Christopher Cole

With a potential US government shutdown looming, Megha Sinha, Kamet Consulting, discusses the impacts on pharma manufacturing and development.

How a Government Shutdown Causes FDA Inspection Bottlenecks and Backlogs

In this part 1 of a 2-part video interview on the impacts of a government shutdown on pharmaceutical manufacturing and development, Megha Sinha, CEO, Kamet Consulting Group, discusses the complex logistical challenges teams face during a resulting FDA shutdown. She clarifies that a shutdown is typically a slowdown rather than a total stop, but one in which predictability drops significantly, creating downstream delays for new submissions and manufacturing changes.

Sinha categorizes the immediate risks to the industry into three specific areas: inspection schedules, agency responsiveness, and backlog behavior. She notes that while mission-critical safety work and core reviews funded by user fees often continue, the "operational glue"—such as meeting coordination and administrative processing—becomes severely constrained. According to Sinha, "The fastest way these type of shutdowns can turn into supply risk is through inspection and response bottlenecks."

What Are the Manufacturing and Clinical Constraints?

For manufacturers and clinical trial sponsors, Sinha says the challenges are often physical rather than administrative:

• Onsite Inspections: Facility readiness and site travel become the primary "gating factors" for approvals.

• Prioritization: Routine inspections are often reduced to prioritize high-risk or "for-cause" activities, leaving those waiting for pre-approval inspections in a state of uncertainty.

• Lot Release: Even for high-priority items like biologics and vaccines, the processing cadence slows as staffing and time become constrained.

What Are the Industry Impacts Upon Reopening?

The most significant takeaway from Sinha’s analysis is that the end of a shutdown does not mean an immediate return to normal. Sponsors will likely experience a loss of cycle time and friction in regulatory communication that persists long after funding is restored.

As Sinha summarizes, "the net is that the biggest manufacturer risk isn't that the FDA disappears. It's the queue that will start to form, and the recovery period really after reopening can… be as disruptive as the shutdown itself." This backlog creates a "ripple effect" that can impact approval decisions and supply chains for months.



Watch Part 2 of this interview about treating FDA disruptions as predictable risks by protecting milestones and early readiness!

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



Hi, I'm Megha Sinha, CEO of Kamet Consulting Group. At Kamet, we support life sciences teams through high-stake changes, so acquisitions and divestiture transformation and technical advisory. I bring 17-plus years across industry and consulting, including eight years at PWC.

Yeah, so I think we need to think slow down, not total stop, but the predictability is going to drop. So, many ongoing reviews that FDA has can continue because that really heavily relies on user fees and carryover funding for core review work. But the really big breakpoint will be that US FDA generally would not accept new fee-bearing submissions during a lapse in appropriations, which will form a queue that can cause downstream delay

For clinical trials, missions critical safety work will continue, but really the non-urgent interaction—so think of, you know, any setups of the meetings, follow up—that can be constrained as the staffing shifts.

And then for manufacturing changes, the risk is really less about the paperwork, but what is really needed to close it out. So, if there is any onsite inspection required, facility readiness verification, site travel, that will become really the gating factor for manufacturers.

So, for approvals really in progress, a short shutdown may be absorbed, but really the shutdown creates this backlog, and that's the effect you'll see after reopening. And you know, I think as you may be seeing in the news, right, there's some bills that are already passing, so there might be still funding available; it's just, you know, which part of the FDA gets that funding, which will be the high-critical items.

So, the fastest way these type of shutdowns can turn into supply risk is through inspection and response bottlenecks. I would really categorize the immediate risk clusters into three pieces. So, it's the inspection schedule, it's the agency responsiveness, and it's the backlog behavior.

First, in case of inspection, in a shutdown scenario, FDA staffing and travel can be constrained. So, the routine inspection may be reduced while the higher-risk or for-cause activity will be prioritized. And this can create uncertainty around pre-approval inspection or follow ups, which can be a critical path for certain approvals and for sure manufacturing changes. So that's going to start to impact the manufacturers who are waiting for that.

