IBJ Health Care and Life Sciences Weekly

Q&A

Wednesday, November 28, 2007

"Local biotechnology startup ImmuneWorks LLC is attempting to develop treatment for autoimmune diseases in human lungs. Life science industry veteran Wade Lange became its CEO this summer."

Q: "You helped research the marketing launch for Prozac at Eli Lilly and later ran the Indiana Health Industry Forum trade group before you took charge of ImmuneWorks. What's the biggest difference between each job?"

A: "The big difference is just the level of experience and resources you have at your disposal. At any large company, there are 100 people around who have seen any problem you're going to encounter. You have a lot of people who know how to deal with the FDA and clinical trials. And you have money. You're not out simultaneously raising funds while you're doing clinical work.

The other side is [at a startup], you've got the ability to make a decision quickly and then act on that decision, whereas at a large company, it takes levels of approval and things turn more slowly. Here we can make a decision any morning that has profound consequences for the company, because the decision makers are all around one table. To me, that's part of the challenge and excitement of a small business."

Q: "ImmuneWorks is preparing to begin clinical trials of its product next year. What will you do if the results don't turn out as expected?"

A: "One of our core challenges is to understand what happens in a clinical trial. If it's not safe, we have to understand if we overdosed or underdosed patients with the medicine, or if there's something in the nature of the product. We don't expect to see side effects, but if we do, we'll have to understand why they're happening.

If you read the pharmaceutical industry's stuff, they'll tell you it's 10 to 12 years to take a product from identification to market, and the stage where we are it's about a 90-percent failure late. It's long and fraught with potential for failure.

You have to really understand the results that you see from clinical trials. Which is one of the reasons we're putting together a board of leading scientists. That's so we can have our best shot on goal when we go to our first trial. But it's also so that we can react to that trial, because it is time-consuming and risky."

Q: "Your company is located inside Indiana University's Emerging Technologies Center, the business incubator on Indianapolis's Central Canal. There's a waiting list of entrepreneurs who would like to take your spot there. How has the incubator assisted ImmuneWorks so far?"   
    
 
A: "[IUETC President] Mark Long and his staff are helping with licenses and thinking through some early-stage issues of running the company. But the biggest advantage of being here is the community of people around going through the same problems, or who have gone through them already.

I'm always concerned with building a list of things that I don't know. Things you just don't know can really trip you up. Having people around who know about raising venture capital money, dealing with the FDA or any number of issues-who have dealt with those problems-can help. And hopefully I can contribute to them as well."