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Celera s Kathy Ordoez on Combining Therapeutics, Diagnostics

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At A Glance Name: Kathy Ordoñez

Title: President of Celera Diagnostics and Celera Genomics

Background: President of the Celera Genomics Group — 2002; Founding President of Celera Diagnostics — 2001; President and Chief Executive Officer of Roche Molecular Systems — 1991-2000

Education: Honorary Doctor of Science from Hartwick College, Oneonta, New York — 2000; BS in Chemistry from Hartwick College, Oneonta, New York — 1972

With more than two years under her belt heading up both Celera Diagnostics and Celera Genomics, Kathy Ordoñez has been working toward turning drugs and theranostics out of Celera Genomics’ technological capability and the intellectual property of Applera subsidiary ABI. She spoke at the Scientific American Targeted Medicine conference in New York on Nov. 11 about developments along the pharmacogenomics route, and Pharmacogenomics Reporter spoke to her afterward about Celera’s role in pharmacogenomics.

How is Celera working toward linking up diagnostics and therapeutics?

Of course, we’re the company that published the sequence of the human genome, and as we completed that task and our initial business strategy was a database strategy to sell the data — we then moved into a large-scale proteomics discovery effort on the same site where the human genome sequence was done. Focusing on cancer, I showed some of the data today where we looked at cancer from multiple sources — breast, lung, colon, pancreas — we’re moving now into other cancers and looking at how proteins are differentially expressed on the surface of those tumors. What this is useful for is, first of all making drug targets, because we have a protein sitting on the edge of a tumor, and it’s present in 60 percent of colon cancer. And if you have a sense of whether it’s present in breast or whatever, you can bring in a therapeutic antibody, a monoclonal antibody that binds to that. And either by designing the antibody in a certain way or linking it to a cytotoxin, you can go after the tumor.

In addition, these proteins have a diagnostic application. You can imagine that you could use a tumor sample in the way that the FISH test is used to select therapy.

At [Celera Diagnostics], we have set up a huge-scale discovery platform in genomics. And [in a conference lecture], I gave an example from the PTPM22 SNP — we take thousands of samples of people who have a given disease and case and controls. The example I used was people who have arthritis — people that have RA, people who do not — sometimes you try to get sibling pairs. And then, you genotype them. And we’ve developed what we call a functional genome scan across most genes where we can look for SNP on a scale you just couldn’t imagine a couple of years ago. Thousands and thousands.

In pools, we’ve worked out ways to do up to five million genotypes a day. So, we get thousands of case-control samples from around the world because we want to deal with the geographical differences in race and population and whatever, and then identify where our genes are different in disease. And that information is extremely useful in drug development, again, and in diagnostics, because we can predict risk for disease using that information, or rate of onset, or when disease will occur. And we can sub-stratify — [Larry] Lesko [director of the US Food and Drug Administration’s Office of Clinical Pharmacology and Biopharmaceuticals] was saying how these complex diseases are not one disease. Altzheimer’s is probably five or six or eight different diseases; we can say, ‘You have type A — take Aricept. You have type B — take this other drug.’

So, we’re doing those activities across a range of diseases. And we also have a small-molecule drug group in South San Francisco that takes these discoveries directly into drug development.

What we can do is use this information to develop new drugs, develop new diagnostics, to put the two together in targeted medicine, and also gain an understanding of existing therapies.

An example that [Eric] Topol gave from DeCode, with the drug that they in-licensed from Bayer that was an asthma drug that goes against a target that they learned from their genomic studies could, should have implications in heart disease. It is a huge clue. And it actually allows you to identify the patients who should respond to the drug. Now, whether this will work or not, we won’t know until they finish the clinical trial. But we’re sitting right in the center of the opportunity to pursue these types of things.

You said earlier that pharmas are driving the development of theranostics. Can you elaborate?

They have to go hand in hand. So, if I develop a test for a therapy that doesn’t exist, I can’t sell the test. So, they really have to go hand in hand. The pharma industry has to take a leadership role, because they’re developing the drugs.

We’re fortunate at Celera, because we’re in between drugs and diagnostics. And there are a couple of large healthcare companies — Roche is an example, Bayer is an example of a company that has both the diagnostic and therapeutic component. But none of these companies is as close to the discovery as we are. I mean, that’s the essence of who we are and what we are — making these discoveries and trying to create value from them.

This is where I was going — having a drug discovery arm, how does that compare to a diagnostic company partnering with a really large pharmaceutical company?

Well, the key assets that we have involve our discovery path — the proteomics discovery, the genomics discovery, and the informatics that we have that link it all together. Creating long-term value relies a lot on our own internal diagnostics products development and small-molecule development.

In the meantime, we’re putting a lot of partnerships in place for the exact reasons you’re thinking about. Some of the large pharma companies — Abbott is an example, we have a relationship with them — they own a group called Knoll that makes therapeutic antibodies. They have this in place, they’re very excited about the proteins they see from our proteomics program. So we have a relationship with them, where we basically give them some proteins and they turn them into drugs and then we share the value that comes out of it.

If Celera Genomics and Diagnostics are working so close together, and with you heading both of them — is it still best for them to be separate entities?

Well, today it is. Who knows, long term, what is the right thing? You always have to take a real fine look at these questions.

But Celera Diagnostics was formed as a joint venture between Celera Genomics and Applied Biosystems, and both companies put a lot of assets into the joint venture. ABI put in a lot of IP — that’s very important to Celera Diagnostics — and also access to its sequencing instruments and other instrument technology and other capabilities. Celera Genomics has given Celera Diagnostics access to its databases and bioinformatics capabilities, proteomics discoveries. And both companies have contributed cash.

Celera Diagnostics is not in its infancy, I’d say we’re kind of a teenager — we’ve got products on the market, we’ve had a lot of success, we have the collaboration with Abbott, we’re moving toward profitability.

It’s a good place for us to sit with the two parents [ABI and Celera Genomics], because we get a lot of riches from both parents. Out in time, as we move to profitability with new genetic tests that are based on all of this discovery we’ve been doing, come to market, and as other projects that we’ve been working on collaboratively with Abbott come to market, and we become profitable, you might think that a different paradigm would make sense.

With Cathy Burzik taking the helm at ABI, and her very strong diagnostics background, how does that play into this?

Cathy’s role within Applera is not diagnostics. The fact that she has that experience is very valuable, because diagnostics is perhaps a more disciplined industry than the research industry. So the skill set that she’s bringing to ABI of process controls and application of six-sigma techniques and those types of things, I think is a very good thing for ABI, where it is in its evolution right now.

So, I think she’s the right person for the job at this time. And her experience in diagnostics is always a very good thing for us, because when we want to talk about locking down a level of software on the sequencer, she understands what I mean — which is not always a simple thing when you’re talking to somebody that’s developing products for the research environment.

How did you come to Celera Diagnostics?

I came to Applera in December of 2000, and very quickly, with some colleagues, we had a vision. The molecular diagnostics industry had already been built out — I ran the PCR business for years before I came here. And it was becoming very successful, very impactful in medicine. All the infectious diseases in viral-load testing, and then the application of the technology to blood screening — these things were happening.

The next wave was the application of these techniques to genetics. To me, this is the ideal place to do it. We had the sequence of the human genome first — we have all these tools to see how human variation relates to disease, and to do this at a scale that you just couldn’t imagine.

In a large pharma company, it would take more time to get the capital equipment requested. You know what I mean? I don’t mean that in a negative way — I’m just saying this is a problem for biotech. Figure out which genes and which proteins are associated with which diseases, and then to turn them into diagnostic products — that’s what I’ve done all my life. It’s not a simple process.

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