The February, 2012 issue of Life Science Leader has a wide-ranging interview with G. Steven Burrill. It’s an interesting, insightful read, and we can recommend the interview.
Mr. Burrill makes an interesting point several times in the interview that are worth repeating:
Let’s not just assume that we will always be going through a lengthy development process. We’re going to change the way clinical development happens and how we gain access to markets. Maybe we don’t go the FDA route first; we go to the market in Brazil or China or Timbuktu, we get our product revenue from that business, and then we come to the U.S. market after we get more clinical experience. There are lots of ways that we will build companies differently from how we did it 40 years ago, when you could go through the rounds, get PoC, and go public. That is not a model that works today. It doesn’t mean you can’t develop technology. Funding development is more challenging, it puts a reward on the creative, but the game is not over.
Then, later in the interview:
One, companies have to compete more globally. Let’s say you spin your rights to a Brazilian investor who will take those rights and accelerate your commercialization in Brazil but provide you with nondiluted capital to do what you want to do in this country….
What Burrill correctly points out is that reversing the traditional US/EU First model makes a lot of sense in this environment for the right opportunities. Some countries generally frown upon being involved in First-In-Man studies, for example. Further, some countries all but require FDA approval before approval in their own country. Regardless, it’s a very different way of thinking which has profound implications from a venture capital and business development perspective.