Weave Bio

What does it take for a lean biotech team to prepare its first IND? Trace Biosciences prepared its first IND for NerveTrace Dx using the Weave platform as a structured drafting environment. Results: • First IND draft in 14 days • Submission-ready IND in 50 days • FDA clearance within the 30-day review window Read more about the experience↓ hubs.ly/Q045z83F0

Weave has been named to AgenticAI AI's The Agentic List 2026, highlighting the most admired and trending agentic AI companies as recognized by industry executives. This recognition carries weight. It comes from enterprise leaders who are actively building with agentic AI and is backed by in-depth research into what’s actually working. At Weave, agentic AI isn’t a buzzword. It’s embedded across our platform. From AutoReview to AutoUpdate, our product features are designed to act with context and purpose, and we leverage agentic AI internally across key aspects of product development. Proud of the recognition. Even more motivated to keep pushing the category forward.

Weave Wednesday: Creating Complex Tables—Made Simple It's easy to bring complex table structures into your documents using the Weave Platform. ✨ Build complex tables from examples Copy a table from Word or Excel and paste it into Weave—no manual setup needed. ✨ Paste an example, generate with new data Use an example in your AI template and Weave keeps the structure while filling in your source data. ✨ Easily format in-text tables Format or merge cells, adjust layouts, and undo with CTRL-Z. 🎥 Watch the video to see it in action. 🌐 Learn more: weave.bio #WeaveBio #AIinPharma #Automation #RegulatoryOperations #LifeSciences

⏱️ When Health Authorities have questions, every hour counts. Meet HAQ Manager, Weave’s new AI-native solution that automates and accelerates Health Authority Question responses — built with Takeda. 🔗 Read more: businesswire.com/news/home/2025… 🎥 Register for the live demo (Nov 14): weave.bio/webinars/intro… #WeaveBio #HAQ #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

⚡ Last week, the FDA took an important step toward transparency. By publishing the same filing checklists CDER reviewers use internally, the FDA is helping sponsors understand what “complete and reviewable” really means. It’s a practical move that could prevent avoidable Refuse to File (RTF) delays that can cost teams months or even years. You can read the full announcement here: 👉 fda.gov/news-events/pr… For anyone managing regulatory data, this release underscores what we see every day: clarity and organization aren’t just nice to have, they’re make-or-break. At Weave, we help teams stay ahead of these moments. Our platform connects data, context, and collaboration so you’re never scrambling to meet the standard—you’re already there. Learn how we can make your next submission go smoother at weave.bio. #WeaveBio #FDA #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

We build tools that support people. By combining human expertise with intelligent automation, Weave helps regulatory and development teams work smarter, with more accuracy and less busywork. As more companies partner with Weave, our team is growing across product, engineering, AI research, and go-to-market. Current openings include: 💼 Go-to-Market: Account Executives (Biotech & Enterprise), Principal Customer Success Manager, Product Marketing Manager, Vice President of Sales ⚙️ Engineering: AI Engineering Team Lead, Frontend Engineering Team Lead, Senior/Staff Backend Engineer, Senior/Staff Frontend Engineer 🧩 Product: Senior Product Manager 🧠 Research & Strategy: AI Research Scientist 👉 Visit our careers page to learn more: weave.bio/careers #WeaveBio #Hiring #LifeSciences #DrugDevelopment #AIinHealthcare

🚨 The FDA and White House are accelerating drug approvals for therapies tied to national priorities. This shift changes how companies must manage regulatory strategy. 🧠 Weave isn't replacing regulatory expertise — it empowers it. The Weave Platform gives leaders clarity, continuity, and control across the full development lifecycle. ✅ Data is structured as it's generated for eCTD-ready modules and decision packages ✅ Workflows across clinical, nonclinical, and CMC are centralized for full visibility ✅ AI-powered authoring and content reuse reduce manual work while keeping experts in control In accelerated pathways, readiness is built from day one — not at the finish line. 👉 Learn more about The Weave Platform: weave.bio 📄 Article: forbes.com/sites/greglich… #WeaveBio #FDA #Biotech #DrugDevelopment #RegulatoryInnovation #AIinPharma

