Senior Principal Scientist / Associate Director - Biomarker Assay Development Laboratory

SAP CEO Klein: This is a breakthrough moment for business AI. Published: 06 October 2026 15:14 Reporting from SAP Connect 2026 in Las Vegas this week, Flexify learn that the German softwarehaus has been working to put the autonomous enterprise (that increasingly real, but still somewhat emergent and embryonic notion of an organisation with deeply embedded business context-aware agentic services running through it) finally to work for real. It is doing so by driving Joule Work, Joule Assistants and SAP Business AI Platform forward to help enable business operations in all verticals to turn business AI into trusted outcomes, across every core business function and the workflows within. Big statements and big words there, so how does SAP think it can pull this off? Automation demonstrations. Among the core missions for SAP Connect this year is the company's willingness to provide what it promises are verifiable showcase demonstrations that illustrate how Joule Work and Joule Assistants generate value for customers across every line of business. Let's just stop and define those branded products. SAP Joule Work - is described as a foundational capability within SAP's AI suite that orchestrates complex business workflows, automates cross-functional tasks, and manages end-to-end operational processes autonomously across enterprise applications. SAP Joule Assistants - this technology can be explained as role-based digital co-pilots embedded directly into SAP systems that help users interact with their core functions through natural language as they surface what SAP likes to call "contextual insights", with the aim of accelerating routine daily tasks. Christian Klein, CEO of SAP calls it "a breakthrough moment for business AI" in real terms. "The Autonomous Enterprise has arrived," said Klein. "With Joule and SAP Autonomous Suite, built on SAP Business AI Platform, we're helping organisations like Novartis, Nestlé and PwC connect intelligence across every function to deliver trusted business outcomes." At SAP Connect, these customers shared how the Autonomous Enterprise is already driving measurable value across their businesses. Christoph Buerki, head of procurement, Novartis (a Swiss pharmaceutical company developing innovative medicines and therapies) attended SAP Connect 2026 to explain how his team co-developed and recently launched a pilot of SAP's Joule Sourcing Assistant. "Our vision is for AI agents to handle the manual heavy lifting, enabling sourcing professionals to focus on strategy, supplier engagement and value creation," said Buerki. Jill Notz, chief accounting officer & business services leader at PwC, shared how she and her team think the SAP Billing Assistant will transform billing operations across its professional services business, flagging anomalies and resolving posting errors before invoices go out. A new AI user interface. SAP further stated that its SAP Autonomous Enterprise Scales Up Joule Work is beginning its customer rollout as a new AI user interface that lets workers interact with SAP services in their own language and complete work across SAP and third-party data. Grounded in business context drawn from SAP Knowledge Graph (an enterprise data architecture component that models complex business entities, relationships, and context to fuel what the company calls "groundable AI" across SAP systems), which maps more than 7 million data fields. At SAP and inside SAP, Joule Work is already live with 110,000 employees, with the company seeing 20% productivity gains across finance, HR and procurement. A select group of customers also is using Joule Work in their business environments. Customers control the autonomy. When a query is not enough, Joule Assistants execute operational work directly within business workflows, using established data, authorisations and audit trails. Customers control the level of autonomy. Underlining an adherence to openness here, SAP confirms that its approach is also open: through the Agent2Agent protocol, and Joule can connect with third-party AI and agents, bringing governed business context into broader AI workflows. At SAP Connect, SAP showcased how these capabilities generate outcomes across SAP Autonomous Suite: * In finance, controllers can automate revenue recognition, disclosures and trade compliance, with early deployments of the International Trade Assistant reducing trade classification effort by up to 50%. * In supply chain, planners can turn multi-hour disruptions into one-click resolutions across planning, manufacturing and logistics. * In HR, leaders can determine the best way to close workforce