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2025 in Perspective: Reflections From Our Newest Colleagues

Every year brings new faces, fresh ideas, and inspiring stories to Cytel. In 2025, these colleagues joined us from across the globe, each bringing unique experiences and ambitions. As the year closes, we asked them to share what stood out, what they’ve learned, and how they see their work shaping something bigger. Their reflections tell a story of connection, growth, and purpose.

 

Joining Cytel: Memorable moments and settling in

For Kasum de Souza Mateus (Senior Biostatistician, FSP) the most memorable part of joining Cytel was simple yet meaningful: “Being able to meet colleagues and mentors in person.” That feeling of connection resonated with many new Cytelians, from Adish Jindal (Senior Recruiter), who described the joy of reconnecting with familiar faces, to Luke Hilliard (Event Manager), who fondly recalls a team meeting: “I really enjoyed the trip to Bruges. It was such a pleasure meeting everyone in person. We came away with some fantastic ideas that we’ve since put into action for our events.”

Others found their defining moments and success in challenges that brought people together. Kanchan Kulkarni (Manager, Accounting) stepped into her role during a major system transition: “One of my most memorable experiences has been leading the Global GL Accounting function across EMEA, APAC, and NA regions during our Oracle ERP transition. It wasn’t just about systems and numbers — it was about connecting people, aligning processes, and building something stronger together.” And for Scott Rogers (CFO), the most powerful moment came during a Town Hall: “I was very moved by the presentation where we heard directly from a patient and understood how our work helped him realize the benefits he was seeing.”

For Macarena Pazos Maidana (Senior Market & Business Development Manager) success came early: “During my third week, I successfully secured a key renewal with a major pharmaceutical client for the East Horizon™ platform. This achievement not only boosted my confidence but also reinforced my belief in the value our solutions bring to the industry.” And Hannes Engberg Raeder (Principal Biostatistician, FSP) found pride in collaboration: “I’m proud of having been able to support one of our partnerships through process improvements that helped strengthen collaboration and overall efficiency.”

 

Leaning on advice

Of course, starting something new means leaning on advice from colleagues or mentors, and some words of wisdom stuck. Nicole Sheridan (Manager, Talent Management) shared the famous mantra that shaped her approach: “’Do or do not, there is no try.’ It’s simple, but it completely changed how I think about my work and even life outside of work. I realized it’s not about being perfect but it’s about showing up, committing, and seeing things through. That mindset has really helped me take initiative, stay resilient, and turn ideas into results.

Damian Kowalski (Principal Statistical Programmer, FSP) emphasized collaboration: “Don’t be afraid to ask questions. Collaboration is our strength.” And Sydney Jenkins (Senior Employee Relations & Engagement Partner) shared a perspective that guides her work: “Trust your logic. That perspective reminds me to approach challenges with a clear, rational mindset, even under pressure!”

 

Growth and ambition

This year was not only about settling into their role for our new Cytelians, however. It also marked a year of growth and achievements. Adish honed his global recruitment expertise: “One skill I’m particularly proud of developing in 2025 is my ability to manage global recruitment processes more effectively.” Monica Chaudhari (Associate Director, Biostatistics, FSP) shared a technical milestone: “My first study that I got assigned to was already closed. To help myself support the team through database lock, review of final outputs and drafting of the CSR, I created a swimmers plot summarizing all important endpoints on each subject’s trajectory that helped identify major deviations.”

Valeria Duque Mora (Project Coordinator, Resource Management) reflected on teamwork: “My current team has made a real difference in my daily work. They are the foundation of our success, always supporting each other and sharing new information with kindness and collaboration throughout every process.” For Dominika Wisniewska (Senior Statistical Programmer, FSP), the impact was deeply personal: “I am grateful that Cytel gave me the opportunity to work directly for our client where I work on research within rare diseases and neurology diseases. I am particularly interested in neuro because of personal reasons, and I am happy to participate in maybe discovering new treatments.” And Sankhyajit Sengupta (Senior Statistical Programmer, FSP) embraced learning: “In this very short period of time (three months), I’ve had the opportunity to gain exposure to R programming in live studies and also completed required trainings on R, an important step as the industry is moving in this direction.”

