Abstract
On 29 June 2010 Brad Gray became the President and Chief Executive Officer of the privately held life sciences company NanoString Technologies, WA, USA. Previously the Vice President of Product and Business Development at Genzyme Genetics, the diagnostic services division of Genzyme Corporation, Brad was in charge of developing molecular diagnostics and partnering activities. In December 2010, NanoString announced its securing of an exclusive worldwide license to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping with the PAM50 gene signature. Brad Gray received a BA in Economics and Management from Oxford University, where he studied as a British Marshall Scholar, and an SB in Chemical Engineering from the Massachusetts Institute of Technology. Brad was also a management consultant in the healthcare practice of McKinsey & Company.
▪ With a background in economics & chemical engineering, what led you into the field of personalized medicine?
I came by way of the pharmaceutical industry. I first got interested in biotechnology and pharmaceuticals when I was a chemical engineering student focused on manufacturing protein therapeutics via large-scale cell cultures for genetically engineered drugs. I studied economics and management right after I finished my engineering degree and decided not to practice, but to participate in the healthcare and biotech industry on the business side and joined McKinsey & Company immediately thereafter. In the early 2000s, we didn‘t call it personalized medicine, but targeted therapeutics. The way that was changing the drug industry was part of my work at McKinsey.
I joined Genzyme in 2004 on the drug side. I found myself gravitating repeatedly to the diagnostics division, Genzyme Genetics, which was providing testing services for cancer and reproductive health. In that business, a lot of the fastest growing products were related to the prediction of drug response. I kept getting pulled into the very interesting strategic opportunities created for both the drug and diagnostic industries.
▪ You recently attended the San Antonio Breast Cancer Symposium in Texas to discuss NanoString‘s plans for the breast cancer intrinsic subtyping assay; what was discussed?
The first objective at San Antonio was to unveil to the world our plans of developing in vitro diagnostics that are capable of delivering multiplex gene-expression-based tests in a decentralized way. We focused on introducing our plans for the PAM50 breast cancer intrinsic subtyping assay to the breast cancer research community. We had a series of excellent conversations with leading researchers around the world, many of whom have access to clinical material that can be used to help validate the utility of our breast cancer assay and who are interested in working closely with us to explore other potential uses of the test we are developing. The symposium was really about establishing NanoString‘s presence in the breast cancer community.
▪ How is this subtype classification & prognostic score generated by the PAM50 gene signature different from other currently available diagnostic tests?
What is unique about our assay is that the gene-expression patterns of the 50 genes it looks at fall into one of four basic categories for each patient. These intrinsic subtypes relate to the biological pathways that are up- or down-regulated in that particular cancer. These 50 genes allow us to categorize women in a way that is clinically useful in terms of assessing her risk of recurrence after treatment and in terms of predicting which particular therapeutics she is most likely to benefit from taking. It is not so much about the number of genes being analyzed, but having the right genes and looking at them in this particular way that acts as a subtyping test for breast cancer.
▪ What are the next steps for validating the gene signature?
The next step is to pursue US FDA approval in the USA and CE-marking in Europe for a device to perform this test. That will require a significant amount of clinical validation to prove that we can predict outcomes with the test. That is really our focus for 2011 and 2012, to conduct those clinical studies and to prepare for submission to the FDA.
▪ How is this set to impact personalized medicine at the hospital level?
Our future vision is that there will be a diagnostic version of our nCounter analysis platform in pathology and hospital laboratories worldwide, being progressively used in more oncology assays. This is set to have a tremendous impact on the hospital community. First, for oncologists and their patients, it allows for sophisticated testing to take place with a very rapid turnaround time at the same institution where the patient is being treated and where the test is being conducted by the pathologist with whom the oncologist normally collaborates on assessing different cancer markers and so on. For the pathologists who are part of that institution, it allows them, for the first time, to participate directly in this very rapidly growing and high-impact area of cancer molecular diagnostics. They have a chance to participate in processes that had previously only been possible in centralized reference laboratories – for which they previously simply provided material.
Finally, for the institution itself, it potentially changes very significantly the economics of these tests. Instead of being a cost center for the institution, where they have to send material and money to somebody else who is performing the test, they will be able to perform the test themselves, and at least in the USA, bill health insurers for that service like they would for any other. This could potentially provide profit centers for both the hospital and institution. There are a lot of important changes, all of which relate to the disruptive nature of our business model which is geared towards this decentralized approach to high-complexity testing.
▪ What other projects are you currently involved in?
NanoString is first and foremost a provider of research instrumentation to the genomic and translational research communities. We have a thriving business providing our nCounter Analysis System to research laboratories worldwide. We have introduced a series of new applications that can be conducted on that system, starting with gene expression, whereby we enable researchers to measure the expression of up to 800 genes from a single sample with just 100 ng of RNA. That was how we got started and it is that fundamental technology that we are taking forward into our first diagnostic product.
Last April we launched our first miRNA measurement product, which was for the human miRNAs. That very quickly became an extremely popular application with our research customers, who began clamoring for a mouse version of that kit. And so, this January we launched a version of that kit covering the mouse miRNAs.
In addition, back in November 2010 we launched a method allowing for the measurement of copy number variations (deletions and insertions in the DNA) using our systems, and this presents a new and very exciting area for us as well.
▪ Where do you think your research interests will be focused in the next 5 years?
Our ultimate vision is to provide researchers in the translational medicine setting the opportunity to run their validation experiments on a platform that can be both excellent in the research context, and also if they so choose, that can go all the way to the clinic.
In 5 years I see NanoString continuing to serve both the research and global markets, but also partnering selectively with our research customers to commercialize their inventions as molecular diagnostics. I think that cancer will represent for us the first wave of new product opportunities over the next 5 years, but other possible uses of our platforms are in immunology and inflammation; important areas in which you would want to look at a whole bunch of different genetic targets at once, and which could yield global diagnostics in the future. So, we‘ll be participating in both the research and diagnostics businesses and, I suspect by then, not just in cancer but in other areas as well.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.