Episode 2: Tackling Rare Diseases & Inside the FDA

Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe, an expert in rare disease drug development. Amy, Mo and Zizi discuss how the industry can work to deliver more innovative treatments for rare disease patients and the reality of working with the Food and Drug Administration (FDA). In the first segment, the experts share their insights working with the rare disease/orphan drug community, including patients, physicians, regulators and patient advocacy groups. Next, they focus on FDA’s recent leadership change and tackle some common misconceptions about working with the Agency.