
Create your personal agenda –check the favourite icon
Ingenix's Biological Reasoning Engine brings auditable, mechanism-grounded reasoning to the high-stakes decisions in drug development. We demonstrate one: whether a biomarker is ready to enrich or stratify a trial, with the evidence chain behind the call.
Through Modality Fusion, we connect modalities across biological scales: target biology, pathways, omics, model systems, and clinical data – integrated at the representation level into one architecture that reasons over the whole.
We run the stress test on a real biomarker: what makes it enrichment-grade, where the evidence breaks, and how our recommendation held up against the trial's actual readout.
Pharmaceutical R&D organizations are investing heavily in agentic AI while also developing their own research platforms, copilots, and orchestration environments. However, many implementations still depend on fragmented data sources, inconsistent retrieval methods, and outputs that scientists must manually reconcile before they can support research decisions. This limits reproducibility, makes provenance difficult to preserve, and creates uncertainty about what evidence an AI system has used.
We describe Elsevier’s Life Sciences evolution from a cross-portfolio, multi-agent alpha to a modular architecture based on reusable scientific connectors and task-level agents. Connectors provide controlled access to trusted scientific data and capabilities including retrieve, resolve, normalize structured and unstructured evidence. Agents combine these components to address defined research tasks within broader workflows.
Examples from current work in chemistry, pharmacokinetics, and drug safety include compound identity resolution, chemical structure search, cross-source evidence retrieval, data harmonization, and structured evidence packaging. Separating these scientific capabilities from higher-level agent behavior makes them reusable across different products, models, and customer environments, while allowing provenance, completeness, and individual components to be evaluated explicitly.
Taken together, these examples provide a practical framework for deciding what should be implemented as a connector and task-level agent, or user-facing workflow, and for designing scientific AI that complements rather than replaces the enterprise research platforms pharmaceutical organizations are already building.
By the time many studies are designed, executed, and published, treatment patterns have shifted, prescribing behaviors have changed, and new clinical questions have already emerged. This lag between what is happening in practice and what is captured in evidence is becoming increasingly difficult to ignore, particularly in rapidly evolving therapeutic areas such as GLP-1 receptor agonists.
Using GLP-1 RA therapies as a case study, this session explores how AI-enabled real-world intelligence can rapidly identify emerging trends, answer research questions, generate hypotheses, and prioritize areas for deeper investigation. Attendees will see how early signals from continuously updated healthcare data can be translated into validated evidence, creating a seamless path from insight to decision-ready research.
The future of evidence generation is not simply faster studies. It is a continuous cycle of intelligence, validation, and learning. Learn how to identify meaningful signals, verify findings with rigor, and generate regulatory-grade evidence that keeps pace with real-world change.
Learning objectives
By the end of this session, attendees will be able to identify new ways to keep pace with rapidly evolving clinical practice and therapeutic markets, evaluate how AI can help generate real-world intelligence and accelerate evidence generation, and identify emerging patterns and generate research hypotheses from continuously updated healthcare data.
What if you could move from target to candidate in a single click?
In this session, discover how Biocytogen’s RenSuper Workstation seamlessly integrates large-scale in vivo RenMice immunization, NGS, AI-powered high-throughput screening, and experimental validation to deliver high-quality, development-ready antibody sequences.
Learn how this platform unlocks access to a rich library of experimentally validated, fully human antibodies—complete with data packages to support faster, more confident decision-making. Explore how it enables rapid candidate identification, flexible antibody design, and data-driven workflows, reducing early discovery risk and compressing timelines from years to months.
Most AI isn't built for research. It's built for chat, for dashboards, for demos. In HEOR, that gap shows up fast. Fragmented data. Opaque models. Manual workflows that break the moment a regulator or peer reviewer asks how an answer was produced.
This session outlines a different approach: healthcare-native AI designed specifically for rigorous, defensible evidence. Three pieces, working together. A Healthcare Map of 60+ curated sources with validated representativeness across payers, regions, and care settings. A research-specific architecture with unified visit consolidation, 95%+ cost fill, and continuous enrollment, built so methodology holds up under scrutiny. And an AI engine with visible code generation, stepwise validation, and explicit articulation of every limitation.
