Wim Verreth, head of Business Development and Support at SGS Life Sciences — Clinical Research, gives us his thoughts on the changes, trends, opportunities and challenges of the year.
2017
1. What has been the biggest opportunity of 2017 for your company/organisation?
SGS Clinical Research has developed and launched a cGMP-manufactured, non-haemagglutinating, wild-type strain of Influenza A H3N2. This novel virus has consistent performance characteristics, closely emulating a wild type infection which can be used as a challenge agent in controlled, human infection studies to develop effective vaccines.
Considering recent failures in global vaccination programmes versus H3N2 (which has been responsible for 3 of the last 4 global epidemics), a novel challenge agent capable of rapidly providing evidence regarding vaccine effectiveness, and which enables candidate selection prior to vaccination programmes, could positively affect future measurements of disease burden.
2. In your opinion, what has been the most important innovation for the year?
For SGS Clinical Research, this new virus strain, and its use in human challenge testing, is a step-change, as we believe its use in such trials may substantially de-risk late phase community studies, and also serve to reduce the reliance of efficacy programmes on the seasonal incidence of influenza. Human challenge studies ensure the safety of subjects, accelerate development timelines, and allow informed go/no go decisions to be made earlier in the pipeline development cycle.
3. Which factors have driven the biggest changes to the industry in 2017?
We have witnessed a significant switch amongst our partners from a focus on curative medicines to preventative therapies, and R&D spend increasing in this field.
4. What market trends have been influential for 2017?
From a clinical trial standpoint, we are seeing growth in areas that could be broadly categorised under “targeted indications,” such as personalised medicine, orphan drugs and relevant vaccines. Obviously, strong R&D trends such as eSource, more specifically immediate electronic capturing of data at the bed side or ePRO (electronic collection of patient reported outcomes), and the use of wearable devices by the subjects improve the quality and speed of the data collection, and allows us to better monitor the overall safety and efficacy of the new treatments.
5. What have been the biggest challenges of the year?
For us, the development and validation of the H3N2 virus was a massive regulatory and scientific challenge to overcome. The clinical trials we undertook showed it to have very high attack rates (up to 100% in antibody-naïve, healthy adults) and clear and progressive symptomology characteristics of a mild influenza like illness.