Current Edition

FDA attempting to address unmet needs
Volume 11 Issue 3

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 treatments and clinical trials are …

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Academic collaboration with contract research
Volume 11 Issue 3

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 can present academic organisations and …

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Providing regulatory clarity for cell and gene
Volume 11 Issue 3

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 are working to provide further …

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What can LOINC do for SDTM
Volume 11 Issue 3

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 measurement data such as Labs …

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Modelling and simulation is key to modern
Volume 11 Issue 3

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 been slow to adopt. These …

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Clinical evaluation and post-marketing
Volume 11 Issue 3

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 post-marketing surveillance requirements of medical …

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How engaging patients in trial design
Volume 11 Issue 3

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 medicine. Clinical trial design and …

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Drug delivery to the eye
Volume 11 Issue 3

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 within this area is a …

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Clinical research in rare disease
Volume 11 Issue 3

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 or twice a day, salmon-coloured …

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Volume 11 Issue 3

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 continue their success through developing …

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