Travelers’ Jennifer Ampulski on Life Sciences Risk Trends

As part of our expanded coverage of our 2026 Life Sciences & Pharmaceuticals Power Broker® winners and finalists, Risk & Insurance® recently spoke with Jennifer Ampulski, Head of Travelers’ Life Sciences practice. Travelers’ is a sponsor of this year’s class of Life Sciences/Pharmaceuticals Power Broker winners. What follows is a transcript of that discussion, edited for length and clarity.

Risk & Insurance: Jennifer, thank you for joining us. You lead Travelers’ Life Sciences segment and have had a front-row seat to many shifts in the industry. What forces are shaping the life sciences landscape today?

Jennifer Ampulski: Life sciences companies are under pressure to innovate quickly, but they’re doing so in an environment defined by rising research and development costs, significant regulatory oversight and continued scrutiny on data integrity and patient safety. At the same time, scientific breakthroughs — including cell and gene therapy, personalized medicine and AI-enabled drug discovery — are accelerating the pace of development.

These opportunities come with operational and compliance considerations. Fragmented global supply chains, geopolitical uncertainty and the increasing reliance on contract research or manufacturing organizations are adding complexity. In the pharmaceutical industry, companies are navigating what’s known as the “patent cliff,” where large patent expirations expected over the next few years could materially affect revenue streams.

In our recent Travelers Special Report on mergers and acquisitions (M&A) in the life sciences industry — which examined five years of deal activity through our partnership with PitchBook, and included a survey of over 200 risk professionals — we saw how these forces are influencing strategic decision-making. Companies may turn to M&A not only to access new intellectual property or late-stage assets, but also to help build the infrastructure, distribution capabilities and manufacturing capacity needed to bring products to market more efficiently and at scale.

R&I: That’s interesting. What stood out to you about the M&A trends for life sciences  — and why should brokers be paying attention?

JA: One clear takeaway is that M&A remains a central growth strategy in life sciences. Over the past two years, the industry saw more than $150 billion in deal value, with transactions often driven by the need to access high-potential intellectual property, reinforce drug pipelines or scale next-generation manufacturing capabilities. Rising R&D costs and regulatory hurdles continue to push companies toward acquisitions as a way to accelerate development while managing risk.

Private equity is also playing an increasingly important role. While strategic buyers still account for the majority of deals, private equity firms have remained active across the sector, particularly in businesses with strong IP, scalable operating models and outsourcing capabilities such as contract research and manufacturing organizations. These investments can introduce new growth expectations and operational changes, which may alter a company’s risk profile in meaningful ways.

Consolidation is occurring nationwide, but larger transactions continue to concentrate in established life sciences hubs. The West Coast has accounted for the highest share of deal value, followed closely by New England, while regions such as North Carolina’s Research Triangle have also shown sustained activity. These patterns often reflect access to talent, research institutions and regulatory infrastructure  — all of which influence how companies scale and integrate.

Another important aspect is the operational impact of these deals. According to our survey, over 70% of companies experienced leadership changes, more than 65% saw employee resignations, and 76% implemented new tools or processes following a transaction. These shifts can introduce risks related to documentation, quality systems, data management and supply continuity. At the same time, it’s encouraging that 94% of respondents reported stronger risk management practices post-M&A, underscoring that disciplined integration can strengthen an organization over time.

For brokers, understanding not only the financial motivations behind a transaction, but also how ownership structure, geography and operational changes affect compliance and risk management is critical. M&A continues to reshape life sciences risk profiles, and advisers who recognize those dynamics early are better positioned to help organizations navigate transition without creating unintended gaps.

R&I: As life sciences companies move from R&D into commercialization, how does the FDA process itself become a risk management issue?

JA: As companies progress through the product lifecycle, the FDA approval process becomes increasingly complex and resource-intensive. Filing requirements are highly detailed, timelines can shift, and even small gaps in documentation or quality systems can lead to delays that affect revenue, investor confidence and long-term viability.

