Gil Y. Roth11.06.09
Newsmakers: Dr. Michael Gilman
Q&A with a new biotech about building a virtual network
By Gil Y. Roth
I’m always curious about how biotech startups develop their outsourcing expertise. They need to go outside for almost all functions, of course, but how do they figure out where to go? To get some insight into that question, I spoke with Dr. Michael Gilman, founder and chief executive officer of Stromedix, a startup founded in 2007. Dr. Gilman came from a company that handled most everything in house (Biogen), but his VC-funded company is making steady progress with its first MAb, STX-100, after developing a unique clinical path for this fibrosis treatment.—GYR
Contract Pharma: Tell me a little about your history and how Stromedix came about.
Michael Gilman: I began my career in academia, before moving to ARIAD and then to Biogen in Cambridge, MA, where I was executive vice president of research. I left Biogen in late 2005 and began talking to people about starting up a new company. I have to say, it was delightful to have a blank piece of paper in front of me.
Dr. Michael Gilman is founder and chief executive officer of Stromedix, Inc., a company focused on developing novel therapies for fibrotic diseases. Prior to founding Stromedix, Dr. Gilman spent over six years at Biogen Idec, most recently as executive vice president, Research. Dr. Gilman spent the previous five years at ARIAD Pharmaceuticals, where he was executive vice president and chief scientific officer. From 1986 to 1994, Dr. Gilman was on the scientific staff of Cold Spring Harbor Laboratory in New York, where his research focused on mechanisms of signal transduction and gene regulation. He was a postdoctoral fellow at the Whitehead Institute. He holds a Ph.D. in Biochemistry from University of California, Berkeley, and a S.B. in Life Sciences from Massachusetts Institute of Technology. He is a member of the board of directors of EPIX Pharmaceuticals and several scientific advisory boards. |
CP: Was your departure related to the Idec merger?
MG: No. In fact, I was part of the integration team. So, shortly after leaving Biogen, I connected with a pair of VC firms: Atlas Venture and Frazier Health Care Venture. I spent about 14 months in the Atlas office, working on the problem of fibrosis.
CP: Which is?
MG: Fibrosis is essentially “wound repair gone bad.” It results in organs accumulating scar tissue and ultimately failing. There are no treatments for fibrosis, even though the biology is quite well understood.
CP: Why is that?
MG: Partly it’s a chicken-and-egg issue. Because there are no existing drugs, there’s no established development pathway. Also, it’s a pathology, and not a disease per se; it takes a very long time to develop, and once it’s progressed, it’s considered difficult to treat. And since it’s a tissue-based condition, it requires biopsies, not blood-tests. So taken together, you can see why it’s a tough nut to crack.
That said, it’s a huge greenfield. These diseases affect over 20 million people in the US alone.
CP: So your “only” problems are developing a clinical pathway and finding a drug?
MG: As far as the pathway goes, we concluded that the renal transplant patients were a great place to start. In that patient group, there’s a near-guarantee of fibrosis in the new kidney, which starts out healthy, but is subjected to all manner of stress from the patient’s immune system, other drugs, and even the storage process from the time it’s taken from its donor. In addition, taking biopsies is more practical than in other patient groups, because transplanted organs get routine biopsies, so we can get the data we need.
There are around 150,000 people in the U.S. who have had kidney transplants, and they will pretty much all develop fibrosis at some point, so this is a very important indication to pursue. Ultimately, we want to expand to other forms of chronic organ failure in kidney, lung and liver and to related settings like acute organ failure and cancer.
CP: And finding a drug?
MG: As it turns out, there was a candidate back at Biogen. It was being developed for idiopathic pulmonary fibrosis, but Biogen put it on the shelf as part of its annual R&D portfolio review. We licensed the MAb — now known as STX-100 — from them in May 2007, went live a month later, had our pre-IND meeting with the FDA in October 2007 and conducted Phase I testing in 2008. During that time, we also raised an additional $25 million in our second round of financing.
CP: How much work had Biogen done on the drug?
MG: They had done all the preclinical and tox studies and had filed an IND. The existing work made a great foundation for us when we were putting together our new IND. Biogen also made plenty of drug material, enough to last us at least through our Phase 2 trials.
CP: So no bulk manufacturing for you to worry about?
MG: Not yet, but we do have plenty of other activities to outsource. Stromedix is an eight-person company. In fact, when we were thinking about starting the company, it was important to us to find a clinical-stage asset. That way, we wouldn’t need to get our own lab space.
CP: What outsourcing expertise did you bring to Stromedix?
MG: Personally? None. I had no experience in outsourcing, coming from a company that did so much work in house. But one of the great benefits about a biotech hub like Cambridge is that there’s so much experience residing here. There’s a whole ecosystem of consultants: people who worked for one of the major biopharmas or have run startups before and can help connect you build a virtual network of providers.
CP: Can you tell me some of the companies that Stromedix relies on?
MG: Sure! Our fill/finish is being handled by Formatech, which is nearby in Andover, MA. Blue Stream Laboratories here in Cambridge performs analytical work for us. MPI Research is doing our toxicology, while Charles River Labs is doing some other work for us.
CP: Sounds like you’ve found a good local network.
MG: Well, our clinical CRO, CTI, is out in Cincinnati and the Charles River group we’ve used in is Montreal, but yes, we put a lot of this together based on networking. There really is a critical mass of experience in this area. That’s why I think it’s very difficult to start a biotech hub from scratch; I don’t think it’s as easy as, “if you build it, they will come.” You need a certain level of local expertise, an infrastructure that can only build up over time. I have to say, what Stromedix doing is a lot easier here in Cambridge.
CP: What involvement has Biogen had since handing off STX-100?
MG: They continue to store the drug for us and to perform stability studies. Also, I should note that Biogen is a part-owner of Stromedix; we exchanged equity in the company to license the STX-100 program (I say this because there are multiple antibodies associated with the license).
CP: What made out-licensing STX-100 an attractive proposition to them?
MG: They had made a perfectly rational business decision not to invest further in this drug. So it really wasn’t going anywhere at Biogen. Licensing it to us put it in the hands of a very focused, very experienced management team that is highly incentivize to figure out how to make it work. So it’s attractive to everyone. To Biogen because, if we succeed there’s significant upside for them; to investors and management because we secured a terrific drug; and, ultimately, to patients, who could one day benefit from a drug that was likely never to see the light of day otherwise.
CP: So no plans to try to bring it to market on your own?
MG: Not at the moment. There’s considerable interest in this drug from large pharma companies, so we expect to partner it when it makes business to sense to do so. Until that time, though we have to make sure our CMC plans support commercial scale manufacturing; we can’t just say, “We did the clinical work; you figure it out!” to a potential buyer or the FDA.
CP: You’ve worked in biopharma for 15 years. In your early days, did you ever imagine that a company would be able to operate with eight staffers and no in-house capacity?
MG: I wouldn’t have dreamed of it back then. It’s certainly a different way to work. But the virtual model has become so much more practical in the past decade, and it makes the most efficient use for a startup’s precious capital.
The challenge in outsourcing is finding people whom you trust and who bring the same sense of urgency you have for your product. Those are virtues largely built on relationships.