1. Regulatory workflows are complex but structured.
The presentation highlights that regulatory processes—spanning data management, authoring, reviewing, publishing, and health authority queries—are intricate yet follow consistent patterns. They are highly collaborative, interdependent, and mission-critical to bringing therapies from candidate nomination to market
2. AI is powerful but needs context and precision.
While AI excels at understanding and summarizing information, it struggles with reasoning and lacks domain-specific (drug development) context. Effective use of AI in regulatory work requires clear task definition—large enough to matter, but small enough to manage
3. Human-AI collaboration transforms regulatory efficiency.
When applied thoughtfully, AI can make regulatory work up to 100× faster without compromising quality—reducing months of effort to hours. Studies with Takeda and partnerships with Parexel demonstrate how AI can accelerate timelines, elevate human expertise, and make portfolio knowledge computable across programs
Lindsay Mateo
CCO
Weave Bio
Weave Bio
Website: https://www.weave.bio/
Weave Bio is an AI-native company reimagining how life science organizations navigate regulatory work. Through its core product, the Weave Platform, Weave brings intelligence, structure, and collaboration to every stage of the regulatory process.
The Weave Platform connects people, data, and technology in a unified workspace that combines AI-powered drafting, source-linked data, and configurable workflows. By keeping experts firmly in the loop, it transforms complex, manual regulatory work into transparent, traceable, and collaborative processes.
Built for biotech, pharma, CROs, and regulatory consultants, Weave supports the full regulatory lifecycle—from early development through submission—helping teams move faster, maintain quality, and scale with confidence.
- Learn how real-world data is transformed into structured, usable intelligence through PRISM (Patient Record Inference & Structuring Module), an AI-enabled engine that converts fragmented, multi-modal patient data into inference-ready patient journeys supporting scalable clinical insights and model validation.
- Explore how Zephyr’s AI-enabled multi-modal models (AIM Suite) predict drug response and reconstruct gene expression from clinically available inputs, such as NGS data from commercial LDTs and whole-slide images, enabling retrospective and prospective evaluation of treatment predictions across oncologic therapeutic classes.
- Discover how Zephyr’s AI-driven software accelerates co-development and clinical integration, enabling fine-tuned foundation models to embed directly into R&D workflows while supporting rapid clinical intelligence queries, cohorting, and data-driven decision-making.
Anshu Jain, MD
Chief Business and Clinical Officer
Zephyr AI
Dr. Anshu Jain is Zephyr AI’s Chief Business and Clinical Officer. A double board-certified radiation oncologist and clinical informatician, he leads business development, clinical strategy, medical affairs, and partner collaborations—translating Zephyr’s AI and large-scale real-world data into solutions that help biopharma and diagnostic partners advance precision medicine for patients. Prior to Zephyr, Dr. Jain served as Chief Medical Officer at Aster Insights.
Dr. Jain has authored peer-reviewed publications in Nature Communications, Journal of Clinical Oncology (JCO), and JCO Clinical Cancer Informatics, and has served as a principal investigator for early- and late-phase oncology trials. He has advised the FDA Office of the Commissioner and the Oncology Center of Excellence, and provided clinical leadership to large-scale data initiatives including the NCI SEER program.
He serves on the Board of Directors of the Community Oncology Alliance, the Board of Advisors for the Duke Cancer Institute, and is an Assistant Professor at the Yale School of Medicine.
Dr. Jain trained in internal medicine and radiation oncology at the Massachusetts General Hospital and Columbia New York Presbyterian Hospital. He earned his M.D. with Highest Distinction from the University of Kentucky College of Medicine and a degree in Economics from Duke University.
Zephyr AI
Website: https://www.zephyrai.bio/
Zephyr AI is a precision-medicine company unifying enterprise-scale real-world data with multi-modal AI to deliver actionable, biologically interpretable insights across the therapeutic lifecycle—from discovery to clinical deployment. Our software-native, AI-enabled modules predict drug response and reconstruct gene-expression signatures from clinically available DNA-based inputs and drug metadata, and can be fine-tuned to novel therapeutics or diagnostics. Pilots stand up in weeks, informing patient stratification, trial optimization, label expansion, and indication discovery.
