Thursday, May 21, 2009

Notes from BIO: NCI's Bridge Over FDA Troubles

"We're from the government and we're here to help you."

Here's a twist on that cliche: a government program that really might help. The National Cancer
Institute's $100 million SBIR (Small Business Innovation Research Program) is promoting a new "bridging" program to try to carry projects that it has previously funded in early formation through the ominous "valley of death" period as the developers face the first tough requirements of preparing for contact with the Food & Drug Administration.

NCI program's program director for therapeutics development, Ali Andalibi, was at a BIO breakout session in Atlanta on May 21 to spread the word about NCI's new largess. Andalibi was quite convincing: the center has money allocated to the bridging program (up to $10 million during the current fiscal year) and a practical model that involves trying to bring in private money and regulatory skills to make sure that projects don't die on the vine after two rounds of initial NCI funding support.

Andalibi, who has worked in academia, the biotech sector and for the National Science Foundation's SBIR program prior to joining NCI, has the range of different perspectives on government funding and resource support that could be very valuable to cancer start-ups.

As close FDA watchers, it particularly impressed us that NCI is adding regulatory consulting into its package of assistance for the start-ups. That's often a missing ingredient at that point in development. NCI wants to help the start-ups get through IND filing and safety testing before turning them loose for full private funding.

NCI and FDA have not always seen eye-to-eye on commercialization requirements, but they have been much closer partners in recent years. It cannot hurt fledgling private companies to have the assistance of NCI in finding the right advisors and coaching on regulatory strategies.

NCI is selling this new funding proposal to a relatively small group of potential prospects: only those firms that have received previous awards: Phase I (R41, R43, six-month feasibility studies) and Phase II (R42, R43 up to two-year projects with commercialization plans). The bridging grants are patterned after Phase IIB funding from NSF.

The government expects the developers to raise private money to supplement the new bridging loans. Andalibi says NCI will try to help locate angel funding sources. The private money is important to NCI as it also brings in the closer oversight and rigor of the investor community.

NCI has been selling the idea of bridging funding for at least eight months. It will be interesting to follow the projects that take advantage of the funds and to see whether a little help and advice from one of FDA's government cousins can move more projects through the IND and early human trials period.

1 comment:

Anonymous said...

As an ex-FDA reviewer of these early development studies. I would often cringe at anything that was done by NIH. Typically they were so bad that they really needed to be redone and there were often excessive numbers of bad studies.

Rather than hire academicians who don't know regulatory requirements and how to do the appropriate studies NIH should hire someone who has actually worked at FDA. Otherwise this will be a waste of money on studies that will need to be redone.