Looking ahead, our new colleagues are already thinking about how to make an even bigger impact in 2026. Kanchan hopes to drive automation and efficiency, Luke dreams of organizing a standalone event, and Ye Miao (Associate Director, Biostatistics, FSP) plans to deepen expertise in R programming to contribute more effectively to data analysis and reporting tasks in his FSP role. Sydney aims to strengthen policy awareness and consistency across the organization, while Macarena is focused on enhancing client retention and satisfaction. Each goal reflects a commitment to making an even bigger impact in year two.

 

Connecting to the bigger picture

Every role at Cytel connects to our mission of improving patient lives. Adish summed it up well: “As a Global Senior Recruiter, I help bring in the talent that powers our mission. Every great hire strengthens our culture, drives innovation, and helps the company achieve its goals globally.” Wyatt Gotbetter (Senior Vice President, Global Head Evidence, Value and Access) described the EVA team’s role: “I like to describe the work of EVA as the essential ‘last mile’ in our client’s drug development journey — after decades of scientific discovery, animal and human trials, and regulatory approvals, we play a vital role in helping ensure patients get access to needed therapies.” And Damian reminded us of the impact behind the data: “Every dataset we program and validate helps ensure reliable insights for clinical trials. It’s amazing to know that our work plays a role in bringing life-saving therapies to patients worldwide.”

 

The voices of our newest colleagues remind us that Cytel is more than a workplace. It’s a community driven by purpose, collaboration, and innovation. Here’s to their continued success and to another year of making a difference together.

Women’s Health Is Society’s Wealth: Unlocking Economic Value When Bridging the Gender Health Gap

When the facts are loud and clear: investing in women’s health could unlock $1 trillion in global gross domestic product annually by 2040, prevent 24 million female life years lost to disability, and yield exponential returns to economy for every investment across obstetrics and gynecology, female and maternal health, immunology, neurology, cardiology, and oncology.

 

Improving global health equity has been increasingly recognized as a strategic priority for different stakeholders in healthcare,1 including policymakers, industry, governments, investors, and global health organizations. Beyond an ethical and human rights imperative, reducing health inequities and ensuring that everyone has a fair opportunity to achieve their full health potential — independent of socioeconomic status, sex, gender, geography, or race/ethnicity — leads to economic and societal benefits and resilient healthcare systems.2 Although progress continues to be made toward improving general health outcomes, Cytel researchers have found that this has not translated equally for men and women.3

 

The gender health gap: A global health crisis

Attention to women’s health inequities and the potential economic impact from closing this health gap remain largely unnoticed. The gender health gap — the long-standing, unfair differences in health outcomes between women and men — has been only recently recognized as a medical and healthcare issue. The underinvestment in female health research, the absence of systematic data collection to understand and document the unique biological needs of females and assess disparities, as well as biases in male-dominant clinical trial programs have all contributed to the neglect of women’s health issues. The survival paradox is documented, with women outliving men but experiencing poorer general health, including mental health; recent data showing that women live approximately five years longer than men does not adequately categorize the fact that women spend more than one-quarter of their lives in poor health.4, 5 This health gap is a global health crisis that affects women of all ages to varying extents depending on geography and income levels.4

The gender health gap is generally defined by the conditions that affect women uniquely, differently, or disproportionately, and are not limited to those related to sexual and reproductive health.4 For example, women from the general population are at significantly greater risk of mental health disorders (e.g., depression, suicide) than men, and women with type 2 diabetes mellitus have a disproportionally higher risk of adverse cardiac events, including mortality.6 Men, on the other hand, are significantly more likely to have adverse events after specific types of surgeries and higher mortality after COVID-19.6 Despite the fact that cardiovascular disease is the top cause of death for women in the US, males outnumber females two to one in related clinical trials.7

 

Quantifying the economic benefit of closing the women’s health gap

Quantifying the economic benefit of closing the women’s health gap for societies and economies is important for several reasons and makes visible the “invisible” topic of women and their health. By attaching a measurable economic gain — such as productivity gains, increased workforce participation, reduced healthcare spending — policymakers and investors can grasp the tangible impact on global economies and growth. As financial pressures are restraining healthcare spending, prioritization of resource allocation where interventions yield the greatest returns to economies, such as women’s health, may be placed higher in the list of investment priorities.7 Therefore, systematic efforts to quantify the economic value when bridging the gender health gap will push reframing health equity as a driver for inclusive and sustainable growth, making it a strategic imperative for governments and businesses and overturn the negligible investment in women’s health (only 5% in 2020).8

 

Our findings: The value of investment to improve women’s health

We conducted a comprehensive literature review that aimed to systematically investigate and summarize quantitative evidence on the economic impact of investments to close the women’s health gap globally. We identified robust evidence to demonstrate that when investment is made to improve women’s health, there is return to this investment by bringing back higher value to economies.

