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.
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.
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.
Sharing my rare disease story - Tamie Joeckel
ICON's Tamie Joeckel shares her personal experience with Type 3 Hereditary Angioedema.
Sharing my rare disease story - Amanda Huber
ICON's Amanda Huber shares her personal experience with Alpha-1 Antitrypsin Deficiency (Alpha-1).
Sharing my rare disease story - Julia Tonge
ICON's Julia Tonge shares her personal experience with Amniotic Band Syndrome (ABS).
mRNA vaccines from COVID-19 to HIV
How one virus accelerated vaccine research, spurring innovation and hope for a cure in another
Executing under pressure: Developing a strategy for high risk devices under IVDR
Manufacturers who have not begun preparations will need to adopt a strategy to address gaps in meeting the new regulation.
The Importance of partnering for bioanalytical studies
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Clinical Evidence under IVDR - how much is enough?
The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements.
Data capture: The benefits and evolution of eCOA
As the demand for improving patient safety in clinical trials continues to rise, so will the use of technology as a way to better capture data and enhance clinical outcome assessments (COAs).
Risk, vigilance, and remediation under IVDR
The In Vitro Diagnostics Regulation (IVDR) — which goes into effect on May 26, 2022 — will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.