Research shows that many small to mid-sized life sciences companies underestimate how much internal structure is required as they approach FDA milestones. Hiring experienced regulatory staff, working with specialized consultants and maintaining compliant quality systems can strain budgets and internal teams, especially during periods of rapid growth.

From a risk perspective, delays or missteps in the FDA process don’t just affect timelines  — they can expose weaknesses in governance, documentation and operational readiness. Brokers who understand where a company is in the FDA journey can help anticipate these pressure points and guide conversations around how insurance and risk management strategies should evolve as the business scales.

R&I: Many life sciences products and therapies are highly regulated. What regulatory or oversight trends are having the greatest impact on companies right now?

JA: At the forefront is the continued focus by the FDA on product safety, efficacy and data integrity. The FDA continues to emphasize rigorous documentation, quality control and adherence to Good Manufacturing and Good Clinical Practices. As companies adopt advanced technologies – including AI – to support drug discovery or clinical trial planning, the FDA has also signaled that these technologies must be explainable and appropriately validated, with safeguards in place to help protect patient safety.

Another significant factor is HIPAA, especially for companies that interact with protected health information either directly or through research partners, clinical sites or technology platforms. HIPAA’s requirements around privacy, permitted uses and disclosures, data minimization and breach notification continue to shape how organizations manage sensitive information. As data flows between more parties  — especially in decentralized or technology-enabled trials  — the expectations around maintaining secure, compliant systems have only grown.

The Federal Trade Commission (FTC) is also playing a larger role, particularly in its enforcement of privacy, data accuracy and deceptive practices. The FTC has brought actions against companies that misrepresent how health or biometric data is collected, shared or secured, and has made clear that organizations handling sensitive biometric, wellness or diagnostic information will be held to a high standard. These expectations extend to claims made about AI-enabled products, including whether their performance is supported by scientific evidence.

Together, these regulatory forces reinforce the need for strong governance, transparent processes and clear documentation throughout the product lifecycle. Frameworks from agencies such as the National Institute of Standards and Technology (NIST), which address AI risk management and cybersecurity practices, can help organizations think through how to align innovation with oversight. As companies expand their pipelines, enter new therapeutic areas or integrate new technologies, aligning quality systems, data practices and compliance protocols early can help reduce friction and support successful growth.

R&I: Cyber risks in life sciences seem unique compared to other sectors. What should brokers be thinking about when advising these companies?

JA: Cyber risk looks different in life sciences because of the sensitivity and variety of the data involved. Companies are often managing proprietary drug formulations, clinical trial data, patient health information and manufacturing systems at the same time. A cyber incident can quickly become more than a technology issue  — it can disrupt operations, raise regulatory concerns and put intellectual property at risk.

This challenge is often magnified as companies grow. Many early-stage life sciences organizations operate with an informal culture and may not initially see the need for formal cybersecurity policies. As those companies scale, add partners and connect more systems, cyber exposure increases  — not just because the business is larger, but because loose controls can create gaps that bad actors can exploit.

The threat environment itself is also evolving. Attackers have more tools than ever, and healthcare remains one of the most targeted sectors. At the same time, companies are increasingly seeing cybersecurity requirements written directly into customer and partner contracts, including expectations around cyber insurance and incident response readiness.

Medical technology adds another layer of complexity. Devices are becoming more connected, which means vulnerabilities can potentially lead to bodily injury, property damage or financial loss. The FDA has formally defined “cyber devices” and set expectations manufacturers must meet. If those requirements aren’t addressed, companies can face delays in product approval and higher development costs.

For brokers, it’s important to recognize when a company’s cyber maturity needs evolve – particularly as contracts, regulators and partners begin to impose more formal requirements. They have the opportunity to help organizations step back and assess whether their cybersecurity practices match the sensitivity of their operations – ideally well before a cyber issue arises. That includes looking at access controls, incident response planning, vendor oversight and how cyber preparedness aligns with regulatory and contractual expectations. Starting with a strong risk mitigation framework and introducing appropriate cyber insurance can help life sciences companies build resilience as they grow.

