CHICAGO - Advice for start-up therapeutic and device companies on how to find the most efficient regulatory path to the clinic is in the offing for grantees in the National Cancer Institute's Small Business Innovation Research program.

Through the regulatory assistance program, Phase II grantees in the NCI program will be eligible to apply for up to 30 hours of consulting time "to help them with their regulatory approach," Andrew Kurtz, program manager, said in an interview at the Biotechnology Industry Organization meeting in Chicago. While 30 hours of advice may not be enough to start filling out FDA paper work, it should be enough for the company to know what its next steps should be, Michael Weingarten, director of NCI's SBIR center, added.

The NCI program is in the process of selecting two consulting companies for the government contracts, one in therapeutics and one in devices. Once the consulting firms are on board, they will help set up the criteria for the awards. About 120-150 companies will be eligible for the program, with 30-40 slots up for grabs. The program plans to start accepting applications in the fall.

Not The First Innovative Move For The NCI Program

Offering regulatory counseling isn't the first innovative fillip the cancer institute's SBIR center has put on the program, which is offered by all federal research agencies.

In June 2009, the center made its first Bridge awards to extend funding for its Phase II grantees into the translational space. The Bridge grant program requires grantees to match the NCI funding at least one-for-one with a third-party source. The first winner in the therapeutic category, Lpath Therapeutics, managed a six-to-one return by inking a licensing deal with Merck Serono for its lead compound (Also see "Lpath, OptoSonics First To Win New Bridge Grants From NCI’s SBIR Center" - Pink Sheet, 8 June, 2009.)

Bridge funds go toward projects such as some Phase I research, as well as biomarker studies to use as assays in selecting indications to go after for later stage trials. The center has made six total Bridge awards so far, two for companies developing therapeutics and four for diagnostics companies. All are three-year awards, and almost all are for $1 million a year, for a total of $17.7 million. The program doesn't set a ceiling on the grants, but asks companies to lay out their plans and their funding needs and makes awards accordingly.

In third-party matching dollars, the program is over $15 million. The goal was for one-to-one matching, but it's running closer to three-to-one, Kurtz said, noting that the Lpath award is somewhat of a spoiler.

The program is validated by the fact that even in trying economic times for early-stage programs, investors are still interested in the model, Weingarten said. The program's reviewers, a mix from the drug and device industries, academia and the investment sector, will meet in a few weeks to go over 25 new applications with a view toward making up to 10 more awards by September.

It's All About Mitigating Risk

With early stage risks mitigated by the rigorous process involved in winning Phase I and Phase II SBIR funding, companies are in a position to attract industry funding partners. In October, the NCI center set up a venture capital-like showcase to match Phase II grantees with potential leverage partners for Bridge funding, as well as to show off its Bridge award winners (Also see "A First: National Cancer Institute Showcases Its SBIR Start-Ups To Attract Investors" - Pink Sheet, 30 October, 2009.).

Based on that meeting, several potential partnerships are in due diligence now and one received a strong letter of recommendation from a third party for its Bridge application, Weingarten said.

The NCI center is hosting a West Coast version of the meet-and-greet in November at Stanford University in collaboration with the San Jose BioCenter, an incubator that is "one of the best networked" the center has worked with, Weingarten said.

-Shirley Haley (s.haley@elsevier.com)

NCI Will Offer Regulatory Coaching To SBIR Grantees

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