Company: Pfizer Inc.
Liaison(s): William Ports, Bonnie Vlahos
Pfizer Inc. (Pfizer) is a research-based global biopharmaceutical company. Pfizer is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio includes medicines and vaccines, as well as consumer healthcare products. Pfizer manages its commercial operations through two business segments: Innovative Health (IH) and Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients’ lives, as well as products for consumer healthcare. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology, rare diseases and consumer healthcare. As of December 31, 2016, the Company sold its products in over 125 countries.
Pfizer is performing a lifecycle update on one of their currently approved products in an effort to broaden the indication. The goal of the Team Master’s Project was to develop their lifecycle proposal (LCP) for a new indication and to assess the regulatory and market landscape for the proposed indication. The TMP team is an extension of the internal Pfizer team and have completed 1) work on specific activities to gain further scientific and regulatory knowledge 2) assisting towards clinical trial design development 3) identifying program risks and mitigation development. These team goals were completed through a detailed SWOT (strengths, weaknesses, opportunities, threats) analysis for their LCP, analyzing mechanisms of action compatible with the approved product, performing precedence searches of competitor products, compiling a scientific research repository, drafting a clinical study design for the LCP, and surveying key opinion leaders and stakeholders for better guidance in finalizing the clinical studies.