PRISM, our SOC 2/HIPAA-aligned data and compute infrastructure, powers rapid cohort construction, synthetic control arms, and real-world validation with intervention-specific risk modeling. Through Aster Insights™ and the ORIEN Total Cancer Care® study, Zephyr provides access to deeply annotated oncology assets—lifetime-consented patients with linked clinical, exome, transcriptome, and whole-slide imaging—to enable fit-for-purpose data generation. We partner with biopharma, diagnostics, and digital-pathology leaders, integrating seamlessly into existing workflows with no new assays required. Together with a rigorous validation engine grounded in real-world outcomes, Zephyr bridges experimental and clinical domains to extract signal from heterogeneous data, de-risk development, and bring effective therapies to patients sooner. Our mission is to make precision medicine accessible and immediate—turning fragmented data into confident, patient-impacting decisions at scale.
Data powers the engine of artificial intelligence (AI), but not all data is created equal. While software capabilities are rapidly accelerating, the biopharma industry still largely lacks the intelligent hardware needed to generate clean, contextualized, and high-quality data that AI and machine learning (ML) models require to deliver on their promise.
Explore how today’s in silico process development tools for bioreactor scaling and mechanistic modeling of chromatography can help you get it right the first time now, and why the next generation of intelligent hardware will be critical to unlocking the full potential of AI/ML in biopharma.
Tobias Hahn, PhD
R&D Director, GoSilico
Cytiva
Tobias Hahn is R&D Director of chromatography mechanistic modeling activities at Cytiva. As former co-founder and CEO of GoSilico, now part of Cytiva, Tobias is responsible for delivering simulation software and workflows for in silico process development. He received his undergraduate education in computational mathematics and technical physics in Karlsruhe and Stockholm, earning his PhD in chemical engineering from Karlsruhe Institute of Technology (KIT). During his doctoral studies, he utilized his background in mathematics and software engineering to create the simulation software now known as GoSilico™ chromatography modeling software.
Cilon Li
Sr. Director of Engineering, Digital Products Development
Cytiva
Cilon Li is a digital and IT executive with over 15 years of experience in healthcare and biopharma. He is a strategic leader with a proven track record in driving digital transformation across supply chain management, product management, and R&D. At Cytiva, Cilon drives the company’s digital strategy and expanding product portfolio, encompassing Internet of Things (IoT), data analytics, AI/ML, software as a service (SaaS) and enterprise applications to help customers progress their digital biomanufacturing journeys.
Cytiva
Website: https://www.cytivalifesciences.com/about-us
Cytiva is a global life sciences leader dedicated to helping customers discover and commercialize the next generation of therapeutics. Together, we bring dedicated technical expertise and a broad portfolio of tools and technologies that enable the development, manufacture, and delivery of transformative medicines to patients. Visit cytiva.com to learn more.
Review how decision intelligence is transforming the way organisations plan and execute complex projects. Apply decision intelligence to high-stakes environments such as clinical trials and learn how AI can dramatically reduce trial-planning timelines, optimise trial execution, and improve portfolio-level decision-making. Explore how leading enterprises are using Decision Intelligence platform to bring greater clarity, speed, and confidence to their most critical operational and strategic decisions.
Andrew Brookes
Chief Technical Officer & Co-Founder
Faculty
Andrew leads Faculty’s technical teams and developed the backbone of Faculty’s AI operating system, Frontier. His accomplishments span building the NHS Covid Early Warning System and mission critical projects for the UK Ministry of Defence. Before Faculty, Andrew led an engineering team at investment management firm BlackRock. He holds a Master’s degree in Computer Science from the University of Warwick.
Faculty
Website: https://faculty.ai/
Founded in 2014, Faculty is one of Europe’s leading applied AI companies. Our suite of AI services and products helps organisations design, build, and deploy high-performing AI solutions that deliver measurable impact for their frontline teams. Faculty is also the developer of Faculty Frontier™, a Decision Intelligence platform used by leading pharmaceutical companies to transform decision-making at scale.
Widely recognised as a leader in AI safety, we work closely with the world’s top AI labs, such as OpenAI and Anthropic, to ensure their latest models are safe, human-led, and explainable. Our expertise spans advising Boards, leadership teams, and governments on AI strategy; delivering AI systems that improve critical public services and business outcomes; and equipping organisations with the knowledge and skills they need to thrive in the AI era.
Our PhD-heavy team has delivered hundreds of real-world AI projects across every sector of the economy. Headquartered in London, Faculty remains founder-led and has raised over £40m from investors including The Apax Digital Fund, LocalGlobe, and GMG Ventures.
