Dr Catherine Stace, Platform First Ltd
treatments to market (e.g. the pharmaceutical pipeline), and bolstering the industry through partnering deals or business acquisition. Many of these young ventures are ‘platform’ companies, exploiting a particular biological process to provide a specialist service or portfolio of products. The company relies on this core technology for its products, growth and value. A Biotechnology enterprise faces many challenges early in its lifecycle: proof-ofconcept, business model & investment, and scale-up – all dependent on a robust platform. Organisations exist to help with the funding and strategic aspects of commercialisation, but there is scant guidance for the practical tasks of translating an academic success into an industrial machine. During this crucial development stage, there is no technical roadmap to follow, and earlystage companies independently ‘reinvent the wheel’ as they each transition through the same challenges. The construction of the platform system is typically lead by specialist scientists, who have a deep knowledge of the science, but who usually are facing the design & assembly of a complex system for the first time. As the system gradually evolves in this highly-fluid environment, it is common to find disparity between business and technical needs, inefficiencies, and an increasing need for retrospective changes.
The Biotech industry is underpinned by a huge network of small enterprises, suppling the larger corporations with materials and methods to progress Preview Winter 2019
Nevertheless, Biotech is a highly successful industry, full of energy, ideas and intelligent people. It is no surprise that many of the fundamental techniques of SE are recognisable in biotechnology: technical processes such as integration, verification, validation
and information management are cornerstones of any good scientific pursuit in the laboratory, and SE management processes are commonplace in larger organisations. But the application can be piecemeal and disconnected, and rarely considered as part of an interdisciplinary engineering effort. Introduction of a generic framework should be a natural step forward and improve systems thinking.
I am now an INCOSE ASEP and for the last few years I have worked with small Biotech companies (typically <20 people) to help them enhance their core technologies through application of a basic SE methodology. It is during the early stages in the lifecycle – the Concept, Development & Production stages – where there is the greatest need and where SE can have the most impact on downstream prospects. The approach centres on tailoring SE for specific project type, and adopting methods that align with the existing skillsets of the team.
There are two particularly suitable entry-points for SE in this environment: The first is prior to the production of a platform, where the company is undergoing the ‘technology transfer’ phase as they translate the science into a commercial facility. The second, is once the initial platform is in operation, as the 23