Secondly, regulatory communication. So even when the review work is continuing under the user fee carryover, the operational glue—so, think of meeting coordination, really rapid back and forth with the agency, administrative processing—these will all get constrained. So, this is where sponsors will start to feel real friction because you start to lose cycle time and delay in approval decisions.

Third, with respect to lot release and release-related interaction, for certain biologics and vaccines, lot release activities are obviously higher priority than routine work, but because of the staffing issues, the processing cadence can still slow down, because staff and time gets constrained.

So, really the net is that the biggest manufacturer risk isn't that the FDA disappears. It's the queue that will start to form, and the recovery period really after reopening can just be as disruptive as the shutdown itself.

Videos

A government shutdown impacts pharmaceutical manufacturing and development by creating logistical challenges, particularly with the FDA. While critical safety work continues, the predictability of operations decreases, leading to delays in new submissions and manufacturing changes. Key risk areas include inspection schedules, agency responsiveness, and backlog behavior. Manufacturers face physical constraints, such as facility readiness and site travel, affecting approvals. Even after reopening, the backlog and disrupted regulatory communication can prolong recovery, causing a ripple effect on approval decisions and supply chains for months.

Geneva / Switzerland - February 23, 2020: sign and logo of The World Health Organization (WHO/OMS) and UNAIDS | Image Credit: © hectorchristiaen - stock.adobe.com

United States’ withdrawal from the World Health Organization (WHO) on January 22, 2026

 marks a significant shift in global health governance. While WHO expressed regret over the decision,

 the move is rooted in U.S. allegations of organizational failure and politicization. This withdrawal is not merely a political event; it signals potential disruptions to global regulatory alignment, supply chain stability, and international research collaborations. “From a pharmaceutical manufacturing and development perspective, a US withdrawal from WHO would primarily be felt through regulatory fragmentation and loss of alignment, rather than any immediate operational shock,” notes Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Sciences.

WHO responded to the US notification by highlighting the country's historical role as a founding member that contributed to the eradication of smallpox and progress against threats like polio, HIV, and antimicrobial resistance.

 WHO countered specific US claims with the following points:

• Refuting "Failures" in COVID-19: The US cited "WHO failures" and the "concealed" obstruction of information during the pandemic as a primary cause for exit. WHO defended its record, stating it activated its emergency system on December 31, 2019, and alerted the world through formal channels by January 11, 2020.

• Impartiality vs. Politicization: The US claimed the WHO pursued a "politicized, bureaucratic agenda."

 WHO maintained that it remains an impartial UN agency governed by 194 member states, existing to serve all countries without "fear or favour."

• Sovereignty: Addressing claims that it compromised US independence, WHO noted that while it recommended tools like vaccines and masks, it never recommended mandates or lockdowns, leaving those decisions to sovereign governments.

WHO warned that this withdrawal makes both the US and the world "less safe."

 The decision will be reviewed by the WHO Executive Board in February 2026 and the World Health Assembly in May 2026.

Why US Withdrawal From WHO Matters to Pharma Professionals?

Drug development, manufacturing, regulatory compliance, and supply chain management all rely on international stability and standardized frameworks to bring therapies to market efficiently. “WHO actually plays a critical, but often under-appreciated, role in providing global reference standards, technical guidance, and convergence frameworks, particularly for GMP, quality systems, pharmacovigilance, and essential medicines,” Johanning adds. “For industry, that translates into increased complexity: parallel regulatory narratives, more conservative development strategies, duplicated justifications, and higher friction when moving products across markets.”

 on pharmaceutical registration. The US withdrawal could lead to a divergence between US standards and those set by WHO and other international bodies. Such fragmentation complicates 

, as manufacturers may need to adhere to 

A critical concern for drug discovery and R&D teams is the proposed Pathogen Access and Benefit Sharing system.