A recent report jointly published by the World Economic Forum and the McKinsey Health Institute, for example, highlights that investments in addressing the women’s health gap could not only extend life years and healthy life years, but also have the potential to boost the global economy by $1 trillion annually by 2040.4 These findings were supported by an additional impact analysis conducted by Women’s Health Access Matters across three indications: rheumatoid arthritis, coronary artery disease, and Alzheimer’s disease. Key findings indicated that an investment of $300 million in women’s health research across these three diseases would conservatively result in a $13 billion return to the US economy.7

Over the past 70 years, the influx of women into the workforce has been closely linked to economic growth.4 Since nearly half of the health burden affects women in their working years, this can have serious consequences for the income-earning potential of women, causing a ripple effect on society.4 Economic benefits in the same direction were also documented by simulation studies in other countries such as the United Kingdom whereas limited data were identified for low- and middle-income countries.

We are committed to standing at the forefront of assessing public policy trends and critical policy matters that highlight emerging challenges and seizing opportunities for improving public health. Some examples include our environmental scan of publicly available data repositories to address disparities in healthcare decision-making,9 an umbrella review of the impacts of climate change on maternal health and birth outcomes,10 and blueprints for collective action to close the women health gap.

 

 

Interested in learning more?

Grammati Sarri, Lilia Leisle, and Jeffrey M. Muir will be at the upcoming ISPOR Europe conference in Glasgow, Scotland, where they will present “The Economic Case for Gender Equity: How Closing the Women’s Health Gap Benefits Healthcare Systems and Economies” on Wednesday, November 12, 2025, from 9 to 11:30 a.m. Register below to book a meeting or visit us at Booth #1024 to connect with our experts:

Generative AI in Evidence Synthesis: Harnessing Potential with Responsibility

The integration of AI into the healthcare research landscape is accelerating, with one obvious area of application being evidence synthesis. From early scoping reviews to comprehensive systematic literature reviews (SLRs), AI promises to reduce manual burden and enhance efficiency by saving time. However, it is crucial to understand both the strengths and limitations of using AI in this broad context to ensure compliance, reliability, and scientific rigor.

 

Knowing where it works: A targeted approach

Artificial intelligence, including generative AI models, shines when used for targeted literature reviews (TLRs) or when generating summaries of scientific articles to support evidence-based decision-making at an early development stage. AI can synthesize large volumes of information quickly, offering valuable insights during exploratory or early-phase research.

However, it’s critical to distinguish these from regulatory-facing systematic literature reviews, especially those intended for payer or health technology assessment (HTA) submissions. In this context, SLR extractions have traditionally been completed by two independent human reviewers. This human oversight ensures objectivity and reproducibility, key elements of regulatory compliance.

 

Expertly trained models vs. generalist giants

The current landscape is filled with large generalist language models trained on diverse internet-scale data. While impressive, these models often exhibit hallucinations — the generation of plausible but incorrect or fabricated content — particularly in domain-specific applications like evidence synthesis.

This is why domain-trained expert models are preferred. These models are fine-tuned on biomedical and scientific corpora, ensuring higher reliability and reducing the risk of misinterpretation or erroneous conclusions. They understand field-specific terminology, data structures, and compliance requirements far better than their generalist counterparts.

 

The imperative of data traceability

In evidence synthesis, transparency is non-negotiable. Any AI-generated output must allow users to:

  • Highlight the exact source (i.e., sentence or section) of the original scientific article from which a conclusion or data point was extracted.
  • Compare the model’s interpretation with the source text to identify discrepancies or nuances that could affect meaning or validity.

Using structured tags to annotate key terms, qualifiers, and relationships can make these comparisons clearer and more systematic but also inform advanced search and retrieval activities. By surfacing subtle differences, tagging supports expert review, preserves contextual integrity, and strengthens the reliability and defensibility of the synthesized evidence.

 

Measuring what matters: Precision and beyond

Traditional evaluation metrics like precision, recall, and F1 score (the harmonic mean of precision and recall) remain foundational when assessing AI model performance in literature screening and data extraction.

