Building awareness with National Diabetes Month and new T2DM treatment guidelines

Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with Type 2 diabetes mellitus (T2DM).

Mining real-world data with cutting-edge analytical tools: helping to achieve patient recruitment targets

In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.

Inflammatory bowel disease clinical studies – where do we go from here?

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large focus upon the development of new drugs for the treatment of IBD. While this is undoubtedly a welcome fact for patients and their families, the current level of research activity brings logistical challenges when conducting clinical trials.

Designing a comprehensive drug discrimination study

Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Abuse Potential, we are sharing how we design and setup accurate and valid nonclinical GLP abuse liability study types required by regulatory agencies: self-administration, drug discrimination and physical dependency.

How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario.

ISO 14155 update: key risk management changes for medical device clinical investigations in 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

Treating age-related macular degeneration (AMD) with a novel stem cell therapy

The Audacious Goals Initiative (AGI) for regenerative medicine is a program run by the National Eye Institute (NEI), aimed at finding new therapies for eye diseases that remain difficult to treat.

What’s changing in SEND 3.1?

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints.

Future-proofing residue analysis services

As the regulatory landscape across the globe is rapidly evolving, more sophisticated requirements must be met by registrants and scientists. In parallel, scientific advances have impacted previous methodologies that were once seen as cutting edge but now may fail to adequately address new regulatory challenges.

Preserving lifecycles: renewing established pesticides

The regulation that governs the marketing, sale, and use of pesticides is just a fact of life, but the standards imposed are constantly evolving as our scientific insight and knowledge increases. This series of informational blogs is designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.