 This system, part of the WHO Pandemic Agreement, is designed to ensure the rapid sharing of pathogens with pandemic potential to facilitate the development of vaccines and therapeutics. By withdrawing, US-based pharmaceutical companies might lose streamlined access to global pathogen data, potentially slowing down the 

 processes that the industry is currently prioritizing to 

The pharmaceutical industry is already sensitive to 

; even the threat of tariffs can rattle drug supply chains. The US exit from a central global health body adds a layer of geopolitical uncertainty that can complicate 

 for APIs and excipients. “In highly regulated environments, uncertainty itself becomes a cost driver,” says Johanning.

WHO coordinates global efforts against antimicrobial resistance and infectious diseases.

 For companies specializing in anti-infectives or vaccines, the loss of US involvement in WHO-led initiatives may shift the landscape for clinical trial sites and international procurement through organizations like WHO.

Industry professionals should view the US withdrawal as a catalyst for potential regulatory and operational volatility. As the industry shifts toward "agentic AI" and "sustainable efficiency," the loss of a unified global health framework may require firms to invest more heavily in independent regulatory intelligence and diversified supply chain strategies to manage the fallout.

“In the short term, most companies will continue to operate against FDA, EMA, and ICH requirements as before,” concludes Johanning. “The longer-term concern is whether reduced US engagement weakens global harmonization efforts at a time when supply chains, development programs, and manufacturing networks are more interconnected than ever. Interdependency and interconnections are key here; fragmentation anywhere ultimately creates friction everywhere.”

WHO Statement on Notification of Withdrawal of the United States

Articles

The United States' withdrawal from the World Health Organization (WHO) marks a pivotal change in global health governance, potentially disrupting regulatory alignment, supply chain stability, and international research collaborations. WHO countered US allegations of organizational failure and politicization, emphasizing its impartiality and historical contributions. The withdrawal could lead to divergent standards, complicating quality assurance and control in the pharmaceutical industry. It may also hinder US-based companies' access to global pathogen data, affecting drug discovery and development. The industry must prepare for increased regulatory and operational volatility.

US WHO withdrawal triggers pharma regulatory and supply chain risks while impacting global R&D collaborations.

US Withdrawal From WHO Creates New Pharma Logistics Vulnerabilities

 has been the voice for practical, real-world strategy. We make complex breakthroughs professionally applicable, and we help drive advanced development and manufacturing every day.

Today, we’re taking our brand to the next level so we can strengthen our commitment to scientists, innovators, and C-suite leaders who trust us for science-driven insights for faster and smarter manufacturing of safe, effective, successful therapies.

For nearly 50 years, we’ve officially been 

. You do, too. Everyone does. Why? It’s precise. Gets right to the point. It aligns with our approach to the industry and what you expect from us.

We earned our place as the market leader by creating uniquely expert content and engaging media platforms. Through 2025, we developed a bold, new look, refined content strategy, and optimized digital experience. The design is incredible and we can’t wait for you to experience it.

Our content authority comes from alignment with top experts across the field. By staying united with key opinion leaders in pharma, we can deliver impartial and objective insights. Our renewed strategy elevates these stars, giving them the spotlight they deserve through bold, accessible content built for busy industry leaders. 

Call us humble. We earned #1, and we focus on excellence. But this industry is defined by competition. So, we’re putting on the gloves as the comprehensive leader in engagement with key decision-makers in pharma and biopharma. Reach, quality, and versatility—always.

We’re so excited to enter 2026 with this renewed focus. We hope you enjoy the new 

 experience, and we welcome any feedback you have. 

-Christopher Cole
Associate Editorial Director


PharmTech is enhancing its brand to better serve scientists, innovators, and executives in the pharmaceutical industry. With nearly 50 years of experience, PharmTech is known for its precise and practical approach to pharmaceutical technology. The company is introducing a new look, refined content strategy, and optimized digital experience to increase engagement. By collaborating with top experts, PharmTech aims to provide objective insights and elevate industry leaders. As a market leader, PharmTech is committed to excellence and competition, focusing on reach, quality, and versatility.

