Greenleaf Health worked with a multinational biopharmaceutical manufacturer to reinitiate their phase 3 program for a women’s health product, which had stalled after the FDA had voiced concerns with the design of the pivotal trial. The client needed a way to fulfill the Agency’s request for additional long-term outcomes data, which would require an expansion of the trial’s scope and a significant increase in trial enrollment, while minimizing the associated increase in financial resources. As part of our work for the client under a monthly retainer structure, the Greenleaf team collaborated with technical experts and the client’s leadership team to develop a regulatory strategy for restarting the stalled program that was amenable to the client and also met the FDA’s expectations.
Through a series of working group meetings with the client’s regulatory research and development teams, Greenleaf guided the client in the proposed redesign of their phase 3 program and in articulating the revised strategy to the FDA. To ensure that the renewed development strategy was responsive to the FDA’s concerns, Greenleaf conducted careful reviews and edits of all correspondence and written responses. As a result, the client received the clear direction from the FDA that they needed to restart the program. Following these productive interactions, the revised plans for the phase 3 development program were agreed upon by both the FDA and the client’s leadership team, leading to the successful reinitiation of the phase 3 program.