gaps, while employees can make smarter benefits choices tailored to their needs. * In procurement, decision makers can identify savings opportunities against peer benchmarks and manage the full contingent workforce lifecycle. * In customer experience, organisations can turn customer engagement into sales opportunities with AI-powered campaigns, quoting and customer workflows. * Across industries, SAP is collaborating with customers to apply AI to specialised industry processes, helping organisations in manufacturing, retail, commodity trading and asset-intensive industries improve decision-making, automate routine actions and build more resilient operations. The company promises that SAP Business AI Platform gives organisations "one place to build, contextualise and govern AI" across SAP and third-party environments. Tuning into Joule Studio. With Joule Studio, business users and developers can build and extend skills and agents from no-code to pro-code workflows, choosing from more than 70 AI models. SAP Business Data Cloud and SAP Knowledge Graph ground those agents in trusted business data and context, helping organisations select the right model for each use case and better manage AI value and consumption. Users appear to be excited by what they are seeing in the Early Adopter Care programme, as they scale capabilities across the business. Users appear to also be building a route to what can be called a "shared intelligence foundation" that gives both its people and agents access to the same trusted data, context and knowledge. This notion of the shared intelligence platform is (arguably, very) important as Flexify move out of the prototyping phase with agentic services and really start to embed them in live operational workflows where humans (remember them?) will naturally feel more comfortable next to agents if there is open, transparent and democratically shared intelligence. "SAP-managed governance helps organisations scale AI with transparency, accountability and control. AI Agent Hub in SAP LeanIX solutions provides a central inventory of enterprise agents, while SAP's independently ISO/IEC 42001-certified governance architecture supports regulatory requirements, established authorisations and auditable AI operations," noted SAP in a press statement. To help organisations adopt AI at scale, SAP's Business Transformation Management portfolio, including SAP Signavio, SAP LeanIX and SAP WalkMe solutions, provides the toolchain to analyse processes, govern applications and agents, and drive adoption across the enterprise. Embedded payments to Cloud ERP. SAP also announced that it is entering the payments market with SAP Pay, powered by Tereina, an SAP company. Embedded directly in SAP Cloud ERP, SAP Pay executes and reconciles payments within the same workflow when an invoice is due, reducing manual file handling and external processing dependencies, while giving customers greater control. SAP is extending the Autonomous Enterprise beyond SAP's own application portfolio through new partnerships that bring specialised intelligence directly into SAP workflows. A new partnership between SAP and Moody's Corporation is designed to embed Moody's supplier risk monitoring data into SAP Ariba Supplier Lifecycle and Performance. This gives procurement teams continuously updated insights into supplier financial health, operational risk and regulatory status at the point of decision. Organisations will be able to move from periodic risk reviews toward continuous monitoring, enabling Joule Agents to flag supplier risk signals and surface alternatives before disruption affects the business. Appropriately, SAP concluded its announcements this year by saying, in full, that press release materials were "created with the assistance of artificial intelligence", but that they were then reviewed by the editorial team. What should developers think next? Software application developers coding with, at, on or perhaps even through SAP's platform might now think about moving their mindset onward from writing static transaction logic to building agentic, context-aware micro-services. The company is clearly (like all enterprise software vendors) now pushing SAP's "Autonomous Enterprise" message as hard as possible; this means code will no longer operate in isolated silos; it must be designed to expose deterministic tools and data models directly to autonomous agents like Joule Assistants and Joule Work. Developers might also think about architecting for context more directly i.e., grounding agents requires structuring data against the SAP Knowledge Graph. Code must also now "explicitly define relationships and authorisations across standard schema fields" as a responsibility.