We're embracing who we are, magnifying engagement for scientists and innovators, personifying expertise for science-driven insights, and taking our brand and your business to the next level. Welcome to the renewed PharmTech.

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

M4Q(R2) Draft Guidance | Created with Canva

FDA has released a draft of the guidance document “M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (1). The guidance is being distributed for public comments through March 23, 2026. Information on how to ensure FDA considers a comment on the draft priorto beginning work on the final version can be found 

The M4Q(R2) draft guidance is a globally harmonized framework developed by the International Council for Harmonisation (ICH) that establishes the location, structure, and granularity of quality information for medicinal product registration applications (2). Endorsed in May 2025, it applies to all medicinal products for human use, supporting initial marketing authorizations, post-approval changes, and master file submissions. Its primary goal is to ensure that safe, effective, and high-quality medicines are developed and maintained efficiently by standardizing regulatory expectations across global regions.

How is quality information structured under the M4Q(R2) framework?

The guidance organizes quality information into two complementary sections: Module 2.3 (Quality Overview) and Module 3 (Body of Data) (2). Module 2.3 provides a comprehensive, science- and risk-based evaluation of the medicinal product and serves as the primary basis for regulatory assessment. It includes general information, overall development strategies, and core quality information, which covers the essential data necessary for marketing authorization and lifecycle management. Module 3 acts as a repository for the detailed technical descriptions, methods, and supportive data that validate the summaries provided in Module 2.3.

A central feature of this update is the DMCS (Description, Manufacture, Control, and Storage) model. This standardized structure is applied to all materials within the medicinal product, including:

• Drug substances and substance intermediates.

• Excipients, starting materials, and raw materials.

• Drug products and product intermediates.

• Medical devices and packaged medicinal products.

By utilizing this four-pillar structure, the guidance ensures information is presented with enough granularity to facilitate digitalization, easy knowledge management, and efficient regulatory analysis.

How does the guidance address development strategies and product lifecycle management?

The guidance emphasizes a holistic overall control strategy that addresses the manufacturing process from initial starting materials to the final packaged drug product. Applicants must provide a quality target product profile and identify critical quality attributes to demonstrate how their development strategy ensures intended quality. This is supported by Section 2.3.4 (Development Summary and Justification), which provides science-based rationales for key development choices, such as the selection of manufacturing processes, container closure systems, and analytical procedures.

Furthermore, M4Q(R2) is designed to be highly flexible, accommodating emerging technologies and novel processes that impact product quality. This includes the use of:

• Advanced manufacturing and continuous manufacturing processes.

• Bioinformatics and advanced analytical tools.

For ongoing product maintenance, the guidance integrates lifecycle management concepts from ICH Q12, such as the identification of established conditions and the maintenance of a product lifecycle management document. These tools allow for more efficient post-approval changes by defining specific reporting categories and change management protocols. For complex regulatory pathways, an optional section for product quality benefit–risk considerations is included to help mitigate uncertainties related to evolving product knowledge.

Guidance Document: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

The FDA has released a draft guidance document, M4Q(R2), for public comment until March 2026. Developed by the International Council for Harmonisation, it standardizes the structure and granularity of quality information for medicinal product registration. The guidance organizes information into two sections: Module 2.3 (Quality Overview) and Module 3 (Body of Data). It introduces the DMCS model for structuring information and emphasizes a holistic control strategy for product lifecycle management. The framework accommodates emerging technologies and integrates lifecycle management concepts from ICH Q12 for efficient post-approval changes.

The draft, focused on quality information for medicinal product registration applications, was released to allow for public comments through March 23, 2026.

FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use

In recent weeks, the global political and economic landscape has been jolted by the high-stakes standoff involving the United States, the European Union, and the strategic territory of Greenland. President Trump issued a startling ultimatum: he would impose a 10% tariff on imports from eight European nations—Denmark, Germany, France, the UK, Norway, Sweden, the Netherlands, and Finland—unless they supported his plan for the United States to purchase Greenland (1). These levies were scheduled to rise to 25% by the summer of 2026 if a deal was not reached.

