New gene-therapy may be approved in EU
New treatment Glybera has been recommended for marketing in the European Union as a treatment for severe and multiple pancreatitis attacks due to lipoprotein lipase deficiency (LPL).
Glybera (alipogene tiparvovec) is the first gene-therapy medicine to be recommended for authorisation in the European Union. Designed to replace defective genes with a working copy, the gene-therapy treatment Glybera will add working copies of the LPL gene into muscle cells to enable production of the enzyme in the cells.
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LPL deficiency is an extremely rare inherited disorder estimated to affect one or two people per million. Due to a defective gene, patients with this disorder cannot produce enough LPL, an enzyme responsible for breaking down fats. So far, management of patients with the disorder consists of strict reduction of dietary fat to less than 20% of the daily caloric intake. It is very difficult to comply with such a dietary regimen and as a consequence many patients experience life-threatening pancreatitis attacks requiring admission to hospital.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of market authorisation in ‘exceptional circumstances’, based on the requirement that the company marketing Glybera will be required to provide data from a registry set up to monitor outcomes in patients treated with Glybera.
“The evaluation of this application has been a very complex process, but the use of Glybera in a more restricted indication than initially applied for, which targets the patient population with greatest need for treatment, and additional analyses by the Committee for Advanced Therapies (CAT) have added to the robustness of the data provided and allowed the CHMP to conclude that the benefits of Glybera are greater than its known risks”, said Dr Tomas Salmonson, acting Chair of the CHMP.
NeuTigers: edge AI in healthcare
What is edge AI?
Edge AI is essentially a combination of edge computing and artificial intelligence. Algorithms are processed locally - directly on a mobile device or server - rather than in the cloud. This reduces cost, computing power and energy requirements. There are also claims that edge AI is so fast it is possible to reach near real-time analytics.
Edge AI devices include smart speakers, smart phones, laptops, robots, self-driven cars, drones, and surveillance cameras that use video analytics.
Who is NeuTigers?
NeuTigers is a spin-off company from Princeton University, formed in 2018 to apply edge AI and machine learning to solve challenges in healthcare, energy, productivity, and security.
With offices in Princeton, NJ, the company is based at one of the top AI accelerator programs of FutureLabs in New York, and has also established a subsidiary in Nice, France.
How is NeuTigers applying edge AI to healthcare?
The NeuTigers AI Technology Stack uses deep neural networks that mimic how the human brain perceives and interprets the world. The company has developed the StarDeepTM Smart Health Platform for health monitoring and biomedical imaging, to improve the accuracy and speed of diagnosing diseases.
NeuTigers say the platform has the potential to monitor and screen for thousands of conditions, when used in combination with medical devices and smart sensors already deployed in healthcare settings.
Are there any real world examples?
In January NeuTigers launched CovidDeep, a tool that predicts COVID-19 with more than 90% accuracy, using physiological data from a wristband along with blood pressure and blood oxygen readings. It then analyses the data and gives a prediction within two minutes.
This week NeuTigers announced a new study to detect the early signs of complications with sickle cell anaemia. Conducted at a hospital in Paris, the research will begin by looking at changes to skin response, heart beat, sleep and temperature to predict an acute episode of sickle cell anaemia, and how this impacts on the patients’ disease conditions and quality of life.
The second phase of the project is to expand with prospective studies across different sites in EU, Africa and the US to explore the models' accuracy and clinical effectiveness.
Adel Laoui, CEO and founder of NeuTigers, says: “The best way to deal with a crisis is to avoid it happening in the first place. We are now entering a new era where medical early warning systems have become a reality.
“We are excited at the possibility of deploying a technology that can save lives of patients dealing with sickle cell anaemia. The potential of the StarDeep platform to dramatically improve patient outcomes while slashing some of the highest costs of healthcare makes it one of the most exciting developments in preventative personal medicine.”