Name: Sam Tetlow
Position: Author, D&MD Publications' "How to Succeed in Personalized Medicine by Using Tools and Technologies"; Consultant, Clearview Limited
Education: MBA, Kenan-Flagler Business School, University of North Carolina at Chapel Hill
Sam Tetlow is author of a new report from D&MD Publications about successful strategies in the pharmacogenomic arena, and he is the author of a book in a similar vein called Successful Pharmacogenomic Business Models from 2004.
Pharmacogenomics Reporter spoke to Tetlow about factors for the success of companies in the personalized medicine space, and about what shifts he expects to take place in it.
What are the major changes you see happening in the field of pharmacogenomics in the near future?
There are a couple of fundamental activities going on in the marketplace.
The first is just a focus on the specific enzymes that are being tested. [CYP450] 2D6, 2C19, 2C9, is the family where drug companies are getting traction, and diagnostics have already been there, but those are the three that are really hitting.
There is [CYP450] 3A4, 3A5, a lot of 2Cs — those are not getting as much attention. The baseline is that you've got to be in the clinic to play — that's been the case for about a year — versus being in the preclinical arena.
The big change is that diagnostic companies are getting linked up with drug companies, so it's happening in the clinical development activities. So, drug companies are bringing [pharmacogenomics] through phase I, II, and III — more phase I activity than phase III activity. But the fundamental shift that's going on is that there's some alignment between diagnostics and drug companies.
You've got to get with a drug company. And most often it's going to be specialty pharma that you'll probably have the best access to work with. Allen Roses at [GlaxoSmithKline] is developing an Alzheimer's drug using a 2C19 marker, so there's big pharma activity happening as well.
How long has this shift in alignment with drug companies been going on?
It's been going on slowly for about a year and a half to two years.
Has it changed in intensity recently?
I have seen it ramp up, and we're seeing it ramp up at the start of this year.
What other major trends do you see as underway?
The other dynamic is that you see a little bit of a blurring as to 'what is pharmacogenomics?' as opposed to 'what is proteomics?' in the research activities. In the clinic, it's still very much genomic activity. So, in the research, the preclinical activities, there is a little bit of a 'munging' of what historically has been a pretty sharp division between genomics and proteomics and metabolomics. Now you're starting to see a little bit of a munging of those three into that 'omics' dynamic.
Should we come up with a new term at some point then?
Yeah, and we're going to call it 'omics.' [oh goodie - I can't wait…]
What do you see developing in the policy area? Last year we had the voluntary guidance for pharmacogenomic data submissions — what's the next step?
The next major change is going to happen on the Medicare/Medicaid side, with [Mark] McClellan taking over [as director of] [the Centers for Medicare and Medicaid Services].
There's a reason why VGDS came out of the FDA after McClellan left - he helped make it happen — Larry Lesko [director of the Office of Clinical Pharmacology and Biopharmaceuticals at the FDA's Center for Drug Evaluation and Research], Janet Woodcock [deputy commissioner for operations and chief operating officer at the FDA], and all of those folks and their respective organizations were instrumental in making that happen, but McClellan really helped drive it from the top.
So the next big change — although I think it's going to happen slowly - around the FDA is the submission of data in this non-review format that the FDA is talking about [the VGDS process]. You'll start to see more companies start to submit. And it won't be used in the clinical evaluation, but I think you'll see some companies just do it because they've got the data and they want to establish a positive working relationship with the FDA and there's a premise for them submitting it, and they theoretically won't get penalized, and they feel comfortable enough in that application that they're OK submitting all of their pharmacogenomic data.
I don't think you'll see a change in the positioning from the FDA, but you'll see some actual submissions to the FDA.
But the big activity is going to happen on the reimbursement side — that's where things are going to start to change from current activity.
We saw the FDA start to allow submissions. Very few submissions were actually occurring. I think you'll see that submissions are going to climb slowly, but a change in policy is going to happen on the CMS side.
The most recent change I've seen is the reimbursement decision received from CMS by Genomic Health for their breast cancer diagnostic. What area of the field do you see the next reimbursement decision coming from?
I would characterize it as an area of unmet need where there's no therapeutic drug, and there's a big mortality issue. So, the FDA fast-tracks a drug like Herceptin that has a high toxicity case in a small percentage of the population, but the rest of the population feels [that] it's mandatory, and CMS is going to do the right thing and think, 'How are we going to address this medical need?'
It's not going to be a Lipitor diagnostic test that's going to get reimbursed, or even a mini-blockbuster drug. It's going to be an area of unmet need where there's no drug today, and getting a drug on the market fast is going to be instrumental in addressing mortality.
So something serious like cancer or cardiovascular disease?
That's a distinct possibility. I am speculating, but it's probably easier to do it in a specialty application like gastrointestinal disease — [for example in] post-operational surgery, there is an emptying of the stomach that has to occur for the patient before and after surgery — there is a condition called post-operative ileus [in which the gut's motility stops functioning due to trauma or surgery] that affects 1.4 million people today, and there's no drug for it. There's a clear need for this drug, and I don't know if therapeutics would have an adverse reaction set or not, but that's one way. It will be an area of unmet need.
What are some of the major intellectual property issues coming up?
I only have general comment, which would be: In areas where diagnostic companies can identify the gene that characterizes some mechanism of action, they're going to understand the application of that as it pertains to a drug — they're going to hold value. The diagnostic company that gets alignment with that composition of matter for the diagnostic application is going to have value.
I don't know specifically about gene numbers and companies, but it's going to be composition [of] matter of the gene in the application — so that's going to mean, 'Is the drug company going to have the drug's intellectual property for that chemical structure? Does the diagnostic company have the application of making the diagnostic kit for that genomic test?'
It's going to be the IP in the application — it's about composition of matter. It's not around process patents or method patents. Those don't really hold a whole lot of value.
If you have to choose a couple of lessons that a specialty pharma could take from this report, what would they be?
Number one: The infrastructure to bring a drug to market concurrent with a diagnostic test is ready to go. You've got the technology, the business model has been shown in areas, you've got the FDA, who has approved it. It's ready to happen, all of the elements are there for specialty pharma. Genentech did it with Herceptin.
Number two: Big pharma faces this productivity issue with new chemical entity introduction and their revenue model. Specialty pharma can build a franchise around CNS or pain or oncology or cardio, and they can build a franchise quicker using pharmacogenomic tools in drug development, in drug discovery, and at point of care.
It's all about speed to market for those companies — they can either get a drug to market, or big pharma can purchase them.
What's relevant for specialty pharma? Well, they can get, as a company, purchased by big pharma, and big pharma's comfortable that they're very smart at deploying the technology enabling drug development and drug discovery. They probably would want to do that rather than figuring it out themselves.
The tools and the technologies enable specialty pharma to be a better and bigger specialty pharma, so 'Use those tools' is the takeaway. And you'll get a drug to market faster if you [do], than if you don't use those tools.
So then have we dispensed with the blockbuster model?
No, it'll happen - rarely. It'll continue to happen, but it's probably going to be as scarce as it ever was.