we could harness the power of multiple Flagship scientific platforms and create novel treatment options that benefit more patients, sooner?
Pioneering Medicines is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.
More than 40 companies across the Flagship ecosystem are creating and applying innovative approaches to help address major health and sustainability issues. Given the broad applicability of many Flagship platforms, there is a tremendous opportunity to expand the reach of these scientific innovations by creating medicines in disease areas where the companies are not yet focused. With access to all Flagship companies, Pioneering Medicines is well positioned to conceive new medicine ideas both internally and in collaboration with strategic partners. We also have the unique ability to combine these platforms in ways never before considered, harnessing the power of multiple Flagship scientific innovations and creating truly novel medicines.
By identifying and pursuing opportunities earlier than the platform companies could focus on them and advancing these medicines through a robust discovery and early clinical development capability, Pioneering Medicines can reach patients across more disease areas much sooner than the individual platform companies could on their own.
Pioneering Medicines R&D Process
Diseased Based Exploration: Pioneering Medicines leverages Flagship's innovation process to conceive and develop novel treatments. During the exploration stage, we assess the biology and unmet needs of a particular disease area and identify key innovation opportunities within that disease. We then 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.
Delivering Value
Pioneering Medicines is uniquely positioned to deliver greater value across the scientific ecosystem.
Partnering with Pioneering Medicines
We seek industry collaborations throughout our R&D process
Conceive New Medicines
We work with strategic partners to jointly conceive medicine concepts by combining our partners’ R&D priorities with Flagship Pioneering’s unique platform capabilities. Our partners will gain access to the full spectrum of innovation across Flagship as well as the R&D expertise that Pioneering Medicines offers.
Access Novel Development Assets
Over the next few years, our goal is to develop assets through human proof-of-concept and we will seek the most appropriate partner to acquire or license each asset for late-stage development and commercialization. We are also open to transacting assets earlier and welcome partnering discussions at any point in our R&D process.
In November 2021, we entered into a strategic partnership with the Cystic Fibrosis Foundation to develop therapeutics that address the unmet needs of people living with cystic fibrosis by leveraging the innovations and teams of multiple Flagship-founded companies.
In May 2022, Pioneering Medicines embarked on a strategic partnership with Novo Nordisk to create a portfolio of novel research programs by applying Flagship’s innovative bioplatforms to scientific challenges in cardiometabolic and rare diseases.
In July 2023, Flagship Pioneering and Pfizer announced a partnership to develop 10 single-asset programs within Pfizer’s core strategic areas of interest and addressing unmet needs, including in broad patient populations.
