A pilot program launched this week in four NIH institutes looks to speed up development and commercialization of new products and services generated by projects funded through the agency’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards.

The first class of 21 three-person teams of researchers and entrepreneurs gathered in Chevy Chase, MD, this week, concluding Wednesday, for the launch of the NIH Innovation Corps (I-Corps™) Team Training Pilot Program. The teams are all based at therapeutics, diagnostics, and medical devices companies funded with NIH SBIR Phase I grants, awarded to establish feasibility of proof of concept for commercializable technology.

I-Corps @ NIH is designed to support training that is intended to help project teams at NIH-funded small businesses overcome key obstacles toward innovation and commercialization. The pilot program has been modeled after the successful NSF I-Corps™ program, completed over the past three years by more than 400 three-person teams of scientists and engineers—including teams funded by the U.S. Department of Energy's Advanced Research Projects Agency (ARPA-E).

The NIH pilot effort will focus, however, on accelerating development of new and emerging technologies for detection, diagnosis, treatment, and prevention of disease. The National Cancer Institute’s SBIR Development Center is leading the I-Corps @NIH, along with SBIR and STTR Programs at the National Heart, Lung and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Center for Advancing Translational Sciences (NCATS).

“It requires scientists who at least will agree, ‘I want to learn to build a successful venture.’ Not, ‘I want to just get more funding for my science, and I’m going to use some commercialization pool to do that,’” Steve Blank, the serial entrepreneur and academic who designed the I-Corps curriculum.

I-Corps is a modified version of his model for teaching startup entrepreneurship, the Lean LaunchPad. Each I-Corps team consists of a C-level corporate officer, an individual with previous business development background, and the assigned program director or principal investigator on the company’s SBIR/STTR Phase I award. Project teams must attend a three-day “Entrepreneurial Immersion” course together, then participate in a roughly nine-week training course administered online.

The course introduces Alexander Osterwalder’s Business Model Canvas concept, designed to map out commercialization hypotheses for validation through active contact with some 10 to 15 potential customers, partners, and regulators weekly. Startups then build their product or service incrementally, refining or revising as they learn more. At the end of the course, each team must attend a two-day report-out session where they share what they did, and learned, with peers.

“It’s quite similar to what scientists already do: It’s about framing hypotheses, designing experiments, running those experiments, getting some data, extracting some insight, and either validating or invalidating hypotheses. Boy, that sounds like what scientists have been doing for hundreds of years,” Blank said.

“We’re just now observing that we could actually apply that to the commercial side of the business, and we could teach you what those hypotheses mean in a very short order. We can give you enough information for you to understand what some of the regulatory and IP and reimbursement and other commercial issues are,” Blank added. “Companies regardless of their industry that use this method tend to be incredibly more efficient in the use of their time and capital. It doesn’t guarantee success, but it in fact accelerates efficiency. That’s what we’re going to do for the NIH.”

I-Corps trains the teams to commercialize their ideas cheaper and faster by applying “lean” startup concepts articulated by Blank and protégé Eric Ries, who like Blank is a Silicon Valley entrepreneur and author. The lean paradigm stresses creating more value for customers with fewer resources. Teams launch and grow their startups using lean methods that include: 

  • Define clinical utility before spending millions of dollars
  • Understand their core customers, and the sales and marketing process required for initial clinical sales and downstream commercialization
  • Assess intellectual property and regulatory risk before they design and build
  • Gather data essential to customer partnerships/collaboration before doing the science
  • Identify financial vehicles before they need them

How much is lean management expected to drive the science of startups, and how much, complement the science?

“Making the science more accessible and better is a different process than understanding commercialization, and they need to occur in parallel. They need to be driven, initially, by the PI, the big idea,” said Blank.

Yet PIs need to understand business processes such as regulation, IT, reimbursement, and managing clinical trials – processes that traditional biopharma CEOs have until lately largely relegated to other executives, or to third parties: “That really does a disservice, we now understand, to the commercialization activity. It’s not something you can outsource. If you want a successful license, or partnership, or new venture, you actively have to be involved in commercialization,” Blank said.

“The key part about I-Corps is, we now know a process to teach principal investigators this without making them MBAs,” Blank added. “We can do it very rapidly and efficiently, such that they will have an appreciation for the rest of their careers about what this other component of building a commercial venture means.”