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BioArray Q&A: Roche NimbleGen CEO Gerd Maass on Taking a Tech Company into Personalized Healthcare


Gerd Maass' name was spelled incorrectly in an earlier version of this story. The spelling has now been corrected.

By Justin Petrone

gerd.jpgName: Gerd Maass

Title: CEO, Roche NimbleGen

Background: 2008-present, CEO, Roche NimbleGen; 2007-2008, head, R&D, Roche Applied Science; 2001-2006, manager, pharmacodiagnostic programs in cancer, Roche; 1997-2001, cancer drug R&D, Roche; 1995-1997, head, cancer gene therapy research center, MediGene, Munich, Germany

Education: PhD — University of Tübingen, Germany; BSc —biology, University of Heidelberg, Germany

Before taking over as CEO of Roche NimbleGen 13 months ago, Gerd Maass spent most of his professional life working in research and development for pharmaceutical and diagnostics companies. Now one of his main goals is steering the firm, which Roche paid $272.5 million to acquire in 2007, towards wider involvement in drug and test development (see BAN 6/19/2007).

Beyond its personalized healthcare aims, Roche NimbleGen has been busy under Maass' tenure building out a full workflow including instrumentation for its arrays and expanding its catalog of arrays and applications.

To get a better sense of where Roche NimbleGen has been over the past year and where Roche intends to take it, BioArray News spoke with Maass this week, after the firm announced the selection of its platform for a copy number variation association study by the Korean Centers for Disease Control and Prevention. Below is an edited transcript of that interview.

What is your background and how did you become CEO of Roche NimbleGen?

I am a PhD and my thesis was on HIV research. Even then, I was doing partnerships with industry. I went to work with Boehringer Ingelheim as a postdoc, where I got into therapeutics and oncology. From there, I moved on and worked with MediGene AG in Munich, where I was involved in research and development of vaccines. 12 years ago I joined Boehringer Mannheim and then three months later they were acquired by Roche. From that point on, I have held several functions in Roche in both the Diagnostics and Pharmaceutical divisions. The Pharma and Diagnostic divisions began to collaborate more closely, initially focusing on oncology. I led that initiative from 2001 to 2007 as head of the biomarker program [in] oncology. After that, I became head of R&D at Roche Applied Science. I held that position until last year, when [Stan Rose], the former CEO of NimbleGen, left the company and Roche asked me to take over.

What was it like moving from running drug development programs to taking charge of a technology company?

I worked on several programs before that utilized array technologies and NimbleGen was already a part of the life sciences portfolio. I had visited Madison at least three times the previous year, so it was not completely unknown to me. NimbleGen was very technology focused, and because of my background and experience, I came in looking at what we needed from a different angle, looking more at the value to healthcare with a drug-development perspective.

In our development projects, we ran specific assays for single biomarker detection like immunohistochemistry or PCR, but often also used arrays to get a broader picture of the drug response of the individual patient. So, arrays were often a part of this research, but in the early days, it was primarily for gene expression. When I came to NimbleGen, I asked our scientists how this technology could fit with medical research. We decided to shift from a purely technology point of view to working closer with our customers, as well as with our Roche Pharma partners and drug development teams, to adjust the technology to better suit the drug development process.

That is one of the key ways which really helps NimbleGen to become more integrated within the Roche network. Another impact of that process is that we are discovering, along with our Roche Pharma partners, how to best apply the technology in a drug discovery environment. That will lead to new products that will further the development of the drug pipeline at Roche as well as be a very viable candidate to sell to other pharmaceutical companies. It's about joining two parts of a company together and letting scientists exchange ideas.

How has Roche NimbleGen changed over the past year?

Overall, we became more focused, business oriented, and medical value driven. On the internal side, we are communicating much more within the Roche network than we were a year ago and are able to use the strengths and value our Pharma division brings and combine it with the strengths of the diagnostic side. Our technology is being used more and more in the Roche network as we are partner with the pharma side of Roche in early discovery, toxicology, and drug development.

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What is the status of the subsidiary in Iceland? Are there any plans to significantly restructure the company?

There are always ongoing discussions on how to best optimize the way Roche is structured to ensure optimal use of our resources. Today, the Iceland facility is well structured and positioned to serve our service and production needs at Roche NimbleGen very well. The focus in Iceland is on service and production, but their focus in the future will depend on how we grow and how the market continues to develop. The personnel, laboratory, and production facility combined with the environment in Iceland is an ideal setup for us currently.

What is NimbleGen doing to remain competitive against other array vendors?

Every year, we sit down and discuss the advantages of our system and how we match up against the market needs. This is a technology-driven company and one which remains extremely flexible. There are several market segments where our technology of high-density, long-oligonucleotide microarrays is very strong against the competition. It’s in these key areas where you will see Roche NimbleGen continue to focus our resources and development to produce leading arrays for the market. We also look ahead to the coming years to prepare to capture additional market share in various segments. In today's market, many times the competition fights on price and volume. We think tomorrow's market is more about being first and best in class in terms of technology and being able to quickly react to the market and nimbly provide for the requirements of researchers worldwide in specific segments. By the end of this year, we will have a complete array workflow, which includes our recently released MS 200 Microarray Scanner.

Is there demand for a complete workflow?

Over time, our service customers get more convinced of the benefits of the technology and they want to run more arrays, they want to have broader system to analyze samples in house. We have responded and adapted to that need. The big genetic centers often use several technologies in parallel. Many times this includes both a service product and processing of arrays in their own laboratories. In discussions with them, it's not either/or — they want all of it.

