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      1. EMEA/
      2. Our innovation /
      3. Focus areas/
      4. Oncology /
      5. Prostate cancer/
      6. The ORACULUM study: harnessing the power of data

      The ORACULUM study: harnessing the power of data

      Through the ORACULUM study, Johnson & Johnson is exploring natural language processing artificial intelligence (NLP-AI) to help analyse prostate cancer patient data collected in electronic health records in several European, Middle Eastern and African countries. This allows us to more accurately understand and describe the epidemiology, diagnosis, management and outcomes of patients with prostate cancer along the entire disease pathway in real word practice, as well as to identify potential prognostic and predictive factors of response.[19]

      ORACULUM is highly complementary to other big data initiatives running in parallel on prostate cancer (PIONEER Consortium) that are supported by the European Union through the Innovative Medicines Initiative (IMI).[19]

      In addition to this, Johnson & Johnson is also collaborating with nine other pharmaceutical companies from across the industry in the Machine Learning Ledger Orchestration for Drug Discovery (MELLODDY) project, which seeks to solve the challenges of data sharing within pharmaceutical research, while also significantly advancing drug discovery through predictive models.[22]

      [1] IARC. Online analysis table. Available at: https://gco.iarc.fr/today/online-analysis-pie?v=2020&mode=cancer&mode_po.... Accessed January 2023.

      [2] Smith-Palmer et al. Literature review of the burden of prostate cancer in Germany, France, the United Kingdom and Canada. BMC Urology. 2019 19, 19.

      [3] European Medicines Agency. Zytiga authorisation details. Availabe at: https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga#authorisation-details-section. Accessed February 2023

      [4] European Medicines Agency. ERLEADA Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/9832/smpc#gref. Accessed December 2022.

      [5] European Medicines Agency. ZYTIGA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf. Accessed June 2021.

      [6] Hait, W.N. et al. Moving upstream in anticancer drug development. Nat Rev. 2018; 18: 159-160

      [7] Delgado, A, et al. Clinical endpoints in oncology - a primer. Am J Cancer Res. 2021; 11 (4): 1121-1131

      [8] Golden Gate Cancer Center. Men with newly diagnosed prostate cancer – a primer. Available at:https://www.goldengatecancercenter.com/blog/men-with-newly-diagnosed-prostate-cancer-a-primer. Accessed January 2023.

      [9] European Federation of Pharmaceutical Industries and Associations. Precision Medicine. Availabe at: https://www.efpia.eu/about-medicines/development-of-medicines/precision-medicine/#:~:text=%E2%80%9CPrecision%20medicine%20is%20a%20healthcare,resulting%20in%20improved%20health%20outcomes%E2%80%9D. Accessed February 2023

      [10] ClinicalTrials.gov. A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE). Availabe at: https://clinicaltrials.gov/ct2/show/NCT03748641?term=niraparib++magnitude&draw=2&rank=1 Accessed February 2023

      [11] The Pharmaceutical Journal. The precision medicine approach to cancer therapy. Available at: https://pharmaceutical-journal.com/article/research/the-precision-medicine-approach-to-cancer-therapy-part-1-solid-tumours Accessed January 2023

      [12] John Hopkins. Prostate Cancer Prognosis. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/prostate-cancer/prostate-cancer-prognosis. Accessed January 2023

      [13] Cancer.net. Prostate Cancer: Statistics. Available at: https://www.cancer.net/cancer-types/prostate-cancer/statistics. Accessed January 2023

      [14] Seyhan, A.A., Carini, C. Are innovation and new technologies in precision medicine paving a new era in patients centric care?. J Transl Med 2019;17:114

      [15] ClinicalTrials.gov. An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS. Availabe at: https://clinicaltrials.gov/ct2/show/NCT02531516?term=erleada+atlas&draw=2. Accessed February 2023

      [16] American Association for Cancer Research. Intercepting Cancer by Tackling Precancer. Available at: https://www.aacr.org/blog/2021/01/15/intercepting-cancer-by-tackling-precancer/. Accessed January 2023

      [17] Clinicaltrials.gov. Molecular Studies and Clinical Correlations in Human Prostatic Disease. Available at: https://clinicaltrials.gov/ct2/show/NCT00578240. Accessed January 2023

      [18] Smith, R, M, et al. Relationship Between Metastasis-free Survival and Overall Survival in Patients With Nonmetastatic Castration-resistant Prostate Cancer. Clinical Genitourinary Cancer. 2019; 18: 180-9

      [19] Carles, J. et al. ORACULUM. A Retrospective Observational Epidemiological Study Using Artificial Intelligence and Natural Language Processing in Electronic Health Records to Characterize the Prostate Cancer pathway, Management and Outcomes in Europe, Middle East and Africa (EMEA region). Poster presentation at the European Society for Medical Oncology Virtual Congress, September 2020 (abstract #695TiP).

      [20] Astex. Astex Announces New Drug Discovery Alliance with Janssen Pharmaceutica N.V. Available at: https://astx.com/wp-content/uploads/2016/11//ASTX_News_2008_6_9_General_Releases.pdf. Accessed January 2023

      [21] Ahuja AS. The impact of artificial intelligence in medicine on the future role of the physician. PeerJ. 2019;7:e7702.

      [22] MELLODDY. MELLODDY Project meets its year one objective: deployment of the world’s first secure platform for multi-task federated learning in drug discovery among 10 pharmaceutical companies. Available at: https://www.melloddy.eu/y1announcement. Accessed January 2023

      [23] WebMD. What Is B-Cell Lymphoma. Available at: https://www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma. Accessed January 2023

      [24] Zhang, et al. Clinicopathological factors in bladder cancer for cancer-specific survival outcomes following radical cystectomy: a systematic review and meta-analysis. Available at: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5924-6. Accessed January 2023

      [25] World Bladder Cancer Patient Coalition. Annual Meeting Report 2020. Available at: https://worldbladdercancer.org/wp-content/uploads/2020/11/WBCPC-Annual-Meeting-2020-Report.pdf. Accessed January 2023

      [26] Cancer.Net. Lung Cancer - Non-Small Cell: Statistics. Available at:https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed January 2023