I am curious what Sponsors prefer as the structure for submitting INDs and Master protocols when multiple versions of a biological product are being studied. The FDA guidance provides three options but there could be more.
If you are studying multiple versions of a biologic under different INDs (primary and secondary) and Master Protocol, and determine to discontinue studying Product A in the Master trial, how have you done this? How convoluted is it to keep the primary IND open with the Master protocol when that IND is no longer relevant in the trial otherwise? Has anyone here submitted an IND with just the clinical Master Protocol?
The biologics guidance provides three options (copied below). Keeping the Primary IND open is preferred with FDA. https://www.fda.gov/media/152536/download
"The Primary IND (e.g., IND A) includes CMC and P/T information for Product A along with the clinical information for the umbrella trial. If the sponsor would like to
discontinue studying Product A, we do not recommend that the sponsor withdraw Primary IND A because it contains the relevant clinical information. Instead, we
recommend that the sponsor submit an updated protocol to Primary IND A that no longer includes the arm with Product A.
If the Primary IND A is withdrawn for any reason, but the sponsor intends to continue studying products other than Product A under the clinical protocol, then the sponsor
would need to do the following:
- Designate another IND (e.g., IND B or IND C) as the new Primary IND;
- Submit complete, up-to-date clinical information to the new Primary IND;
- Submit any essential CMC or P/T information from the old Primary IND to the new Primary IND; and
- Update all cross-references so that the Secondary INDs now cross-reference the new Primary IND, and the new Primary IND cross-references the Secondary INDs. We recommend that the cover letters for each IND amendment clearly specify the new Primary IND and Secondary INDs.
ALTERNATIVE APPROACHES
There may be alternative approaches to structuring and organizing INDs for studies in a single disease of multiple versions of an investigational product. For example, sponsors may choose to submit a stand-alone IND that includes only clinical information, with CMC and P/T information from other INDs incorporated by cross-reference."
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Stephanie Markey
Associate Director
Fraser CO
United States
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