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Every clinical trial runs on a hidden currency: time. Not protocol milestone time — patient time. When a patient has a six-month prognosis, rapid time to treatment is critical. Join us as we share key insights and opportunities to accelerate time to treatment through a novel study setup approach, ensuring rapid & consistent vendor onboarding and simplified study management. Ultimately, faster trial setup translates directly into faster access to care—turning lost time into life-impacting opportunities for patients.
EPAM empowers life science organizations to modernize end-to-end operations from early discovery through clinical delivery. Our pairing of deep life science subject matter expertise with award-winning software engineering optimizes business processes and elevates core offerings. Contact us to learn how we can accelerate your business.
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.
From rapid hypothesis generation and intelligent experimental design to complex computational and multi-modal data analysis, Google Cloud's AI for Science solutions (e.g. Co-Scientist, AlphaGenome, AlphaFold, and AlphaEvolve) can act as a force multiplier for your team.
Learn how to:
Whether you’re in drug discovery, materials science, or academic research, this session will show you how to merge human expertise with AI precision to stay at the forefront of innovation. Don’t miss the chance to see the future of science in action.
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.
Pharmaceutical research and development (R&D) laboratories have made major progress toward paperless workflows. Electronic lab notebooks, laboratory information management systems (LIMS), and chromatography data systems capture measurements digitally. Yet when a model flags an atypical impurity trend or recommends a formulation change, scientists often cannot trace that recommendation through instrument calibration, method validation, sample history, and study context to the original measurements. The data is digital; the evidence chain remains fragmented.
This keynote introduces evidence infrastructure: governed, bidirectional provenance created as data flows from instruments to scientific decisions. Grounded in the ICAD Principles (Integrate → Contextualize → Analyze → Decide), each integration enriches a scientific context graph. Typed relationships link analytical results to methods, specifications, stability protocols, batch genealogy, instrument state, and regulatory submissions. As these connections accumulate, the context graph becomes an operational knowledge graph whose conclusions remain traceable to source evidence.
The talk shows why evidence chains should be created during ingestion rather than reconstructed for each AI deployment, and how this supports scientific review, human oversight, and evolving transparency expectations. Attendees will leave with practical architectural patterns for assessing whether their digital lab produces accessible data alone or defensible evidence for scientific AI.
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 programs in drug discovery do not fail at the model. They fail at the data underneath it. Data sits scattered across systems, annotated inconsistently, and largely invisible to the teams building the models. This session covers what AI-readiness actually requires: resolved identifiers, traceable provenance, reconciled assay conditions, and curation quality you can measure. It also covers how to tell a genuinely curated asset from a merely cleaned one, and how AI readiness shows up in model performance. Excelra's experience in maintaining curated scientific data assets at scale offers a practical view of when data readiness accelerates AI-driven R&D
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.
Biopharma organizations have long navigated the "laboratory compromise"—the physical and operational divide between wet-lab experimentation and dry-lab computational modeling. This structural separation creates data silos that slow research timelines and limit the impact of computational tools. Today, the industry is transitioning to a model where scientific data acts not just as a laboratory record, but as an active foundation for closed-loop discovery. Addressing this division requires a fundamentally different approach to both technology and organizational collaboration.Google’s Agentic R&D Cloud meets this challenge through a cross-functional, vertically integrated R&D stack that was built with the research operations of Google DeepMind and Google Research in mind. Google’s Agentic R&D Cloud marries emerging specialized models and agents (e.g. AlphaFold, AlphaGenome, AlphaEvolve, and Co-Scientist) with the enterprise infrastructure and scale needed to support advanced scientific computing without the latency, integration gaps, data silos, or errors common in piecemeal systems.
Grounded in real-world deployments and collaborative success stories with leading biopharma partners, this session will explore how Google’s unified R&D stack today is accelerating R&D. Attendees will walk away with a practical agentic blueprint showing how a co-designed R&D stack scales laboratory hypotheses into validated biological discoveries.
Session illustrates how intelligent coordination across planning, monitoring, data review, and study management can improve visibility, predictability, and execution quality.
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.
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.
The current wave of healthcare AI has focused heavily on digitizing administrative overhead, but true digital transformation is yet to come. For healthcare organizations to capture the economic potential of the AI era, they must shift from human-assisted AI to autonomous workflow execution and into the Agentic Era.12
The future of enterprise healthtech depends not on the intelligence of base models, but on architectural integrity and security. What then is required to unlock enterprise adoption?
Autonomous Execution: Moving beyond text generation to trigger multi-step, clinical, and back-office actions.
Zero-Trust Data Boundaries: Treating security and privacy as a commercial velocity engine rather than a compliance roadblock.
