Medical Device Link.

Originally Published IVD Technology November/December 2005

IN PERSON

New Roche Diagnostics head Tiffany Olson seeks to infuse simplicity into the complex world of diagnostics.

Tiffany Olson is president and CEO of Roche Diagnostics Corp. (Indianapolis). She can be reached at tiffany.olson@roche.com.

On June 1, when Tiffany Olson became president and CEO of Roche Diagnostics Corp. (Indianapolis), she took the reins of a company that had seen a decade of steady expansion and growth. During the first six months of 2005 alone, Roche's diagnostics division recorded $3.1 billion in sales.

In the eight years that Olson has been at Roche—serving as vice president of corporate accounts, vice president of molecular diagnostics, and, most recently, as global head of market development—she has played an instrumental role in its success. Still, despite her familiarity with Roche's myriad businesses, she has had to adjust to the monumental task of leading a company with 3500 employees and a presence in every major area of testing.

IVD Technology editor Richard Park spoke with Olson to find out how she is adjusting to life at the world's largest IVD manufacturer. In this interview, Olson explains her philosophy of simplifying business complexities and discusses her impressions of the current state of diagnostics. She also talks about trends in automation, the need for industry to better convey the value of diagnostics, and whether this will be the year that pharmacogenomics finally takes off.

IVD Technology: Since taking over as the head of Roche Diagnostics North America in June, what have you had to learn and adapt to?

Tiffany Olson: One of the things I've learned is the strong dedication and passion of our people, in their desire to help those affected by Hurricane Katrina. The other area that I have learned a great deal about is the pipeline of products in our different businesses. We have launched a lot of our new products in the second half of this year, but will also remain very active going into 2006 and beyond.

How have you gone about familiarizing yourself with these different areas?

One way I've familiarized myself has been what I call my "leadership approach," which is to listen, to learn, and then to lead. I feel strongly that, coming into the position, I have really needed to listen to our employees to better understand the challenges and barriers they are facing and to learn how we can overcome some of these challenges. In addition, I've had to make sure that the senior leadership team is working with the same goals and a common message, and that this direction is understood throughout the rest of the organization.

The American Association of Clinical Chemistry meeting in July was a marvelous opportunity to spend some one-on-one time with customers. I have also been able to visit some customers in person, and others by telephone. One of the goals that we are working toward is to redefine what we mean by being "customer focused." In order to do that, we have to communicate with our customers and understand their needs.

Management and Leadership

With any management change there are always questions about how the company will be affected. What types of conversations have you had with your customers, and what message have you wanted to convey to them?

The message really is their experience with Roche Diagnostics. What experiences have they had that they have enjoyed and want us to continue? Which ones have they found challenging? The conversations have been more of a higher-level strategic discussion, in which we make sure that we are doing what we can to help them with their challenges, as well as talk to them about our portfolio and some of the new products that we will be bringing to market.

For instance, our CYP450 AmpliChip assay is a test that requires educating the marketplace—physicians, payers, and also consumers. We have worked with all of these groups to learn how we can help to increase the education for our products. Similarly, since our reimbursement system does not lend itself to this type of technology, we have been working with the IVD industry in general to find out how to approach the government most efficiently to discuss possible reimbursement changes needed for new assays in the marketplace.

What challenges have you encountered being part of a leadership team responsible for managing and overseeing a multinational, multi-billion-dollar diagnostics corporation?

Any company with our size and scope encounters complexities in its business. Part of managing these is to try to make them as simple as possible. One strength of Roche Diagnostics is the diversity of our team. From working overseas and working in the United States, I've learned that Roche defines diversity in two ways—narrowly, in terms of race, religion, and physical attributes, as well as broadly, taking into account an individual's experience and approach to solving problems. Both of these are equally important for Roche. When you have an organization that handles Asia Pacific, Japan, South Africa, Europe, the United States, South America, and Canada, you work on teams with a variety of people from different backgrounds. This provides us with an incredible ability to solve problems and look at challenges from very different angles.

As I noted, it is important to make sure that the team understands the main objectives and has the information and the tools to make that message known throughout the entire organization.

You mentioned complexities. At a company of Roche Diagnostics' size, I imagine there are quite a few. Can you give an example of the sorts of complexities you have to address on a regular basis, and how you go about making them as simple as possible?

Because of how big we are, we really run the gamut on different market segments. And with each of those different market segments, business is done just a little bit differently and the market dynamics are diverse. What takes some of the complexity out of that is considering the customers in the specific market segments. What do we need to provide them today to make sure that they are getting the products and the service they need? What is it we need to know to ensure that we can continue to provide for them in the future? Also, how do we make sure that we are an employer of choice, the company that people want to work for?

You have a strong background in molecular diagnostics and in marketing and sales, at both Roche Diagnostics and elsewhere. In your new position, what adjustments have you had to make in your management style, and in the way you approach and think about the IVD business as a whole?

I have been with Roche Diagnostics eight years, so the knowledge I've gained of our culture as both a U.S. and global organization has been very important. In addition, I've been able to learn a lot about our customers. I was vice president of corporate accounts for a couple of years and was responsible for our different segments: diabetes care, molecular, centralized diagnostics, and point-of-care units. That kind of broad understanding has proven extremely helpful in my new position.

