Omnalis’ cover photo
Omnalis

Omnalis

Biotechnology Research

San Francisco, California 126 followers

Establishing the Global Gold Standard for Regulatory Intelligence

About us

Team of cracked YC/EF backed & regulatory forward founding engineers/operators, clinical ops leaders, big pharma consultants, and regulatory affairs reviewers. Long Journey Ventures resident & Define Ventures AI fellow Contact liz@omnalis.tech to learn more!

Industry
Biotechnology Research
Company size
2-10 employees
Headquarters
San Francisco, California
Type
Privately Held
Founded
2025

Locations

Updates

  • Omnalis reposted this

    Omnalis is heading to NYC! Excited to share that we are finalists for the 2048 Ventures Vertical AI Pitch Competition June 2nd during TECH WEEK by a16z! I'm a big believer in what the NYC builder ecosystem brings to hard-domain problems and am looking forward to meeting other builders in the room! If you're in NYC and free from 4–5:30 pm, we'd love to see you there. RSVP link in the comments. #VerticalAI #NYCTechWeek #Biotech #HealthcareAI #ClinicalTrials

    View organization page for 2048 Ventures

    17,396 followers

    🏥🤖 Attending NY TECH WEEK by a16z? Join our Pitch Competitions on June 2 This event is for you if you're: 🔬 A founder building in healthcare or vertical AI (come watch, get inspired, make connections) 💼 An investor interested in two of the fastest-growing sectors 🏢 An ecosystem partner who wants a front-row seat to what's next 📍 Healthcare & Vertical AI pitch competitions 📅 June 2 • Brown Rudnick LLP • New York 💰 $50K investment for each vertical winner Spots are limited, grab yours now! 🎟️ Healthcare: https://lnkd.in/e_ueh9xi 🎟️ Vertical AI: https://lnkd.in/eQfv5dDa

  • Omnalis reposted this

    One of the biggest challenges I face as an early founder is figuring out where to spend my time. Last night's Spring Biotech, Healthcare x AI Pitch Night was worth every second. The room was full of operators and leaders who have been inside the FDA submission process. I walked away with cross-industry insights from my fellow presenters Calvin Carter, PhD, Russell Ernst, Ph.D., Renaud Schuck, Elena Arzumanyan & Jesse Eaton and invaluable feedback from judges Dr. Prasun Mishra, David Kiewlich, Paola Torre, and Prof. PK Prasanna Kumar. Thank you to Vanloan Nguyen (Berkeley Pharma Tech Foundation), Perkins Coie, and MedAxis AI LLC for giving me the opportunity to showcase Omnalis and Robert Ross Cameron Ross for your support! #clinicaltrials #biotechAI #drugdevelopment #healthcareAI

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  • Grateful to the support of the Define Ventures community as we navigate the early days of Omnalis

    View organization page for Define Ventures

    8,236 followers

    "You have to imagine a world that doesn’t exist yet, and then claw your way there." Thank you, Nigam Shah, for helping us kick off our third cohort of Define Ventures AI Fellows this week. So excited to meet our next class of incredible AI healthtech entrepreneurs. We can't wait to see what these folks build!

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  • Omnalis reposted this

    The success of AI-enabled life sciences hinges entirely on high volumes of data.    FALSE   At Stanford University Graduate School of Business's Health Care AI Summit, the Life Sciences Innovation Panel kept returning to a different reality. Dietmar Berger from Gilead put it clearly during the life sciences panel: "I don't need a thousand measurements per second." The real questions are, "What is the relevant data point?" and "How can I measure that reliably and with regulatory quality?" At Omnalis, this is the foundation we build on. We're measuring data quality, ensuring replicability, and building systems that generate insights defensible in a regulatory context. This is the documentation discipline that the life sciences have built over decades, and it is applied directly to AI development. Tech companies building in regulated spaces are still treating those as afterthoughts. We'll continue this conversation in a longer Substack essay and in future IRL roundtables, diving deeper into how we think about causal, regulator‑grade data and governance patterns. Dietmar Berger, Mark DePristo, Marc Tessier-Lavigne, Matt Donne, PhD, and Aditya Narayan #LifeSciences #ClinicalTrials #Biotech #HealthcareAI #RegulatoryAffairs

