we could create novel therapeutics that benefit more patients, sooner, by building internal drug development expertise and capability that harnesses the power of Flagship’s unique ecosystem of bioplatform companies?
Pioneering Medicines is Flagship’s in house drug discovery and development unit. Our team of drug development experts creates new therapeutics built from Flagship’s innovative bioplatforms and novel modalities.
More than 40 companies across the Flagship ecosystem are pioneering innovative platform technologies to address major challenges in human health. Pioneering Medicines explores and identifies new product concepts and then works jointly with Flagship’s companies to form integrated teams that advance medicines through robust discovery and early clinical development.
Pioneering Medicines also partners with external collaborators across biopharma throughout our R&D process. We apply our unique approach to the R&D priorities of our partners through highly co-creative relationships that draw on the expertise of our respective teams.
Pioneering Medicines leads Flagship’s Innovation Supply Chain Partnerships with Novo Nordisk and Pfizer to speed innovation in drug development and bring novel therapies to patients. The team also leads a partnership with the Cystic Fibrosis Foundation to develop therapeutics that address the unmet needs of people living with cystic fibrosis.
Our Pipeline
Pioneering Medicines’ portfolio includes programs in multiple therapeutic areas including obesity, MASH, cystic fibrosis, and other disease areas representing significant unmet medical need for millions of people around the world.
Our portfolio includes both partnered and unpartnered programs. Our goal for our unpartnered programs is to develop assets through human proof-of-concept and 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.
Our R&D Process
Pioneering Medicines leverages Flagship's unique innovation process and the diverse expertise of its team to take multiple approaches to explorations and to identifying new product concepts. Some explorations target a particular disease area, some a specific target or pathway, and others a particular bioplatform technology.
We conduct these explorations ourselves or with an external partner based on their priority areas. Once we have a medicine concept, we conduct early research to determine the scientific feasibility and market fit of the potential asset. We develop robust discovery and pre-clinical plans and prioritize which assets to move forward as a single asset company.
In close partnership with a particular Flagship bioplatform company, Pioneering Medicines then focuses on driving the asset to a candidate for preclinical development. We conduct pre-IND activities, and if the data are supportive, develop clinical plans and move toward filing an IND. We then initiate Phase I clinical trials and work toward demonstrating human proof-of-concept. At this point, we also begin discussions to identify a company to acquire the asset for late development and commercialization. If the asset is already associated with an external partner, this is typically when the partner can exercise their option to acquire the asset.
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.