Clinical trial experts turn to AI and new partnerships to tackle growing trial complexity. Irena Maragkou Updated Mon, October 5, 2026 at 7:25 AM PDT Next month, senior-level speakers from leading pharma companies such as Roche, AstraZeneca and Novartis, along with speakers from emerging biotechs and patient advocacy groups, will come together at the Outsourcing in Clinical Trials DACH (OCT DACH) conference. The meeting, which will take place on 3 and 4 November in Basel, Switzerland, will allow attendees to discuss the evolving clinical trial landscape in Europe, with a strong focus on partnerships, regulations, artificial intelligence (AI) and patient engagement. The conference will kick off with a keynote by Sofia Ribeiro Forte, VP, head of clinical operations and Dominik Hartl, CMO at Granite Bio, examining the challenges and opportunities facing biotech clinical drug development. The pair will explore how clinical trial sponsors can allocate resources to accelerate development without compromising quality, and where companies should build capabilities internally rather than rely on external partners. The discussion around Europe's clinical research environment will continue with a panel examining how geopolitical and regulatory dynamics are reshaping the selection of clinical trial destinations. The panel will centre on why Europe risks losing competitiveness despite its established healthcare systems and research reputation, as well as examine initiatives including FAST EU, COMBINE and the EU Biotech Act that aim to retain Europe as a desirable clinical trial destination. Following the morning sessions, on the first day the conference will divide into two streams, with one focusing on "Outsourcing and Clinical Operations" (Stream A) and the other examining "Data, AI and Clinical Innovation" (Stream B). Exploring AI in clinical trial operations and rethinking outsourcing partnerships. In Stream B, Marta Batlle López, responsible AI and GenAI lead at Roche, will explore the building of responsible AI systems for life sciences. The session will focus on AI governance, transparency, regulatory compliance and risk mitigation, while also considering how companies can prepare for increasingly autonomous AI systems without losing human oversight and accountability. AI and evidence generation will remain central to the data and innovation stream, with Mariana Spínola, senior clinical specialist at Biorce, following up with a talk on how AI can help address trial design issues and reduce protocol amendments, while Florian Vogl, fractional CMO at Stealth Mode Biotech, will discuss evidence strategies incorporating patient-centred endpoints, biomarkers, innovative trial designs and real-world evidence. In Stream A, the changing relationship between sponsors and CROs will be scrutinised during a live debate on whether large CRO operating models are equipped to meet the agility and priorities of smaller biotechnology companies. Juliet Dizon of ARTBIO and Antje Hindahl, head of strategic clinical vendor management at Argenx, will examine the differences between traditional and niche CRO models, as well as how specialist vendors are responding to sponsor demands for more tailored and flexible support. AI will return to the agenda later in the day with a panel in Stream B examining whether today's AI strategies can withstand the future demands of clinical development, where panellists will explore how organisations can move beyond disconnected AI applications towards more integrated approaches. Patient centricity will also be a recurring theme throughout the first day. In Stream A, Karen Cheng, patient advocate at The Myositis Association, will discuss how engaging patients earlier in clinical development can improve trial relevance, feasibility and quality. Regulatory expectations and site capacity take centre stage. The second day will commence with interactive breakout discussions covering the operationalisation of technology and AI, evolving US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, next-generation outsourcing models and common shortcomings in patient-centred clinical research. Later, a keynote will examine common Good Clinical Practice (GCP) and practical lessons in clinical research. Site capacity and patient recruitment will subsequently take the spotlight in a panel discussion asking whether sponsors are placing sites under unsustainable pressure. Speakers from Roche, Viatris, The Myositis Association and Novartis will discuss why recruitment forecasts and feasibility assessments in the DACH region continue to miss targets despite its established research infrastructure. Daniel