Guiding IBD treatment with PredictImmune

Project Overview

In December 2018, PredictImmune launched PredictSURE IBD™, the world’s first, truly validated and CE-marked prognostic test for guiding treatment options in inflammatory bowel disease (Crohn’s disease and ulcerative colitis). By using only a small blood sample, PredictSURE IBD™ tells clinicians the likely course of their patients’ IBD – differentiating between aggressive and milder forms of the disease.

PredictSURE IBD™ is an easy-to-set-up blood-based biomarker test, combined with a sophisticated algorithm to produce a disease risk score. Users submit the raw biomarker data…

… and receive rapid online test result reporting via a secure web portal.

PredictImmune chose Tier 2 Consulting, a Hertfordshire-based software development specialist with significant experience in the biotech industry, to work in partnership to design, develop and support the custom web portal element of the PredictSURE IBD™ offering.

Project Delivery Approach

The web portal was designed and developed within a structured project delivery approach, compliant with requirements of the ISO13485 quality standard for medical devices.

As well as Tier 2’s proven expertise in delivering high-quality custom web solutions, ability to comply with this quality standard was a key aspect of PredictImmune’s decision to work with Tier 2. This was validated through a formal audit process, covering all aspects of Tier 2’s design, development, testing, release and support processes.

Requirements Confirmation / Solutions Architecture

The first stage of the project was the completion of a Requirements Confirmation / Solutions Architecture Exercise, during which Tier 2 worked closely with PredictImmune to define and document a backlog of requirements in the form of user stories.

Tier 2 then developed a selection of screen mock-ups – to provide a visual interpretation of some of the main requirements, as well as to present initial branding and user experience concepts for review / rework.

The technical design aspects of this exercise paid particular attention to security requirements, such as how best to implement 2-factor authentication (2FA), and to ensure compliance with the OWASP guidelines for critical web application security risks.

In addition, the design included consideration of electronic record requirements, as defined in the FDA’s 21 CFR Part 11 guidelines.

Agile Web Development

Once the requirements had been finalised and signed off, this software development project was structured as a series of 2-week ‘sprints’ – with each sprint delivering working, tested functionality.

The benefit of this approach is that it encourages ongoing interaction between the development team and the business users, ensuring review and feedback throughout the development process – it is generally much more efficient to identify differences in requirement interpretation or detail throughout the development process, rather than at the very end.

On completion of all the development sprints, PredictImmune completed a formal User Acceptance Phase of the PredictSURE IBD™ solution – including detailed testing of the interface between the portal and the predictive algorithm software.

Phase 1 of the solution went into production in December 2018, with further changes, to support PredictImmune’s evolving business model, planned for 2019.

Ongoing Support

Tier 2 provides break-fix support for the production version of the PredictSURE IBD™ web portal.

The support service includes analysis and resolution of issues encountered by users – within a service level agreement which defines response and resolution targets for defects based on their criticality.

Technical Solution

The PredictSURE IBD™ web portal is a browser-based Web Application, designed to support leading browser versions such as Chrome. Our development team created the user interface (UI) in Angular, to provide a fast and responsive application – because there are no page refreshes, the user experience is a vast improvement over server-side rendered web applications.

The back-end comprises a set of micro-services developed in Java 11, Spring Boot, Spring JPA/Hibernate and Apache Commons.

• Resource services: provides application resources such as locale-based message bundle, images etc
• Admin services: provides CRUD operations to update and maintain Labs and Users (including registration)
• E-mail services: provides email operations integrating with a designated SMTP server or relay
• Document services: provides access to view / download / encrypt and decrypt documents stored on the local filesystem
• Test results services: provides access to the report view, handles IXO upload, report document download and integrates with the algorithm software via the SFTP server
• Security services: provides authentication against the users stored in the database and integrates with Twilio / Auth0 to provide 2-factor authentication

Apache HTTPD serves the angular Single-Page Application (SPA), and acts as a proxy for the Tomcat-based microservices.

About PredictImmune

PredictImmune aims to develop and commercialise a series of biomarker tests to guide physicians in the treatment of patients with immune-mediated disease, through prediction of long-term clinical prognosis. The first such test, for inflammatory bowel diseases, was discovered and developed in the laboratory of Professor Kenneth Smith, Head of the Department of Medicine at the University of Cambridge in collaboration with gastroenterologists at Cambridge University Hospitals NHS Foundation Trust and other UK NHS hospital trusts. His group has published on the underlying biology of the prognostic biomarkers that comprise the test, which also have relevance in other inflammatory and autoimmune diseases, including vasculitis and Lupus (SLE), where clinical research and development is ongoing in the Smith laboratory. Independent market research indicates that physicians, patients and payers will recognise the value of personalised treatment guidance in Crohn’s disease and ulcerative colitis. The company is currently progressing its Crohn’s Disease prognostic test towards CE mark registration within the European regulatory process and is engaging with payers to model potential health-economic impact.

About Tier 2 Consulting

Tier 2 Consulting helps organisations create custom software for web, mobile and enterprise applications – often including integration with 3rd party products and services.

We are experts in a core stack of industry standard software technologies and frameworks, and were the first UK company to be awarded Premier Middleware Partner status by Red Hat, the world’s leading provider of open source technology.

We use an agile development approach to promote evolutionary development and delivery, and to accommodate changing and evolving requirements – whilst ensuring that the approach can comply with more traditional project governance requirements.

We work across a range of industry sectors including biotech, insurance, automotive and legal, and our customer list includes well-known brands such as Suzuki, Ed Broking, Motability Operations, Lloyd’s of London, GlaxoSmithKline, and EY.