave 80 Biosciences

Daniel Laser
Wave 80 Biosciences Inc. develops next-generation molecular diagnostics for infectious disease, cancer, autoimmune disease and other human health conditions. The company began operations in 2003, with a small team of engineers, biologists, and chemists working out of warehouse space in San Francisco’s Dogpatch neighborhood to develop high-performance, cost-effective technologies for processing complex fluid samples.

In 2007, the company initiated a development program to address emerging needs for viral load monitoring to accompany expanding access to antiretroviral therapy among the estimated 30 million people living with HIV in low- and middle-income countries. The first versions of the EOSCAPE-HIV system are scheduled to enter beta testing in clinics in Kenya and South Africa in 2012.

President and CEO Daniel Laser spoke with the CHI Blog to explain how Wave 80, a name born of an anagram, has contributed to improving tests that treat for both infectious and noninfectious diseases, including hepatitis C, hepatitis B, cardiovascular disease, autoimmune disease and cancer.

Q: How did the company get a name like Wave 80 Biosciences?

A: My wife and I came up with it sitting at the Top of the Mark in 2003 while applying for the first grant application that got the company started. It is actually an anagram that includes the name of the chemist whose discovery of electro-osmosis led to one of our seminal patented technologies, an architect whose work inspired certain structural aspects of our product’s design, and the word “silicon,” which is the basic element of our key technology components. My wife is an English major so she probably deserves the credit.

Q: How did you decide to start this company, and what were you looking to accomplish at the time?

A: The company has had a couple of major phases of its development. The current phase started in 2007 when we began focusing on HIV.

In the earlier phase of the company, we were more of a research and development shop doing specialized work for the U.S. military. There were some challenges that the military felt were on the horizon in the wake of 9/11, relating to new chemical and biological weapons and battlefield medicine more generally. I had become aware of those military R&D interests through involvement with Professor William Perry at Stanford, who had previously served as the U.S. Secretary of Defense. Through my work with Perry’s group, the Center for International Security and Cooperation, I saw an overlap with some of the work I had been involved with as a graduate student. My graduate work was focused on the semiconductor industry, but I saw the opportunity to port the technology into healthcare and became intrigued.

It was not clear that it could solve the issues that the U.S. military was confronting, but it just seemed like it might, and it was pretty clear that the only way that work was going to get done would be if I made it happen. There was no one else who was likely to both be aware of the technology and also be aware of the military-specific needs.

Q: So what brought Wave 80 into HIV?

A: We were doing foundational work with the U.S. military regarding how to move proteins around inside miniaturized assay cartridges, initially unrelated to HIV. However, we established a link with the head of research and development at a group called the International AIDS Vaccine Initiative (IAVI). The head of R&D at IAVI, Wayne Koff, found out about Wave 80’s work for the military and was acutely aware of unmet needs in HIV in the developing world. Wayne had the foresight to see how the military technology could be paired with a specific assay method and that it might be fruitful, which is exactly what how it turned out.

There is now a fairly extensive and well-developed infrastructure for HIV patient care and clinical research in sub-Saharan Africa as well as Southeast Asia, the Caribbean and Latin America. I think maybe more remarkable, at least to me, is the extent to which this relatively new HIV patient care infrastructure is serving as the basis for improving treatment of both infectious and noninfectious diseases such as tuberculosis, hepatitis, cardiac disease, diabetes and many others.

A positive outcome of the great tragedy of the HIV epidemic is this significant improvement in the healthcare infrastructure of countries around the world. Wave 80 is building HIV and other products to increase these clinics’ capabilities in caring for the local populations.

Q: Talk about your partnership with the San Francisco Public Health Laboratory and San Francisco General Hospital to pilot the quicker, point-of-care test.

A: One of the challenges that comes with HIV is identifying individuals who are HIV-positive as early in the infection cycle as possible. Standard HIV diagnostics that one sees in an HIV clinic or in a primary care setting are based on what is called a serologic response. This is when HIV antibodies appear in the patients’ blood, but these antibody-based diagnostics only turn positive several weeks after infection.

Something that we are at the forefront of now, along with UCSF, SF General and the SF Public Health Lab, is identifying HIV-infected patients during what is called the acute phase before the antibodies appear. It turns out that transmission risk is highest in the acute phase, so, if you can diagnose HIV in its first few weeks, then the prospects for reducing transmission go up greatly.

I think we can all look forward to, if not the end of the epidemic, a significant decrease in the number of new infections as these universal “test and treat” measures take hold.

Q: What do you see as some of your biggest goals in the next few years?

A: We have one overarching goal which is to move the products fully into the clinical setting. We are entering the validation process right now. If it were a U.S. product, this would essentially mean preparing the FDA submission. We are bringing this product through the FDA, but for the global market it is not really desirable to hold up the product while waiting for U.S. regulatory approval.

Instead, what we do is we work through a very rigorous set of validation procedures. The U.S. Centers for Disease Control and Prevention (CDC) will oversee the bulk of early validation. The World Health Organization and the Ministries of Health of the countries into which the machines are going to be placed will also be involved. We gradually work through approvals and demonstrations of our diagnostic specs and capabilities in the settings where our products will be deployed.

Alongside that, we have the goal of using Wave 80’s HIV diagnostic platform in HIV vaccine clinical trials. This is actually a major driver of the funding package that we have from the U.S. government, in order to help differentiate between someone who is HIV positive versus a vaccine trial participant who is HIV negative, but whose blood may carry antibodies from exposure to a potential vaccine.

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