The threat sent shockwaves through highly regulated sectors, particularly the life sciences. 

 Editorial Advisory Board member Henrik Johanning, Senior Vice President at Epista Life Science, voices the concerns of many industry leaders regarding the potential for massive supply chain destabilization. He warns of the operational risks, stating, “The pharmaceutical industry depends on deeply integrated US-EU cross-border flows of, for example, APIs, intermediates, equipment, and specialized services. Tariffs driven by geopolitical negotiations risk destabilizing already validated manufacturing and sourcing supply chains that cannot be reconfigured quickly without regulatory burden, increased cost, and delays to innovation and ultimately patient access.”

Johanning further emphasizes that drug development and manufacturing are "highly dependent on cross-border flows" between the US and Europe, and that introducing trade barriers for political leverage created material uncertainty for complex global networks.

European Resistance and the "Trade Bazooka"

European leaders did not remain passive. The European Commission pointed to its Anti-Coercion Instrument (ACI), often referred to as a "trade bazooka," which allows the EU to retaliate against economic blackmail with its own tariffs and restrictions on services or capital markets (1). While UK Prime Minister Sir Keir Starmer sought to avoid a trade war, stating that such a conflict was "in nobody’s interests," the EU indicated it would do "everything necessary" to protect its interests.

Johanning notes the local tension in Denmark earlier this week as the rhetoric escalated. “Trump is on everyone’s lips these days in Denmark,” he noted on January 20. “From a Danish perspective, last week’s meetings in Washington (2) between the foreign ministers were generally seen as constructive and pragmatic. That said, it appears the situation is now being framed rather differently by Trump himself.”

The tension reached a crescendo during the World Economic Forum in Davos, Switzerland on January 21, 2026. President Trump delivered a special address, characterizing Greenland as a "core national security interest" and a "big piece of ice" that only the United States could properly defend (3). He claimed that while he sought "right, title and ownership," he would not use force to acquire the island. He also teased the construction of a "golden dome" for North American defense, which he claimed would be built on Greenland's territory.

Following the speech, the Trump administration indicated it was backing away from the immediate threat of tariffs in favor of a "framework for a future deal" (4).

Despite the withdrawal of the tariff threat, Johanning points out that the damage of such "tactical" maneuvers lingers. “What stood out to me in Davos was less the immediate policy substance and more the signaling,” he says. “The subsequent indication that the administration may be backing down on Greenland-related tariffs only reinforces how fluid and tactical this phase still is. For highly regulated industries like pharmaceuticals, that fluidity is exactly the challenge.”

How Could Europe Respond to Trump's Greenland Tariffs?

A Look at the Strategic Importance of Greenland as Trump Escalates Threats

Davos 2026: Special Address by Donald J Trump, President of the United States of America

Trump Says He Won’t Impose Tariffs After Reaching Greenland Deal ‘Framework

The geopolitical tension involving the US, EU, and Greenland has created significant uncertainty, particularly impacting the life sciences sector. President Trump's tariff threats on European imports, linked to his proposal to purchase Greenland, risk destabilizing pharmaceutical supply chains. European leaders have prepared to counteract with their Anti-Coercion Instrument. The situation reached a peak at the World Economic Forum, where Trump emphasized Greenland's strategic importance. Although the immediate tariff threat has been withdrawn, the fluidity of geopolitical maneuvers continues to challenge regulated industries like pharmaceuticals.

Even the threat of Greenland-related tariffs rattled drug supply chains and uncovered industry vulnerabilities to instability. 

Pharma Industry Uncertainty in Wake of On/Off Greenland Tariffs

2025 Employment Survey Report | Created with Canva

1.0 Introduction: Gauging the Pulse of the BioPharma Workforce

This report provides a deep, comparative analysis of the bio/pharma employment landscape, offering critical insights into the evolving sentiment and stability of its workforce. Drawing on data from our 

 (2024 Survey)—conducted during Q4 2024—and our 

 (2025 Survey)—conducted in Q4 2025—this analysis dissects key trends across compensation, job security, employee satisfaction, workforce mobility, and industry outlook. By comparing these two periods, the report aims to construct a comprehensive and nuanced picture of the sector's human capital dynamics, identifying significant shifts in employee priorities and perceptions. This examination begins with one of the most fundamental aspects of the employer–employee relationship: financial compensation.