The result is RWE that's faster, scalable, and trusted. Cohort identification compressed from hours to minutes. Descriptive statistics that used to take months. Industry standard R-package integration for inferential methods like propensity score matching, survival modeling, and weighted analyses, all version-controlled and replicable. Ready for the moments that matter most: market access discussions, internal strategic decision making, peer reviewed publications, and guideline directed medical therapy for real patients.
Key Learning Objectives
By the end of this session, attendees will be able to:
The pharmaceutical industryis rapidly adoptingdigital transformation andAI to accelerate clinical development, butthese technologiesalone do not reduce business risk. As AI-generated analyses become part of workflows, sponsors face a new challenge: how to establish confidence that outputs are accurate, traceable, and suitable for regulatory submission. Without an independent mechanism to verify AI-generated results, organizations risk undermining the very efficiencies digital transformation is intended to deliver.
When evaluating AI platforms and strategic technology investments, the question is no longer whether AI can generate clinical outputs; it is whether those outputs can be trusted. Building that trust requires an independent validation layer that provides objective evidence of quality, reproducibility, and regulatory readiness without relying ontraditional quality control methods that rely heavily on independent double programming, making them resource-intensive and difficult to scale in an era of AI-assisted development.
Beaconcure Verify, an AI platform designed specifically for regulated clinical development. Rather than automating statistical programming itself, Verify independently validates AI- and programmer-generated TLFs by reconstructing expected outputs directly from clinical datasets, SAPs, and specifications. Powered by a domain-specific AI model trained to reason like an experienced statistical programmer, the platform interprets clinical metadata, analysis logic, and programming intent to generate independent results that are compared against production outputs.
This independent verification approach enables rapid identification of discrepancies, strengthens risk-based quality strategies, and provides transparent evidence supporting submission readiness. By serving as a validation layer, Verify complements existing programming environments while helping organizations scale AI adoption with greater confidence and governance.
Attendees will gain insight into how trust, validation, and independent verification are emerging as essential components of AI strategies in life sciences. The session will explore how specialized validation platforms can reduce implementation risk, strengthen regulatory confidence, and enable organizations to adopt AI more broadly across clinical development while maintaining the quality standards required for submission-ready deliverables.
Roughly 40% of the clinical facts research needs never reach a structured data field: diagnoses, medication adherence, biomarkers, staging, social determinants, family history. Frontier LLMs can read that text, but at population scale they're expensive, non-deterministic, and hard to audit. This session shows how specialized medical language models extract and de-identify clinical facts at regulatory-grade accuracy: 98% F1 on PHI detection, and primary site, histology, and tumor staging extracted from unstructured pathology text at regulatory-grade accuracy (over 95%) – all at over 80% lower cost than current frontier models, with deterministic, reproducible output. Those facts become a governed, OMOP-standard real-world-evidence asset, with every value traced to its source note and every extraction carrying a confidence score. With that foundation in place, and a shared MCP boundary on top of it, use cases like cohort building, real-world evidence, clinical trial matching, and protocol design become far easier to build and to audit.
AI has already reshaped preclinical development — now it's transforming Phase I-III trials. Study start-up is being compressed through AI-driven protocol design, site selection, and feasibility work. Real-world data is enabling synthetic control arms that can reduce the need to enroll patients into placebo groups, cutting study timelines and costs at a point where every day of a Phase III trial can cost upwards of a million dollars. And patient recruitment itself has flipped from a passive, wait-for-patients-to-come model to a proactive one, with AI matching protocol criteria against real-world data to identify eligible patients and where they're being treated — cutting recruitment workload by roughly 80%The next leap is agentic AI: systems that don't just surface insights but actively execute the work. But speed only matters if you can trust the output.In this session, Suzanne will share what "AI-native" really means in practice — where subject matter experts stay firmly in control of agentic workflows, why sourcing and human oversight are the foundation of trustworthy AI rather than an afterthought, and how real-time monitoring is already compressing feedback cycles from days and weeks down to minutes.Attendees will walk away with:
How Zifo helped a global biopharma turn disconnected data silos across different platforms into a single FAIR, AI-ready data ecosystem by automating ingestion, data models and metadata management . A practical playbook for building governed, reusable data that scientists trust and AI can actually use.
