The award comes after SGS was initially selected in a shortlist of 15 entries and received the most online votes from the publication's global print and digital readership. The SGS H3N2 virus (A/Belgium/4217/2015) can be used for human challenge testing in the company's human challenge unit which forms part of the clinical pharmacology unit in Antwerp, Belgium. Launched in 2015, the annual Medicine Maker Innovation Awards recognize the most exciting, commercial drug development and manufacturing technologies released onto the market over the course of the year.
"Innovation is crucial in any industry, but its impact is perhaps best felt in the pharma, medical and healthcare fields where it saves lives," commented Stephanie Sutton, Editor of The Medicine Maker. She added, "The quality of the 2017 entries was exceptionally high and we received thousands of votes for the shortlisted entries from around the world. We congratulate SGS on their success with the groundbreaking H3N2 challenge agent."
SGS's Project Director of its Human Challenge Unit, Adrian Wildfire, added: "We are extremely pleased to have received this award in recognition of the work we are undertaking developing new, improved challenge agents such as the H3N2 virus. Having access to this wild type strain for challenge trials allows real-world insights regarding the effectiveness of a vaccine or drug in the field to be assessed within a safe and controlled environment and helps accelerate solutions for influenza and respiratory disease."
H3N2 is a community-sourced influenza virus manufactured to (c)GMP for use as a challenge agent and has lineage from the seasonally epidemic, non-haemagglutinating H3N2 viruses that arose in the 2010-2011 influenza season, and that have come to predominate since 2014-2015. The H3N2 Challenge Virus therefore represents one of the most common current circulating strains of influenza of a pandemic origin and can be used for testing the H3N2 portion of prospective prophylactic and therapeutic vaccines. It shows clear and progressive symptomology characteristic of a mild influenza like illness. Previously, some influenza challenge agents have evidenced egg-adaptation and subsequent markers of disease (both infectivity rates and viral shedding). This agent (A/Belgium) has retained a WT genome and has shown 90-100% infectivity rates in clinical trials.
When seeking FDA approval for a vaccine, manufacturers require proof of real-world effectiveness, which can be achieved in studies in the community; however, such trials are expensive and the low rates of infection can lead to the need for a large patient pool. A challenge agent with a high attack rate – used in conjunction with controlled, human infection studies – may help reduce reliance of such programs on the seasonal incidence of influenza. The efficacy of the vaccines can be determined directly by measuring both virological and host (clinical) endpoints. Ensuring the safety of subjects, whilst maximizing data relevance (quality), allows informed go/no go decisions to be made earlier in the pipeline development cycle.
SGS provides clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in the Americas, SGS offers clinical trial (phase I to IV) services encompassing drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs services. SGS has its own Clinical Pharmacology Unit in Belgium, including a human challenge testing facility and two phase I patient units based in Belgium and Hungary. SGS has a wealth of expertise in First-In-Human studies, viral challenge testing, biosimilars and complex PK/PD studies, with a therapeutic focus on infectious diseases, vaccines, and respiratory conditions.
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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.