medialis – Medialis

Development of a definition for real-world evidence using the Jandhyala method for observing consensus opinion among medical affairs pharmaceutical physicians

August 12, 20240

Introduction Low rates of inclusion of real-world evidence (RWE) during regulation may arise from lack of clarity and consensus on its definition. A conceptually mature definition of RWE may have pragmatic utility, increasing its inclusion during regulation. The aim was to develop a definition of RWE to promote inclusion in regulatory submissions and assess...

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A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch

May 22, 20220

Introduction The optimal launch and adoption of novel medicines require effective navigation of the commercial and regulatory landscape, including three key gatekeeper groups: regulators, payors, and prescribers. Traditionally, despite lacking generalisability, the pharmaceutical industry provides Phase III randomized controlled trial evidence to gatekeepers. Despite additional real-world evidence (RWE) improving the generalisability of evidence, the...

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The multiple stakeholder approach to real-world evidence (RWE) generation: observing multidisciplinary expert consensus on quality indicators of rare disease patient registries (RDRs)

May 22, 20220

We Medialis Ltd are pleased to share with you the third of a series of updates on the principles underlying our work, the four pillars of our medical #thirty22 #realworldevidence strategy. Pillar 3 of our strategy focuses on the application of the #multiplestakeholderapproach to #realworldevidence generation for #clinicalstudies. Our research showed that stakeholder groups have...

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Neutral theory via the Jandhyala method

May 22, 20220

We @Medialis Ltd are pleased to share with you the second of a series of updates on the #medicalaffairs principles underlying our work, the four pillars of our medical #thirty22RWEstrategy in the #pharmaceuticalindustry, #rarediseases and #orphandrugs. Pillar 2 of our strategy focuses on the application of #Neutraltheory via the #Jandhyalamethod to observe #consensusopinion from #keyopinionleaders...

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Neutral theory

May 22, 20220

We @Medialis Ltd are pleased to share the first of a series of updates on the #medicalaffairs principles underlying our work, the four pillars of our medical #thirty22RWEstrategy in the #pharmaceuticalindustry, #rarediseases and #orphandrugs. Pillar 1 of our strategy focuses on the application of #Neutraltheory to #constructmeasurement problems in #clinicaltrials and #clinicalstudies. #Neutral theory allows...

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Jandhyala Method Application

May 22, 20220

Medialis Ltd is thrilled to announce the completion of our first proprietary software application: JeMa (Jandhyala Method Application). This app enables us to seamlessly administer the #JandhyalaMethod, shortening the time to delivery of the completed research for our clients considerably. Incorporating our own state-of-the-art AI, JeMa will enable Medialis to further develop our algorithms to...

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Medialis key findings 2021

May 22, 20220

We Medialis Ltd are celebrating the end of another successful year as the only #medicalaffairs consultancy and CRO. We showed why our unique approach matters in seven key research projects in 2021. Our work in 2021 on the four pillars showed how #medical affairs enhances #rwegeneration and strategy for #pharmaceuticalcompanies. With increasing payor and...

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Estimation of Reduction in Influenza Vaccine Effectiveness Due to Egg-Adaptation Changes—Systematic Literature Review and Expert Consensus

May 22, 20220

This work, carried out by Medialis, is the first study to estimate the impact of egg-adaptations on #influenzavaccine effectiveness. Our experts agreed that compared to TIVs and QIVs, avoiding egg-adaptations could improve #influenza #vaccineeffectiveness by up to 16%, suggesting that new technologies that avoid egg-based manufacture could deliver increased benefit to patients. We used the...

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FGF23 and its role in X-linked hypophosphatemia-related morbidity

May 22, 20220

Background X-linked hypophosphatemia (XLH) is an inherited disease of phosphate metabolism in which inactivating mutations of the Phosphate Regulating Endopeptidase Homolog, X-Linked (PHEX) gene lead to local and systemic effects including impaired growth, rickets, osteomalacia, bone abnormalities, bone pain, spontaneous dental abscesses, hearing difficulties, enthesopathy, osteoarthritis, and muscular dysfunction. Patients with XLH present with elevated levels of...

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Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

May 22, 20220

Background A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the...

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