Edge AI in Production: Real-Time Decision-Making in Sanofi’s Cryo-EM CoreModern cryoEM and other high-throughput scientific instruments generate vast amounts of data, yet mismatched infrastructure often limits throughput, delays scientific insights, and allows poor-quality data to propagate. This session presents a deployment of on-premises edge AI that enables real-time data processing and decision-making directly at the instrument. By detecting anomalies and data quality issues from minute zero, the system ensures only high-value data advances through the pipeline. We will show how near-real-time analytics can also trigger automated device actuation, allowing instruments to adjust and optimize performance dynamically - without manual intervention. This approach reduces data movement and infrastructure costs while accelerating time to insight. Drawing on testing at Sanofi’s cryoEM core, attendees will gain practical insights into architecture, deployment considerations, and measurable impact on throughput, data quality, and operational efficiency.
Most pharma organizations can build an AI model. Far fewer can get that model into a validated GxP environment and sustain that validation through inspection, model change control, and ongoing oversight as agentic systems evolve. This session is about the infrastructure, governance, and validation architecture that senior R&D and IT leaders need to operationalize AI across GxP-regulated workflows at enterprise scale. We'll cover what it takes to move an entire portfolio of models and agents into production, not just one successful pilot, and what changes when that foundation is built in from the start rather than added after a model has already been deployed.
Session illustrates how intelligent coordination across planning, monitoring, data review, and study management can improve visibility, predictability, and execution quality.
Real-world data (RWD) is essential to biopharma R&D, but critical signals often remain locked in unstructured data types such as clinical notes, out of reach from standard analytics. Automation alone cannot reliably extract these features; success requires context, and context only emerges when clinical expertise is embedded throughout such workflows.
To capitalize on the phenotypic depth of its EHR-derived RWD, NashBio built a multi-layer LLM extraction system designed around clinical experts who informed extraction criteria, guided prompt and workflow refinements, and evaluated model output against source records to improve capture of clinically meaningful events. Applied to a 2,800 patient inflammatory bowel disease (IBD) cohort, the pipeline surfaced treatment response outcomes from each patient’s IBD clinic notes, spanning a predefined list of 25 medications. The result was more than 58,000 structured medication-response assessments, each substantiated by a verbatim quote from the attending healthcare provider and reviewable in context. This human-in-the-loop architecture achieved >90% accuracy on sampled review and 96% reproducibility – a level of rigor typically reserved for manual chart review – delivered at scale to advance more personalized medicine. Automation alone also missed important documentation patterns unique to specialty care and institutional practice.
NashBio's experience challenges the perception that AI eliminates the need for humans. This work reinforced the fact that, as extraction systems scale, human-in-the-loop matters more, not less; it is what keeps accuracy and context intact. We will also demonstrate how this framework extends to other applications relevant for biopharma R&D, including hepatology feature extraction and biomarker curation.
Large language models have transformed what is possible in regulatory content creation, but generating fluent text is only the beginning. As the industry moves toward agentic workflows and increasingly automated submission processes, the defining challenge is no longer whether AI can write, but whether its outputs can be trusted.
This session explores what separates regulatory grade AI from general purpose AI, and why successful implementations in regulated environments require more than a language model. Attendees will learn how organizations are combining LLMs with deterministic logic, structured domain knowledge, validation frameworks, and governed human oversight to produce outputs that support the expectations of regulated content development.
Drawing on emerging industry practices and evolving regulatory expectations, the session provides a practical framework for evaluating AI solutions against the capabilities that matter most in regulated environments, including transparency, repeatability, auditability, source traceability, and accountability. Attendees will leave with a concrete framework for assessing whether an AI system is truly designed for regulatory workflows.
What actually moves things forward is quieter, and far harder to get right: clean, carefully chosen data, and one problem that genuinely matters in practice.
This session is a behind-the-scenes case study of how Innomagine moved from concept to action. We didn’t start with the technology — we started with the people behind the work, and built a connected suite of engagement solutions on one foundation: the Evidence Eagle platform.
We’ll walk through three AI applications already used every day:
Because all three use the same trusted data, insights flow seamlessly from research to engagementtoaction.
We then turn to the question every team faces: build, or buy? Building in-house is tempting, but the hard parts surface later — curating data you can trust, keeping scarce AI talent, and maintaining infrastructure long after the pilot ends. We make the case for the “smart buy”: a focused partner whose platform, curated data, and proven use cases are ready today — so teams reach value in weeks, not years.
