Year: 2013-14

Company: Amgen

Liaison(s): Naseem Kabir

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes to dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company. As Amgen continues to build a pipeline of therapeutic medicine with breakaway potential, its current products provide improved therapies to millions of patients around the world. The Amgen Regulatory TMP developed regulatory landscapes for hypercalcemia of malignancy and lung cancer during the 1st semester. During the second semester, the team focused on a similar document for Graft Versus Host Disease (GVHD). Finally, the team developed a regulatory strategy for a hypothetical GVHD product seeking approval in the US marketplace. These landscapes and this strategy were presented to the senior staff of Amgen. The team will present the 2nd semester effort focused on GVHD. To construct an FDA regulated landscape for therapies directed at GVHD, the team first characterized the disease demographics and pathologies. This work was then expanded to include an examination of the literature for previously approved therapies, clinical studies and investigational treatments for this disease. Ultimately, the team located essential public information and compiled a series of milestone reports with key observations and insights which might help guide Amgen as it navigates the regulatory barriers for GVDH disease. The Amgen TMP provided the student team with an excellent experience in the regulatory challenges associated hypercalcemia of malignancy, lung cancer and GVHD. Ultimately, the TMP team provided Amgen with detailed supporting information for these diseases as well as some discussion of the potential regulatory approaches to pursue investigational drugs in these therapeutic areas.