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NCI Starts SBIR Regulatory Help Effort

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Cancer Institute has started a new effort to help firms that have won Phase II funding under its Small Business Innovation Research program to work their way through the regulatory approval process.

The pilot Regulatory Assistance Program, open to new and recent SBIR and Small Business Technology Transfer grantees, will provide up to 30 hours of time with regulatory consultants to companies developing new medical devices or therapeutics.

"We are very excited to launch the new pilot [program], designed to help guide promising technologies through the regulatory approval process," Ali Andalibi, program director and head of NCI's Therapeutics and Diagnostics Section in the SBIR Development Center, told GenomeWeb Daily News in an e-mail.

"The program is part of our latest efforts to go beyond funding support and help small businesses bring innovative cancer products to market to ultimately help in the fight against cancer," Andalibi added.

Run by NCI's SBIR Development Center, the regulatory pathway program is one of several new initiatives at the institute aimed at supporting small business grantees, including the Phase II Bridge awards program, which more than triples the amount of SBIR funding a firm can win to up to $3 million over three years.

Another new NCI program for SBIR awardees is a recurring series of investor forums that introduce small businesses to biotechnology and life sciences investors and provides guidance on ways to secure venture capital funding.

Applicants that are accepted for the Regulatory Assistance Program will be matched with experienced consultants who will help them develop "a comprehensive regulatory plan aimed at optimizing each company's movement through the FDA approval process," according to an NCI description of the program on its website.

Applications for the program will be accepted until Feb. 4, 2011. Final selection of participants will be made by March 4, 2011, said NCI.