Weave

🚨 In Case You Missed It: This Week at FDA Our friends at Regulatory Affairs Professionals Society (RAPS) released their weekly FDA update on Friday, covering the latest regulatory shifts and industry-impacting news. This edition dives into key developments, including major leadership changes and policy updates that could have significant effects across biotech and pharma. Staying informed is critical in a fast-moving regulatory landscape—don’t miss out on the latest insights. 🔗 Read the full update here: https://lnkd.in/gsfsdACn #RegulatoryAffairs #FDAUpdates #LifeSciences #AIinBiotech #AIinPharma

We ❤️ AI Roses are red, Violets are bright, Weave’s AI workbench Helps get submissions done right!  💡🤖 This Valentine’s Day, we’re swooning over our AI-native regulatory automation management platform—saving time, boosting efficiency and making drug regulatory work a little more lovable!💕✨ 💬 Tag someone who loves AI as much as we do! 💙 #ILoveAI #ValentinesDay #AIinpharma #AIinbiotech #AIinRegulatory #WeaveBio

📢 #AutoIND February Release: Data Exploration ➡️ Publishing Our February release is just the thing to shake you out of the January doldrums. We're significantly extending workflow support with Publishing v1 and Data Exploration, covering both earlier and later stages of your submission workflow. Content quality is also getting a big boost with Data Tags, offering greater precision and flexibility when mapping source data to templates. Highlights: 🔗 Add links throughout the dossier that always stay up-to-date 📄 Better first drafts and more powerful templates with Data Tags (especially in CMC/Module 3) 📊 Instantly tabulate your entire Data Room however you wish with the new Data Room Overview ❓ Ask any question of your source documents and get your answer as a summary, table, list, or letter …and more! ➡️ Review the full release here: https://lnkd.in/g8XjcfCs #WeaveWednesday #AIinPharma #AIinBiotech #AIinRegulatory #AIinnovation #regulatoryautomation

👨🍳 Document creation just got a Michelin star upgrade! Shoutout to our CPO, Brandon Rice, for the inspiration behind this spicy take!🌶️ Using LLMs is like trading in endless prep work for full creative control in the kitchen. No more spending all day slicing and dicing data. Now you get to plan the menu (strategize), create signature dishes (generate insights), and perfect the flavors (refine your story). LLMs aren’t just tools; they’re your new AI sous-chefs 👩🍳, helping you serve up success with flair and consistency. 🔥 Hungry to learn more? Connect with us at info@weave.bio. Let's cook up something great together! 🍽️

Wow! What an incredible time we had at #RSIDM25! 🎉 A huge thank you to everyone who stopped by and engaged with us—your energy and curiosity made this event unforgettable! 💬🙌 Special shout out to DIA for organizing such an informative and inspiring event. If you left wanting more, there’s plenty for us to explore together: ✔️ Weave platform capabilities – See how we support your IND and regulatory journey ✔️ Our study design and early results – Accelerating data-driven decisions and timelines ✔️ #Quality measures/rubric suggestions – Raising the bar with innovative best practices ✔️ Partnership opportunities – Collaborating for mutual success We'd love to keep the momentum going! 📧 Reach out to schedule time or request follow-up information: info@weave.bio #DIA #RSIDM25 #WeaveInnovation #regualtoryoperations

Weave Wednesday: Reflecting & Projecting (pt 2) Today, we're sharing the second part of a personal message from our CPO, Brandon Rice, about what's ahead for Weave. "Reflecting and Projecting (pt. 2)" The beauty of starting with the IND is that it lays the foundation for everything that follows. IND clearance begets more studies, bigger batches, and tighter timelines; but it’s all eCTD at the end of the day (in the US). Moreover, every regulatory submission follows the same core workflow that we established under the IND: upload, draft, refine, review, QC, publish. So we need not build a brand new platform for each document, we can simply extend the platform we already have. So what’s the plan for 2025? The natural progression after building a product for the very first regulatory submission in a drug’s life is to build the products for the rest of them. And that’s what we intend for this year: to enable the rest of the regulatory lifecycle on the Weave Platform. Concretely, that means clinical-phase filings. Clinical study reports, protocols, and amendments to start. Safety reports, annual reports, and (improved) IB’s to follow. We aim to cap the year going beyond the clinic to NDA’s and BLA’s, but we prefer to under promise and over deliver, so I’ll come back to you on that in six months. We are not on this journey alone. We are building for you, our customers. There is less hand-wringing these days about AI taking jobs, and for good reason. Human experience and judgment, especially in drug development, is irreplaceable. But the jobs themselves will inevitably transform, and that is happening as we speak. Come join us in shaping a new paradigm for the therapeutic regulatory lifecycle. Brandon Rice Chief Product Officer #WeaveWednesday  #AIinpharma #AIinbiotech #AIinRegulatory