In a market flooded with AI buzzwords, Weave is solving one of drug development's most critical bottlenecks: regulatory workflows that determine how quickly life-changing therapies reach patients. Today, we're proud to announce our $20M Series A, led by @USVP_ , with participation from @iendeavors, @magneticvc, @trailmixvc , @CharacterVC, and Serrado Capital. This isn't just about technology—it's about impact: ✅ Accelerating regulatory timelines by 50%+ ✅ Expanding across the full therapeutic lifecycle (IND to NDA to post-market) ✅ Scaling globally to serve drug developers worldwide What sets us apart? We're AI-native by design, not by rebranding. Our platform delivers speed, accuracy, and compliance—powered by AI, validated by human expertise. The future of regulatory workflows is here. And it's built on substance, not hype. 👉Read the full announcement: businesswire.com/news/home/2025… #WeaveBio #SeriesA #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

💬 Weave Wednesday: AutoUpdate Confidently Draft Earlier with AutoUpdate This week, we’re highlighting an enhanced capability within the Weave Platform — AutoUpdate, now even smarter and more seamless. New source data? No problem. When new reports or data versions arrive, AutoUpdate identifies which drafted documents need attention — no guessing, no rework. Review suggested edits, copy them directly into your document or Refinement panel, and mark them as resolved once complete. With AutoUpdate, you update rather than regenerate — keeping your work intact while staying accurate and audit-ready. ✨ Smarter updates. Seamless collaboration. Complete confidence. 🎥 Watch how it works: hubs.ly/Q03NJqr90 👉 Want to learn more? Visit weave.bio or reach out to our team to see AutoUpdate in action. #WeaveWednesday #LifeSciences #Regulatory #Biotech #AI #DrugDevelopment

We’re thrilled to partner with @Parexel . This collaboration brings together Parexel’s deep regulatory expertise and Weave’s AI-native platform to open new possibilities for how therapies move from development to patients. It’s an exciting step toward shaping the future of regulatory automation and the impact it can have across the industry.

Parexel today announced a partnership with @weave_bio, a pioneer in AI-native regulatory automation management solutions, aimed to accelerate regulatory submission processes and the time to market for new therapies. 🔗newsroom.parexel.com/news-releases/…

Exciting news! We're thrilled to announce our strategic partnership with @Parexel ! Parexel brings deep regulatory consulting expertise that enhances our AI solutions, enabling us to expand The Weave Platform across the entire regulatory lifecycle. Together, we’ve already delivered proven results with 50% faster IND authoring timelines, helping sponsors initiate clinical trials sooner while maintaining the highest quality and standards. Read the full announcement: newsroom.parexel.com/news-releases/…

💬 𝗪𝗲𝗮𝘃𝗲 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆 Your words keep us moving forward. Every time we hear how 𝗧𝗵𝗲 𝗪𝗲𝗮𝘃𝗲 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺 saves you hours, catches the details you missed,  or helps regulatory writing feel less like a bottleneck — we listen. And we build. This feedback doesn’t just make us smile (although it does) — it shapes our roadmap. It’s the reason we keep pushing to make The Weave Platform faster, smarter, and even more helpful for biotech and pharma teams. Your feedback isn’t just heard — it’s built into the future of The Weave Platform. 🚀 #WeaveWednesday #CustomerFeedback #Biotech #Pharma #RegulatoryWriting #ProductInnovation

𝗪𝗲𝗮𝘃𝗲 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆: 𝗔𝗜 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀 𝗠𝗮𝗱𝗲 𝗘𝗮𝘀𝘆! Using AI to craft regulatory documents doesn’t have to be complex. With 𝗔𝗜 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗪𝗲𝗮𝘃𝗲 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺, it's as familiar and flexible as working in your favorite doc editor. 💡 𝗙𝗮𝗺𝗶𝗹𝗶𝗮𝗿 𝗙𝗼𝗿𝗺𝗮𝘁 Templates look like traditional documents with headings, body text, and clear blue AI instructions. No special syntax or coding required. 🪄 𝗦𝗺𝗮𝗿𝘁 𝗜𝗻𝘀𝗲𝗿𝘁𝗶𝗼𝗻 𝗧𝗼𝗼𝗹𝘀 Add AI-generated text, tables, variables, or standard text using a simple dropdown next to each section. 🔁 𝗗𝗿𝗮𝗴 𝗮𝗻𝗱 𝗗𝗿𝗼𝗽 𝗙𝗹𝗲𝘅𝗶𝗯𝗶𝗹𝗶𝘁𝘆 Need to move a study summary or reorder sections? Just click and drag a paragraph, a table, or an entire section. ⚡ 𝗦𝗲𝗮𝗺𝗹𝗲𝘀𝘀 𝗧𝗼𝗴𝗴𝗹𝗲 Switch from content view to template mode in one click to fine-tune the instructions behind any AI-generated section. Your documents, your structure. AI just makes it faster. 👉 𝗟𝗲𝗮𝗿𝗻 𝗺𝗼𝗿𝗲 𝗮𝘁 𝘄𝗲𝗮𝘃𝗲.𝗯𝗶𝗼 #WeavePlatform #AITemplates #RegulatoryWriting #WeaveWednesday #AIinPharma

