Weave Bio: AI-Powered Regulatory Automation for Drug Development

Funding announcements in biotech are more than business headlines—they're signals of technological momentum and bets on new ways of accelerating drug development. These moments offer a glimpse into where innovation is headed, what investors are prioritizing, and how artificial intelligence is making its way into the regulatory process.

In this series, we're covering early-stage biotech companies that recently raised capital, spotlighting the ideas—and the technology—behind them. Next up: Weave Bio.

Weave Bio's Mission

Weave Bio, a San Francisco-based AI software company, addresses a critical bottleneck in drug development—regulatory document preparation, particularly for Investigational New Drug (IND) applications, which historically can take more than a year to complete using conventional methods.

The Regulatory Challenge

Regulatory workflows represent the foundation of a therapeutic candidate's success, requiring scientific precision, strategic expertise, and meticulous execution. These processes have historically been entirely manual, making them time-consuming, costly, and resource-intensive for pharmaceutical companies and biotech firms.

The IND submission process involves high stakes, as it determines whether a therapeutic candidate can proceed to clinical trials. Drug developers face increased pressure to bring new therapies to market faster due to patent expirations, regulatory changes, and unmet patient needs. This creates a significant opportunity for technology-driven solutions that Weave Bio aims to address with its AI platform while maintaining expert oversight.

The Weave Platform

Weave Bio has developed The Weave Platform, an AI solution built to support regulatory workflows across the entire lifecycle of a therapeutic. The platform combines AI-powered data organization, authoring, review, publishing, and streamlined responses to health authority questions.

• AutoIND: The company's flagship offering, AutoIND, automates the preparation, writing, and review process for INDs. AutoIND automatically generates content based on users' own source data, regulatory guidelines, and public information.

The platform offers a robust quality review process, which builds a living record of the development process for a therapeutic candidate while significantly enhancing editing capabilities and oversight for teams. While conventional IND preparation processes can take more than a year, AutoIND can produce a first draft in a single day. The platform reduces the overall time to generate a submission-ready IND by over 50%, from initial data gathering through final quality review.

Validated Results

A study conducted with Takeda Pharmaceuticals demonstrated AutoIND's capabilities. The collaboration found approximately 97% time savings in drafting large IND summaries, turning what would typically require 100 hours of work into just 3 hours.

Perhaps most importantly, the study found no critical regulatory errors in AI drafts, demonstrating the platform's reliability and accuracy. The results confirmed that while AI dramatically reduces preparation time, human expertise remains essential for clarity and refinement.

Leadership Team

Weave Bio is led by a team of experienced professionals in artificial intelligence, regulatory affairs, and software development:

Brandon Rice, CEO and Co-founder: Rice leads the company's vision to integrate AI into every stage of regulatory workflows, empowering teams to focus where human judgment adds the most value.

Ari Caroline, Co-founder: Caroline emphasizes the company's awareness of the high stakes involved in IND submissions, ensuring AutoIND streamlines tasks best delegated to AI while maintaining expert oversight.

The company was founded in 2022 and has quickly established itself as a pioneer in AI-enabled regulatory automation solutions.

Strategic Partnership

In September 2025, Weave Bio announced a transformative partnership with Parexel, a leading global clinical research organization (CRO). Under this collaboration, Parexel will serve as Weave's CRO design partner, leveraging its extensive regulatory consulting expertise across clinical, non-clinical, pharmacology, and chemistry, manufacturing and controls (CMC) domains to strengthen Weave's AI platform and product pipeline.

Parexel will maintain a period of exclusivity as the only CRO licensed to use Weave's innovative solutions following new product launches. Parexel has already deployed AutoIND to support multiple IND applications, demonstrating real-world validation of the platform's efficiency gains.

Funding Trajectory

Weave Bio has demonstrated impressive capital-raising momentum, securing $30 million in total funding through two major rounds:

• Seed Funding ($10M): In May 2024, Weave Bio closed $10 million in seed funding co-led by Innovation Endeavors and Magnetic Ventures. This financing enabled the public release of AutoIND and allowed the company to significantly advance development of its platform.
• Series A ($20M): In October 2025, Weave Bio announced $20 million in Series A funding led by USVP, with participation from Innovation Endeavors, Magnetic Ventures, Character, TMV, and Serrado Capital. This round will enable the company to expand its platform capabilities and commercial reach.

Platform Expansion

With the Series A capital, Weave Bio will pursue an ambitious expansion strategy. The company will develop complete coverage of the entire regulatory lifecycle, including market applications (NDA/BLA), responses to health authority questions (HAQ/RTQ), and post-market submissions. Weave Bio will also extend into global markets beyond the U.S. FDA, including Europe, Japan, and Latin America, while developing advanced AI capabilities that provide portfolio insights and support strategic decision-making across the drug development process.

Market Position

Weave Bio operates in the $14+ billion regulatory affairs market, positioning itself as the first AI platform built specifically for drug development. The Weave Platform has earned industry recognition, winning the "Biotech AI Innovation of the Year" award.

The platform serves pharmaceutical companies, biotech firms, CROs, and regulatory consultants, helping teams prepare and manage complex dossiers more efficiently. By combining AI automation with expert oversight, regulatory teams gain speed, consistency, and confidence while reducing preparation time and cost.

Weave bridges life sciences, regulatory expertise, AI innovation, and enterprise software to solve critical challenges in drug development. The platform has been widely adopted for preclinical IND preparation and has since expanded to encompass clinical and approval-stage submissions.

Looking Ahead

Weave Bio represents a new paradigm in regulatory workflows, where AI automation streamlines complex processes while preserving expert judgment where it matters most. By combining substantial capital, a validated technology platform with proven results, and strategic partnerships with industry leaders like Parexel and Takeda, the company holds credible potential to become the standard for AI-enabled regulatory automation.

As drug development timelines face increasing pressure and regulatory complexity continues to grow, Weave Bio's approach positions the company to play a transformative role in bringing new therapies to patients more efficiently.