But in generative contexts — where the task may be summarization, paraphrasing, or abstract reasoning — additional measures become valuable:

  • Answer correctness: Does the output convey a factual, verifiable point?
  • Semantic similarity: How closely does the AI output align in meaning with the ground truth?
  • BLEU, ROUGE, and BERTScore: These Natural Language Processing metrics offer quantitative insights into the quality of generated text, especially for summarization and content generation tasks.

Selecting the right mix of these metrics provides a comprehensive view of model performance and reliability.

 

Where AI makes a difference: Screening and beyond

One of the most promising applications of generative AI in evidence synthesis is in literature screening, or the ability to assess whether a publication (abstract or full text) meets the criteria for inclusion. Studies and pilot implementations suggest that AI can reduce screening time by up to 40%, making it a powerful ally for research teams.

AI tools have been leveraged to assign a probability of inclusion to a title or abstract or full text to guide the screening process but also to allow researchers to quickly understand the impact of modifying search strategies on yield. By automating this repetitive and time-consuming phase, organizations can reallocate expert human resources to higher-value tasks, such as:

  • Resolving ambiguous or context-dependent data extractions
  • Validating nuanced findings and offering insights into implications of these findings
  • Ensuring alignment with HTA submission standards

In this way, AI doesn’t replace human reviewers but augments them, driving efficiency without compromising accuracy.

 

AI with guardrails

Generative AI is reshaping the landscape of evidence synthesis, but its integration must be strategic, measured, and compliant. By combining domain-trained models, robust traceability, appropriate evaluation metrics, and human oversight, organizations can unlock the true value of AI — accelerating workflows without sacrificing quality or compliance.

When used thoughtfully, generative AI becomes more than just a tool — it becomes a partner in advancing scientific research.

 

Meet with us at ISPOR 2025!

Manuel Cossio and Nathalie Horowicz-Mehler will be in Glasgow for ISPOR Europe 2025! Click the link below to book a meeting, or stop by Booth #1024 to connect with our experts:

Breaking Barriers in Rare Disease Research with Generative AI and Synthetic Data

In healthcare innovation, one of the most pressing challenges lies in rare disease research. There are approximately 7,000 rare diseases affecting over 300 million people worldwide. With only a handful of patients dispersed globally, gathering sufficient data to power robust clinical studies or predictive models is a monumental hurdle. However, a solution is emerging at the intersection of generative AI and real-world data (RWD) — a novel approach with the potential to reshape possibilities and unlock insights to address unmet medical needs in rare diseases.

 

The rare disease data dilemma

In the U.S., rare diseases are defined as conditions affecting fewer than 200,000 people. Despite their low individual prevalence, rare diseases collectively impose a significant burden on both patients and healthcare systems.

Research and development in rare diseases often face a vicious cycle: low prevalence leads to data scarcity. Traditional clinical trials are often infeasible and/or statistically underpowered due to the limited pool of participants.

Meanwhile, RWD sources such as electronic health records (EHRs), insurance claims, registries, and patient-reported outcomes offer valuable, albeit messy and fragmented, glimpses into the patient journey. Yet even RWD struggles to paint a complete picture in rare diseases. This is where generative AI steps in.

 

Enter generative AI: Making data where there is none

Generative AI — especially models like Generative Adversarial Networks (GANs), Variational Autoencoders (VAEs), and, more recently, large foundation models — has a transformative ability: it can learn patterns from limited datasets and generate synthetic yet realistic datasets.

How it works

  1. Learning from RWD: Even small datasets from rare disease patients can be used to train and fine-tune generative models. These models identify patterns, distributions, and time-dependent relationships present in the data.
  2. Synthesizing patients: Once trained, the model can create new, synthetic patient records that preserve the statistical properties and characteristics of the original data. These “digital patients” simulate disease progression, treatment responses, and comorbidities.
  3. Validating realism: Synthetic data must be validated to ensure it reflects the real-world data it was trained on. Techniques like distributional comparison, propensity scoring, and expert validation are used to ensure accuracy and utility.

 

Why synthetic data matters for rare diseases

Synthetic data can enhance rare disease clinical research in many ways, including:

 

1. Augmenting small cohorts

Synthetic data can boost sample sizes for rare disease studies, enabling:

  • Simulation of clinical trials
  • Development of more robust predictive models
  • Generation of synthetic control arms where traditional controls are ethically or logistically impractical

 

2. Enhancing privacy

In rare diseases, patient re-identification is an increased risk due to unique phenotypes or genetic markers. Synthetic data protects patient privacy, while at the same time preserves the utility of the data.