🔬 Join Weave at the @CIInstitute's BioProcessing Summit 📍 Booth #314 | 📅 August 19–22 | Boston, MA Upstream, downstream, and everything in between: bioprocessing drives innovation, and The Weave Platform helps make sure that innovation doesn’t get stuck in regulatory bottlenecks. Our AI-native cloud platform helps regulatory and technical teams tackle the most complex parts of submissions, especially CMC sections tied to process development and manufacturing. The result is less manual work, more consistency, and faster turnaround on critical documents. 💡 Live demos at the booth 🤝 Meet Daniel Pointing, Associate Director of Business Development 📅 Book a 1:1 in advance: calendly.com/daniel-weave Let’s talk about how regulatory work really flows. #WeaveBio #BioProcessingSummit #CMC #RegulatorySubmissions #AIinBiotech

𝗪𝗲𝗮𝘃𝗲 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆 – 𝗪𝗲’𝗿𝗲 𝗛𝗶𝗿𝗶𝗻𝗴! This one’s for the AI evangelists who are equal parts engineer, educator, and product consultant. 🚀 Weave is hiring our first 𝗔𝗜 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁—someone to help life sciences teams scale LLM-powered tools to generate high-quality scientific and regulatory content faster than ever. If you're passionate about improving drug development with AI, love educating customers, and want your ideas to shape the product—let’s talk. 🛠️ What you’ll do: • Customize “AI Templates” for submission-ready content that reflects each customer’s science and style • Teach teams how to adapt and manage their own templates • Document best practices • Collaborate with product and commercial teams to bring AI into real-world pipelines 🧩 You might be our missing piece if: • You’re fluent in prompting LLMs and getting results • You’ve worked in biotech, CRO, or CDMO—INDs, NDAs, and CMCs are familiar territory • You love teaching and are comfortable in early-stage, fast-moving environments 💎 Remote. Full-time. Want to help shape how AI is applied in one of the world’s most regulated industries? Apply now 👉 job-boards.greenhouse.io/weave/jobs/400… #WeaveWednesday #Hiring #AIJobs #LLMs #LifeSciences #MLForGood #DrugDevelopment #WeaveBio #AIPrompt #AITemplate #AIImplementations #RegulatorySubmission

✍️ At Weave, we define a writer as someone who brings scientific precision, clarity, and intention to work that directly impacts patients. That’s why this question from the @NobelPrize resonated with us today: “What’s your definition of a writer?” Regulatory writers might not make headlines—but their work moves science forward. They translate complex data into submissions that are scrutinized, reviewed, and relied on to bring therapies to the people who need them most. 🧬 At Weave, we build AI-native tools to support that mission—not to replace the human writer, but to amplify them. Because in regulatory writing, it’s not just what you say—it’s how clearly, accurately, and precisely you present the data.💡 #RegulatoryWriting #WritersOfScience #NobelInspiration #HumanCenteredAI #Weave #AIinPharma

