ISS was called on to provide strategic guidance to a mid-size pharmaceutical company struggling with getting their investigational product out of Phase II clinical trials. The client had conducted a number of studies that raised questions about a theoretical safety risk. Despite numerous meetings with the FDA, the company was unable to convince the agency that it had a rational plan for forward development and were stymied for over a year.

ISS developed a comprehensive approach to address the FDA's questions and assisted the sponsor in the development of a compelling FDA meeting package. This resulted in a favorable decision to move the program forward.  Part of this exercise involved soliciting the views of thought leaders in the field with expertise in the therapeutic area as well as regulatory science to ensure that the strategy was robust and defensible.

Based on the recommendations of an expert panel convened and chaired by ISS, a number of white papers were developed to advocate the sponsor's position and were included in the FDA briefing package.

Understanding the key needs of regulators and packaging the materials in a manner that can effectively address issues is a fundamental strength of ISS. In fact, it's the reason a majority of our clients come back year after year.