Service is an important part of our business concept, and part of our strategy is to establish certified service labs around the world to better serve our rapidly expanding business. Over the past years, we have been migrating from a services-focused company to one with multiple key competencies, including top-notch service as well as a complete array workflow solution that can be run in a customer’s lab. Services will not be the utmost important part of our sales in the future, as we see delivery, or processing of arrays in the customers lab, as an important part of our business. We will also continue to expand and deliver catalog arrays, work together with pharma companies, and expand into new areas like cytogenetics.

Overall, there is a definite need from customers for complete workflow. For them, our service lab is often used for pilot studies. They utilize that to develop their array design, research, and realize the extensive data that our high-resolution arrays provide. In proving their concept and our technology, many times they then move to purchase our entire array workflow. Many times, they want to gain more control over that process and want to be able to bring the process in house.

Some see second-generation sequencing as a threat to traditionally array-dominated markets like gene expression. What is the company's position on how array vendors can respond to the adoption of this newer technology?

It's been very nice to work for a global company as we have both technologies in house with the microarrays from Roche NimbleGen and the sequencing technology from 454 Life Sciences. From a broader perspective, whatever happens in the market, we are poised to ensure we can follow the direction the market takes.

Is there a threat from whole-genome sequencing? Based on the higher costs and time investment of whole-genome sequencing currently, there is still a definite market for array technology. As such, we are looking to further expand our potential and product mix for the sequencing market. We have a very exciting product in development to do sequence capture in liquid phase to provide either a solid-phase or liquid-phase sequence capture product to the market depending on the researcher’s requirements. We expect to launch it in the fourth quarter of this year.

We also have good relationships with key scientific opinion leaders. They are key in our development as they understand where the market is heading and can help us define what kind of product they and the market need. If they want solution phase, because they are gearing up for larger studies, then we will work hard to provide them with that product as soon as possible.

It may be that sequencing eventually replaces part of our portfolio, or that our product shifts to fulfill a different role in the sequencing market. However, it doesn’t mean that we won't have new products in other markets. As mentioned, we are looking into cytogenetics, drug development, and drug discovery. We are also looking into protein screening, enabling us to work with screening serum and other body fluids. We will focus on the development of technologies that will bring us ahead in the market and where we have distinct advantages we can offer the researcher. So yes, sequencing continues to grow, but we have to think strategically how NimbleGen will fit into this sequencing market in the future, not how we will be replaced.

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How do you envision using Roche NimbleGen's products in personalized healthcare and can you provide some examples of how your products are being used?

The development of a particular drug from discovery to launch is in the range of a billion dollars. This is a different ball game. In a drug discovery environment, you start on preclinical aims on hundreds and sometimes thousands of compounds. Maybe 20 make it to clinical trials. Of that 20, one might make it to the marketplace.

At Roche, we believe we have a unique position and are the market leader in having our pharma and diagnostics divisions integrated. Initially, we considered if we could partner with many small diagnostic companies and use their technology when needed. But if you have hundreds of ongoing R&D programs, it would be complicated to manage all of the companies' milestones. Also in this market, things change quickly and new biomarkers emerge all the time, making portfolio management very complicated. We came up with a landscape where we decided what technologies we needed to be really competitive in Roche and developed or acquired them. Now we have most of the important diagnostic technologies under one roof. We can incorporate everything.

We can smoothly move from the early screening process into the launch of drugs combined with diagnostic tests. With some technologies, we can develop them into IVDs. Other technologies are more for research and fishing, but will mature, possibly making it to an IVD stage at a later point.

Right now, though, arrays are an important part in discovery and early development. This can be based on methylation patterns or gene expression profiling or, in the future, hopefully, peptide screening.

For example, many people use xenografts in oncology and virology research. You implant a tissue in a mouse. Our gene expression technology can help here. If you take part of this tissue and find inflammation, we can tell which part comes from the host and which is from the xenograft. This can become a really powerful tool for drug development. You can see if the inflammation is really on the tissue you implanted or a reaction from the host. You'll get much more information out of your experiment if you can verify that what you see is what you would like to see.

How is the company expanding to handle these new projects?

We have structured R&D in a way that our larger department is focusing on building the array and workflow portfolio. We have another department taking care of biomarker discovery and working with pharma. We have substantially increased the R&D headcount over the last 18 months. We had something like 40 R&D scientists. Now we have almost 70 on staff.

How will Roche NimbleGen change over the next year?

We will complete our workflow this year. That puts us in a position to offer a complete array processing solution to customers from the arrays to reagents and instruments. We also will come up with interesting focus areas, articles and publications in the pharma area. This will not be initially with the launch of a drug together with an array, but we'll provide the excellent data that helps drive the drug discovery process and demonstrates how we influenced the drug decision-making process. It will show how, based on logical good information made with arrays, we were able to influence that process. In terms of products, NimbleGen Sequence Capture and CGH/cytogenetics are important fields. As a result, we expect to see continued sales growth with 50 to 60 percent growth year over year

The strategic vision of the firm, how to define the future market, is not to shy away from the challenges we face from product needs or the competition. You have to be proactive. It is a moving target and people working in this environment have to understand this and push towards innovative solutions for this market. What’s rewarding is that this is fun and exciting to see the ever-changing sides of healthcare, and be able to have the technology, personnel, and ability to react to it.

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