𝗧𝗵𝗶𝘀 𝗰𝗮𝘂𝗴𝗵𝘁 𝗼𝘂𝗿 𝗮𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻—𝗮𝗻 𝗔𝗜-𝗲𝗻𝗮𝗯𝗹𝗲𝗱 𝘁𝗼𝗼𝗹 𝗻𝗼𝘄 𝗙𝗗𝗔-𝗰𝗹𝗲𝗮𝗿𝗲𝗱 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗯𝗿𝗲𝗮𝘀𝘁 𝗰𝗮𝗻𝗰𝗲𝗿 𝘀𝘂𝗿𝗴𝗲𝗼𝗻𝘀: @SimBioSys just received its third FDA clearance for 𝗧𝘂𝗺𝗼𝗿𝗦𝗶𝗴𝗵𝘁 𝗩𝗶𝘇 1.3, a platform that uses AI to transform standard breast MRIs into detailed 3D visualizations to assist with surgical planning. 🔍 𝗪𝗵𝘆 𝗶𝘁’𝘀 𝗻𝗼𝘁𝗮𝗯𝗹𝗲: • Applies advanced imaging and AI to support more precise excision • Aims to reduce reoperations and preserve healthy tissue • Reflects a broader trend: AI-powered tools earning regulatory validation through clinical performance At Weave, we’re encouraged to see AI thoughtfully integrated into solutions that help clinicians make confident, timely decisions. It’s another example of how 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆, 𝘄𝗵𝗲𝗻 𝗮𝗹𝗶𝗴𝗻𝗲𝗱 𝘄𝗶𝘁𝗵 𝗿𝗲𝗮𝗹 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗻𝗲𝗲𝗱 𝗮𝗻𝗱 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗲𝗱 𝗿𝗶𝗴𝗼𝗿𝗼𝘂𝘀𝗹𝘆, 𝗰𝗮𝗻 𝗲𝗻𝗵𝗮𝗻𝗰𝗲 𝗰𝗮𝗿𝗲 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘆. 📖 Read the full article: chicagobusiness.com/health-pulse/a… #𝗠𝗲𝗱𝗧𝗲𝗰𝗵 #𝗕𝗿𝗲𝗮𝘀𝘁𝗖𝗮𝗻𝗰𝗲𝗿 #𝗔𝗜𝗶𝗻𝗛𝗲𝗮𝗹𝘁𝗵 #𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲 #𝗦𝘂𝗿𝗴𝗶𝗰𝗮𝗹𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 #𝗙𝗗𝗔 #𝗗𝗶𝗴𝗶𝘁𝗮𝗹𝗛𝗲𝗮𝗹𝘁𝗵

🔹 Weave Wednesday 🔹 What if creating a Clinical Study Report didn’t take days—or weeks? 💡 With The Weave Platform, it can take just one hour. We’re showing how structured data and human-driven automation come together to accelerate regulatory workflows—without cutting corners. Watch how it works—and imagine reclaiming time for what really matters. Interested in a custom demo? Book here: app.hubspot.com/pages/23328296… #WeaveWednesday #ClinicalStudyReport #RegulatoryWorkflows #Biotech #Pharma #AutoIND #WeavePlatform

🚀 From preclinical to clinical, Weave is redefining regulatory submissions. In this issue of The Loom, our quarterly newsletter, we’re sharing big strides: AutoIND has gone from a bold idea to a trusted platform — helping regulatory teams cut submission timelines by over 70% and draft clinical protocols in minutes, not months. Now, that same AI-powered precision extends to Clinical Study Reports (CSRs), bringing instant traceability, rapid iteration, and full control. 🛠 Plus, new features like an enhanced Data Room and customizable AI Templates make your workflows even smarter. 💬 Hear from our team — including reflections from CPO Brandon Rice and prompting tips from our Chief AI Officer. Read the full issue of The Loom: 👉 hubs.ly/Q03v0jZF0 #WeaveBio #RegulatoryTech #ClinicalSubmissions #AIinRegulatory #DrugDevelopment #WeavePlatform

📣 @RAPSorg members - there is still time to register for the education webcast focused on how our new feature, AutoCT, helps regulatory teams dramatically reduce the time spent on clinical program submissions. ⌚ What used to take 3 weeks can not take just 1 hour—and that's only the beginning. Learn how Weave's AI-native platform shortens timelines, streamlines workflows, and keeps your teams focused on what matters most. 📅 Friday, June 27, 2025 | 1:00 - 2:00 PM Eastern Time 🎯 Hosted by RAPS Education | Sponsored by Weave 🔗 Register now:raps.org/events/sponsor…? To learn more about our platform, visit our website: weave.bio #RAPSWebcast #RegulatoryAffairs #AutoCT #ClinicalSubmissions #AIforBiotech #WeaveWednesday #WeaveBio #RegulatoryInnovation