Navigating Uncontrollable Challenges in Medical Affairs

In the life sciences industry, even the best-laid plans can be derailed by circumstances beyond a company’s control.

Regeneron Pharmaceuticals faced such a challenge on August 20, 2024 when the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) delaying the approval of linvoseltamab, the company’s promising treatment for multiple myeloma. This delay wasn't due to the drug's efficacy or safety profile — elements typically within the control of medical affairs teams — but rather stemmed from issues at a third-party manufacturing facility, a factor entirely outside of Regeneron’s direct control.

This situation highlights a crucial reality for medical affairs professionals: external factors can disrupt even the most meticulously executed plans. Despite having little to no control over these disruptions, medical affairs teams are often at the forefront of managing the fallout.

This article explores the types of challenges that can arise in such situations and discusses how strong communication and risk management strategies can help mitigate the impact of these external disruptions.

How external disruptions impact medical affairs

1. Regulatory delays due to manufacturing issues

In Regeneron’s case, the FDA’s decision to issue a CRL was driven by findings during a pre-approval inspection at a third-party fill/finish manufacturer. Despite Regeneron’s internal teams executing their roles effectively — achieving strong efficacy data and preparing a robust submission — the regulatory approval process was stalled due to external manufacturing issues.

• Impact on Medical Affairs: Medical affairs teams, while not directly involved in manufacturing, must manage the consequences of such delays. This can include adjusting timelines for product launches, re-aligning communication strategies with healthcare professionals (HCPs), and ensuring that any information about the delay is accurately conveyed to stakeholders.
• Key Takeaway: Proactive communication with regulatory bodies, HCPs, and internal stakeholders is critical. Medical affairs teams should be prepared to explain the nature of such delays, emphasizing that the drug’s efficacy and safety remain uncompromised, while managing expectations around new timelines.

2. Impact on product launch timelines

The delay in regulatory approval inevitably impacts product launch timelines. For a company like Regeneron, which was positioning linvoseltamab as a competitor in the blood cancer market, the delay not only postpones potential revenue but also affects market strategy, competitive positioning, and relationships with HCPs and patients who might have been awaiting this new treatment option.

• Impact on Medical Affairs: Medical affairs teams must navigate the reputational risks associated with delayed launches. HCPs, patients, and other stakeholders may express frustration or lose confidence in the company, regardless of the reason for the delay.
• Key Takeaway: Strong communication strategies are essential. Medical affairs teams should provide clear, transparent updates to all stakeholders, including details on revised launch timelines, to maintain trust and manage expectations.

3. Reputational risk and communication challenges

Regeneron’s situation also underscores the reputational risks that arise when external factors cause delays. The company now faces the challenge of maintaining its reputation as a leader in the oncology space while managing the perception of its manufacturing capabilities.

• Impact on Medical Affairs: Medical affairs teams are often the first line of defense in protecting the company’s reputation. They must ensure that all communications — whether with HCPs, patients, or the media — are consistent, accurate, and reinforce the company’s commitment to patient safety and product quality.
• Key Takeaway: Crisis communication plans should be in place to quickly address and mitigate reputational damage. Medical affairs teams should work closely with public relations and marketing departments to ensure that all messaging aligns with the company’s values and commitments.

4. Dependency on external partners

Regeneron’s reliance on a third-party manufacturer is a common scenario in the pharmaceutical industry. While outsourcing can be cost-effective and efficient, it also introduces risks that are largely out of the control of internal teams.

• Impact on Medical Affairs: Medical affairs teams must manage the consequences of issues that arise from external partnerships. This includes responding to delays or quality concerns that were not caused by internal processes but still impact the company’s ability to deliver on its promises.
• Key Takeaway: Robust risk management strategies are crucial. Medical affairs teams should regularly assess the risks associated with external partnerships and develop contingency plans for potential disruptions. This includes having alternative communication strategies and being prepared to address any concerns raised by HCPs or patients.

Mitigating the impact: The role of communication and risk management

The Regeneron case highlights the importance of strong communication and risk management strategies in mitigating the impact of challenges that are beyond the control of medical affairs teams. Here are some key strategies:

Proactive communication

• Regularly update stakeholders about potential risks and any steps being taken to mitigate them.
• Ensure that messaging is clear, consistent, and aligned across all channels.

Crisis management planning

• Develop crisis communication plans that include protocols for dealing with delays, regulatory setbacks, and other disruptions.
• Conduct scenario planning exercises to prepare for various challenges that could arise from external factors.

Strengthening external partnerships

• Build strong relationships with external partners, emphasizing the importance of maintaining high standards and clear communication.
• Regularly review and assess the performance of external partners to identify potential risks early.

Risk assessment and contingency planning

• Continuously assess risks associated with external dependencies and develop contingency plans to address potential disruptions.
• Ensure that these plans include clear roles and responsibilities for the medical affairs team in managing the fallout from any issues.

Mastering the response to external challenges

The Regeneron case serves as a reminder that even the most well-executed strategies can be derailed by factors beyond a company’s control. For medical affairs teams, the key to managing these challenges lies in strong communication, proactive risk management, and the ability to adapt quickly to changing circumstances. By implementing these strategies, medical affairs teams can help mitigate the impact of external challenges, protect their company’s reputation, and maintain the trust of HCPs, patients, and other stakeholders.

While medical affairs teams may not be able to control every aspect of the drug development and approval process, they can certainly control how they respond to challenges — and in doing so, play a critical role in the success of their organization.