🚀 Day 2 at DIA RDISM – Don’t Miss Our Talk! Day 1 was packed with incredible conversations and energy, and Day 2 is shaping up to be just as exciting! Today, we’re thrilled to present our session on Evaluating Time Savings in Regulatory Writing, featuring preliminary insights from a study with a top 20 pharma company. 🕒 Time: 10:05 - 10:35 AM 📍 Location: Forest Glen Room (lower level) After the talk, stop by Booth #100 to continue the conversation, explore how Weave can support your goals, and create your own AI caricature! See you soon at DIA RDISM! #RDISM2025 #RegulatoryInnovation #DIA

#RSIDM Day 1: Stop By and See What's Happening! We’re excited to jump start the week at this premier event focused on advancing regulatory submissions, information, and document management. 🎉 Today is all about engaging with YOU! Here's why you should swing by Booth #100: 🔍 Live Demo: Explore the AI-native Weave platform and get a live demo of #AutoIND, our flagship offering that’s transforming the way experts think about regulatory document preparation. 🎨 Test Drive for Fun: Get your very own AI caricature - playful, unique, and custom - made just for you! 💬 Meet the Team: Our CEO, Ari Caroline, and CCO, Lindsay Mateo, MBA are ready to chat one-on-one about your regulatory challenges. #DIA #RSIDM #Regulatory #AIinregulatory #AutoIND #RegulatoryReimagined Stop by and make Day 1 unforgettable! ✨

💪Finding Strength in the Startup Journey🚀 Our CTO, Levi Malott, shared some powerful reflections on the volatility of startup life—where moments of triumph can quickly turn into moments of uncertainty. It takes resilience, adaptability, and staying connected to your why to keep moving forward. While building Weave's regulatory automation management platform, we've certainly faced twists and challenges. Yet, we stay grounded in our mission: empowering biotech and pharma innovators by streamlining regulatory processes and reducing complexity, helping them thrive on their own journeys—no matter how difficult the road gets. 🎯 Levi’s advice is spot on: know your WHY. It’s what will carry you through tough times and keep you focused on building something extraordinary. Check out Levi's full post and share your thoughts—what’s your why on this journey? #WeavingSuccess#Startuplife#LeadershipThoughts#RegulatoryAutomation#AI#AIinParma#AIinBiotech

Weave Wednesday: Reflecting & Projecting It’s Weave Wednesday, and today, we’re sharing a personal message from our Chief Product Officer, Brandon Rice, reflecting on a big year for Weave and what’s ahead. "Reflecting and Projecting (pt. 1)" 2024 was a big year for us at Weave. We launched #AutoIND, our first product — we welcomed our first customers, and together with those customers, we generated our first INDs (submission pending…). In doing so, we have turned months into minutes, transformed tedium into delight, and began defining an entirely new paradigm for building regulatory submissions. The shift is simple but profound: regulatory submissions are no longer written — they are generated. Historically, more than half the time spent by a team on an IND consisted of extracting data from source documents, constructing tables, and drafting summaries. Today, AI handles all of those tasks, and more, freeing your team to focus their time on strategy, interpretation, and narrative. The new experience is more akin to design and engineering than drafting and editing, though humans still remain firmly in the driver’s seat. With AutoIND, we went end-to-end on a single submission for a therapeutic, the IND. Today, you can organize and curate your source data, draft and refine content, review and QC the documents, export and publish. You can do all of that on a single platform with AI support at every step. The result is a high-quality submission in half the time and effort, and we’re just getting started. We chose the IND as our initial focus because it is the origin of every drug’s regulatory journey, the foundation. But our aim is to build a platform to support the entire regulatory lifecycle. Now that we have a single submission workflow covered, at the onramp to regulatory, we are ready to move forward. Come back next week to hear about our plans for the year ahead. Brandon Rice Chief Product Officer #WeaveWednesday #AI #AIinRegulatory