Focusing on Compliance: Key Takeaways from the Pharma and Medical Device Panel at Porzio, Bromberg & Newman's Life Sciences Symposium

At a time when healthcare compliance demands in the life sciences industry remain complex, with an ongoing level of scrutiny from a public and governmental perspective, a standout session at Porzio, Bromberg & Newman’s recent Life Sciences Symposium brought together leading compliance professionals to share how they are evolving their approaches to meet the current environment and balance that with business needs. The conversation centered on building influence, collaborating with legal, engaging with leadership and board members, conducting effective risk assessments, and adapting compliance programs to align with global and cultural realities.

Moderated by Jennifer A. Romanski, Life Sciences Principal at Porzio, Bromberg & Newman, the panel featured insights from expert industry panelists representing different stage companies. With experience spanning pharmaceutical and medical device sectors, the panelists offered candid and practical strategies for embedding compliance into business operations—highlighting the function’s role as partner and trusted advisor.

1. Building Influence: The Role of Compliance as a Business Partner

Compliance professionals can be most effective when they act as ambassadors—leading from within and aligning their strategies with the organization’s business environment. A key theme of the discussion was the importance of fostering a speak-up culture rooted in transparency, collaboration, and trust, not fear. Rather than only creating policies, successful compliance teams recognize how to execute upon them in a compliant and “user-friendly” way. This includes the importance of explaining the “why” behind guidance and decisions, such as, for example, when guidance is tied to enforcement trends.

The panel also discussed relationship-building. Initiatives like informal office hours or open Q&A sessions are helpful tools for education, humanizing compliance, keeping an open dialogue, and allowing for questions and concerns to be raised. Trust grows when compliance is seen not as an obstacle, but as a resource that understands the business and works collaboratively to support it.

Compliance should be fully integrated into business processes, especially where companies identify areas of potential risk. Teams facing resource constraints were encouraged to use the business as a resource—engaging and collaborating with colleagues across departments to help manage risk and support a culture of compliance. 

2. Legal and Compliance: A Collaborative Relationship

Clarifying the distinct but complementary roles of legal and compliance within an organization can be challenging, but is important for effective collaboration. For example, legal may focus on defining certain risks and boundaries, while compliance can help operationalize controls within those parameters. When these functions align and are part of an organization’s leadership team, this effectuates a pathway toward clear and impactful guidance for the business.

The panel emphasized that organizational effectiveness can be affected when legal and compliance operate in silos. Regular communication, mutual respect, and aligned messaging are essential. 

3. Risk Assessment: A Living, Breathing Process

Risk assessments are most effective when they are ongoing, adaptive, and personalized. Static annual reviews may not necessarily capture real-time risks or emerging issues. Other options may include the use of a combination of techniques such as surveys, interviews, and other methods to gather data, understand the business, and routinely evaluate, prioritize, and address risk as appropriate.

A critical insight was that identifying risks is only half the job—knowing who is responsible for monitoring and addressing those risks, and whether they have the capacity and support to do so, is just as important.

4. Messaging Upward

With continued external expectations and guidance around board-level compliance oversight, how compliance professionals communicate with the board and company leadership (such as through a compliance committee) is important. It is not about overwhelming these important stakeholders with minutiae but should include strategic insight into ethical culture and risk trends.

Panelists stressed the importance of tailoring content to the audience, which includes not overwhelming with slides and materials, but focusing on high-level issues that may impact governance and long-term corporate integrity.

5. Training and Education: Targeted, Practical, and Empowering

Compliance training for company personnel can be enhanced with focused, behavior-driven learning. Bite-sized, scenario-based training modules can be effective. Additionally, programs that empower frontline managers to act as compliance champions can extend the reach and relevance of training efforts. 

There also is value in effectively partnering with external vendors who can deliver training in diverse formats that are suited to various learning preferences and needs. As there is no one-size-fits-all approach, considering each organization’s structure, business needs, risk/benefit analysis, and overall culture can be helpful.

6. Global Parent, Local Realities

Operating under a global parent company requires education and collaboration, along with the recognition that there can be differences in regulations, culture, and communication styles. At the local level, it is important that compliance teams help international colleagues understand U.S.-specific requirements—especially when local regulations and norms differ.

Final Thought

As the compliance function continues to evolve, success depends on adaptability, collaboration, and clear, consistent communication. Whether guiding culture, collaborating with legal, assessing risk, or navigating other complexities, compliance is not a back-office function—it is central to the success of a business.

The Life Sciences Symposium presented by Porzio Bromberg & Newman provided not just a snapshot of current challenges; it delivered a strategic blueprint for compliance professionals tackling data privacy, state transparency law compliance, investigations, and more to consider within their organizations and an ever-changing environment.

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