Dr. Ray Kurzweil, a futurist, inventor, pioneering computer scientist, and director of engineering at Google, believes that in the next 10 years 3D printers will be able to print human organs using modified stem cells derived from a patient’s own DNA, thereby providing an inexhaustible supply of organs with no rejection issues. While Kurzweil’s vision may seem based in fiction, there is already one company, Organovo, designing and creating functional human tissues via 3D bioprinting technology. In biopharma, if we are to realize any semblance of the predictions of futurists like Kurzweil, our leaders must embrace an entrepreneurial and risk-taking spirit that transcends the mere ability to see and react to the latest trends.
Qu Biologics cofounder and CEO, Hal Gunn, M.D., put it succinctly when, during a recent discussion, he stated, “Opportunity in biopharma lies in doing things outside the way they are commonly done.” Elizabeth Holmes is a good example of this philosophy. After dropping out of Stanford at the age of 19, she started Theranos with the goal of disrupting the $76 billion laboratory-diagnostic industry. Her idea was to eliminate blood vials and tourniquets and, instead, gather a very small amount of blood in containers (i.e., nanotainers) half the size of your thumbnail for diagnostic testing. Although the concept made Holmes America’s youngest self-made female billionaire before the age of 30, it also has made her the target of the guardians of convention. Case in point, this past October the FDA declared Theranos’ tiny vials to be “an uncleared medical device.” Despite the FDA not having formal oversight for blood tests that clinical laboratories develop with their proprietary techniques, the agency opted to examine the nanotainers under its authority as a medical device regulator.
Prior to the FDA declaration, Holmes took fire from John Carreyrou, a journalist with the Wall Street Journal. In October, Theranos and its founder began bearing the brunt of Carreyrou’s pen when he published a two-part series that called into question the company’s business model. Not long after, in a CNNMoney article, Bill Maris, Google Ventures’ managing partner, said regarding Theranos and Holmes, “In the life sciences space, you need MDs, you need PhDs.” In other words, would nonscientist college dropouts like Elizabeth Holmes and Bill Gates please stop meddling in the life sciences? It’s likely General Motors and Ford are thinking the same thing about Google with its selfdriving car. But as Gunn insinuates, there are times when it is necessary to break from convention.
This month’s signature issue represents an unprecedented move by the Life Science Leader editorial team. We reached out to the largest collection of biopharma trendsetters and industry insiders in our history to gain their outlooks for 2016. In the following pages you will find not only insights on industry trends across key disciplines but also the knowledge and wisdom to best prepare you for the coming year. We hope you like it and welcome your suggestions for how to make 2017’s outlook issue even better.