Major Pharma Companies, Including Novartis And Merck, Build Federated Learning Platform For Drug Discovery

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Institut De Recherches Servier, Janssen, Merck, and Novartis — inked an agreement to build a shared platform called MELLODDY (Machine Learning Ledger Orchestration for Drug Discovery). In partnership with Nvidia, Owkin, and others, the group sought to leverage techniques like federated learning to collectively train AI on datasets without having to share any proprietary data.

Today, contributors to the three-year MELLODDY project announced they have reached their first-year objective: successfully deploying the platform. Marking a larger milestone, they say they have also completed the platform’s first federated learning runs.

Fewer than 12% of all drugs entering clinical trials end up in pharmacies, and it takes at least 10 years for medicines to complete the journey from discovery to the marketplace. Clinical trials alone take six to seven years, on average, putting the cost of R&D at roughly $2.6 billion, according to the Pharmaceutical Research and Manufacturers of America.

The MELLODDY project’s cofounders assert that federated learning can accelerate this process. In machine learning, federated learning entails training algorithms across decentralized devices holding data samples without exchanging those samples. A centralized server might be used to orchestrate the steps of the algorithm and act as a reference clock, or the arrangement might be peer-to-peer. Regardless, local algorithms are trained on local data samples, and the weights (the learnable parameters of the algorithms) are exchanged between the algorithms at some frequency to generate a global model.

Melloddy

To build the MELLODDY platform, tech vendors BME, Iktos, and Nvidia implemented machine learning solutions for drug discovery, ensuring privacy and optimizing training on Nvidia graphics cards. Owkin supplied Owkin Connect, its privacy-preserving framework designed for multitasking federated learning, while KU Leuven provided an open source library called SparseChem for training machine learning models specific to drug discovery. Kubermatic deployed its Kubernetes platform to build the infrastructure for each pharmaceutical partner. And Substra Foundation managed the technical operations, monitored workloads, and hosted the open source code that’s part of Owkin Connect.

Within the MELLODDY platform, a portion of which is hosted on Amazon Web Services, partners securely register their datasets in a local instance of the architecture. (A spokesperson told VentureBeat the platform passed “extensive” security audits conducted by an external company and by IT teams from each pharmaceutical partner.) A private blockchain provides traceability, with a ledger distributed in a decentralized way across pharma partners.

During the initial runs, all participating pharmaceutical companies managed to simultaneously train their predictive models in a de-identified, aggregated fashion without exposing private research, data, or information, according to a spokesperson.

MELLODDY project partners say they have begun scientific and business case assessments of the results of the first cycle of modeling runs. They will look at publishing those results in a scientific paper, and over the next two years the MELLODDY project will focus on improving the performance of the common predictive model by exposing it to an increasing amount of data.

The MELLODDY project builds on other efforts to uncover health insights through the use of federated learning. In May, Intel revealed the details of a National Institutes of Health-funded program that will leverage AI to identify brain tumors while preserving privacy. With the Perelman School of Medicine at the University of Pennsylvania (Penn Medicine), the company will coordinate a federation of 29 international medical centers in the U.S., Canada, the U.K., Germany, Switzerland, and India to train AI models using federated learning.

Beyond this, the American College of Radiology, Brazilian Imaging Center Diagnosticos da America, Partners HealthCare, Ohio State University, and Stanford Medicine collaborated to develop a federated learning model using more than 130,000 images from 33,000 mammography studies. And Nvidia began working with collaborators to release COVID-19-related models trained with federated learning through the company’s Clara Imaging Software platform, following a collaboration with King’s College London on a federated learning neural network for brain tumor segmentation.

The MELLODDY project has an estimated budget of €18,4 million ($21.76 million) and receives funding from the Innovative Medicines Initiative, a public-private partnership between the European Union and the European pharmaceutical industry. (Pharma partners contributed €10 million and Nvidia contributed €120,000, with the rest coming from public grants.) Johnson & Johnson subsidiary Janssen Pharmaceutica NV serves as the pharmaceutical industry lead, with coordination from Owkin.

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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