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QMS for Biotech: Interview with Cyrille Drouot from Genoscience Pharma

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Genoscience Pharma is a French company founded in 2001 by CEO Philippe Halfon, a world renowned medical expert on viral diseases, especially on Human Immunodeficient Virus (HIV) and Hepatitis C Virus (HCV). The company was initially focused on the development of anti-HCV agents. Two protease inhibitors were thus developed and out-licensed to BioLineRX.

A new scientific direction was taken in 2012 after the discovery of a new chemical family: autophagy inhibitors. Following promising preliminary in vitro and in vivo results from these small molecules, including against cancer stem cells, Genoscience Pharma has decided to take the opportunity to make the difference in Oncology, especially in cancers where medical needs are still unmet. Furthermore, regarding the global Coronavirus crisis, they have initiated a clinical project for  COVID-19 infection linked to its mechanism of action, related to hydroxychloroquine hypothesis.

Now, Genoscience Pharma is a clinical stage biopharmaceutical company focused on translating novel scientific insights into medicines for patients with cancer.

What's your role in your company?

I'm the Quality and Chemistry Manufacture Control Director. I'm in charge of managing all the development activities of new chemical entities from discovery to drug candidate.

Genoscience Pharma outsources all synthesis and manufacturing activities which requires a specific and intense overview of all subcontractors. As a consequence Quality Agreements serve as the basis for the contract with ours suppliers. I manage the quality relationships with all contractors in order to ensure that GxP are in force and adequately applied on our projects.

As Genoscience Pharma is the clinical trial sponsor, it has also developed its own quality system management to comply with regulatory rules.

What were the major pain points prior to using QualityKick?

Any quality system requires documentation implementation, and paper-based systems are rapidly invasive and hard to manage for a small company that has limited human resources that should be dedicated to science and operational activities for pharmaceutical development.

What were the reasons you decided to buy QualityKick?

We did a thorough research on web-based options for simple software which would allow us to implement an electronic documentation system. Our criteria were: simple tool, easy to use, to manage, with reaction review and control of our SOPs. The system should have "remote access" with no need of a full validation on site, which is time consuming and expensive, and should allow us to flexibly increase the number of users depending on the company’s growth rate. Of course, the cost should really be reasonable and linked to the number of users. At last, additional modules should be available for later implementation like Deviations, CAPA, Equipment's management.

By using QualityKick, which are the benefits for your company?

Having a simple tool for quality documentation management without having to spend a significant amount of full time equivalent on documentation. And having a tool which allows each collaborator to be really implicated in the lifecycle of the documentation with a tool that is easy to use: to read, write and review documents with a full tracking log of all the actions carried out within the system. Doing all of this paper-based would be very time consuming.

Discover how QualityKick could help your company, request a demo!

 

Núria Broo, Management Support

Helping management succeed every day.