2.0 Analysis of Compensation and Financial Sentiment

Compensation remains a primary driver of employee satisfaction and a critical tool for talent attraction and retention. Its strategic importance cannot be overstated, as shifts in salary trends and employee perceptions of pay directly impact morale and stability. This section examines how salary adjustments and satisfaction levels have evolved between the two survey periods, revealing a workforce facing growing financial pressure.

A direct comparison of reported salary changes reveals a notable downturn in positive adjustments and a significant increase in pay decreases (Table I).


The data reveal a stark contraction in compensation growth: the proportion of employees receiving any salary increase fell from 55.65% to 38.64%, while the share of those experiencing a pay cut more than doubled, from 12.09% to 25.00%.

Mirroring the trend in salary adjustments, overall satisfaction with compensation has also seen a slight decline. In the 2024 Survey, a combined 54.84% of respondents reported being "fully satisfied" (16.13%) or "mostly satisfied" (38.71%) with their salary. In the 2025 Survey, this combined figure fell to 52.27%, with 15.91% feeling "fully satisfied" and 36.36% feeling "mostly satisfied." This erosion in satisfaction, though modest, aligns with the tangible decrease in reported salary gains. These compensation trends signal a tighter financial environment for employees, a factor that directly influences their sense of stability and job security.

3.0 Job Security and Perceptions of Market Stability

Job security is a critical indicator of both industry health and employee confidence. A workforce that feels secure is more likely to be engaged and productive, whereas rising insecurity can foreshadow increased turnover and diminished morale. This section assesses the changes in perceived job security and rates of involuntary job loss to gauge the stability of the biopharma employment environment.

The data reveal a significant erosion of confidence among employees. In the 2024 Survey, a majority of respondents (50.81%) felt their job security was "about the same" as the previous year. In the 2025 Survey, this figure decreased to 43.18%. More alarmingly, the percentage of employees feeling "much less secure" in their roles more than doubled, rising from 11.29% in 2024 to 25.00% in 2025.

This decline in perceived security is substantiated by a sharp increase in actual involuntary job loss. The percentage of respondents who reported changing jobs involuntarily within the past two years increased from 14.52% in the 2024 Survey to 27.27% in the 2025 Survey. This nearly two-fold increase confirms that the anxieties captured in the sentiment data are a direct reflection of tangible market volatility, such as layoffs or organizational restructuring.

The correlation between declining perceived job security and the steep rise in involuntary separations paints a picture of growing instability within the bio/pharma employment market. This is not merely a shift in sentiment; employee anxieties are demonstrably rooted in market realities. This growing instability in foundational job security compels a deeper look into what, beyond security, is now driving overall job satisfaction in a more turbulent environment.

4.0 Deep Dive into Job Satisfaction and Its Core Drivers

Beyond financial rewards and a sense of security, overall job satisfaction is paramount for fostering the innovation, productivity, and talent retention that the biopharma industry relies on. This section moves beyond security to explore overall satisfaction levels and, more importantly, the specific factors that contribute most significantly to a positive employee experience.

Comparison of Overall Job Satisfaction Levels

The data on overall job satisfaction present a complex picture of a polarizing employee experience. The percentage of "fully satisfied" employees increased substantially, moving from 14.52% in the 2024 Survey to 29.55% in the 2025 Survey. Simultaneously, however, the cohort of "not satisfied" employees also grew significantly, from 9.68% to 22.73%. This polarization is explained by the collapse of the middle ground: the share of "mostly satisfied" employees shrank dramatically from 53.23% to 29.55%. This suggests the workforce is increasingly divided into two camps—those who are thriving and those who are struggling.

