FDA Attempting to Address Unmet Needs for Patients with Brain Metastases
Molly Fellin Spence of Clarivate discusses the FDA’s efforts towards advancing the development of products for CNS metastases, where effective…
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Academic Collaboration with Contract Research Organisations: Reaching Out to the Right Expertise at the Right Time
Drug discovery and development, while usually a role of the pharmaceutical industry, is a long, difficult and expensive process, which…
Providing Regulatory Clarity for Cell- and Gene-based Therapies
Adam Istas, DIA explores how global regulators are responding to dramatic increases in cell and gene-based products in development. Regulators…
What Can LOINC Do for SDTM?
LOINC is an internationally recognized classification system and is often requested in regulatory data submissions to provide context to clinical…
Modelling and Simulation is Key to Modern Drug Development
The FDA has been promoting innovative and disruptive approaches towards modernizing drug development and clinical trials, which the industry has…
Clinical Evaluation & Post-marketing Surveillance of Medical Devices in Singapore
Dr Balamuralidhara V. et al of the JSS College of Pharmacy present a study which examines the clinical evaluation and…
How Engaging Patients in Trial Design Maximises Orphan Drug Success
Orphan drug discovery presents both opportunities and challenges, with research in this space having some of the highest hurdles in…
Drug Delivery to the Eye: The Challenges and Opportunities of Drug Delivery Through a Complex Barrier
Eye health and vision has a major impact on the quality of life, and as such the development of products…
Clinical Research in Rare Diseases: Adult Onset Still’s Disease
Adult onset Still’s disease (AOSD) is a rare inflammatory joint disease of unknown aetiology, characterised by arthritis, fevers spiking once…
The Case for Response Adaptive Trial Design for Rare Diseases
With 7,000 rare diseases affecting 350 million people worldwide, Holly Jackson at Quanticate identifies how businesses exploring rare diseases can…