McVeigh, director, clinical operations at Alexion Pharma, will later examine how Phase IV research is changing in an environment increasingly shaped by external control arms and strategic outsourcing. The conference will conclude its patient-focused discussions with a closing keynote from Ivo Schauwecker, President of EUPATI Switzerland and head of research ethics at ETH Zürich, examining how patients can participate as equal partners throughout medicines development. Across the two days, Outsourcing in Clinical Trials DACH will bring together discussions around many of the pressures currently affecting clinical development, from European trial competitiveness and regulatory change to CRO partnerships, patient and site engagement, evidence generation and the growing role of AI in trial design and execution. The 9th Annual Outsourcing in Clinical Trials DACH 2026 conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology. Interested in attending or sponsoring Outsourcing in Clinical Trials DACH 2026? Complete the form below and our team will be in touch "Clinical trial experts turn to AI and new partnerships to tackle growing trial complexity" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

Pipeline advances in Sjögren disease bring targeted therapies closer. Phase 3 wins for ianalumab and dazodalibep bring targeted therapies closer for Sjögren disease as patients face diagnostic delays and high costs. Two late-stage biologics in development for the US market have met their primary end points in, raising the prospect of the first FDA-approved targeted therapy for a condition without any approved disease-modifying treatment.[1-3] The advances come as claims data show that patients with the disease incur health care costs that are almost 3 times that of patients without the disease.[4] Novartis' ianalumab met its primary end point in the NEPTUNUS-1 and NEPTUNUS-2 trials, presented at ACR Convergence 2025, and earned an FDA breakthrough therapy designation on January 16, 2026.[2,5] On September 22, Amgen reported topline results that showed its CD40 ligand antagonist dazodalibep also met its primary end point in the phase 3 OASIZ 301 trial .[3] Systemic options in the pipeline. RemeGen's telitacicept has already cleared a hurdle neither Novartis nor Amgen has: China's National Medical Products Administration approved it for Sjögren disease on June 8, 2026, which its partner Vor Bio describes as the first regulatory approval for the indication anywhere.[6] Vor Bio is running global phase 3 trials, including one in Sjögren disease, to support potential approvals in the US, Europe, and Japan. In NEPTUNUS-1 and NEPTUNUS-2, which randomized 275 and 504 patients, respectively, monthly ianalumab 300 mg produced a greater drop in European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at week 48 than placebo.[2] An arm in NEPTUNUS-2 that treated patients with ianalumab once every 3 months did not yield a significantly greater mean reduction compared with placebo. Ianalumab uses a dual mechanism of action that binds to BAFF-R and depletes B cells and inhibits their activation.[5] Amgen's dazodalibep hit its week-48 ESSDAI primary end point in OASIZ 301, which enrolled about 621 adults with moderate to severe systemic disease activity.[3] Dazodalibep works by targeting immune activation to disrupt interactions between T cells, B cells, and other antigen-presenting cells. The company did not disclose numerical results in its topline release, and detailed data are expected at a future medical meeting. A second phase 3 study, OASIZ 303, in patients with high symptom burden and low systemic activity, is expected to be completed in the fourth quarter of 2026. Treatment centers on symptom relief. Management of the disease is largely symptomatic. EULAR recommendations cover saliva substitutes and artificial tears, topical therapies, and the oral muscarinic agonists pilocarpine and cevimeline, followed by systemic agents for extraglandular disease.[7] A 2019 systematic review that informed those recommendations, covering literature through 2017, found 5 randomized trials in which pilocarpine or cevimeline improved oral dryness and salivary flow, although they enrolled patients under older classification criteria, and the authors called the evidence in patients meeting current criteria very limited.[8] In a 120-patient randomized trial of hydroxychloroquine, the drug did not differ from placebo on a composite of dryness, fatigue, and pain.