Date: 16th June 2015
Cambridge, UK, 16th June 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it has signed up for the early-stage development of a novel vaccine targeting prevention of influenza. The project signals ELC Group’s entry into the pharmaceutical development market.
The vaccine development will be overseen by a specialist R&D team at ELC Group, including regulatory vaccines experts who have worked on and regulated a number of key worldwide paediatric vaccines. The highly experience team includes a number of current advisers to the World Health Organisation.
ELC Group is working with pre-clinical partners to carry out toxicity and immunogenicity testing, and is harnessing innovative new techniques to create the novel vaccine. ELC Group will also be responsible for setting up the regulatory pathway to ensure a smooth transition to market and approval from international regulators. The market value of the project assigned to ELC Group is an estimated 1 million Euros.
According to World Health Organisation figures (2014), the global incidence rate of influenza is estimated at 5%–10% in adults and 20%–30% in children. Illnesses can result in hospitalisation and death mainly among high-risk groups (the very young, elderly or chronically ill). Worldwide, annual epidemics rates are currently estimated to result in about 3 to 5 million cases of severe illness, and about 250, 000 to 500, 000 deaths globally.
Commenting on the vaccine development, ELC Group CEO Marco Rubinstein said: “We are very excited to be moving into the pharmaceutical development market with this key launch project, targeting an important therapeutic area. With the ability to take this product through our concept to commercialisation model by our unrivalled team of world-class team experts, we are confident of a successful project delivery.”
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About ELC Group:
ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade.
From Concept to Commercialisation is one of the key partnership areas in which ELC GROUP is creating its fast-growing success. From the development stage through to the implementation of clinical trials, completion of product registration, and successful marketing of the product, ELC GROUP aligns itself as a strategic partner to help pharmaceutical companies achieve their healthcare goals.
ELC GROUP’s worldwide network of professionals spans all major Regulatory Affairs services across the key healthcare vertical markets of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary. The team ranges from former FDA investigators to individuals with over 30 years of industry experience and broad capabilities, including in the areas of integrated advanced technologies, Regulatory Affairs consulting and commercialisation services.
ELC GROUP works with equal success in partnership with large multi-nationals, small enterprises and start-ups, biotechs, CROs and device manufacturers.