Defining a Transition “Trigger”
DoD is not the only agency or organization that faces the challenges described herein. Others, such as pharmaceutical companies in the commercial sector and BARDA within the US government also must manage transitions effectively. There are three commonly used and referenced transition points early in a product’s development that are seen as logical “triggers” for the transition from basic research to development of a product. They are (1) submission of an investigational new drug (IND) and (2) completion of the Phase I trial of a material. a As one example of how these triggers could be incorporated into the CBDP, the Material Development Decision (MDD), which currently resides with JPEO-CBD, could become trigger for initiation and development of an IND application for submission to FDA. Practically, this would mean all discovery and preclinical activity would reside under JSTO-CBD management, and successful programs would be presented to JPEO-CBD for a MDD. MDD approval would trigger construction and submission of the necessary applications to enter an FDA-approved regulatory approval path. Alternatively, transition to JPEO-CBD management could occur after completion of a Phase I trial.
Under a third alternative (3), as part of a broader strategy within the CBDP for FDA-regulated products to more efficiently use available advanced development funds, successful programs could be “parked” after construction of the IND or after Phase I trial completion. This could be especially useful when the program has multiple potential products in any given area of need. Regardless of the chosen trigger, expertise, within or contracted by JSTO-CBD and JPEO-CBD, needs to be appropriately positioned. This approach would also be supportive of overlap in JSTO-CBD and JPEO-CBD personnel engagement on the project to ensure smooth and knowledgeable transitions.
a Selection of either an IND submission or Phase I completion in the common JSTO-JPEO transition point would generally align with DoD 5000 service recognition milestones A (“first in human”) or B (“point of concept”), respectively. It would also generally align with transitions from 6.2 to 6.3 or 6.3 to 6.4 funding.
An additional potential benefit would be the inclusion of FDA scientists, such as those within the Medical Countermeasures Initiative (MCMI) program. Clearly, the earliest possible settings of expectations from the FDA—even from an advisory position—on the types of data sets that may be required to reasonably complete a Phase I trial would be helpful in managing the overall process. See Box 5.2 for a discussion of possible transition points for medical product development.