Innovate or Stagnate: Overcoming Model Governance Challenges in Life Sciences

There’s never been a more critical time for life sciences organizations to adopt strategies that help them strike a balance between mitigating risk and fueling innovation. AI has created a plethora of exciting opportunities for these organizations to drive breakthroughs faster than ever before. Unsurprisingly, 66 percent of life sciences companies are already using generative AI to enhance operations. This number will only continue to grow as more organizations leverage AI to bring new pharmaceuticals, medical devices, and other products to market faster. 

However, life sciences organizations operate in a highly regulated, high-stakes environment where safety must always come first. This is why having strong model governance is absolutely crucial. The AI boom has underscored just how important it is for organizations to have visibility and control over their data, especially as regulatory demands evolve and grow more stringent by the day.

Despite the availability of modern governance solutions, many life sciences organizations still take a largely manual approach to model governance. But this outdated strategy hinders innovation, creates silos, and is increasingly becoming unsustainable in today’s rapidly changing landscape. By treating model governance as a proactive, integral part of operations rather than a box to check after the fact, life sciences organizations can uphold compliance, better allocate their resources, and gain a competitive edge.

Let’s take a closer look at how life sciences organizations are handling model governance today, and how they can modify their approach for better business outcomes.

Adopt a risk-based approach

Generally speaking, life sciences industries like pharmaceuticals are highly risk-averse. It makes sense, too. When people’s lives are quite literally on the line, safety is paramount. But taking a calculated, risk-based approach — where organizations focus on the most critical risks to patient safety versus applying the same level of scrutiny across all aspects of their operations — is the best strategy for protecting patients and moving business initiatives forward. 

What does this look like in action? A risk-based approach can help pharmaceutical companies get drugs to market faster without compromising safety. Speed is the name of the game when it comes to drug development, and taking even one or two extra days to approve a model can have a significant financial impact. To put this into perspective, “blockbuster drugs” generate up to $2.7 million dollars per day, so adopting a risk-based approach that accelerates operations will in turn unlock massive unrealized financial potential.

Manage processes, not documents

Many life sciences organizations still rely on a combination of manual processes and disparate tools to enforce model governance: They have tools in place to manage process, like workflow orchestration and line of business tools, plus quality management systems (often Excel-based) to manage compliance.  The goal should be to go from managing documents and different tools to managing processes.

Embedding governance directly into the tools the organization relies on to execute processes enhances efficiency and — perhaps most importantly — provides increased visibility into their processes overall. This allows life sciences organizations to define their plan and approach for how they’re going to develop models/analyses, while being able to associate work efforts and generated artifacts with that plan. Additionally, life sciences organizations can document and attest that the process was followed to generate those work items. Eventually, this will auto-guide and constrain the process and next steps to ensure process alignment. 

Adopt automated solutions

Life sciences organizations may be hesitant or slow to adopt automated governance solutions because of preconceived notions about what it entails from a talent, budget, and time investment perspective. And, historically, automating model governance did require a good deal of time and resources. But modern solutions don’t demand organizations hire new talent or spend exorbitant amounts of time overhauling their infrastructure to experience the benefits of automated governance.

Today’s systems connect easily to an organization’s existing tools, providing automatic versioning, tracking, and reproducibility to ensure compliance. As a result, life sciences companies can more effectively allocate their resources since less time is being spent on manual governance processes. This frees up their talent to focus on making more impactful contributions to the business. 

Get the whole team on board 

Whenever an organization introduces a new way of doing things, it’s common to be met with some level of resistance. As life sciences organizations transition to a modern approach to model governance, it’s important they educate their teams on what the new strategy will look like. Model governance isn’t something to be feared or just another roadblock that will slow them down: It’s simply a process guardrail that will enable them to do their jobs more effectively and focus their energy in different areas.

Educating teams on the business’s rationale behind adopting any new technologies, and being transparent about how it will impact their day-to-day is key. Organizations should highlight the perks of automated governance: Get employees excited about how it will free them up to focus on things they actually like doing, whether that’s programming, AI development, or some other area.

Modern governance solutions are quickly becoming a necessity for life sciences organizations to keep up with changing regulations, maintain compliance, and support innovation. As AI continues to proliferate, the need for these solutions will only become more pronounced. Now is the time for life sciences organizations to rethink their approach to model governance so they can accelerate breakthroughs and bring life-changing innovations to market faster.

Picture: tuk69tuk, Getty Images

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