One of the things that concerns me is how we, as an industry, can make sure that we are getting the message out about the value of diagnostics. Roche Diagnostics, along with our industry association AdvaMed (Washington, DC), helped sponsor a study by the Lewin Group on the current value of diagnostics and what we need to do to make sure that the true value is understood by the government and the healthcare industry. Looking at some of the new, emerging platforms, this becomes especially important. Assessing the entire value of diagnostics means looking at reimbursement, education, as well as innovation.

At Roche Diagnostics, we need to make sure that we continue to innovate in the area of automation to address the challenges of a declining workforce. As our tests become more complex, we need to consider how to take some of this complexity out of the test itself and put it into our instruments.

And as the market and environment change with new technologies, company dynamics will also evolve. It is essential to continue learning and making sure that the organization is moving forward.

How do you see Roche Diagnostics evolving? What are some of its goals and objectives?

We feel that we have the ability to shape the way that medicine can be delivered through our products. The molecular-testing marketplace has traditionally focused on infectious diseases and microbiology. We are also looking at diseases with high mortality, such as cardiovascular diseases and cancer—at not only the therapy selection ability of some of the tests that we will introduce, but also at helping to diagnose and to treat.

More laboratories are now able to conduct molecular testing, but there is still a need for them to explain to physicians exactly what the test is instead of just providing data. In that way, we see automation playing a large role. Automation not only helps remove some of the complexity from testing, but can increase productivity and help with the decreasing workforce in clinical chemistry in immunoassay areas.

The Current Marketplace

What are your impressions of the current state of the molecular diagnostics market?

The market is very promising. A lot of rapid growth is occurring in this area. We have also seen more laboratories become interested in conducting this type of testing. In the future, we see molecular diagnostics going outside of the typical infectious-disease testing that occurs now. At Roche Diagnostics, we plan to introduce the very first HIV fully automated system into the marketplace this year. The other area in which molecular shows promise is with personalized medicine and pharmacogenomics.

There was a lot of hope, especially after the completion of the Human Genome Project, that molecular diagnostics was going to be the next best thing. During the last couple of years, it hasn't quite reached the level that some people had anticipated. What do you think has caused the market to expand slower than expected?

I actually think that molecular testing has been growing very rapidly at over 15% per year. Part of what we have to do to bring a test to market is go through clinical trials, which can take time. We are working very closely to make sure that we understand what we need to do both in clinical trials and in the health economics area. When you bring out a product that has the ability to change the standard of care, sometimes it just takes a while to provide the education and proof sources and studies to show its full impact and value.

One thing that perplexes me a bit about Roche Diagnostics, as well as about Bayer Diagnostics (Tarrytown, NY) and Abbott Diagnostics (Abbott Park, IL), is that their parent companies possess huge pharmaceutical divisions in addition to large diagnostics businesses. Even so, there hasn't been much collaboration between the two. With FDA releasing a pharmacogenomic data submissions draft guidance and drug-diagnostic codevelopment paper in the past year, do you believe that we'll see more developments in personalized medicine from these companies?

The short answer to that is "yes." I do think that you will see more collaboration. For example, we have the Roche Biomarker Program, which combines both our diagnostics and our pharmaceutical groups for certain projects. With the FDA draft guidance, we are still very involved with the discussion of what the impact of pharmacogenomics can be. We are working closely with FDA in that area.

The company's purchase of Boehringer Mannheim provided a good base for two very strong businesses coming together, both pharmaceutical and diagnostic. The Roche Biomarker Program that I mentioned has been around for a while and is working on a number of active and promising projects. In coming out with a drug, as you know, there are many years between when the actual discovery and investigation and then clinical trials occur. Heino von Prondzynski, the global head of Roche Diagnostics, sits on the executive leadership team, which comprises diagnostics and pharma representation.

Before your appointment, you served as the global head of market development at Roche Diagnostics, so you have an understanding of global markets. What are your views of the potential of overseas IVD markets?

We see tremendous growth in overseas markets. We are seeing that in both China and India. We have also had wonderful growth in Japan and are the number one diagnostics company there. With Japan, however, the challenge of the healthcare market is in the lengths of hospital stays as well as the aging population. They have a much faster-aging population, from what I have seen statistically, and they have a very long length of stay in their hospitals. Through showing the savings and impact that diagnostics can bring, we have had tremendous growth.

Diagnostics Trends

What are your views regarding the state of the diagnostics industry as a whole?

It is a very dynamic and exciting time to be in the industry. We are seeing new tests come out. We are seeing the impact that diagnostics can have on healthcare. We believe that we have the ability to shape the way that medicine is delivered by showing what diagnostic testing can bring—not only through better patient outcomes, but also in a decreased cost to the entire healthcare system. So we feel good about the IVD industry, about where it is going, and about our ability to contribute to that.

How do you envision the future of the IVD industry? What challenges do you think IVD manufacturers like Roche Diagnostics will need to overcome?

Well, for us, we see more automation in the future. We believe this will occur in all parts of our business, whether to get something simpler, easier to use, and smaller, or to be able to provide information versus data. Automation is an extremely important piece of our innovation.

Some of the challenges for us include changing demographics. Not only are some of the diseases that hospitals are seeing changing, but also the workforce. The workforce is shrinking and it is becoming harder and harder to recruit laboratory workers. Our competition is changing. There are smaller competitors coming in. There are also larger competitors that may not be in the industry today but see attractive markets in the new viruses and strains that are occurring. We have seen severe acute respiratory syndrome, West Nile virus, as well as others, and we need to make sure that we are prepared for the next virus strain. In addition, we see reimbursement for our new assays as something that Roche Diagnostics, as well as the industry, needs to continue to work on.

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