Members

Universidad Politécnica de Madrid (UPM) is the PharmaLedger project coordinator. UPM leads WP1 for the business value and requirements, including the support for the integration of regulatory framework in requirements and WP7 coordination and project management. They will guide the development of the health data marketplace, analytics and machine learning. UPM plays a major role in the blockchain reference architecture and supply chain integrity use case implementation. UPM is the largest Spanish technological university.

Novartis Pharma AG (NVS) is the industry leader of the project. Together with the project coordinator, they will lead and manage the project. They will co-lead WP3 PharmaLedger architecture and reference implementation, WP6 culture and adoption and WP7 coordination and project management. In addition to being an industry member, they will play a major role in drawing participants to the PharmaLedger platform. Novartis has pursued blockchain technology solutions since 2016, including several proofs of concept for supply chain, clinical trial supply, third-party risk management and drug sample distribution. NVS is headquartered in Basel, Switzerland, and provides innovative healthcare solutions that address the evolving needs of patients and societies.

PDMFC (PDM) will lead WP2 reference domain applications use cases implementation, validation and piloting. PDM’s main roles will make a major contribution to the blockchain platform reference implementation. They will lead the reference implementation by guiding the supply chain integrity, as well as privacy dissemination of project results while supporting security compliance, regulations and the standardisation strategy. PDM is an SME created in 1991 by a group of IST (Instituto Superior Técnico – Lisbon) engineers.

RomSoft (RMS) will research, design and implement software with business processes and integrate PharmaLedger with a distributed ledger.RMS is a specialised software development company with especially strong expertise in privacy, blockchain, online applications and mobile software development. RMS is involved in advanced research aimed at scaling blockchain-based systems and secure digital values storage. They are also involved in complex integration with smart contracts and executable choreographies.

Arteevo Technologies (AVO) will play a key role in the definition and implementation of the PharmaLedger architecture, governance and domain reference applications, reference implementation of the clinical trials application, off-chain storage and defining blockchain standards. Arteevo will work on the PharmaLedger framework architecture, the governance DAO and UI implementation. They will also co-lead the PharmaLedger governance and operating model (WP4). Arteevo is an SME specialising in the creation and implementation of innovative business models, architectures and distributed applications (DApps) enabled by secure blockchain/distributed ledger technology.

Technovative Solutions Ltd. (TVS) will play a major role in the supply chain integration and drug provenance application layer, platform reference implementation and blockchain deployment in the project. They will be responsible for distributed data integration, processing, sharing, data warehouse/data mart implementation in the foundation layer. TVS will also co-lead culture and adoption and play the role of dissemination manager. TVS is a UK based SME and has diverse expertise in data analysis, machine learning, AI, software development and solutions including cloud computation and deployment, industrial ontology, IoT, decision support system, design optimisation, knowledge-based engineering, process automation, measurement and monitoring system development etc.

EKON Modeling Software Systems Limited (EKON) will be leading the development of the collaboration platform based on DKM (Dynamic Knowledge Management), which supports data access from the platform to the health data marketplace and includes smart contract access. EKN will also contribute to PharmaLedger architecture and reference implementation. EKON is a dynamic and innovative software development and consultancy firm. They help small and medium-sized businesses and government institutions to connect their employees, customers/citizens and other stakeholders through a social, collaborative and knowledge-driven ecosystem.

The Centre for Research and Technology Hellas (CERTH) will be the scientific manager of the PharmaLedger project. They will lead task 3.9: Research and implementation of vertical IoT technology integration in PharmaLedger. They will also play an important role in implementing PharmaLedger governance and operating model. CERTH is one of the largest research centres in Greece. CERTH promotes the triplet Research – Development – Innovation by conducting high-quality scientific research and developing innovative products and services. They build strong partnerships with industry leaders (national and international) and strong collaborations with research centres, universities in Greece and abroad.

AbbVie (ABBV) will be the industry lead for WP2 reference domain applications, use cases implementation, validation and piloting. They will also lead T1.3: Technical requirements for DRAs and T1.4: Domain reference applications and use cases with the full description and organisational model for implementation. In addition to being an industry member, they will play a major role in drawing participants to the PharmaLedger platform. ABBV is a global research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. AbbVie was formed in 2013 following separation from Abbott Laboratories. AbbVie is a founding member of the Mediledger consortium and creates innovative blockchain implementation for US DSCSA compliance.

