Legacy devices under MDR/IVDR: a path forward
Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.
Health Technology Assessment: informal deal between council and European Parliament
In June 2021, representatives of the European Parliament and the Council of European Union reached an agreement to boost cooperation amongst EU member States on HTA.
Leveraging in-home services for Parkinson’s Disease
New technologies like wearables and mobile devices, in-home services, and increased patient engagement can change the way we treat Parkinson's disease.
MDR & IVDR bottlenecks: Challenges persist despite deadlines
The new In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) provide regulatory frameworks and conformity assessments that promote medical device safety and efficacy.
How to improve participation of asymptomatic patients in neurodegenerative disease registries
Insight into the power of patient-registries and how they can be used to increase participation of neurodegenerative patients.
New procedures for drug prices negotiations and reimbursement in Italy
In March 2021 the Italian Medicines Agency adopted new guidelines for drug pricing and reimbursement decisions.
10 lessons learned about secondary “real world” data strategy
Insights and lessons learned about operationalizing the use of real world data.
Managed access programs as an alternative to long-term follow up studies
Managed Access Programs (MAPs), are one solution for early access to investigational products that are gaining traction.
The data revolution: Big data’s role in clinical trial patient recruitment, retention and engagement
How big data can be leveraged by pharma to solve key challenges in patient recruitment and drug development.
The role of technology in Parkinson’s treatment and research
Constant study and innovation of Parkinson's Disease (PD) research has shown the implementation of medical devices, AI, and mobile applications pave the way forward.
Event report - DIA Europe 2021: Advancing health priorities
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
Biomarker assays: Bioanalytical meets CLIA
The blog considers current perspectives on the use of biomarkers, differences between the needs of biomarker assays developed for use in bioanalytical labs or clinical labs, and what may be needed in the case that a biomarker assay needs to migrate into a CLIA lab.
Looking back and looking ahead: Trends in HEOR
In-person research became impossible due to the pandemic, and forced us to re-examine how patient's voices were being captured. In 2021 we continue to build on what we learned.
Navigating complexity of cell therapy manufacturing during the COVID-19 pandemic
Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.
Navigating complexity in oncology cell and gene therapy clinical trials
As more knowledge is revealed about the genetic underpinnings of cancers, cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients
Innovation in oncology drug development: A focus on patient benefits
Improved diagnostic technologies, prevention methods and the advent of targeted therapeutic approaches have together contributed to lowering the mortality rate for the 10 most prevalent cancers
Cell and gene therapy trials - delivering differently
The success of cell and gene therapies (CGT) has transformed the delivery of clinical trial services, requiring the design of new workflows, processes and tools.
Multidiagnostic approaches for patient selection biomarkers in immuno-oncology
Advances in our understanding of cancer biology and the tumour microenvironment (TME), have led to the development of personalised drug and therapy designs to better prevent disease progression and relapse.
Briefing: The UK NICE methods of health technology assessment
In a statement on February 2021, the UK’s National Institute for Health and Care Excellence (NICE) launched a public consultation on proposals for changes to the processes it uses to develop its guidance on medicines, medical devices, diagnostics and digital health technologies.
Sharing my rare disease story - Hayley Christensen
ICON's Hayley Christensen shares her personal experience with Cystic Fibrosis.