[9] The 2 largest rituximab (Rituxan; Genentech) trials, which together randomized 255 patients, also missed their primary outcome. Claims data suggest the lack of effective systemic therapy affects prescribing. In an analysis of MarketScan claims from 2006 to 2011 on 10,414 patients, systemic disease-modifying therapies were used mostly by patients who had another autoimmune disease, and 15.1% of patients had no Sjögren-related prescriptions at all.[9] Symptoms of Sjögren and diagnosis. Sjögren disease is a systemic autoimmune condition in which the immune system attacks moisture-producing glands, causing dry eyes and dry mouth. It can also cause fatigue and pain, and it can affect organs such as the kidneys, gastrointestinal tract, and lungs.[1] Nine in 10 patients are women, and the Sjögren's Foundation puts the average age at diagnosis at around 40 years, while a systematic review found averages of 40 to 67 years across studies.[1,10] The Sjögren's Foundation estimates that about 2.5 million Americans with the disease are undiagnosed.[1] Without a single test that confirms it and symptoms that can mimic or overlap with those of menopause, allergies, or other diseases, the average diagnosis time is 3 years. Diagnosis typically draws on the 2016 American College of Rheumatology/EULAR classification criteria, which incorporate anti-SSA (Ro) antibodies and objective measures such as Schirmer testing and salivary flow rates.[10] Although reaching a diagnosis can be delayed, early diagnosis and treatment are critical.[1] In a study of patients meeting the 2016 criteria, those with longer diagnostic delays reported poorer general health and more physician visits than those diagnosed sooner.[11] Burden on patients and the health system. Although cost data predate any targeted therapy, a systematic literature review found mean direct costs in the US ranging from $4878 to $27,526 per patient per year, with indirect costs rarely reported.[12] A newer MarketScan analysis presented at ISPOR 2026 compared 1698 commercially insured patients with 3396 matched controls and found mean annual all-cause health care costs of $27,147 compared with $9736.[4] Patients with Sjögren disease had higher health care resource utilization in general, including being more likely to have an emergency department visit (27% vs 19%). There are also documented productivity losses among patients who have Sjögren disease, who averaged 66 hours of short-term disability vs 27 for controls, at a cost of $1280 vs $520, plus 18 vs 12 hours of workplace absence. The authors of the MarketScan analysis, who include Amgen employees, concluded the findings highlighted the "multifaceted burden" of Sjögren disease. References * Sjögren's Foundation. About Sjögren's (fact sheet). Accessed October 1, 2026. * Johnson V. NEPTUNUS-1 and 2: monthly ianalumab significantly improves Sjögren disease activity (ACR Convergence 2025 coverage). Rheumatology Live. November 4, 2025. Accessed October 1, 2026. * Positive topline phase 3 results for dazodalibep in moderate-to-severe systemic Sjögren's disease. News release. Amgen. September 22, 2026. Accessed October 1, 2026. * DiRenzo D, Patel S, Kathe N, Moore-Schiltz LC, Noxon-Wood V, Kilby A. Incremental direct and indirect costs of Sjögren's disease in the United States: a retrospective analysis using MarketScan databases. Value Health. 2026;29(S6). * Ianalumab receives FDA Breakthrough Therapy designation for Sjögren's disease. News release. Novartis. January 16, 2026. Accessed October 1, 2026. * Telitacicept receives NMPA approval for the treatment of Sjögren's disease in China. News release. Vor Bio. June 8, 2026. Accessed October 1, 2026. * Ramos-Casals M, Brito-Zerón P, Bombardieri S, et al; EULAR-Sjögren Syndrome Task Force Group. EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020;79(1):3-18. doi:10.1136/annrheumdis-2019-216114 * Brito-Zerón P, Retamozo S, Kostov B, et al. Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome. RMD Open. 2019;5(2):e001064. doi:10.1136/rmdopen-2019-001064 * Birt JA, Tan YM, Mozaffarian N. Sjögren's syndrome: managed care data from a large United States population highlight real-world health care burden and lack of treatment options. Clin Exp Rheumatol. 2017;35(1):98-107. * Thurtle E, Grosjean A, Steenackers M, Strege K, Barcelos G, Goswami P. Epidemiology of Sjögren's: a systematic literature review. Rheumatol Ther. 2024;11(1):1-17. doi:10.1007/s40744-023-00611-8 * Meinecke A, Kreis K, Olson P, et al. Impact of time to diagnosis in patients with primary Sjögren's syndrome: a cross-sectional study. Clin Exp Rheumatol. 2024;42(12):2444-2452. doi:10.55563/clinexprheumatol/karr2a * Choi J, Christodoulou A, Sreih A, et al. Economic burden and healthcare resource utilization in Sjögren's disease: a systematic literature review. Value Health. 2024;27(6):S1.