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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact

Medicine --- Drug Development --- innovation --- Collaborative Research --- Partnership --- Health Systems --- clinical research

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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact

Medicine --- Drug Development --- innovation --- Collaborative Research --- Partnership --- Health Systems --- clinical research

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Remicade® contains infliximab, a monoclonal antibody that neutralises the effect of Tumour Necrosis factor α. In this way it has a regulating effect on the inflammation process. This case study will describe the life cycle of Remicade®. New York University and Centocor B.V. applied for a patent on the 18th of March 1992. The first application for MA at the EMA was on 27 March 1998 by Centocor B.V. This application was done via the centralised procedure and assessed by the Committee for Proprietary Medicinal Products. After proving the safety and efficacy via pre-clinical and clinical tests, a first MA under special circumstances was granted for the treatment of short-term treatment of severe, active Crohn's disease and fistulising, active Crohn's disease in patients who have not responded to conventional therapy. Authorisations for other indications were granted in the course of years after proving positive clinical effects of treatment with Remicade®. These effects were measured and proven in elaborate clinical trials. Remicade® now has MA for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Nowadays, the drug falls under reimbursement category B in Belgium. Data of the original application for reimbursement were not found. Since the expiry of the patent in February 2015, 2 biosimilars of infliximab, Inflectra® and Remsima® also gained MA in Belgium. Comparison to Stelara® showed the same MA procedure but a difference in application for reimbursement. These findings are in line with the results of the additional research project. The aim of this study was both to investigate whether any changes have occurred in the regulatory framework of biological drugs and to describe the current status and future challenges for the treatment of Crohn’s disease with biologicals. Information was gathered via literature studies and by interviewing 16 experts on the different topics. A biological drug is defined by the European Medicines Agency as a medicine that contains one or more active substances made by or derived from a biological source. Currently, three classes of biologicals are used in the treatment of Crohn’s disease: anti-tumor necrosis factors, anti-interleukins and anti-integrins. The disease is characterised by a chronic relapsing, remitting inflammation of the gastrointestinal tract. Two major challenges for the future came forward in the study. The first problem is finding a way to increase the efficacy of biological treatment in Crohn’s disease. A second challenge is keeping treatment with biologicals affordable for the healthcare. Besides the specific regulations for biosimilars, no major changes have occurred in the regulatory framework of biologicals. Minor changes such as the updating of guidelines, changes in the legislation and the establishment of several committees were described. A general evolution towards European harmonisation was noticed alongside with an evolving role of the committees involved in the application procedures for market access. The role of these commitees evolved from evaluating the final application towards a more guiding role throughout the entire process.

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Background: In Western society, patients are searching for information before consulting a physician and want to get involved in their treatment options. A clear overview of digital platforms for patients with neurological disorders and the benefits for different medical stakeholders was missing in literature. This literature review aimed to gain insights into the currently available digital platforms for patients with neurological disorders and their potential added value for patients, their caregivers and the pharmaceutical industry. A second aim was to investigate the terms of medical privacy on digital platforms. Methods: Three databases were used: Pubmed, Embase and Science Direct. One search strategy was conducted to find information about the current digital tools and the different stakeholders' perspectives, another search strategy was performed to gain information about data privacy. A third search strategy was performed in Pubmed to find extra information about digital platforms for Parkinson's disease and Alzheimer's disease. Results: In this literature review 35 digital platforms for patients with MS, four digital platforms for Parkinson's disease and four for Alzheimer's disease were summarized. The potential added value for patients could be the possibility to find information in an understandable language and to interact with a physician, caregiver or with other patients. Physicians on the other hand might use digital platforms for treatment decisions. Pharmaceutical companies might benefit from digital platforms because they speed up the recruitment of participants for clinical trials. Platforms must guarantee data anonymization. Conclusion: A lot of tools are currently available for patients, but there is still room for improvement. Patients suggested a more safe and trustworthy platform. Caregivers wanted more tools that are specifically made for them. For the physician, platforms can lead to a more efficient consultation. Pharmaceutical companies take advantage of these tools to speed up the process of developing new treatments. Background: Digital platforms have gained increased attention in the healthcare system. In this project, stakeholders' perspectives on digital platforms were examined in context of Multiple Sclerosis and Parkinson’s disease. The objective was to examine the strengths and weaknesses of digital platforms, their essential elements and their contribution to drug development. Methods: Stakeholders’ needs and concerns were studied by semi-structured interviews with neurologists, pharmaceutical representatives and patient representatives (n=12) and questionnaires with patients with neurological disorders (n=374). Results: Patients mainly searched for information on Google or patient organizations’ websites. Neurologists, pharmaceutical and patient representatives stated they used or created digital platforms to support patients. Many strengths and limitations of digital platforms were mentioned, better informed patients and possibility to share. The contribution of digital platforms to drug development appeared to be complex. Pharmacovigilance was mentioned as an obstacle to this contribution by the pharmaceutical industry. Conclusion: Many patients found digital platforms user-friendly. However, a need for more online interaction and understandable and up-to-date information was mentioned. The stakeholders' perspectives highlighted barriers which must be reconsidered in platform development.