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US Agent

FDA requires that Sponsor companies wanting to conduct clinical trials in the US must have a US presence. If they don’t have a US address or office, the Sponsor must interact with FDA through a “US Agent.” Sandy specializes in being a US Agent given her long experience working internationally and with FDA. She and her colleagues ensure the initial US clinical trial application (IND) is complete and concise, facilitating its prompt, successful review and ability to proceed. Because many Hecker & Associates clients are small, novice companies, Sandy has specialized in filing INDs electronically to FDA in eCTD format, which facilitates future partnerships and outlicensing of the project, while also saving the Sponsor IND prepration costs. Although FDA provides a mapping chart citing where in the CTD the IND sections required by US regulation should be placed, the guidance is vague in some areas, particularly in terms of where to put prior clinical information. Sandy works with the Sponsor to determine best placement of its data, given its unique project’s history, with an eye toward efficient updating of the IND over the life of the project. Unlike many countries for which a new clinical trial application is filed for each protocol, the US process is for all protocols for the project to be filed to the same IND, meaning consistent and efficient filing of data throughout the life of the IND is critically important for eventual review of the marketing application. It also means the same FDA review team receives each submission, so having a good reputation with FDA–always Sandy’s goal–speeds FDA review of submissions filed later in the life of the IND. Sandy works to ensure her clients have a good reputation with FDA, to ensure future FDA flexibility and support for her clients.

That FDA notices who files applications was confirmed by Sandy’s discussion with multiple FDA reviewers: someone/a company that’s respected by FDA has an easier time in review and more support/flexibility from FDA; Sandy has experienced this.  An unknown, or bad reputation means FDA will review submissions expecting–and finding–problems. Sandy has seen that if a company already has a bad reputation at FDA, its subsequent submissions have more problems and FDA hurdles than well-regarded companies, and its project success is more difficult to achieve.

Once an IND is filed, Sandy maintains the IND by filing protocol amendments, development safety update reports, time-sensitive safety reports for clinical trial patients who have had unexpected (reportable) serious adverse events, and ensures all project regulatory requirements are met. Sandy also frequently interacts with FDA staff to ensure projects stay on track.