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  • Omnalis reposted this

    View organization page for Omnalis

    126 followers

    Shantenu A., thank you for inviting our CEO & Founder, Elizabeth Wells, MPH, to share more about Omnalis with the Bits in Bio community. This community has been a critical part of our early days building Omnalis, from clinical advising and engineering support to meeting stakeholders throughout the clinical trials journey. This was our first in-person event with Bits in Bio, and we're looking forward to engaging in more in the future! Aaron Blotnick, Shantenu A., Pavel Ryzhov, PhD, Anja Zehfuss, and Andee Constine for Organizing!

    𝗦𝗔𝗡 𝗙𝗥𝗔𝗡𝗖𝗜𝗦𝗖𝗢, 𝗖𝗮𝗹𝗶𝗳., 𝗠𝗮𝗿𝗰𝗵 𝟭𝟵, 𝟮𝟬𝟮𝟲 — Bits in Bio, in partnership with CRV, hosted an intimate gathering of founders, investors, and biotech professionals in San Francisco. The event featured four companies tackling key bottlenecks across the life sciences stack. Potato, presented by Nick Edwards, PhD, is building an end-to-end AI system for experimental biology that goes beyond analysis to actively run experiments. The platform connects literature review, protocol generation, and lab automation through a unified design–build–test–learn loop. Using AI agents and lab “world models,” it simulates experimental workflows, enabling rapid iteration and high-throughput experimentation at scale. Contact: 𝗺𝗲𝗿𝗿𝗶𝘁@𝗿𝗲𝗮𝗱𝘆𝘀𝗲𝘁𝗽𝗼𝘁𝗮𝘁𝗼.𝗰𝗼𝗺 Boston Bioprocess, presented by Anupam Chowdhury, is addressing the “valley of death” in biomanufacturing, where processes that work in the lab fail at scale. The company is building a modern process stack that combines machine learning–driven optimization with full traceability, enabling teams to understand, reproduce, and scale complex biological systems. By focusing on execution at the operator level, they are closing the gap between process design and real-world manufacturing. Contact: 𝗮𝗰𝗵𝗼𝘄𝗱𝗵𝘂𝗿𝘆@𝗯𝗼𝘀𝘁𝗼𝗻𝗯𝗶𝗼𝗽𝗿𝗼𝗰𝗲𝘀𝘀.𝗰𝗼𝗺 Omnalis, presented by Elizabeth Wells, MPH, is focused on a growing failure point in clinical trials: disconnected AI tools that generate inconsistent and non-compliant outputs. The company is building a regulatory inference layer that sits across these systems, coordinating outputs, aligning them with standards such as ICH E6(R3), and generating a continuous audit trail. By identifying risks earlier in the process, Omnalis helps reduce delays that can range from months to millions of dollars. She's also raising an Angel Round for those interested. Contact: 𝗹𝗶𝘇@𝗼𝗺𝗻𝗮𝗹𝗶𝘀.𝘁𝗲𝗰𝗵 ZoomLogi, presented by Olivier Causse, is developing an AI-powered logistics platform for healthcare and life sciences that functions as a real-time control tower for critical shipments. The platform integrates courier systems, sensor data, and internal workflows to provide end-to-end visibility, detect issues as they arise, and trigger automated interventions. This is particularly critical for high-value, temperature-sensitive therapies, where failures can result in significant financial loss and patient risk. Contact: 𝗼𝗹𝗶𝘃𝗶𝗲𝗿@𝘇𝗼𝗼𝗺𝗹𝗼𝗴𝗶.𝗰𝗼𝗺 The gathering was organized by Shantenu A., Aaron Blotnick, Pavel Ryzhov, PhD, Anja Zehfuss, and Andee Constine. 🎤 Special shout out to Alexander Olson with Talaria Biotech, Jingwei (Gavin) Lu with Synlico Inc., Pavel Ryzhov, PhD with Space Biotech Hub, and Eric W. with Gaudi Bio for jumping in during the open mic section 🎤 Special thanks to CRV for their continued support, particularly Saar Gur, Reid Christian, Murat Bicer, George Zachary, and Rick Burnes.

