A Disruptive Innovation in Automation
Digital transformation is a strategic imperative for life science companies. This process allows for businesses to accelerate R&D and bring advanced therapies to patients. It enables testing multiple platforms and products in parallel, and nimbleness in data acquisition, analyses, and visualization—thereby giving a competitive edge to those that adopt this technology. Data management becomes as critical as the drug itself when organizations start scaling up processes and move from R&D to manufacturing (a process called technology transfer). The agility with which a company performs tech transfer dictates its success in being able to release their drug within a competitive market.
NECI is a life science company dedicated to providing innovative solutions and operations management—all the way from product development to commercial manufacturing, without significant disruption to processes. Most life science companies have automated their processes. NECI integrates data from these processes and analyzes contextual environments, machines, employee workflows, LIMS, ERP, etc., thereby helping customers optimize technology transfer and lot release for human consumption. NECI serves as a thought partner, helping companies select systems and think through analytics to best utilize the information at hand to facilitate efficient manufacturing.
Depending on client needs in relation to their pipeline and growth, NECI has 3 distinct business models:
1. Personalized medicine development acceleration via digital transformation
There has been a recent industry shift, with more and more companies investing in personalized medicine. This means hundreds of thousands of different batches of drug product need to be developed, thus speed to market becomes critical. Personalized medicine harnesses each person’s clinical, genetic, and environmental information to base treatments and maximize outcomes. A patient’s own cells are isolated from the body, modified outside the body, then transferred back. This industry thinks and works digitally; instead of transforming into digital, everything has been built with digital in mind, from the ground up. Companies working in this field understand the value of digitalization, but many remain resistant.
With increased digitalization comes a dire need to manage patient data and run analytics. NECI has helped Cambridge, MA-based clinical-stage biotechnology companies speed development and production of personalized medicines, by implementing an automated and digitally-enabled clinical development facility. Through NECI’s technology and strategic support, one client observed a 40% reduction of reduced cycle and variability in labor and an 85% reduction in manufacturing deviations. The process production times were cut in half and manual processes eliminated. Most significantly, the client was able to reduce time for batch reviews from 3 days to 3 hours, and aims to go as low as 3 minutes by the end of 2020. Under this business model, there are 3 categories that NECI helps with:
- Technology transfer: scaling-up manufacturing processes, as a massive load of drugs is entering the market from one company.
- Chain of identity: traceability data or genealogy to ensure cells isolated from a patient are going back to the same patient, post modification.
- Release by exception: making an exception to release a product in the instance of a hiccup in the manufacturing process.
2. Digital maturity model
According to the digital maturity model, NECI helps clients reimagine what it would be like to go all-digital. These clients have automated their machines and processes, but are just starting to adopt data digitalization contexts and perform analytics. This relates to pipeline products as well as processes, to enable an overall successful market launch. NECI is currently working with a company in Portsmouth, NH on their operational management strategy. This includes how workers interact with machines and automation and approach data management, to help move toward optimal data processes. The general timeline to digitalize everything in a mature company is around two years. Technology alone can be digitalized in four months, but changing people’s mindset toward digital is the biggest challenge and the rate limiting factor. NECI helps by guiding the implementation of a change management process that helps create awareness, desire, and knowledge so people can ease into the process.
3. Consulting services
NECI also provides consulting engagement to companies, to set up projects and roadmaps. If a company has no digital maturity, it will take much longer to construct a roadmap for the whole facility, compared to doing it for one small part of the process development laboratory. In the latter case, it would take NECI 30 days to create a roadmap.
NECI is strategically building a business model for solutions capabilities that serve biotech and life science industry customers. This model is set-up to be a one-stop-shop for clients. NECI works with startup companies limited in cash flow, and offers them subscriptions to manufacturing plants and all equipment installation. Companies can buy NECI subscriptions and utilize services without having to stretch their bandwidth, increase their workforce, or get distracted in logistics. Thus, all FTE overhead costs are replaced by NECI’s operations management model in the cloud. NECI also offers platforms and services to help automate data workflows (manufacturing execution systems). Outsourcing to NECI speeds things up and gives companies an even more competitive edge.