Flagship Pioneering Launches Pioneering Medicines

CAMBRIDGE, Mass., January 12, 2020 -- Flagship Pioneering, a life science platforms company, today launched Pioneering Medicines, a new division of Flagship Pioneering. Initiated in 2020, Pioneering Medicines’ mandate is to build a world-class biopharmaceutical R&D capability to conceive and develop a broad portfolio of life-changing treatments for patients. By harnessing the power of Flagship’s multiple scientific platforms, Pioneering Medicines will create and advance novel medicines that deliver benefits to more patients, sooner.

Delivering Benefits to More Patients, Sooner
Across the Flagship ecosystem, more than 40 companies are creating and applying innovative approaches to help address major health and sustainability issues. Many of these Flagship platforms including RNA-based approaches such as Moderna, Omega Therapeutics and Laronde, gene-based therapeutic approaches such as Sana Biotechnology, Tessera Therapeutics and Ring Therapeutics, cell therapy approaches such as Rubius Therapeutics and Sigilon Therapeutics, machine learning approaches such as Valo, Generate Biomedicines and Cellarity, and microbiome-related approaches such as Seres Therapeutics, Kaleido Biosciences and Evelo Biosciences, have broad applicability. There is a tremendous opportunity to expand the impact of these platforms earlier by creating medicines in disease areas beyond where the individual companies are focused. With visibility and access to all Flagship companies, Pioneering Medicines is well positioned to originate new medicine ideas based on these platforms. Pioneering Medicines also has the unique ability to combine these platforms, harnessing the power of multiple Flagship scientific innovations to create truly novel products.

“With a resolute focus on creating new products for patients, Pioneering Medicines will lead Flagship from making platforms innovations to advancing both platforms and products. It’s an exciting opportunity with infinite possibilities to address a broad range of diseases,” says Paul Biondi, Executive Partner and President of Pioneering Medicines within Flagship.

By identifying and pursuing new medicine opportunities in parallel as Flagship platform companies build out their platforms, Pioneering Medicines will be able to reach patients across more disease areas much sooner.

Building a Portfolio Through Internal Exploration and Strategic Partnerships
Pioneering Medicines is leveraging Flagship’s trademark innovation process to conceive novel ideas for new medicines. Working closely with a Flagship platform company, Pioneering Medicines creates the product concept and leads the discovery and early-development efforts, advancing the asset through human proof-of-concept. At that point, Pioneering Medicines will seek the most appropriate partner company to conduct late-stage development and commercialization.

“Across the Flagship ecosystem, we have hundreds of scientists and thousands of colleagues pursuing ground-breaking advances built on novel scientific platforms every day. Yet there are innumerable therapeutic opportunities that go unexplored. Pioneering Medicines will leverage our unique innovation approach to uncover these opportunities, conceive new product concepts, and lead robust R&D programs in parallel to the strategies the platform companies are pursuing,” says Noubar Afeyan, Ph.D., Founder and Chief Executive Officer of Flagship Pioneering. “This unique model allows Flagship to achieve greater value from our existing scientific innovations for both patients and investors.”

A complementary path to generating new product concepts is to collaborate with industry partners. Pioneering Medicines works with strategic partners to jointly conceive product concepts by combining partners’ research priorities with Flagship’s unique platform capabilities. Partners gain access to the full spectrum of innovation across Flagship as well as the drug development expertise that Pioneering Medicines offers.

“We engage with companies to understand their therapeutic goals as well as scientific hurdles they have encountered. Pioneering Medicines explores how the unique Flagship platforms, and the combination of platforms, can apply to this therapeutic intent and overcome the existing challenges,” says Mr. Biondi. “Together we can conceive and explore entirely new approaches to treatment.”

Pioneering Medicines’ Leadership Team
Pioneering Medicines is establishing a world-class R&D capability with industry-leading R&D expertise that will advance medicines with speed and steadfast scientific rigor while also providing drug development expertise across the Flagship ecosystem.

• Paul Biondi, Executive Partner and President of Pioneering Medicines, joined Flagship in November 2019 and spent the last year building the Pioneering Medicines strategy and capability, working across Flagship to conceive initial product concepts. Prior to Flagship, Paul spent 17 years at Bristol Myers Squibb (BMS) where he most recently had enterprise-wide responsibility for establishing and evolving BMS's strategy and for executing its business development efforts. Earlier in his BMS tenure, Paul spent 12 years in leadership roles within the R&D organization overseeing strategy, portfolio and project management and clinical business operations.
• Luciano Rossetti, MD, Chief Medical Officer for Flagship and Head of R&D for Pioneering Medicines, joined Flagship earlier this month. Dr. Rossetti will be deeply engaged in the science and capabilities of the platforms within Flagship and will help shape the company’s overall clinical portfolio. He will help lead Pioneering Medicines to conceive and build a portfolio of unique medicines sourced from the broad spectrum of Flagship’s scientific platforms. Dr. Rossetti comes to Flagship after completing a six-year tenure as Global Head of Research & Development at Merck KGaA. He previously served as Merck & Co. Senior Vice President late-stage clinical development and before that was Head of Global Scientific Strategy across all therapeutic areas. Prior to joining the pharmaceutical industry, Dr. Rossetti spent 18 years in academic medicine.
• Alec Reynolds, Senior Vice President, Head of Portfolio Strategy & Operations for Pioneering Medicines, joined Pioneering Medicines in May 2020 and is responsible for building Pioneering Medicines’ operations model and a world-class portfolio strategy. Alec is a successful biotechnology leader who spent 12 years at Celgene and most recently led the project leadership function for all late-stage development projects in hematology-oncology and inflammation-immunology.
• Pam Stetkiewicz, Senior Vice President, Global Program Leadership for Pioneering Medicines, joined Flagship in April 2020 to lead the advancement of Pioneering Medicines’ portfolio in collaboration with Flagship platform companies and potential industry partners. Pam brings more than 20 years of extensive life-sciences pharmaceutical experience with recent experience at Editas Medicine and, prior to that, Novartis Institute of Biomedical Research.
• Gary Sutton, Senior Vice President of Corporate Development for Pioneering Medicines, joined Flagship in July to lead Pioneering Medicines’ partnering strategy and execution. Gary is an accomplished life-sciences corporate development and legal expert. He spent 16 years at Novartis Institutes for Biomedical Research (NIBR) and most recently led the team responsible for the structuring, negotiation and execution of all business development transactions and out-licensing activities.

Pioneering Medicines continues to expand its team with additional R&D expertise as it seeks to conceive and advance a portfolio of life-changing medicines for patients in need.

About Pioneering Medicines
Pioneering Medicines is conducting a live webinar about its strategy and innovative process on February 10, 2021. To register for this event, click here.

For additional information, visit www.pioneeringmedicines.com.

About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $50 billion in aggregate value. To date, Flagship has deployed over $2.2 billion in capital toward the founding and growth of its pioneering companies alongside more than $18 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).