AstraZeneca (AZN) will be the industry leader for Task 3.4: Research and identification of advanced confidentiality methods and Task 3.5: Reference implementation of advanced confidentiality methods. They will play a major role in prioritising use cases. In addition to being an industry member, they will play a large role in drawing participants to the Pharmaledger platform. AstraZeneca has launched several innovative pilot projects to test blockchain for supply chain and clinical trials. AZN is a global innovation and research-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines. They specifically focus on the treatment of cardiovascular, metabolic, renal, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.

Bayer (BAYER) will lead task Task 1.6: Validation and evaluation of use cases in pilot locations. They will play a major role in prioritising use cases and the implementation of them. They will have a special emphasis on supply chain DRA. In addition to being an industry member, they will play a large role in drawing participants to the Pharmaledger platform. BAYER is a global enterprise with core competencies in the life science fields of health care and nutrition. Bayer pursues blockchain technology solutions since 2017, including several proofs of concept for supply chain management.

GSK will play a major role in prioritising and implementing use cases. They will have a special emphasis on supply chain DRA and will play a major role in reference architecture development. In addition to being an industry member, they will play a large role in drawing participants to the PharmaLedger platform. GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas: Pharmaceuticals, Vaccines and Consumer Healthcare.

Janssen Pharmaceutica N.V. (JANSSEN) will play a major role in prioritising and implementing use cases. In addition to being an industry member, they will play a large role in drawing participants to the Pharmaledger platform. Johnson & Johnson has been actively exploring uses of blockchain across its three sectors: Consumer, Device and Pharmaceuticals. They are also engaged in blockchain-focused industry working groups in the US and Europe. JANSSEN is a pharmaceutical company of Johnson & Johnson and provides medicines for an array of health concerns in several therapeutic areas. This includes attention deficit hyperactivity disorder (ADHD), general medicine (acid reflux disease, infectious diseases), immunology and inflammation (rheumatoid arthritis, psoriasis and inflammatory bowel diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management and women’s health.

Merck Sharpe and Dohme (MSD) will co-lead WP1 for the business value and requirements, and they will play a major role in prioritising and utilising use cases. They will be contributing to WP4 governance and WP5 legal compliance. In addition to being an industry member, they will play a large role in drawing participants to the Pharmaledger platform. MSD has used blockchain technology for proofs of concept for supply chain and drug sample distribution. MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc. in Kenilworth, N.J., U.S.A. Through prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, MSD works with customers and operates in more than 140 countries to deliver innovative health solutions.

Novo Nordisk (NOVO) will lead WP5 regulatory, legal and data privacy framework. They will lead all the tasks and sub-tasks in WP5 regarding ethical and legal inventory, study, recommendation and evaluation. They will engage with regulators regarding legal and ethical affairs. They’ll additionally play a major role in prioritising and utilising use cases while drawing participants to the Pharmaledger platform. Novo has experiences with several past and ongoing IMI projects, and they’ve taken up proof of concepts in the use of blockchain technology in clinical trials. NOVO is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. Novo is also helping people to defeat other serious chronic diseases: haemophilia, growth disorders and obesity.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. PFE will be the industry lead for WP4 Governance and Operating Model. Besides they will also play a major role in prioritizing and utilizing use cases and drawing participants to the Pharmaledger platform. Pfizer Inc has been actively exploring uses of blockchain across all business units – manufacturing, commercial, R&D and Finance. We are engaged in blockchain focused consortia and working groups in the US, Europe, and Japan.

Roche (ROCHE) will be involved reference architecture development (WP3) and the governance and operating model (WP4). They will play a major role in prioritising and utilising use cases while also drawing participants to the Pharmaledger platform. Roche has conducted several experiments and PoCs for blockchain in various business areas. Roche operates a small team of blockchain developers in a near-shore location that were involved in several use-cases. ROCHE is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare, a strategy that aims to fit the right treatment to each patient in the best way possible.

UCB will be contributing largely in WP1, WP2 and WP6. They will contribute significantly to use case prioritisation, DRA implementation in health care data marketplace and clinical trials. They will lead tasks T2.3: Distributed data integration, processing and sharing, and in Task 6.1: Engagement through the collaboration platform. UCB is a leading global and research-driven biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products.

The KU Leuven Centre for IT & IP Law (CiTiP) (KUL) will be the legal and ethical manager of the project and lead WP 5 – Regulatory, legal and data privacy framework. CiTiP is a research centre at the Faculty of Law of KU Leuven, dedicated to advancing and promoting legal knowledge about the information society. They do so through research and teaching of the highest quality in the areas of Data Privacy and Information Security Law, New Media and Communications Law, and Information Rights Management.

