“The Right Approach” To Regulating Biomarkers: An Interview With Interleukin Genetics CEO Lewis Bender (Part 3)

Setting standards in an emerging area of science is a big challenge, both for FDA and regulated industry. One diagnostics CEO thinks FDA is taking an appropriately careful approach.

The scientific potential of personalized medicine is unquestioned; the business model is still a work in progress.

Take Waltham-Mass.-based Interleukin Genetics. The diagnostics company, founded more than 20 years ago to explore commercial opportunities related to Interleukin's role in inflammation, qualifies as a pioneer in personalized medicine.

But it is still struggling to find a path to profitability.

Right now, its primary commercial focus is on consumers - offering both diagnostic tests and nutritional supplements. But CEO Lewis Bender is banking on partnerships with pharma and biotech companies on biomarker strategies to help move the business forward. In particular, the company believes it has found some reliable markers for inflammatory response that could be useful in stratifying patients in a number of huge disease areas, like osteoarthritis, rheumatoid arthritis, obesity and even Alzheimer's disease.

Interleukin hasn't found a partner yet, and time is tight: The company recently fended off a de-listing action by AMEX, but its access to capital beyond 2009 is very much in question.

Bender, formerly chief technology officer at Emisphere Technologies Inc., joined Interleukin in January 2008. He chaired a breakout session on biomarker-based drug development strategies during the Biotechnology Industry Organization conference in Atlanta May 19.

We sat down with him afterward to talk about his ideas for applying markers for inflammatory response to drug development. We will let the scientists sort out whether Interleukin's technology can in fact deliver the types of stratification the company says it can - but we think Bender's views on the business and regulatory challenges to biomarker-based drug development merit careful consideration.

In Part 1 of the interview, we discuss the idea of using biomarkers to "resurrect" projects abandoned in development (¹ (Also see "Pipeline Resurrection: An Interview With Interleukin Genetics CEO Lewis Bender (Part 1)" - Pink Sheet, 29 May, 2009.)). In Part 2, we focus on the challenges of getting Big Pharma companies to apply ideas for targeted therapy to markets outside of oncology (² (Also see "Divide And Conquer With Biomarkers: An Interview With Interleukin Genetics CEO Lewis Bender (Part 2)" - Pink Sheet, 1 Jun, 2009.)).

In the third and final part, we discuss the regulatory status of companion diagnostics, starting with Genentech's petition seeking formal regulation of lab-developed tests of the kind Interleukin hopes to apply to drug development (³ (Also see "Genentech Petition Rekindles Debate On Lab-Developed Test Regulation" - Pink Sheet, 22 Dec, 2008.)).

"The Pink Sheet" DAILY: How big a deal is the Genentech petition? How do you hope to see that turn out?

Lewis Bender: Genentech obviously wants to make sure that there is quality for the test that is out there.

It is certainly not something that is going to help advance molecular diagnostic testing. The genome was only sequenced 10 years ago, and this is a science that is still evolving in many ways. If you try to put these restrictions on these early stages of the science, you will stifle innovation to a certain extent.

Making a more difficult way for companies to innovate at a time when innovation for pharmaceuticals is at a very, very low point is probably not the best way for these companies to be acting, in my opinion.

On the other hand, you can't have fly-by-night science. You have to have quality, you have to have a certain level of standardization. But the question of when those standards should come about and how they should come about is important. If they come about too soon, and the regulations become restrictive on innovation, I think you run into an inhibitory process on making new science.

"The Pink Sheet" DAILY: How are you getting these points of view across to the agency?

Lewis Bender: The best representative of that is the Personalized Medicine Coalition. We're members of that. ...That is the best organization to make the case not only to the government, but also to the advocacy groups for the diseases and other players.

"The Pink Sheet" DAILY: FDA is working on guidance on companion diagnostic development. Is that something where there is a danger of the regulator getting in the way, or is there an opportunity for that to make life simpler?

Lewis Bender: I have to compliment the FDA. They are very, very much aware that they don't want to become inhibitors of science and technology that could be very beneficial.

At the same time, they want to make sure that anything that is done is done correctly. I think they are taking a very good approach right now, a very cautious approach. It's the right approach. They are putting out guidances. They are asking for feedback. They have been very responsible in what they have done and what they've said, and I think they are taking the right way to this new science. I think they've done a very good job.

-- Michael McCaughan ([email protected])