Personalized medicine has redefined scaleup and manufacturing, focusing clinical innovators more closely on regulatory submissions’ chemistry, manufacturing, and controls (CMC) section. To speed technology transfer and patient access to breakthrough therapies, many research-focused companies are collaborating with CDMOs.
 
However, some industry leaders believe the traditional biologics CDMO business model limits agility, transparency, and risk management. In July 2020, a group of digital and biotech executives tested that theory by launching National Resilience, Inc. (Resilience), a CDMO with a mission to partner with innovators on tech transfer and manufacturing. It leverages digital and scaleup best practices to streamline the development of cell and gene therapies, nucleic acids, biologics, and vaccines.
 
Resilience is leading the pursuit of novel medicines by revolutionizing how they are made, funded, and scaled. Its model goes beyond transactional outsourcing, including formal risk sharing and other arrangements. As part of its 10-year partnership with AstraZeneca, for example, Resilience will supply therapies from the company’s plant in West Chester, Ohio, while they collaborate to develop new therapies.
 
Resilience continues to recruit digital experts and pioneers in precision medicine whose teams scaled up and manufactured some of the first commercial gene and cell therapies. They are also investing in better ways to help partners optimize CMC and regulatory submissions management across treatment modalities. The commitment helped Resilience grow from 15 to more than 2,200 employees in its first three years, driving a need to scale its GxP operations. 

Thinking Like a Tech Company

At first, Resilience had to manage quality, regulatory, and training programs on paper, says Tamara Redondo, senior manager of digital quality applications. This approach added complexity since the company is growing and adding new facilities, building capacity, and onboarding staff while managing legacy IT systems and equipment inherited through past acquisitions.
 
The fledgling CDMO tackled this challenge with a big biopharma mindset and a systematic, long-term approach to investment and technology. However, it has focused these efforts on standardized, interoperable components and secure, proven cloud-based solutions. To ensure consistency, its IT team evaluates solutions based on four criteria: functionality, interoperability, cloud friendliness, and security. Resilience also takes a data-driven approach to operations and aims for levels of customer focus and transparency that are still more typical in the tech world than in the life sciences industry.

Achieving a New Vision for Employee Training at Breakneck Speed

Resilience’s executive leadership team appointed a chief quality officer in 2021 when its tech teams began implementing a unified quality platform, which is now standard across all company sites. This initiative started with the training learning management system (LMS) and document management system (DMS). After rolling out the GxP training platform within three months, the implementation team moved on to a quality management system (QMS) with change control and deviation, corrective and preventative action (CAPA), and continuous improvement modules, which centralized data and vastly improved users’ ability to access data and reports.
 
Now, the central and site training departments work together as a community of practice (CoP). The synergy of the CoP is effective in developing a strategic business partner relationship across their network, says Tane Demo, corporate head of document records management and GxP training and development.
 
Demo initially thought Resilience’s new LMS was sparse but soon appreciated the LMS-DMS integration. This close connection between the two systems has improved her ability to plan, strategize, and make better fact-based decisions. “If we were using multiple systems, we couldn’t do this,” she says.
 
Once the documents and data were migrated from legacy systems, user adoption grew organically. With the new training system, CoPs developed global documents and training that apply across the network. Sites can also develop documents and assignments to supplement network processes when needed.  

Increasing User Adoption with Fillable Forms and Flexible Training

With a growing and increasingly remote workforce, Resilience gained an advantage from using fillable forms, which help automate web-based signing. The forms offer an alternative to Adobe Sign, or paper-on-glass approaches that eliminate the scans and emails that are usually required.
 
Some sites initially resisted change, preferring paper printouts or a standalone application, which created extra administrative work. To enable change management, Resilience’s central DRM and T&D facilitated sessions that walked users through the eDMS and key processes. “All of a sudden, users weren’t viewing the process from their point of view, but from the team’s,” she says.
 
Demo adds that users need to see the bigger picture and understand what’s in it for them when being trained or asked to adopt any new system. Sometimes, all that is needed is to demonstrate how the new platform will simplify the work they do every day.

Building Strong Partnerships and Scalability Are Crucial to Success

As Resilience’s GxP training program continues to evolve, Demo says the new GxP document, training, and quality management systems have helped speed the development of global procedures and set clear expectations. The improvements are empowering, and Demo encourages T&D members at all sites to be bold, start conversations early, and push back when other departments try to circumvent them.
 
This approach has helped the company’s quality and training teams forge stronger partnerships throughout the organization. “At Resilience, there has been a strategic opportunity for training that I’ve not experienced in other places,” says Demo.