This session explores how hybrid AI infrastructure is transforming drug discovery by integrating on-premises, private cloud, and public cloud resources for optimal data control, computational power, scalability, and security. Attendees will learn how pharmaceutical organizations use cutting-edge AI and machine learning tools for target identification and molecular design, while maintaining compliance with strict regulatory standards. The presentation will cover the architecture and core components of hybrid infrastructure, including high-performance computing, data management, MLOps, and compliance frameworks. Key benefits such as accelerated R&D, cost reduction, improved collaboration, and flexible scalability will be discussed, alongside real-world case studies. The session will also address challenges like data integration, interoperability, regulatory complexity, and AI interpretability, offering practical strategies to overcome these obstacles.
Alex Madama
Distinguished Technologist
Hewlett Packard Enterprise
Alex Madama is a Distinguished Technologist at Hewlett Packard Enterprise, specializing in strategic technology integration for life sciences organizations, including healthcare, pharmaceutical, biotech, and medical device companies. He leads initiatives combining high-performance computing, Hybrid Cloud, IoT, big data, and AI to advance drug discovery, pharmaceutical R&D, and biologics manufacturing, aiming to optimize patient outcomes and reduce costs. Before re-joining HPE, Alex served as Vice President of Product at UnitedHealth Group R&D, where he drove innovation in healthcare research and development. He holds a bachelor’s degree in life science and a Doctor of Osteopathic Medicine from New York Institute of Technology, with additional clinical training at Good Samaritan Hospital Medical Center, and lectures as an Adjunct Professor of Health Information Technology at Hofstra University. Previously, Alex founded Onyx CCS and held leadership roles at Nook.com, Barnes & Noble, AIG, Cravath Swaine & Moore, and as founder of seekPhysician.com.
HPE
Website: https://www.hpe.com/
HPE (NYSE: HPE) is a leader in essential enterprise technology, bringing together the power of AI, cloud, and networking to help organizations achieve more. As pioneers of possibility, our innovation and expertise advance the way people live and work. We empower our customers across industries to optimize operational performance, transform data into foresight, and maximize their impact. Unlock your boldest ambitions with HPE.
Advanced computing is a strategic imperative for pharmaceutical innovation. The industry is at a point where traditional computational methods are no longer sufficient to solve the increasingly complex problems in R&D and operations. Embracing technologies like quantum computing and HPC is critical for maintaining a competitive edge and driving breakthroughs.
A hybrid approach is essential for a complete solution. No single technology is the silver bullet. The most effective solutions come from using the right tools—be it classical, quantum, or quantum-inspired—and combining them into a single, powerful workflow to maximize efficiency and impact. This approach allows companies to apply the best technology to a wide range of problems across the business, not just in drug discovery.
Strategic partnerships are key to capability building. For a large enterprise like J&J, the path to adopting these advanced technologies is best navigated through collaboration. Working with a specialist like Strangeworks bridges the knowledge gap, provides access to powerful platforms, and helps overcome organizational hurdles. The ultimate goal of this collaborations like these is to be able to empower J&J's internal teams to become self-sufficient pioneers of innovation.
Steve Gibson
Chief Commercial Officer
Strangeworks
Steve has held a range of C-Suite positions in technology companies ranging from financial technology services, to data science consulting. Currently he serves as Chief Commercial Officer at Strangeworks; an advanced compute platform as a service (PaaS) company based in Austin, Texas. Prior to Strangeworks, Steve helped build several startups from the ground up, the most successful being Honest Dollar which was the first startup acquired by Goldman Sachs in their 147 year history. Prior to Honest Dollar, Steve worked for a number of large multinational corporations in the European aerospace sector delivering platforms for military, civil and space applications. Steve holds a Bachelor’s degree in Aerospace Systems Engineering from the University of Coventry in the UK.
Selene Sass
Technology Product Manager
Johnson and Johnson
Selene is a technology product manager at Johnson & Johnson with nearly five years supporting the Advanced Computing and Analytics team. Her primary focus is to empower R&D scientists with emerging and innovative technologies in the advanced computing space, including the integration of quantum computing within J&J. Currently, she supports groups working in AI/ML and is exploring how quantum computing techniques can further enhance these capabilities.
Strangeworks
Website: https://strangeworks.com/
Strangeworks is on a mission to turn computational complexity into real world solutions. With the largest catalog of quantum and quantum-inspired computing resources on an innovative cloud platform backed by computational experts, we make the transformative potential of quantum computing accessible to all. Our AI powered workflows make it easier for enterprises to solve today’s toughest challenges, accelerate breakthroughs, and future-proof their operations. Partnering with customers worldwide, Strangeworks delivers immediate ROI while shaping a smarter, quantum-enabled future.
