Although medical research is currently deeply engaged in the study of human microbiomes, it is still a long way from a real understanding. The biopharmaceutical company Finch Therapeutics Inc. is a good example. Based in Somerville, USA, Finch is working to increase knowledge in the field of diarrhoea.
4 billion people affected and 7.5 million deaths worldwide each year
Diarrhoea can be a symptom of many diseases (e.g. infections, food poisoning, tumors). An estimated 4 billion people worldwide suffer from diarrhoea every year. 7.5 million people (especially children) die as a result.
Finch Therapeutics is active in the production of biotherapeutics from stool grafts for the treatment of chronic intestinal diseases (diarrhoea).
Under the leadership of Mark Smith, the team behind the young biopharmaceutical company, some 200-strong, has attracted impressive attention worldwide through the research and development of modern therapies with the help of human intestinal microbes and successfully completed a financing call in the amount of 36 million US dollars at the beginning of 2018.
In the search for a suitable Clinical Trial Management System (CTMS), which replaces Finch’s current landscape of various individual systems ranging from paper-based documentation to various standard IT solutions with a central IT system, the Americans decided in favor of the KAIROS product “CentraXX CTMS”.
CentraXX – Data protection made in Germany
In addition to the draw of implementing a centralized system, CentraXX also impressed Finch with its comprehensive data security, including the dedicated rights and roles concept and the ability to reliably separate personal identifying data from non-personal identifying data.
The system is scheduled to go live in September 2018, following training sessions for Finch employees by KAIROS GmbH in the use of XML and BIRT.
As its first step, Finch will use CentraXX CTMS for subject management (infiltration/administration), after which Finch will use CentraXX CTMS to support the SOP-controlled production of personalized – i.e. individual, tailor-made – drugs. CentraXX CTMS is – through the use of the CentraXX Validation Kit – an essential component of a valid overall system solution for which the company is seeking FDA approval.
KAIROS GmbH, a renowned IT company with experience in the development of software solutions for healthcare and translational biotechnological research, is pleased about a new and so far unique partnership. Finch Therapeutics Group, Inc. of Somerville, Massachusetts, USA, has completed its RFP phase and selected CentraXX from a dozen candidates for its central information management software to help manage complex clinical, biopharmaceutical and quality-related processes.
“Finch is delighted to commission KAIROS to develop and implement a Manufacturing Execution System on the CentraXX platform. The system’s ability to track the generation of samples from donation collection all the way to effective data is critical to us. We are confident that CentraXX will enable us to meet our GMP/GCP requirements while increasing the efficiency of our activities,” said James Sigler, Vice President, Finch Therapeutics Group, Inc.
The aim of this project is to provide a comprehensive scientific software solution that offers the “top of the class” functionality for Finch’s diverse user base. KAIROS has teamed up with Finch to support its growth and mission through the implementation of CentraXX to provide highly secure and available access, manage increasing workloads, monitor complex processes and gain new insights into the microbiome.
Martin Zünkeler, Managing Director and founder of KAIROS, confirms that the partnership “Finch Therapeutics is breaking new ground with the development of its microbial therapies. We are more than happy that they chose CentraXX to develop a fully validated solution that meets GXP standards. We are proud that our product and our continuous contribution to the project enable us to track the entire life cycle of donors and patients involved in working with Finch and document the manufacturing steps with the help of the integrated workflow engine.”
About Finch Therapeutics
Finch is a clinical stage biopharmaceutical company focused on the development and delivery of innovative microbial therapeutics. Their technical approach combines traditional techniques of drug development with the tools for the first human discovery that are unique in this field. As a data-driven and task-oriented team, they use machine learning to obtain molecular data from human intervention studies to build a clinically commented library of strains that advance specific clinical phenotypes that are of interest.
CentraXX, KAIROS’ flagship solution, is a breakthrough tool that enables companies to transform tissue, cells and samples into treasure troves. CentraXX enables its users to use new approaches in translational and personalized research, biobanking and live biologics production. This solution transforms throughout the process from data capture and management to a robust knowledge portal for complex workflows. CentraXX can create a complete knowledge transfer “from bench to bed”. This feature-rich solution aims to accelerate the pace of biotechnology and medicine in all its facets.