by Matt Johnson

Nearly every business is now a digital business. There’s a seemingly endless demand for greater agility across multiple verticals, and it’s not limited to IT departments. Companies across a wide array of industries, including life sciences, are looking to adopt Agile practices in product development to become more customer-centric, improve quality, accelerate speed to market and improve team morale. 

Some companies in highly regulated environments are experiencing tensions within their organizations. Internal teams may worry that Agile’s focus on flexibility and speed are incompatible with the rigors of Good X Practices (GxP) compliance. Given the critical importance of delivering expected results in a regulated environment, they may fear that an Agile approach to product development increases their compliance risk. Conversely, other teams may worry that compliance constraints will impede their ability to develop and launch new products “at the speed of Agile.”

It doesn’t have to be that way.

No need to choose between agility and compliance

Point B has helped many clients in the most regulated industries move teams that are working under strict regulatory compliance to Agile development models. As a result, they’re able to move quickly in sync with customer needs and market dynamics while staying connected and on top of the latest regulatory requirements. No need to choose between agility and compliance; with Agile, they can have both.

With cell and gene therapy (C>) companies, compliance is not only a legal matter, it can also be a matter of life and death. The field is rapidly evolving and the systems and processes to support innovation are complex. Organizations need to be able to quickly adjust to changing requirements while maintaining the safety and integrity of the product above all else.  Additionally, C> companies are feeling increased pressure as new therapy approval processes are being accelerated. By creating partnerships across the organization and involving regulatory and quality teams early in the development lifecycle, Agile practices can enable teams to be more responsive and innovate more quickly without increasing risk. Across the life science industry, companies need to know that, as they adopt Agile models and practices, they’re not putting compliance in jeopardy.

Why some Agile transformations falter

Agile transformations can fall short in regulated environments when companies focus on execution without incorporating a holistic, risk-based approach to compliance. This is typically due to poor implementation planning upfront. It’s exciting to kick off an Agile journey but doing so without incorporating input from compliance or validation teams imperils the outcome. As one of the first steps in any Agile journey, it’s critical to identify how to incorporate traceability, accountability, and data integrity at the most detailed levels. The Quality organization must be involved in defining the strategy and the critical processes and procedures from the very beginning.

It’s worth noting that the founding principles of Agile are not at odds with prioritizing the right levels of quality assurance and validation in product development. In fact, the Principles Behind the Agile Manifesto assert technical excellence. In the case of a regulated environment, we take that to mean that a validated product is required before it can be considered “working” or “technically excellent.”

Taking a phased approach to Agile

We recommend taking a phased approach to Agile transformation—one that enables organizations with regulatory compliance or GxP contexts to preserve options and adapt frameworks to fit their needs. We tailor this phased approach to the strategic priorities and culture of the organization in a logical flow that integrates regulatory and compliance considerations:

  • Assess your organization’s needs—including compliance—and determine which Agile framework will best set it up for success.

  • Train your practitioners and stakeholders to ensure that they understand the values, principles, and best practices for Agile development.
  • Begin to activate Agile practices, adjusting operating models to incorporate aspects of your chosen Agile framework.
  • As part of the activation, collaborate with compliance personnel and subject matter experts to update SOPs and validation plans to stay true to compliance.
  • Identify relevant metrics for product development and team operations and leverage the data to mature and continuously improve business quality.

We find companies that take a phased approach are

able to maintain, and even scale, their regulatory compliance or risk-management coverage while moving toward greater business agility to generate value more quickly.

How a global biopharma manufacturing site went Agile

A phased approach to Agile development can help bring life-saving therapies to market in less time. We recently led an Agile transformation for a global pharmaceutical and biotech firm that wanted a more efficient model of operation for the manufacturing execution systems (MES) division of its cell therapy division. Stakeholders were concerned that an Agile framework might not work well with the rigor required for Good Manufacturing Practices (GMP).

We jumpstarted the transformation to Agile ways of working by coaching business and technology stakeholders and delivering a sustainable, scalable program covering the Agile framework. We created a customized Agile playbook and established an Agile Center of Excellence to enable teams’ continued improvement. As part of the Agile transformation, we formed cross-functional teams, including team members from the Quality organization to ensure validation plans and SOPs were in a position to enable Agile development processes. Our phased approach solved the challenges of making the transformation, which has improved the firm’s throughput in MES and given them the ability to successfully accelerate operational changes. Their Agile transformation has met their needs to quickly scale to increase development capacity, increase the frequency of releases, and accommodate late requirements or shifts in priorities.

Put people at the center of your Agile transformation

The Agile Manifesto’s first principle is “individuals and interactions over processes and tools.” And change is not imposed from the top; Agile democratizes work by moving decisions to the people who are closest to that work. This puts people at the center of any Agile transformation, with business teams and compliance teams working in partnership to deliver a great product to your customers. In this spirit, success is not in spite of compliance; it’s in partnership with compliance.

In our experience, a phased approach to Agile can identify and empower the people best positioned to drive change and build a sense of ownership through new ways of working together.

The bottom line 

Because of its popularity, its legendary success stories and the ubiquity of digital transformation in our world, Agile has become a buzzword.  While it’s important to be empirical in adopting Agile, in regulated GxP environments it’s also critical that compliance is involved in the strategy and critical processes are built in and validated at a cadence that delivers successful and valuable products to your customers. In some cases, being customer-centric may mean changing and even saving lives, and it’s critical to get it right the first time.