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  • View organization page for Omnalis

    126 followers

    Shantenu A., thank you for inviting our CEO & Founder, Elizabeth Wells, MPH, to share more about Omnalis with the Bits in Bio community. This community has been a critical part of our early days building Omnalis, from clinical advising and engineering support to meeting stakeholders throughout the clinical trials journey. This was our first in-person event with Bits in Bio, and we're looking forward to engaging in more in the future! Aaron Blotnick, Shantenu A., Pavel Ryzhov, PhD, Anja Zehfuss, and Andee Constine for Organizing!

    𝗦𝗔𝗡 𝗙𝗥𝗔𝗡𝗖𝗜𝗦𝗖𝗢, 𝗖𝗮𝗹𝗶𝗳., 𝗠𝗮𝗿𝗰𝗵 𝟭𝟵, 𝟮𝟬𝟮𝟲 — Bits in Bio, in partnership with CRV, hosted an intimate gathering of founders, investors, and biotech professionals in San Francisco. The event featured four companies tackling key bottlenecks across the life sciences stack. Potato, presented by Nick Edwards, PhD, is building an end-to-end AI system for experimental biology that goes beyond analysis to actively run experiments. The platform connects literature review, protocol generation, and lab automation through a unified design–build–test–learn loop. Using AI agents and lab “world models,” it simulates experimental workflows, enabling rapid iteration and high-throughput experimentation at scale. Contact: 𝗺𝗲𝗿𝗿𝗶𝘁@𝗿𝗲𝗮𝗱𝘆𝘀𝗲𝘁𝗽𝗼𝘁𝗮𝘁𝗼.𝗰𝗼𝗺 Boston Bioprocess, presented by Anupam Chowdhury, is addressing the “valley of death” in biomanufacturing, where processes that work in the lab fail at scale. The company is building a modern process stack that combines machine learning–driven optimization with full traceability, enabling teams to understand, reproduce, and scale complex biological systems. By focusing on execution at the operator level, they are closing the gap between process design and real-world manufacturing. Contact: 𝗮𝗰𝗵𝗼𝘄𝗱𝗵𝘂𝗿𝘆@𝗯𝗼𝘀𝘁𝗼𝗻𝗯𝗶𝗼𝗽𝗿𝗼𝗰𝗲𝘀𝘀.𝗰𝗼𝗺 Omnalis, presented by Elizabeth Wells, MPH, is focused on a growing failure point in clinical trials: disconnected AI tools that generate inconsistent and non-compliant outputs. The company is building a regulatory inference layer that sits across these systems, coordinating outputs, aligning them with standards such as ICH E6(R3), and generating a continuous audit trail. By identifying risks earlier in the process, Omnalis helps reduce delays that can range from months to millions of dollars. She's also raising an Angel Round for those interested. Contact: 𝗹𝗶𝘇@𝗼𝗺𝗻𝗮𝗹𝗶𝘀.𝘁𝗲𝗰𝗵 ZoomLogi, presented by Olivier Causse, is developing an AI-powered logistics platform for healthcare and life sciences that functions as a real-time control tower for critical shipments. The platform integrates courier systems, sensor data, and internal workflows to provide end-to-end visibility, detect issues as they arise, and trigger automated interventions. This is particularly critical for high-value, temperature-sensitive therapies, where failures can result in significant financial loss and patient risk. Contact: 𝗼𝗹𝗶𝘃𝗶𝗲𝗿@𝘇𝗼𝗼𝗺𝗹𝗼𝗴𝗶.𝗰𝗼𝗺 The gathering was organized by Shantenu A., Aaron Blotnick, Pavel Ryzhov, PhD, Anja Zehfuss, and Andee Constine. 🎤 Special shout out to Alexander Olson with Talaria Biotech, Jingwei (Gavin) Lu with Synlico Inc., Pavel Ryzhov, PhD with Space Biotech Hub, and Eric W. with Gaudi Bio for jumping in during the open mic section 🎤 Special thanks to CRV for their continued support, particularly Saar Gur, Reid Christian, Murat Bicer, George Zachary, and Rick Burnes.

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      +5

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