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Your Subscription to Digitalization

October 15, 2019

Gene therapy is revolutionizing medicine. With a potentially faster path to approval than traditional drug discovery, it is critical for life science companies to embrace digital transformation. Here at NECI we offer innovative solutions and extensive data management capabilities for customers in biotech and life sciences. Through our digital capabilities and ability to offer equipment subscription services, NECI helps customers save time, lower costs, and boost efficiency.

NECI primarily works on subscription models in the startup space, for customers with several open projects and little time or bandwidth to get them done. Our subscriptions are flexible: equipment and platform services can be adjusted to specific lengths of time. NECI also handles equipment calibration/maintenance and works with customers on a long-term relationship continuum. This subscription model enables startups to access state-of-the art technologies, run their manufacturing in a hassle-free way, and shift liability to NECI. It also allows for overhead cost decreases, while maintaining a competitive advantage in drug launch. Ultimately, customers have the flexibility to buy their equipment/services, or continue as a subscription over time.

Life science process development (PD) labs—which constitute part of late stage R&D—look to optimize manufacturing systems performance by identifying and developing new processes. Once developed, these process controls are implemented to ensure high quality products, produced in accurately reproducible and sustainable ways. In a PD lab, equipment produces vital data. One major drawback of PD labs is that while they budget for equipment and large systems, they often fail to get the right data systems in place. NECI has come across PD labs that have multiple data sources, work with flash drives, and use endless Excel sheets to chase data. There is real value in accessing data in the right format: with experimental overlays and batch-to-batch comparison. NECI works hard to switch company mindsets from paying capital for multiple, different systems to not buying anything at all. NECI believes that data should be treated as a utility with seamless access. We intervene by connecting various data sources for PD labs. This ultimately enables ease in data access, without rushing. In other words, NECI provides support throughout the lifecycle process—from PD all the way to product commercialization. For 20 data sources in a PD lab, it can take 2 months to fully cycle. NECI has helped companies switch to digital manufacturing for personalized medicine, enabling them to release batches in as little as 14 days. For clinical manufacturing, it takes 6-9 months full-cycle.

Here are some of NECI’s subscription equipment and services:

  • Replace and integrate bulky equipment/hardware that requires skilled workforce set-up
  • Replace hiring, training, and managing internal staff relating to operations and data management
  • Entire life cycle process handling, from early-stage PD to late-stage commercial manufacturing
  • All of which enables flexibility for both capital and operational purchases!

There are situations where companies may attempt digital transformation by themselves. However, in doing so they run a huge risk of losing valuable data. Even if initially successful, the critical step is manufacturing—which entails rigorous scrutiny by the FDA. Companies must provide evidence of data integrity (especially for fast-track drug approvals, a process that expedites drug development and review to treat rare/serious conditions and fill an unmet medical need). The FDA can conduct its own investigations to ensure 100% drug manufacturing processes compliance. If found lacking, there are serious consequences for a pharmaceutical company. In addition to regulatory processes and investigations cyber security is crucial when dealing with large data volumes from various sources. Cyber-attacks occur in absence of appropriate security measures and can be devastating. However, with NECI handling life cycle processes from early-stage PD to late-stage manufacturing and data analyses, all risks are borne by those with day-in-day-out experience.

From a user experience standpoint, data obtained through NECI is:

  • High quality
  • Instantly and easily accessible
  • Stored safely and securely
  • Easily retrieved and compared

NECI has garnered some of the best practices in the field. We’ve implemented those practices as data visualization agnostic of devices used to access it and notifications when experiments go awry. These added features cost, but come with any software upgrades included. NECI also has an adoption service, through which we conduct timely check-ins to ensure the best data and value over time. NECI’s subscription model is disruptive: it converts data to knowledge, which becomes process to products. It takes away a minimum of 30% data-chasing time, and translates into products getting to market faster. Ultimately, NECI’s early lifecycle process solutions subscriptions add ease and value to companies.