To understand this dynamic, it is essential to examine what employees value most. Table II compares the top five drivers of job satisfaction from each survey, ranked by their weighted average score.

Analysis of Shifting Satisfaction Drivers

This comparison reveals a critical evolution in employee priorities. "Intellectual stimulation" remains the undisputed top driver of satisfaction in both periods, underscoring the importance of meaningful, engaging work in the bio/pharma sector. However, the most significant shift is the rise of "good work/life balance," which jumped from 5th place (3.82 weighted average) to 2nd place (3.91 weighted average) in one year. Conversely, the importance of extrinsic factors like "high salary" (weighted average fell from 3.61 to 3.33) and "job security" (weighted average fell from 3.72 to 3.48) has diminished. This reprioritization suggests that in a market characterized by increasing instability and diminishing salary growth, employees are shifting focus toward intrinsic, controllable factors like personal well-being over extrinsic rewards that now appear less attainable or secure. These shifting priorities are crucial for understanding the decisions employees make about staying with their current employer or seeking opportunities elsewhere.

5.0 Workforce Mobility and Attrition Risk Assessment

Understanding workforce mobility, including voluntary turnover and the underlying desire to leave, is crucial for assessing attrition risk and developing effective retention strategies. This section analyzes employee sentiment and behavior related to job changes to gauge the current and future stability of the bio/pharma workforce.

A comparative look at key mobility indicators reveals a workforce that is increasingly open to change, even if the explicit desire to leave has not grown:

• Voluntary job changes (past 2 years): The rate of voluntary turnover saw a slight increase, from 13.71% in the 2024 Survey to 15.91% in the 2025-2026 Survey.

• Desire to leave job (weighted average): The general desire to leave one's current job remained remarkably stable, with a weighted average of 2.52 in the 2024 survey and 2.53 in 2025.

 leave job (weighted average): This is the most telling metric. The weighted average for employees agreeing they "do not expect to leave" their job dropped from 3.51 in the 2024 Survey to 2.75 in the 2025 Survey, indicating a sharp decline in perceived stability and commitment.

• Desire to leave the bio/pharma industry (weighted average): Critically, the desire to exit the industry entirely has grown, with the weighted average increasing from 1.92 in 2024 to 2.16 in 2025.

The most critical finding from these data is the emergence of a high latent attrition risk. While the active desire to find a new job has not intensified, the psychological anchor holding employees in their current roles has weakened significantly. The dramatic drop in the expectation to 

 suggests a workforce that is more passive and opportunistic, potentially ready to leave if the right offer emerges. This points to a much higher risk of future attrition. Furthermore, the growing desire to leave the bio/pharma sector altogether suggests that the challenges that employees are facing may be perceived as systemic to the industry. Addressing this heightened attrition risk requires a focus on the internal factors that build loyalty, such as meaningful training and career development.

6.0 Training, Development, and the Emerging Skills Gap

Career development and robust training programs are key levers for enhancing talent retention, boosting engagement, and building organizational capability. In a rapidly evolving industry, they are also essential for addressing skills gaps. This section evaluates employee perceptions of these opportunities and examines how companies are perceived to be handling new challenges like digitalization.

Assessment of Career Advancement and Training

While the overall weighted average for career advancement opportunities held steady (2.54 to 2.56) across the two surveys, this top-line number masks a growing polarization in employee experience. A significant increase in the cohort who "completely disagree" that opportunities exist (from 27.64% to 34.15%) suggests that while some employees may feel supported, a larger segment now feels entirely stalled in their professional growth. On a more positive note, perceptions of role-specific training have improved slightly; the percentage of respondents who disagreed that sufficient training is provided fell from 51.22% to 43.18%.

New Challenges in Skills and Talent Management

Data from the 2025 Survey shed light on employee perceptions of how companies are adapting to modern challenges. The findings suggest that most organizations are seen as average at best:

• Bridging the digitalization skills gap: A majority of employees (52.27%) feel their company is merely "comparable to others" in this area. Nearly a third (29.55%) feel their company is "trailing behind."

