ScaleVP’s Mitchell: FDA’s Capriciousness Is Driving Out Life Sciences Investors

to control the studies themselves, and they have more resources. That is certainly one strategy. Sofinnova does the same thing, and just successfully raised a fund. We do think there are some opportunities out there. But it’s difficult, when you are looking at the Phase 2 or Phase 3 stages, where there is some human data, and you are still subject to the capriciousness of the FDA’s approval process. When you look at the ‘Vital Signs’ survey, 61 percent of VCs said that regulatory challenges are the biggest single impact on venture investing, and over the next three years 40 percent said they were reducing their investment in biotech, pharma, and devices. That is the real message.

X: What about the life sciences firms that are still in your portfolio—Alimera, Ascenta, Oraya, Sonexa. How does this shift reflect on them?

KM: We think there is a lot of upside there. These are big markets with a great stable of CEOs—as strong a group of CEOs as you could find anywhere. We have them in regularly; a few weeks ago they were meeting with our LPs alongside our tech CEOs, and our LPs love them. They are good leaders. One of the reasons Marke and Lou are going to be busy is that we want to guide them to an optimal outcome. We have more than adequate reserves to take them through that. For whatever rounds they need, we are fully reserved, and our LPs understand that and approve that. So there is a lot to do here.

X: You’re the past president of the NVCA, the former chair of MedIC, the chair of the IPO Task Force. What do you think it says to the industry, and to government, when your own firm decides to walk away from life sciences investing?

KM: I have had some Congressmen reach out to me already today, and I’m glad that we can have those conversations, frankly. I am obviously not doing it for effect—it really came down to us sitting back and saying what is the right thing to do. But healthcare investing has moved outside our scope, and unfortunately, that does say a lot, and we are going to use it to further the dialog.

Author: Wade Roush

Between 2007 and 2014, I was a staff editor for Xconomy in Boston and San Francisco. Since 2008 I've been writing a weekly opinion/review column called VOX: The Voice of Xperience. (From 2008 to 2013 the column was known as World Wide Wade.) I've been writing about science and technology professionally since 1994. Before joining Xconomy in 2007, I was a staff member at MIT’s Technology Review from 2001 to 2006, serving as senior editor, San Francisco bureau chief, and executive editor of TechnologyReview.com. Before that, I was the Boston bureau reporter for Science, managing editor of supercomputing publications at NASA Ames Research Center, and Web editor at e-book pioneer NuvoMedia. I have a B.A. in the history of science from Harvard College and a PhD in the history and social study of science and technology from MIT. I've published articles in Science, Technology Review, IEEE Spectrum, Encyclopaedia Brittanica, Technology and Culture, Alaska Airlines Magazine, and World Business, and I've been a guest of NPR, CNN, CNBC, NECN, WGBH and the PBS NewsHour. I'm a frequent conference participant and enjoy opportunities to moderate panel discussions and on-stage chats. My personal site: waderoush.com My social media coordinates: Twitter: @wroush Facebook: facebook.com/wade.roush LinkedIn: linkedin.com/in/waderoush Google+ : google.com/+WadeRoush YouTube: youtube.com/wroush1967 Flickr: flickr.com/photos/wroush/ Pinterest: pinterest.com/waderoush/