In May of 2012, John Eastman interviewed Tim Ruane, CEO of InSite Vision (INSV). Their discussion spanned the CEO’s experience in maneuvering in and out of the FDA, clinical trials, managing approved assets, and the CEO’s pragmatic approach towards medical fields and drug commercialization. Below is the first segment of that interview, discussing the 47 year old CEO’s experience with FDA proceedings and clinical trials.
JE: So, you’ve been at InSite Vision since December 2010, and before that you were at Tekmira Pharmaceuticals and at INEX Pharmaceuticals.
JE: Tell me how those positions have prepared you for your position at InSite and why is that experience beneficial to the company, as it makes its way towards commercialization for the existing products?
TR: Well, I think for my entire career I have been climbing through the ranks of marketing positions where I had product and profit line and volume responsibilities. That morphed into business development activities, roles and responsibilities, where I was either in licensing or out licensing products, and creating partnerships beneficial to the company. And then, at a certain point in my career, I started getting involved in new clinical development models, regulatory strategy, commercialization and launching new drugs. And throughout all of those positions, are exactly the things that are needed here at InSite Vision.
InSite Vision has always been a company that has been very good at formulating drugs in our Durasite drug delivery platform. It’s always been very good at early regulatory strategy. But it’s really fallen down on clinical development and on partnering. And the future for InSite Vision is really to become a clinical development machine, and by that I mean taking a look at what the clinical development timelines and standards are in the industry and attempting to cut those in half, because the most costly part of drug development is not the money to develop the drugs. It’s the time it takes keeping the lights on in the organization. When I was working for ILEX Oncology down in San Antonio, Texas, (this was a company that was originally a contract research organization, or CRO) we learned very rapidly from that business that we could cut the costs and the timelines of clinical development virtually in half, if we did certain things. And we ended up transforming that company into a very successful bio-pharmaceutical company, and sold it for a billion-one to Genzyme in 2004. So you can take smaller companies, get them to focus all their resources into the key things that you need to do to advance the drug, or drugs in our case, and then create real value for shareholders.
JE: I’ve read that during the AzaSite process you had spent a lot of time negotiating and talking with the FDA to formulate a more direct strategy. Does that come from your experience as well, the ability to negotiate through the FDA’s pathways?
TR: Absolutely. I think a lot of people in the industry have a lot of strong opinions about the FDA. And I think when you look at the FDA, it really is a lot of individual divisions that operate as they believe in the best interest of the patient segments that are served. I have most of my experience working with the oncology and hematology division, which at a certain point and time I think everybody had labeled as extraordinarily friendly and extraordinarily helpful. There a lot of people that don’t view that division in that manner today. One thing that I like about the ophthalmology division is that it is very helpful, and to us, very friendly and responsive in terms of us charting our clinical development path forward. Now that certainly doesn’t mean that they have been easy on us. We’re dealing with challenging clinical trial designs and in challenging disease areas. But I can tell you this, whenever we have a question, whenever we have a concern, our chief medical officer and other people in our regulatory clinical team really have carved out a very important and strategic relationship with the FDA, that gets us a lot of feedback very quickly to let us know that we’re going in the right direction.
JE: And have you had experience in dealing with the regulatory agencies in Europe and/or Asia and fostering any of the company’s products through approval there?
TR: Well, let me break that down into two answers, and we’ll tackle Europe first. Europe, absolutely. I have not only been involved with the European regulatory agencies historically, we have been involved with the European regulatory agencies in February of this year.
So one of the things we spent a lot of time on, in the first 90 days of me being on board with the company, was taking advantage of hindsight and being able to say, okay, here we are today, what are all the things that we think this company has done correct in its 20 years of existence. You’ve got to remember this was a company started in the mid 80′s that took until 2007 to get its first product approved, and its second one in 2009. I think anybody has to look back on that and say that’s a clear disappointment– to spend 20 years on something as simple as ophthalmology in front of the eye. And one of the things that we recognized is that this company had not approached Europe correctly. It essentially ignored Europe and Asia at the end of formulation development. We recently met with the regulatory authorities in the UK and in Sweden, provided them a full background of information on all the clinical development that we had done in the United States on our AzaSite plus and DexaSite product, and then asked them would this data be sufficient to support filing in Europe? And we were quite pleased to hear that in terms of a regulatory body, and again we’re dealing with a centralized body as well as individual countries, we were very pleased to see that they probably even more so than the FDA were very open and very attentive to our questions. In fact, they surprised us by saying that there is no de facto need for us to run clinical trials in Europeans patients. They view North American patients as identical to European patients. And while there are certain minor formulation differences between European standards and North American standards, these were not things that would require any clinical bridging studies, and in fact if the trials were positive, we could probably file centralized approval process there. So we have always found that, in order to move forward in Europe, we needed to really define what is the manufacturing strategy, what is the regulatory path, and is there a need to do clinical work there, or can we just use our US clinical experience and file in Europe.
Please see remaining installments soon of the interview discussing clinical trials, managing approved assets, and the CEO’s pragmatic approach towards medical fields and drug commercialization.Pages: