Creating novel medicines by harnessing Flagship Pioneering's innovative platforms
Paul Biondi and Luciano Rossetti on Pioneering Medicines
Pioneering Medicines R&D Process
Exploration: Pioneering Medicines leverages Flagship's innovation process to conceive and develop novel treatments. During the exploration stage, we consider many approaches to create medicines in unprecedented ways using Flagship's innovative platforms. We conduct this exploration either internally or in partnership with a biopharma company or disease foundation. Once we have a medicine concept, we conduct early research to determine the scientific feasibility and market fit of this potential asset. We develop robust discovery and pre-clinical plans and, through an ongoing portfolio prioritization and selection process, we determine which assets to form into companies and move forward into the ProtoCo stage.
ProtoCo: Pioneering Medicines establishes formal licensing agreements with the Flagship platform companies to define the value sharing model and their role in the project. We will lead the majority of activities and the platform companies will conduct activities specific to the platform - work that they alone can do. Creating bespoke teams and leveraging external expertise, Pioneering Medicines will drive the asset to a candidate for preclinical development.
NewCo: During the NewCo stage, we will conduct pre-IND activities, and if the data are supportive, we will develop clinical plans and move toward filing an IND. We will then initiate Phase I clinical trials and work toward demonstrating human proof-of-concept. At this point, we will also begin discussions to identify a company to acquire the asset for late development and commercialization. While we will often develop assets through human proof-of-concept, we welcome partnerships at any point during the R&D process.
Pioneering Medicines is uniquely positioned to deliver greater value across the scientific ecosystem.