Company: Ascendis Pharma
Liaison(s): Laura Smith, Praveen Vangeti, Michael Cox, Meng Lee, Dana Pizzuti, Carl Decker
Ascendis Pharma (Ascendis) is quickly becoming a leader in new cutting-edge therapies using its innovative TransCon technology platform. The use of TransCon technology enables Ascendis to create therapeutics that combine prodrug and sustain-released capabilities. Ascendis is currently developing product candidates in two therapeutic areas, endocrinology rare diseases and oncology.
The COVID-19 global pandemic has driven the digitization of the life science industry, forcing companies to transition from traditional clinical trial modalities towards decentralized modalities. Additionally, the increase in data generated through digital technologies has not only presented challenges in data management quality, but also opportunities to implement technologies like data lakes. A final focus of Ascendis for direct-to-patient clinical trials has been home health nursing, as it is an essential component of decentralized clinical trial design.
KGI Team Master Project students were tasked in the first semester with examining the industry landscape of decentralization enabling technologies and evaluating their compatibility with Ascendis’ current clinical trial infrastructure. This was to provide a vendor recommendation in the sectors of decentralization, data management, and risk-based monitoring. In the second semester, the team’s efforts shifted towards evaluating data lake and data warehouse implementation and determining the necessity of either with corresponding best-in-class vendor recommendation. The team is also working to develop and refine a request for proposal (RFP) process for home health nursing services to help Ascendis identify a capable vendor. Lastly, the team is helping develop a high-level process map with integrated standard operating procedures of Ascendis’ study start-up process.