Orchestration Governance: Implementing real-time oversight to ensure deterministic, zero-error execution in regulated environments.
I will discuss a few companies that have indeed succeeded in value creation in this environment, with a VC investment lens.
Biotech and pharma leaders must move past model evaluations and start asking the critical question for agentic systems: "Can we bound its execution in real-time, and can we cryptographically prove why it took that action?"
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:
AI is genuinely making regulatory work faster, and that matters. But getting to a first draft faster is only one piece of what’s possible with AI. . The standard drug development teams must build toward is submission content that holds up under intense scrutiny. And still holds up two years later, when the same information is needed for the next filing, the next market, the next lifecycle update.
Based on real implementations across regulatory workflows, Daniel will cover what AI can do to compress review cycles, prevent rework, and position scientific knowledge in clear and compelling ways to health authorities.
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.
Artificial intelligence and machine learning are transforming drug discovery and development, from target identification and candidate screening to predictive modelling, study design, and decision making across the R&D pipeline. As these technologies become more widely adopted, ensuring they are scientifically robust, validated, and fit for purpose is essential.
This panel will explore how AI is being applied across the drug discovery and development process, highlighting both the scientific opportunities and the practical challenges of implementation. Bringing together perspectives from biotech, pharma, academia, and emerging AI innovators, the discussion will examine how organisations are integrating AI into research workflows while ensuring credibility, reproducibility, and regulatory confidence.
Topics will include the use of AI for early discovery, predictive modelling, and optimisation across the development pipeline, alongside considerations for model validation, risk based credibility assessment, and translating AI driven research into real world drug development. The panel will also explore how collaboration between industry, academia, and emerging biotech is accelerating innovation while maintaining scientific rigour.
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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 turns innovation into a clear, execution-ready growth strategy.
Biopharmaceutical R&D decisions are often framed as expected-value calculations: probability of success multiplied by potential value. This framing assumes that both terms can be estimated reliably. In practice, probabilities of technical and clinical success are uncertain, while projected value depends on changing assumptions about market dynamics, competition, regulatory pathways, and clinical practice. In this context, numerical decision matrices can convey more precision than the underlying evidence supports, while conventional multi-criteria decision analysis can obscure the reasoning behind recommendations and generate rankings that are difficult to justify.We present bfARENAS™, a generalizable framework for structuring complex decisions through comparative evaluation rather than absolute scoring. bfARENAS™ organizes evaluation into explicit decision contexts, or arenas, representing distinct lenses such as biological rationale, experimental readiness, clinical feasibility, or competitive positioning. Keeping these contexts separate preserves differences among evidence types and makes clear what each comparison is intended to resolve.Within an arena, AI agents assemble evidence-based cases for individual candidates. Separate judging agents compare candidates directly and produce both a preference and an explicit rationale. Repeated comparative judgments are then aggregated to estimate relative support and produce a coherent ranking. The resulting outputs remain traceable to the underlying evidence, comparisons, and rationales, allowing experts to inspect where a ranking is well supported, where judgments conflict, and where additional evidence could change the decision.We will describe the bfARENAS™ architecture and its application to decision problems spanning discovery-stage target prioritization and later development decisions. We will show how arena design determines what constitutes a favorable comparison, how separating evidence construction from adjudication improves transparency, and how local comparative judgments can support portfolio-level prioritization without requiring unsupported absolute scores. The broader objective is not to eliminate uncertainty or replace expert decision-makers, but to make consequential judgments more explicit, transparent, and testable when conventional quantitative frameworks exceed what the available evidence can support.
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.
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.
Artificial intelligence is compressing the drug discovery timeline from a decade and $1–2B per drug into a faster, more predictable process—yet only a fraction of life sciences organizations see real payoff today. In this session, HPE and AMD show how the same technologies powering 5 of the world's 10 most powerful GPU-accelerated supercomputers now translate into enterprise-scale advantage for biotech. Drawing on real deployments with leading pharma innovators, we'll trace the path from exascale science to production R&D and quantify the business case for AI-driven discovery.What you'll take away:
Antibody discovery is entering a new era. Advances in AI, automation, and next-generation discovery platforms have dramatically expanded our ability to generate antibody candidates. As a result, the industry's primary challenge is no longer finding molecules, but identifying the right ones.
As the bottleneck shifts from candidate generation to data-driven decision-making, high-quality experimental data has become more critical than ever in modern antibody discovery.This presentation introduces RushData, Biointron's high-throughput data generation platform, designed to rapidly transform antibody sequences into decision-ready experimental data. By integrating scalable antibody production, standardized characterization, digital workflows, and AI-ready datasets, RushData enables researchers to evaluate, compare, and prioritize large numbers of candidates with greater confidence, helping them learn faster from every molecule and make better discovery decisions.