Phase III Decision Support: Evidence-Based and Objective Risk Assessment
Our client, a global pharmaceutical company, sought to decide whether to progress two internal assets into Phase III development based on the Phase II data. The client engaged Prescient to: 1) perform an in-depth assessment of the Phase II data and comparative analyses with in-line and pipeline competitor products; 2) evaluate the potential changes in the regulatory requirements; 3) analyze the impact of the potential entry of biosimilars and their ability to disrupt the marketplace; and 4) help develop an overarching Phase III design consideration, including endpoints and patient population.
Shaping Decisions | Driving Value
Prescient began the engagement by identifying all the inline and pipeline competitor products in the therapeutic area against which the client’s product would be competing at the time of launch. We then conducted in-depth comparative analyses of clinical data for the competitors’ and client’s products and identified other potential disruptors that could affect market dynamics and should be considered while designing Phase III.
Business intelligence was used to profile the current and future dynamics of key launch markets to analyze what would be required to file, achieve reimbursement and maximize demand. Qualitative research was conducted with KOLs and payers to assess how the assets’ target product profile (TPP) would translate into clinical use and pricing power within the key launch markets. Finally, we pressure-tested existing forecasts based on the current TPP and Phase III strategy.
The Prescient Advantage
A detailed competitor landscape as well as potential competitor market entry timelines and data analysis led to the identification of a potential Phase II asset for the client to in-license. Workshops for data analysis, Phase III design and risk mitigation led to the development of a Phase III clinical strategy and recommendation for development. The global development team was able to make a number of business-critical decisions, such as discontinuing the internal assets and licensing an external asset for Phase III development. In addition, Prescient identified possible post-marketing commitments that were being considered by the US Food and Drug Administration for assets that were in pre-registration, thereby informing the client’s ROI assessments. Prescient was retained as the clinical development decision support partner for the in-licensed asset, which progressed into Phase III.