The takeaway: look past the big-data hype, get the build-versus-buy call right, and start with clean data and one problem worth solving. That’s where meaningful AI adoption begins — and where real impact, for your teams and the patients at the end of it, follows.
In this session, we'll cover:
Real-world evidence is evolving from isolated datasets to integrated healthcare intelligence that provides context, not just observations. Learn how Norstella combines multimodal real-world data with proprietary commercial, access, and healthcare intelligence to answer increasingly complex questions that no single nor traditional real-world data source can address, speeding up time to insights.
Objectives:By the end of this presentation, participants will be able to:
Biomedical researchers face a critical productivity gap when working within Trusted Research Environments, where strict security rules ban the use of Large Language Models (LLMs). To solve this, we present the Trusted Agentic Environment, designed to embed AI tools and make them available to researchers by default. By attaching flexible, automated policies directly to datasets, researchers can seamlessly leverage LLMs for code generation, data exploration, and statistical modeling. This integration unlocks complex co-analysis, empowering researchers with advanced AI capabilities to accelerate their scientific output.
Create your personal agenda –check the favourite icon
Strong innovation doesn’t automatically lead to commercial success. Many science-led companies struggle to translate capability into revenue. This session introduces a platform that identifies commercial gaps and turnsinnovation into a clear, execution-ready growth strategy.
As the pharmaceutical industry becomes increasingly data-driven, organizations are generating more real-world data (RWD) and real-world evidence (RWE) than ever before. While RWE presents significant opportunities to enhance patient safety, realizing its full value requires navigating operational, methodological, and regulatory complexities.
Realizing this value requires strong collaboration between patient safety and RWE functions to ensure evidence is appropriately contextualized and translated into meaningful action.
Drawing on practical examples and lessons learned, this session explores the opportunities and challenges at the intersection of patient safety and RWE.
Attendees will gain insights into approaches for strengthening cross-functional collaboration, leveraging RWE more effectively, and improving confidence in the safe use of medicines.
Background:Traditional clinical trial evaluations heavily rely on the Average Treatment Effect (ATE), a metric that can obscure substantial heterogeneity in individual patient responses. This limitation is magnified in observational real-world data (RWD), where simple statistical associations often conflate correlation with systemic selection bias. To enhance regulatory confidence and optimize therapeutic positioning, clinical research must move beyond purely associative analyses and shift toward isolating true counterfactual causation by precisely estimating Individual Treatment Effects (ITE) to enable personalized treatment selection.
Methods:This study presents a deep causal learning framework that adjusts for high-dimensional baseline confounding. Utilizing RWD from a diverse clinical cohort in which more than 80% of participants originate from communities historically underrepresented in biomedical research, the pipeline maps longitudinal, time-fixed, and time-varying covariate vectors into a dense latent space via a pre-trained Med-BERT transformer encoder. These phenotypic embeddings parameterize an integrated causal neural network architecture that features an objective-focused propensity score gate and dual counterfactual potential-outcome heads. To evaluate individual treatment benefit under non-proportional hazards, the architecture maps continuous counterfactual survival curves for patients within the balanced common support region where the propensity score is approximately 0.5. Rather than collapsing temporal dynamics into static metrics, the framework evaluates the global geometry of these curves using non-parametric omnibus tests to isolate and rank an optimized sub-cohort of the top ntreatment responders.
Results:Validation audits demonstrated exceptional predictive fidelity, with the outcome survival network achieving a baseline Concordance Index of 0.9439 ± 0.0771. The causal estimation engine yielded a statistically significant Conditional Average Treatment Effect (CATE) point estimate of 0.6205 (95% Confidence Interval: 0.5934 to 0.6476), with structural validity confirmed by a Leave-One-Out (LOO) cohort stability index of 99.71%. The integrated KONP and multi-directional screening framework successfully isolated the optimized high-responder cohort from the balanced common-support distribution.
Conclusion:Shifting from associative correlation to robust counterfactual inference on highly diverse RWD provides a scalable, causal methodology for predicting personalized treatment response, optimizing trial cohort enrichment strategies, and accelerating precision evidence generation without modifying active clinical trajectories.