Navigating compliance strategy and day-to-day concerns

As companies face increasing regulatory scrutiny and resource constraints, compliance officers are tasked with making strategic decisions that prioritize enterprise-wide cultural elements while addressing day-to-day compliance concerns. The following is an excerpt from a recent panel discussion on the topic.

Daryl Kreml, Chief Enterprise Risk and Compliance Officer for Sage Therapeutics, emphasized the importance of investing in enterprise-wide culture. “If I have to choose between something that is enterprise wide, cultural, structural versus tactical, I’m going to invest in the enterprise culture,” Kremlin said. He argued that instilling core values of honesty, transparency, and accuracy throughout the organization will naturally lead to better compliance practices.

This approach, Kreml suggested, goes beyond mere policy enforcement: “We really have to get to the place where this is about are we doing what’s right for patients, both at a level that we believe, if we were the patient ourselves in the seat that we wouldn’t have, we’d be OK with the process that got the drug in us.”

However, allocating resources between tactical compliance issues and broader strategic initiatives remains a significant challenge. Eric Rogers, Vice President, Ethics & Compliance, Alexion RDU + AstraZeneca Japan, who transitioned from legal to compliance at Alexion, acknowledged the difficulty of this balancing act. “This is the hardest thing that we do,” Rogers admitted. “What do I want the focus of the group to be? I have this many people to deploy. I have these things I have to get done. Which things do I put focus on?”

Rogers highlighted the need for flexibility in resource allocation, noting that priorities can shift often. “It shifts year to year in terms of, as you look across the seven pillars, what’s weakest? What do you need to put some resources in? What is a one-year accomplishment versus a three-year accomplishment?"

Sara Blessing, Director, Compliance Counsel at Ionis Pharmaceuticals, echoed this sentiment, emphasizing the importance of strategic resource allocation in pre-commercial companies. “We’ve been an R&D company since 1989 so all of this is new to our executive team,” Blessing explained. “Some of the challenges are just as we develop a compliance program, a department really, not only starting from the ground up, but starting from folks at an executive level, where this is all new to them.”

Kreml offered a practical example of how to navigate these trade-offs: “Are we going to re-up the agreement with the fair market value vendor to improve our rates this year? I’m comfortable saying, if I have to trade-off and put that money somewhere else, I’m going to use last year’s rates and add 4% for inflation.” He argued that sometimes, it’s more valuable to allocate resources toward team presence in the field or at decision-making tables.

As compliance officers continue to wrestle with these challenges, a common theme emerges: the need for a holistic, strategic approach that balances immediate tactical needs with long-term cultural and structural goals.

Rogers summarized this sentiment: “We spend a lot of time thinking about what are the resources and what are the things that I think are most important that I can deliver for the company.”

By prioritizing strategic initiatives while maintaining vigilance on day-to-day compliance matters, these experts show how their role in shaping ethical, patient-focused organizations prepare them to meet the challenges of tomorrow.

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