Rapid Regulatory Shifts: How Medical Affairs Can Keep Up

Medical Affairs teams used to have weeks or months to respond to regulatory changes. Now they often only have days (or sometimes just hours).

This accelerating timeline was the central theme of "A Rapidly Changing Regulatory Landscape: What Medical Affairs Leaders Should Know," a webinar I moderated recently that was sponsored by BP Logix and the Medical Affairs Professional Society (MAPS) and featured panelists:

• Dr. Jethro Ekuta from Ascendis Pharma
• Dr. Michelle Chernock from Leaders in Medical Affairs
• Dr. Rob Kaper, former VP of Global Medical Affairs at Otsuka

As the discussion unfolded, one insight became unmistakable: Medical Affairs teams face simultaneous shifts across vaccine guidance, drug pricing policy, advertising restrictions, and research funding that are happening faster than traditional operations can handle.

The experts positioned Medical Affairs as evolving into strategic leadership roles, but here's the problem: these expanded responsibilities require operational capabilities that current tools (email workflows, spreadsheet tracking, manual approvals) simply cannot deliver. When vaccine guidance changes overnight or funding models shift suddenly, manual processes create the bottlenecks that prevent teams from executing their strategic mandates.

This post recaps key insights from the webinar and explains why the velocity of regulatory change has made purpose-built automation essential for Medical Affairs teams that want to drive organizational success rather than react to it.

The velocity problem

The most striking theme from our discussion was how the pace of regulatory change has accelerated beyond what traditional Medical Affairs operations can handle.

Dr. Chernock captured our current challenge: "The velocity of those changes seems to be very, very high lately, and Medical Affairs needs to react to that."

We're witnessing simultaneous shifts across multiple fronts:

• COVID-19 vaccine guidance overhauls requiring immediate educational material updates
• Proposed bans on direct-to-consumer advertising that could shift patient education responsibilities entirely to Medical Affairs
• Federal research funding cuts of 18-22% forcing new collaboration models
• Global drug pricing pressures demanding sophisticated market access strategies

Each change alone would challenge traditional Medical Affairs operations. Together, they expose the limitations of email workflows, spreadsheet tracking, and manual approval processes.

The strategic elevation of Medical Affairs

All three presenters positioned Medical Affairs as evolving from reactive support to proactive strategic leadership. Dr. Ekuta emphasized that Medical Affairs professionals must "transform their roles from reactive support functions to strategic drivers of organizational success."

This elevation brings expanded responsibilities that directly connect to the regulatory changes we're seeing:

The question is: can current operational infrastructure support this strategic evolution?

Where manual processes break down

Medical Affairs' strategic elevation creates a fundamental mismatch: expanded responsibilities require sophisticated operational capabilities, but most teams still rely on email workflows and spreadsheets.

The webinar experts highlighted three operational patterns that expose this gap:

• Speed and coordination challenges: Dr. Kaper's emphasis on "speedy market entrance" and global coordination becomes impossible when approvals flow through email chains. Dr. Ekuta's scenario of updating educational materials "overnight" for vaccine changes requires workflow automation that current tools cannot provide.
• Content management complexity: Whether it's vaccine guidance updates, DTC advertising restrictions shifting education responsibilities to Medical Affairs, or expanded scientific communication roles, teams face the same challenge - rapidly creating, updating, and distributing compliant content across multiple audiences and regions.
• Partnership and collaboration demands: Dr. Chernock's research funding insights and Dr. Kaper's global market access requirements both point to the need for systematic tracking of complex relationships, agreements, and progress across multiple institutions and stakeholders.

Each pattern exposes the same fundamental problem: strategic responsibilities that require real-time coordination, audit-ready documentation, and embedded expertise - capabilities that manual processes cannot deliver. This complexity makes clear why Dr. Ekuta emphasized "enable use of technology" as essential for building operational capabilities that match strategic responsibilities.

Building agile, compliant operations

Listening to these three experts, I identified a common thread in their recommendations: Medical Affairs agility requires anticipating regulatory changes rather than reacting to them, fostering cross-functional collaboration through systematic coordination, leveraging data-driven insights for strategic decisions, and maintaining compliance while accelerating response times.

As someone who builds software specifically for Medical Affairs teams, I see three critical implications emerging from their insights that will define the next generation of operations.

1. Teams need platforms they can reconfigure themselves when regulations shift.

2. Compliance must be foundational, not an afterthought.

3. Operational expertise must be embedded in workflows, not dependent on individuals.

Dr. Kaper's recommendations around global market access used to require dedicated specialists and complex project coordination. But when regulatory changes happen rapidly across multiple areas simultaneously, organizations cannot rely on individual expertise being available. The system itself needs to guide any team member through sophisticated processes, democratizing capabilities that were previously limited to specialists.

These insights directly inform how we approach software design at BP Logix. Rather than building generic workflow tools that require extensive customization, we focus on embedding Medical Affairs expertise into configurable platforms. The goal is enabling the strategic capabilities that regulatory changes demand.

This philosophy translates directly into practical solutions. Take publication management as an example. Traditional approaches rely on email chains and manual tracking that create bottlenecks when approvals are needed quickly, exactly the kind of operational failure that becomes critical when vaccine guidance changes overnight. PubPro addresses this by automating workflow routing and maintaining audit trails while allowing teams to reconfigure approval processes without IT intervention.

This approach of embedding domain expertise into configurable, audit-ready systems represents how Medical Affairs operations need to evolve to match their strategic importance.

The path forward

The regulatory landscape will continue evolving rapidly. Federal policies will shift, global market dynamics will change, and new compliance requirements will emerge. But the window for building adaptive operations is narrowing.

The regulatory changes our panelists described represent the new normal, not a temporary disruption. Medical Affairs teams that wait for the pace to slow down will find themselves permanently behind. The teams thriving three years from now will be those that can reconfigure workflows overnight, maintain audit trails automatically, and execute sophisticated processes without relying on individual expertise.

The transformation from reactive support to strategic driver has become inevitable. Your team will either lead this evolution or struggle to catch up.

Want to watch the webinar? Access the full on-demand recording of A Rapidly Changing Regulatory Landscape: What Medical Affairs Leaders Should Know on the MAPS Knowledge Center.

Ready to build Medical Affairs operations that can adapt overnight to regulatory changes? Contact BP Logix to learn how PubPro and Approvia solutions help teams reconfigure workflows without IT dependency.