Weave

"We're not just authoring documents—we're automating entire dossiers and drug programs." 💡 Our Chief Commercial Officer, Lindsay Mateo, MBA, recently sat down with @Fierce Pharma to discuss how Weave is transforming regulatory workflows for biopharma. The conversation explores how our AI-native platform enables scientists and regulatory professionals to move beyond manual tasks and focus on strategic oversight—keeping human expertise at the wheel while AI handles data organization and summarization. Lindsay also discusses our centralized collaboration environment that brings internal teams, CROs, and CDMOs together in one place (finally, no more endless email threads and SharePoint folders), our recent Health Authority Questionnaire (HAQ) solution for instant regulatory inquiry responses, and our expanding partnership with Parexel [Tag] into post-market areas. Her message to the industry: "You have to scale teams for the AI applications of tomorrow"—investing now in the skills and infrastructure that will define the next era of drug development.  🔗 View the full interview: https://lnkd.in/gVeeTVyX

🤝 Day 2 at American Medical Writers Association (AMWA) is all about the connections. Regulatory writers know connection is everything: between data and story, science and submission, teams and timelines. 💡 We’re at booth #21, ready to show how Weave connects the dots across regulatory workflows—bringing together AI, automation, and human expertise to make the path from insight to impact smoother and smarter. Come see how connection drives better regulatory writing. #AMWA2025 #ConnectionsMatter #RegulatoryWriting #WeaveBio

⏱️ When Health Authorities Have Questions, Every Hour Counts We’re excited to introduce 𝗛𝗔𝗤 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 —a breakthrough capability now available in the Weave Platform that brings AI-native automation to one of the most time-sensitive moments in drug development: 𝗿𝗲𝘀𝗽𝗼𝗻𝗱𝗶𝗻𝗴 𝘁𝗼 𝗛𝗲𝗮𝗹𝘁𝗵 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝘆 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 (𝗛𝗔𝗤𝘀). 💡 During post-submission review, regulators may issue dozens of complex questions at once, and companies often have just days or weeks to respond. Teams must coordinate across clinical, CMC, and regulatory functions while ensuring consistency with previously submitted materials. The stakes are high: inadequate responses can delay approval by months. Built in collaboration with Takeda, HAQ Manager simplifies that moment:  ✅ Automates HAQ tracking and management across teams and functions  ✅ Generates draft responses using verified source documentation and historical regulatory interactions  ✅ Maintains version control and traceability to ensure every response is aligned and audit-ready By reducing manual burden and surfacing the right information at the right time, HAQ Manager enables regulatory teams to respond with speed and confidence—delivering quality responses in a fraction of the time. 🌐 This launch extends Weave’s AI-native platform beyond submission authoring into post-submission review phase, marking a significant milestone toward comprehensive regulatory lifecycle support. 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗽𝗿𝗲𝘀𝘀 𝗿𝗲𝗹𝗲𝗮𝘀𝗲: https://lnkd.in/gKr-MMPc 🎥 𝗦𝗲𝗲 𝗛𝗔𝗤 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 𝗶𝗻 𝗮𝗰𝘁𝗶𝗼𝗻. Join us 𝗙𝗿𝗶𝗱𝗮𝘆, 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟭𝟰 for a live demo and discover how Weave is redefining post-submission review. 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗻𝗼𝘄: https://lnkd.in/gjVe7xV7 #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: 👉 https://lnkd.in/gbeYbVAh 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

📍 Come visit us at our Weave Bio exhibit booth, and don’t miss our Chief Commercial Officer, Lindsay Mateo, MBA Mateo, speaking today at 2:30 PM! Lindsay will share how our human-driven, AI-enhanced approach is helping sponsors and research organizations simplify complex workflows and move faster from preclinical to clinical stages. ✨ In her talk, she’ll cover: ✔️ Common workflow bottlenecks ✔️How Weave’s connected platform supports real-time collaboration ✔️Real-world examples of teams unlocking smarter clinical workflows If you’re here at the Westin San Diego Bayview, stop by to connect with our team and learn how the Weavers are redefining what’s possible in clinical trial operations. #WeaveBio #PCTSummit #ClinicalTrials #ClinicalOperations #LifeSciences #AIinRegulatory

From Data to DSUR in minutes ⏱️ Medical writing and safety teams spend countless hours pulling together information from clinical, administrative, and literature sources just to get to a first draft. With Weave’s AI-powered DSUR template, that first draft is just a click away. Within minutes, teams can generate, refine, and finalize their Development Safety Update Reports directly in the Weave platform. Less time compiling. More time crafting the right story. 📖 👀 Watch ✟Wes Galliher, Ph.D. walk through how it works in this quick video. 🌐 Want to learn more? Visit weave.bio to book some time with us. #WeaveWednesday #MedicalWriting #WeaveBio #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

Appreciate the feature from BiotechTV highlighting how Weave is applying AI and automation to simplify regulatory document drafting and accelerate progress in drug development. As Co-Founder and CEO Brandon Rice shares in the segment, following our $20M Series A, Weave’s platform has helped teams cut drafting time from 100 hours to just 3. #WeaveBio #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

Generative AI is reshaping drug development, and Weave is helping teams focus on the work that matters most: getting therapies to patients. 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 sales, marketing, customer success, product, engineering, and AI research. 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 Have questions or want to start a conversation? Connect with our in-house recruiter Sarah Miller. 👉 Visit our careers page to learn more: www.weave.bio/careers #WeaveBio #Hiring #LifeSciences #DrugDevelopment #AIinHealthcare

Weave Wednesday: Building Consistency and Speed with Custom AI Template Sets ⚡ A strong foundation means faster, higher-quality document creation. With Custom AI Template Sets in the Weave Platform, teams can maintain consistency across programs while tailoring content for different modalities, therapeutic areas, or document types. 🧩 Template Sets for Every Situation Get started quickly with Weave’s Baseline AI Templates, or create your own sets designed around your organization’s specific needs. These templates can be applied to any new program—helping teams move faster without sacrificing accuracy or structure. 🏭 Scalable Across the Organization Create organization-wide template sets that keep document frameworks consistent while allowing flexibility where it matters most. Every team can work from a shared foundation that’s adaptable, aligned, and ready for growth. 🎥 Watch the video below to see it in action, or reach out for a demo to learn more. #weavewednesday #WeaveBio #DrugDevelopment #RegulatoryInnovation #AIinPharma #Biotech #LifeSciences

✍️ Medical writing meets momentum. Weave is heading to American Medical Writers Association (AMWA) 2025, and Taylor Ziegler will be on site to connect with the medical writing community about how our platform supports the work that keeps regulatory programs moving. Medical writers are the backbone of high-quality submissions — but disconnected documents, version control chaos, and siloed feedback can slow everything down. That’s where Weave comes in. Our platform gives medical writers: ✅ Clear document structure from day one ✅ Smart reuse of existing content ✅ Real-time collaboration without overwrites ✅ Full visibility into status, edits, and ownership Whether you're working on an IND, CTA, or rolling submission, Weave helps you move faster and more confidently — without compromising accuracy or alignment. We can’t wait to meet the experts who turn science into strategy — and show how Weave makes that process smoother, smarter, and more scalable. #MedicalWriting #RegulatoryWriting #AMWA2025 #WeavePlatform #LifeSciences #WritersInRegulatory #WeaveAtWork