Onorach (ONO) manages Phase I to IV clinical research studies for drug, nutraceutical products and medical devices, including IoT devices. Onorach’s main roles will be to lead the use case(s) related to clinical trials, provide support in the design of the PharmaLedger healthcare architecture and support the PharmaLedger tools adoption. Onorach will support WP5 on clinical trials regulation, WP6 culture and adoption, and focus on the compliance of Blockchain technology with the current regulation in the clinical and health sectors. ONO will engage patients to the collaboration platform and organise Pharmaledger events.

ICSI Rm. Vâlcea (ICS) is involved in the integration and validation of data during preclinical phases of drug discovery. It will provide knowledge across the business use cases, culture and adoption. ICS will also support WP6 culture and standardisation strategy, as well as dissemination and sustainability activities. ICS is acknowledged as a reference national institute in the Romanian research field due to the transfer towards the Romanian industry of both technology and know-how.

Universitatsklinikum Wurzburg’s (UKW) will provide creating useful analysis and data for the healthcare marketplace, and contribute to standards and adoption. UKW will also support WP6 culture and standardization strategy, as well as dissemination and sustainability activities. UKW’s main areas of research in anesthesia are acute respiratory failure, blood-brain barrier, clinical trials and evidence-based medicine. It also includes malignant hyperthermia, microcirculation, emergency medicine, organ protection, pain research, systematic reviews and drug optimisation. They are also a specialist in Neurological disease research.

Democritus University of Thrace (DUT) will provide data and enable behavioural assessment, technological deployment for the collaboration platform. They will also support culture and adoption and reference implementation activities, WP6 culture and adoption, as well as dissemination and exploitation activities. DUT is a nonprofit state university in Greece. Their Laboratory of Hygiene and Environmental Protection belongs to the Department of Medicine and it presents long experience on epidemiological studies, as well as on Occupational Medicine issues.

The Hospital do Espírito Santo (HES) will be involved in piloting, requirements, business use cases and validating solutions to concrete needs. HES will also participate in governance modelling, regulatory, legal and data privacy framework. They will also disseminate the project results in the health care system in Portugal, along with other public hospitals. HES was founded in 1495 and is a reference hospital in the delivery of healthcare for the Alentejo region, serving more than 440,000 people It has specialised medical services in the areas of maternity and paediatrics, cardiology, neurology, infectiology, nephrology, immuno-allergology, rheumatology, physical medicine and rehabilitation, pathology, pneumology, otolaryngology, psychiatry and mental health, psychiatry, childhood and adolescence and dermatology.

The Bambino Gesù Paediatric Hospital (OPBG) will contribute in providing paediatric data (anonymous) and representation in patient interest. They will lead the process, data and model design in clinical trial and health data marketplace use cases. They will also be active in culture and adoption planning while connecting the Pharmaledger project with other IMI project, such as My Health My Data. OPBG is a scientific institute for research, hospitalisation and health care. It’s also an academic medical centre. It is Italy’s main paediatric hospital and provides third-level health care for children while also performing basic, clinical and translational research activities.

INCM specialises in counterfeiting tracking mechanisms. They will be involved in developing supply chain integrity and drug provenance application, culture and adoption, and data management. They will also provide knowledge across the business use cases. INCM will support also WP6 culture and standardisation strategy, as well as dissemination and sustainability activities. INCM’s mission is to develop, produce and supply products and services that focus on security and authenticity features essential for trust services (B2C, G2B, G2C). They innovate and produce applications of high standards of security as a guarantee of their authenticity and trustworthiness.

European Patient Forum (EPF), as a patient organisation, will be involved in patient advocacy and engagement of patients to the project. EPF is an umbrella patient organisation that works with patients’ groups in public health and health advocacy across Europe. Through consultations with a diverse membership across Europe, EPF gathers patients’ views and channels their voice to inform decision making in public health, health-related research and in the definition of innovative patterns for patient involvement.

EFGCP, as a patient organisation, will be involved in patient advocacy and engagement of patients to the project. They will also train hospitals about the use of blockchain and evaluate the performance. EFGCP is a non-profit, multi-disciplinary organisation providing a neutral platform for evaluation and discussion of practical implications of Good Clinical Practice (GCP). This involves planning, performance and evaluation of biomedical research. EFGCP has 25 years of experience in organising multi-stakeholder activities on ethical, quality, patient-engagement and academia/industry-led clinical research aspects, enabling discussions and mutually acceptable solution/proposal generation.

Boehringer Ingelheim (BI) will play a large role in drawing participants to the PharmaLedger platform. BI is a research-driven pharmaceutical company with a goal to improve the health and quality of life of humans and animals. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company concentrates on developing innovative therapies that can extend patients’ lives. In animal health, BI stands for advanced prevention.