Formation Bio
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Last reviewed
Jun 8, 2026
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Source-backed
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Formation Bio (formerly TrialSpark) is an American "AI-native" pharmaceutical company that in-licenses and acquires clinical-stage drug candidates and develops them more efficiently by applying artificial intelligence and software across clinical trials, regulatory work, and operations. Founded in 2016 as TrialSpark and headquartered in New York City, the company rebranded to Formation Bio in December 2023 to reflect its shift from a tech-enabled clinical-trials vendor into a company that owns and advances its own drug portfolio. [1][2] In June 2024 Formation Bio raised a $372 million Series D round led by Andreessen Horowitz with participation from Sanofi, reported at a valuation of roughly $1.7 billion. [3][4] The company is also a partner, alongside Sanofi and OpenAI, in a high-profile collaboration to build generative-AI tools for drug development, and it was named to the 2025 CNBC Disruptor 50 list. [5][6]
Formation Bio describes itself as a "tech-driven and AI-native pharma company." [3] Rather than running its own early-stage drug discovery, the company targets what it views as the central bottleneck in the industry: drug development, the long, expensive, and operationally complex process of moving a candidate from a molecule through clinical trials to approval. Formation Bio partners with, acquires, or in-licenses clinical-stage assets from other pharmaceutical and biotechnology companies, then advances those programs past clinical proof of concept using a proprietary software and AI platform intended to make development faster and cheaper than industry norms. [3][4]
The thesis behind the company is that advances in AI and biology are generating more viable drug candidates than the traditional industry can afford to test, and that a leaner, software-first operator can unlock value by developing assets that larger firms lack the bandwidth or incentive to pursue. [4][7] The company has said it conducts trials substantially faster than industry benchmarks and has supported hundreds of studies across more than ten therapeutic areas. [2][7]
| Attribute | Detail |
|---|---|
| Founded | 2016 (as TrialSpark) |
| Rebranded | December 2023 (to Formation Bio) |
| Headquarters | New York City |
| Co-founders | Benjamine Liu (CEO), Linhao Zhang, Kit Dobyns |
| Business model | In-licensing and developing clinical-stage drugs with AI/software |
| Series D | $372 million (June 2024), led by Andreessen Horowitz |
| Reported valuation | ~$1.7 billion (2024) |
| Notable partnership | Sanofi and OpenAI AI collaboration (2024) |
| Recognition | 2025 CNBC Disruptor 50 (#37) |
TrialSpark was founded in 2016 by Benjamine Liu, Linhao Zhang, and Kit Dobyns. [1][2] Liu, the chief executive, is a Rhodes Scholar who earned a doctorate at the University of Oxford; according to the company's investors and analysts, he identified the development bottleneck after experiencing firsthand how pharmaceutical companies declined to advance promising candidates not for scientific reasons but because they lacked the resources to run additional trials. [2][7] Zhang, the original chief technology officer, had been an early engineer at Salesforce and Oscar Health, and Dobyns, who left in 2019, brought operational experience. [2]
In its early years (roughly 2016 to 2021) TrialSpark operated as a technology-enabled clinical-trials company, building software that integrated patient recruitment and electronic consent with trial operations, and partnering with large pharmaceutical firms including Novartis, Pfizer, and Sanofi. [2] After raising a $156 million Series C round in 2021 at a reported valuation of about $1 billion, the company began acquiring clinical-stage drug assets and running trials in-house, shifting from a pure software vendor toward an integrated drug developer. [2][4]
In December 2023 the company rebranded from TrialSpark to Formation Bio, a change it said reflected its evolution from streamlining clinical trials into building a fully integrated, technology-native pharmaceutical company. [1] (Some secondary coverage dates the rebrand to early 2024, but the company announced the new name in December 2023.) [1] By the mid-2020s the firm had assembled a leadership team drawn from large pharma, including a chief development officer who had been chief medical officer at Allergan, and reported that its team and advisors had collectively worked on dozens of approved drugs. [2][7]
Formation Bio's central idea is that many of the most time-consuming and manual functions in drug development can be automated or accelerated with AI and software. Its platform is built around several integrated layers: AI-assisted drug development that targets tasks such as medical writing, protocol design, regulatory submissions, biostatistics, and data management; a clinical-trial engine that streamlines patient recruitment, site management, and data oversight; and a unified data platform that consolidates clinical, scientific, and regulatory information. [2][7]
