The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

Preparation and Presentation of an IND Application to the FDA

Proposal Status: 

James H. McKerrow PhD,MD

A major unmet need for the entire UCSF research community is a point person, or small team, that can aid individual investigators in the compilation and writing of an application to the FDA for an IND (investigational new drug). While some IND work has gone on at UCSF, primarily in collaboration with commercial entities, there does not exist an individual with the expertise to help an research investigators identify information that must be included in an IND application for a new small molecule drug, and subsequently to help prepare that application itself.


This shortcoming became clear through efforts of QB 3 personnel to assemble such an application for a newly discovered small molecule in collaboration with the UCSF Small Molecule Discovery Center in Byers Hall. While CTSI provided some information on ethics and individual IND components, there was no single individual who could coordinate such efforts and assist investigators in writing the proposal. In the end investigators on the Mission Bay Campus had to utilize the expertise of personnel in QB 3 who had previous experience in this arena while working in the biotech industry. Unfortunately those individuals have now left the University.


CTSI is the logical umbrella organization to sponsor IND support for research investigators at UCSF. An individual with experience in writing such a proposal and presenting it to the FDA should be recruited and made known to the research community at large. CTSI could use the experience of QB 3 personnel to identify the characteristics of such an individual, and the rich biotech environment surrounding UCSF should prove fertile ground for recruitment.


This individual would meet one-on-one with UCSF research personnel who find themselves at the translational end of a drug development process. They would look over the accumulated information on a drug candidate that the investigator has acquired, and counsel the investigator as to what additional studies the FDA would likely ask for. They would also assist the investigator in preparation of an IND application and presentation of this application at a pre-IND meeting with the appropriate FDA section. Currently, contract research organizations such as SRI international in Menlo Park offer this service at a considerable fee. It would therefore be logical for CTSI to recruit and sponsor such an individual as a member of the UCSF translational drug discovery and development community.


This is an excellent idea - a local point person or small team within CTSI to help UCSF researchers with FDA submissions. If this could be expanded to cover not only investigational new drugs (IND) but also the 510(k) and PMA processess that many UCSF researchers face with the development of new devices or drug-device combinations, this would be an even more powerful and helpful tool. When the head of the FDA devices division visited UCSF last year, he said there were no plans for FDA to have a local office here in San Francisco (similar to the new satellite patent office in Silicon Valley), but I wonder if we might propose to FDA to have a local participant or participants in this new effort. Having FDA involved locally through the application process could well be a model for greater efficiency in IND, 510k, and PMA processess that could later be disseminable to other universities or regions with outstanding track records of drug and device innovation.

Commenting is closed.