• Attracting and retaining top talent: The sentiment is similar regarding talent management. While 45.45% believe their company is "comparable," a significant portion (27.27%) perceives their organization as "trailing behind" its competitors.

These internal challenges related to skills development and talent retention are intrinsically linked to employees' broader confidence in their company's future and the industry as a whole.

7.0 Company and Industry Outlook: A Forward-Looking Perspective

Employee sentiment about their company's performance and the industry's future serves as a powerful leading indicator of overall business confidence and workforce morale. A positive outlook can fuel engagement and loyalty, while pessimism can exacerbate attrition risk. This section analyzes and compares these forward-looking perspectives from the two survey periods, revealing a significant downturn in optimism.

Evaluation of Perceptions of Company Performance

When asked to predict their own company's business prospects for the coming year, employee optimism has fallen sharply (Table III).

The data show a pessimistic turn. The proportion of employees expecting their company's prospects to "increase" dropped from 43.44% in 2024 to 29.55% in 2025. Concurrently, the percentage expecting prospects to "decrease" rose substantially, from 14.75% to 25.00%. These results indicate a significant erosion of internal confidence in organizational performance and strategy.

Assessment of Overall Bio/Pharma Industry Sentiment

The pessimism is even more pronounced when employees consider the outlook for the entire bio/pharma industry (Table IV).

Confidence in the broader industry has deteriorated significantly. The percentage of respondents expecting the industry to be "better" in the coming year was nearly halved, falling from 43.55% to 22.73%. At the same time, those predicting the industry will be "worse" increased from 14.52% to 25.00%. The prevailing sentiment has shifted from optimism to a more cautious, if not pessimistic, stance, which provides a crucial context for the other trends identified in this report.

8.0 Conclusion: Synthesis of Key Trends and Implications

The comparative analysis of the 2024 Survey and 2025 Survey reveals a bio/pharma workforce navigating a period of significant change and uncertainty. Four key trends emerge that have profound implications for employers seeking to attract, retain, and engage top talent in the years ahead:

1. Eroding financial and security footing: The data clearly show a more precarious environment for employees. Declining salary satisfaction, coupled with a sharp drop in perceived job security and a near-doubling of involuntary job losses (from 14.52% to 27.27%), indicates that foundational elements of the employment contract are under strain.

2. A polarized employee experience: Job satisfaction has become increasingly polarized as the middle ground erodes. The proportions of both "fully satisfied" (up to 29.55%) and "not satisfied" (up to 22.73%) employees have grown, while the "mostly satisfied" cohort has shrunk. This suggests a widening gap in employee experience, driven by a renewed focus on core intrinsic motivators like "intellectual stimulation" and "good work/life balance," which has surged to become the second most critical driver of satisfaction.

3. Heightened attrition risk and industry exodus: While the active desire to change jobs has remained stable, the expectation among employees that they will 

 in their role has plummeted (weighted average dropping from 3.51 to 2.75). This signals a high latent risk of attrition. Compounding this is a growing consideration to leave the bio/pharma industry altogether, pointing to systemic challenges that transcend individual employers.

4. A waning outlook: A significant decline in optimism permeates the workforce. Confidence in the future prospects of both individual companies and the overall industry has fallen sharply. The percentage of employees who believe the industry will be "better" in the coming year was nearly cut in half, signaling that the workforce anticipates significant headwinds.

The biopharma employment landscape is experiencing significant shifts, as revealed by comparative analyses of 2024 and 2025 survey data. Key trends include declining salary satisfaction and job security, with involuntary job losses nearly doubling. Job satisfaction is increasingly polarized, with a growing divide between fully satisfied and dissatisfied employees. Attrition risk is heightened, with a notable increase in employees considering leaving the industry. Additionally, optimism about company and industry prospects has sharply declined, indicating a challenging environment for talent retention and engagement.

A comparison of 2024 and 2025 bio/pharma employment survey results indicates that industry professionals face eroding security, polarized satisfaction, and rising attrition risk.