To run individual programs, the company has used a subsidiary, or "hub-and-spoke," structure in which each in-licensed asset is developed by a focused team, an organizational model that echoes other modern drug developers such as Roivant Sciences. [2] Formation Bio has said this combination of software, AI, and operational discipline lets it conduct trials meaningfully faster than industry benchmarks and complete patient recruitment several times faster than the standard pace. [2][7]
The "AI-native pharma" framing positions Formation Bio within a broader wave of AI drug discovery and tech-bio companies, though the company is distinctive in emphasizing development and operations rather than molecule discovery. Companies pursuing related but distinct strategies include discovery-focused firms such as Xaira Therapeutics and insitro, generative-chemistry players such as Insilico Medicine, and asset-centric developers such as Roivant. [2][4]
On May 21, 2024, Sanofi, Formation Bio, and OpenAI announced a collaboration to build AI-powered software to accelerate drug development, which the partners described as a first-of-its-kind arrangement in the pharmaceutical and life-sciences industries. [5][8] Under the deal, Sanofi contributes proprietary data as part of its stated ambition to become a biopharma company "powered by AI at scale," OpenAI provides access to frontier AI models, fine-tuning, and engineering support, and Formation Bio supplies engineering resources and its technology-driven development platform to design, build, and deploy AI tools across the drug-development lifecycle. [5][8]
The collaboration's first concrete product, Muse, was unveiled on November 12, 2024. [9] Muse is a generative-AI tool aimed at speeding clinical-trial patient recruitment: it analyzes scientific literature and trial documents, identifies optimal patient profiles, and automatically generates recruitment materials, advertisements, and pre-screening questionnaires tailored to specific populations, languages, and channels. The partners said Muse can produce in minutes work that traditionally takes months, with Sanofi leading early deployment in a Phase 3 multiple sclerosis program. [9] Formation Bio chief executive Benjamine Liu described Muse as "one of the many AI innovations we're building for drug development." [9]
Formation Bio has raised capital across several rounds since its founding. Its Series C round of $156 million closed in 2021 at a reported valuation of around $1 billion. [2][4] The company's defining financing came in June 2024, when it announced a $372 million Series D round. [3][4]
The Series D was led by Andreessen Horowitz (a16z) with what the company called "significant participation" from Sanofi, and additional investors including Sequoia Capital, Thrive Capital, Emerson Collective, SV Angel Growth, FPV Ventures, and Lachy Groom. [3] As part of the round, a16z managing partner Scott Kupor and Sequoia partner Alfred Lin joined the board of directors. [3] In its own announcement, Formation Bio characterized the round as a "material step up" from the Series C valuation but did not officially disclose a specific figure. [3] Secondary sources, including CNBC and PitchBook, have reported the Series D valuation at approximately $1.7 billion, and CNBC reported total funding of about $600 million as of 2025. [6] (Reported valuation and cumulative-funding figures for private companies vary by source and should be treated as estimates.)
Formation Bio said it would use the new capital primarily to acquire and in-license additional drug candidates and to expand its AI capabilities, with the company stating an ambition to bring in roughly ten or more new programs. [3][4] Its in-licensed pipeline has included assets such as sprifermin, an FGF18 candidate for knee osteoarthritis acquired from Merck KGaA, and gusacitinib, a dual JAK/SYK inhibitor studied in chronic hand eczema, among other early-stage immunology and inflammation programs. [2]
Formation Bio is frequently cited as a flagship example of the "AI-native pharma" model: a company built from the start around software and AI rather than retrofitting them onto a legacy organization. [4][7] Its bet is that the binding constraint in bringing medicines to market is not discovering candidates but developing them, and that an AI-enabled operator can run that process faster and at lower cost, then capture value from assets that larger companies underutilize. [4][7]
The 2024 collaboration with Sanofi and OpenAI gave the approach unusual visibility, pairing a top-twenty global pharmaceutical company and one of the most prominent AI labs with a venture-backed startup, and it positioned Formation Bio as a test case for whether generative AI can materially compress drug-development timelines. [5][9] The company's selection to the 2025 CNBC Disruptor 50 list, where it ranked 37th, reflected growing investor and industry interest in tech-bio business models. [6] Whether Formation Bio's pipeline ultimately produces approved medicines, and whether its AI tooling delivers the efficiency gains it claims, remains to be demonstrated, but the company has become a closely watched bellwether for the convergence of AI and pharmaceutical development. [4][6]