R&I: Let’s talk about supply chain dynamics. How are supply chain challenges affecting life sciences companies?

JA: Supply chain resilience is top-of-mind. Many life sciences organizations rely on specialized components, cold-chain storage, sterile environments and precise manufacturing conditions. Disruptions  — whether caused by geopolitical shifts, material shortages or delays at contract manufacturing organizations  — can slow production, increase costs or delay time to market.

Our M&A report also surfaced integration-related challenges. Changes in suppliers, differing quality systems and fragmented documentation practices can create vulnerabilities if they’re not addressed early. Vertical integration, as seen in some recent transactions, is one way companies are mitigating risk by securing more control over their raw materials or production processes.

For brokers, the key is to explore where a company is most dependent on single-source suppliers or specialized vendors and understand how those dependencies might change during a growth event like an acquisition.

R&I: What global or multi-region exposures do life sciences companies face that brokers should be thinking about?

JA: Global exposure in life sciences often develops gradually, but it can become significant quickly as a company moves through different stages of growth. Early on, that exposure may come from international clinical trials, overseas suppliers or research collaborations. As companies commercialize products, it expands to include manufacturing, distribution, data management and employee activity across borders.

What makes life sciences unique is that global risk isn’t limited to where products are sold  — it’s embedded in how products are developed, tested and produced. Companies may rely on foreign suppliers for critical materials, conduct trials in multiple countries or operate highly specialized facilities outside the U.S. Each of those touchpoints introduces regulatory, operational and safety considerations that must be managed consistently.

Regulatory expectations can vary widely by region, particularly around product quality, patient safety, data handling and employee protections. A disruption or compliance issue in one jurisdiction can have downstream effects elsewhere, delaying approvals, interrupting supply or increasing scrutiny across the organization. That’s why global expansion requires careful coordination of documentation, quality systems and oversight.

For brokers, the key is understanding where global touchpoints exist across the company’s operations  — not just physical locations, but suppliers, trial sites, data flows and employee travel. Helping organizations identify those connections early allows them to better manage risk as they scale internationally, rather than reacting after issues arise.

R&I: With so much change occurring across the life sciences industry, how important is it for brokers to have a high degree of specialization in this sector?

JA: Brokers who have a deep understanding of both the scientific context and the regulatory environment in which these companies operate will be better positioned to offer industry-specific guidance. Life sciences organizations manage interconnected risks that span product liability, clinical trials, cyber, property, workers compensation and global operations. Advisers who can help companies see those linkages and think ahead about how growth or innovation may shift exposures play a critical role.

As companies evolve — whether through new product launches, geographic expansion or M&A  — there’s a need for clear communication, thoughtful due diligence and an understanding of how insurance structures should adjust. That could mean helping organizations prepare months in advance for change, rather than reacting after decisions are made. Brokers who ask detailed questions and stay engaged throughout those changes can help support more resilient and informed decision-making.

R&I: Finally, given the speed at which the life sciences sector is advancing, what steps can brokers take to stay current and excel in this space?

JA: Staying current in life sciences requires attention to scientific developments, regulatory updates and how those forces shape operational risk. Brokers who understand how a therapy, device or platform is developed  — and where the critical controls reside  — can better anticipate where exposures may shift as the business grows.

It’s also important to maintain a holistic view. Life sciences risks rarely exist in isolation; product liability, cyber, regulatory compliance, supply chain and workforce considerations are often interconnected. The ability to simplify that complexity and translate it into clear, actionable guidance is essential, particularly as companies move through periods of rapid change.

Finally, staying connected to broader industry and litigation dynamics helps brokers continue to deepen their expertise. Keeping up with reputable scientific and medical journals, along with FDA announcements, is one way to remain grounded in how the industry is evolving. Tracking current mass torts and other significant litigation trends also provides an important lens for brokers. Those who combine wide-ranging awareness with strong communication and analytical skills will be well positioned to support companies in this fast-moving sector. &