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International Clinical Trials
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“Today, 47 million people live with dementia worldwide, more than the population of Spain. This number is projected to increase to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. The total estimated worldwide cost of dementia is US$818 billion, and it will become a trillion dollar disease by 2018” (1).
Because of the social impact of this chronic neurodegenerative disease, it has become a major target for new therapies and, together with Parkinson’s, accounts for approximately a third of all neurological trials initiated over the past five years (2). Despite this, the success of new medicines in the area is poor. At present, the only products on the market are Cholinesterase inhibitors and N-methyl-D-asparate (NMDA) antagonists, providing symptomatic therapy. Consequently, the drive for diseasemodifying treatments is huge, and, despite major setbacks for drugs in trials to date, in 2016, 51 Alzheimer’s trials were initiated compared to five in 2002 (3,4). Dominantly Inherited Alzheimer Network Trial (DIAN-TU) represents a new frontier for assessing the impact of disease-modifying drugs as it targets patients with a genetic predisposition and starts treatment prophylactically.
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News and Press Releases |
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POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS
A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6
Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers |
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Pharmacovigilance and Risk Management Information in Centralised Applications in the EU
United BioSource Corporation (UBC)
Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Industry Events |
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DIA 2018 Global Annual Meeting
24-28 June 2018, Boston, MA
The DIA 2018 Global
Annual Meeting brings together thousands of innovators from around the globe.
Designed to drive insights into action by connecting key policy discussions to
real-world knowledge that you need to do your job every day, your attendance
will accelerate your growth and your organization's performance in the
development ecosystem.
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