Helix AI
Website: https://helixai.com/
HelixAI is a specialist scientific technology company focused on accelerating research and development for biopharmaceutical organizations. Its platform, JarvisAI, enables scientific teams to design and execute in silico R&D workflows that support a wide range of operations from early-stage drug discovery to scale-up and bioproduction. By integrating scientific data from public, private and client domains along with computational models and AI-driven orchestration, JarvisAI helps researchers explore hypotheses more efficiently and prioritize the most promising drug candidates for further development. This approach supports better, faster decision-making combined with optimization of scientific and wet-lab resources.
- Learn how AI analyzes patent and R&D data to identify chemical trends, aiding in compound optimization.
- Discover how integrating diverse data sources streamlines the optimization of drug candidates, enhancing decision-making.
Sam Winders
Account Director
Patsnap
Sam is the lead representative for the healthcare and life sciences team at Patsnap. One of the organization’s longest serving employees, Sam works closely with our leading customers and the Patsnap product development team to ensure that our customers’ needs our met and that Patsnap continues to rapidly expand the technical frontier within the evolving drug discovery space.
Patsnap
Website: https://www.patsnap.com/
Patsnap enables IP and R&D teams to make faster, more informed decisions through advanced AI-powered intelligence. As the global leader in innovation intelligence since 2007, Patsnap provides comprehensive insights that enhance productivity and reduce inefficiencies. Patsnap's domain-specific large language model, trained on extensive proprietary innovation data, integrates with its suite of AI agents to deliver actionable intelligence that increases IP productivity by 75% and reduces R&D waste by 25%. The platform supports seamless collaboration across the complete innovation lifecycle, from patent analysis to competitive intelligence. More than 15,000 companies worldwide, including NASA, PayPal, Sanofi, Dow Chemical, and Wilson Sonsini, trust Patsnap to advance their innovation capabilities through AI.
Christina V. McDonough
Principal
Fish & Richardson P.C.
Christina McDonough helps clients with patent prosecution, portfolio management, reexamination, counseling, and due diligence for clients ranging from small start-ups to large companies and academic institutions. She co-leads the firm’s standard essential patent (SEP) practice.
Christina has particular expertise in the areas of artificial intelligence, digital therapeutics, bioinformatics and medical systems (e.g., telehealth, medical registries, readmission reductions, modeling and predictive analysis of biological data, genetic codes, and immunotherapy response), computational fluid dynamics (e.g., simulation of acoustic and fluid flow properties), complex data processing (e.g., big data and complex events), and financial algorithms (e.g., predictive modeling and forecasting of real-time security trades).
Crystal Culhane Ph.D.
Principal
Fish & Richardson P.C.
Crystal Culhane, Ph.D., applies her extensive academic background in organic chemistry to help life sciences organization protect their products and innovations through U.S. and foreign patent prosecution, client counseling, due diligence, patentability and freedom to operate opinions, patent opinions, and post-grant proceedings.
Known as a responsive communicator with a strong depth of knowledge, Crystal works with clients ranging from universities to start-ups and growing companies to multinational organizations to prepare intellectual property strategies that suit their business goals.
In recent years, Crystal has worked with a number of pharmaceutical clients in high-impact patent prosecution. Her clients include a large pharmaceutical company for which she has helped develop and manage a portfolio of several hundred patent families and another which in 2021 received its first-ever FDA approval for a new drug that treats a rare liver disease.
Crystal earned her doctorate in chemistry at Johns Hopkins University, where her research focused on the design, synthesis, and evaluation of novel optical and radioactive small molecule prostate cancer imaging agents. She has significant experience in various scientific disciplines, including synthetic organic chemistry, radiochemistry, biology, radiobiology, and small animal imaging.
Fish & Richardson
Website: https://www.fr.com/industries/life-sciences/
Fish & Richardson has represented pioneering life science innovators from our earliest days. We work closely with life sciences companies to help them achieve their strategic IP goals through acquisition, partnering, licensing, financing, and enforcement. We do this by bringing a unique holistic approach to our clients’ IP matters, fostered by the collaboration between our patent prosecution, litigation, and regulatory practices. We have helped our clients build valuable patent portfolios worth billions of dollars, score big victories at the Patent Trial and Appeal Board (PTAB), and win bet-the-company cases in court. When life sciences clients come to Fish to build an IP strategy, they know that we will leave no stone unturned when crafting creative and comprehensive solutions to maximize the value of their IP.