 

3. Facilitating global collaboration

As synthetic data is deidentified, it facilitates data sharing among researchers, institutions and borders, minimizing regulatory hurdles and fostering cross-collaborative discovery.

 

4. Accelerating drug development

Pharma and biotech companies can use synthetic data to:

  • Test drug targeting strategies
  • Model long-term outcomes
  • Conduct in silico trials in the earliest stages of development

 

Challenges and considerations

While promising, this approach is not without its challenges:

  • Bias amplification: Synthetic data reflects the biases of its training data. If the RWD is incomplete or skewed, so will the synthetic outputs be. Strategies to handle bias are essential.
  • Regulatory acceptance: Regulatory bodies are still evaluating how to incorporate synthetic data into approval pathways.
  • Validation standards: There is a need for consistent benchmarks and best practices for validating synthetic data — both in terms of privacy and utility, as well as broader generative AI applications in healthcare.

 

Looking ahead

The marriage of generative AI and RWD opens new doors for rare disease research. With the ability to synthesize patient data that preserves real-world complexity, we can begin to break free from the constraints of scarcity — generating insights, hypotheses, and interventions that were once out of reach.

As we move forward, interdisciplinary collaboration among clinicians, data scientists, regulatory bodies, and patient advocacy groups will be key to harnessing this potential ethically and effectively.

 

Interested in learning more?

Download our complimentary ebook, Rare Disease Clinical Trials: Design Strategies and Regulatory Considerations:

External Control Arms: A Powerful Tool for Oncology and Rare Disease Research

In clinical research, the randomized controlled trial (RCT) has been considered the gold standard. Yet in many areas — especially in oncology and rare diseases — running an RCT with a balanced control arm is not always possible. Patients, physicians, and regulators often face a difficult reality: how do we evaluate promising new therapies when traditional designs aren’t feasible?

This is where external control arms (ECAs) come into play. By carefully drawing on existing data sources and applying rigorous methodology, ECAs can help provide the context and comparative evidence needed to make better decisions.

Here, we will explore why ECAs are particularly valuable in oncology and rare diseases, how they support decision-making and study design, what data sources they can rely on, and which statistical methods are essential to reduce bias. We will also introduce the concept of quantitative bias analysis and conclude with why experienced statisticians are key to the success of this methodology.

 

Why external control arms matter in oncology and rare diseases

Oncology and rare disease research share several challenges that make traditional RCTs difficult:

  • Small patient populations: In rare diseases, the number of eligible patients is often extremely limited. Asking half of them to enroll in a control arm may make recruitment impossible.
  • High unmet need: In oncology, patients and families are eager for new options. Many consider it unacceptable to randomize patients to placebo or outdated standards of care.
  • Ethical constraints: For life-threatening conditions, denying patients access to an experimental therapy can be ethically challenging.
  • Rapidly changing standards of care: In oncology, new treatments are approved frequently. A control arm that was relevant when a trial began may become outdated by the time results are available.

In such contexts, single-arm studies (where all patients receive the experimental therapy) are common. But single-arm results alone are not sufficient. Without a comparator, how do we know if the observed survival or response rate truly reflects an advance? ECAs provide the missing context.

Even when a trial includes a control arm, unbalanced designs — such as smaller control groups or cross-over to experimental treatment — can limit the ability to make clean comparisons. External controls can augment these designs, helping to stabilize estimates and provide reassurance that results are robust.

 

Supporting internal and regulatory decision-making

ECAs serve multiple purposes:

  1. Internal decision-making:
    • Companies developing new therapies must decide whether to advance to the next trial phase, expand into new indications, or pursue partnerships.
    • ECAs help answer questions like: Is the observed benefit large enough compared to historical data? Do safety signals look acceptable in context?
  2. Regulatory decision-making:
    • Regulatory agencies such as FDA and EMA increasingly accept ECAs as part of submissions, especially in rare diseases and oncology.
    • While not a replacement for RCTs, ECAs can strengthen the evidence package and demonstrate comparative effectiveness in situations where randomization is not feasible.
  3. Helping the medical community:
    • Physicians, payers, and patients need to interpret trial results. An overall survival rate of 18 months in a single-arm study may sound promising, but how does it compare to similar patients receiving standard of care?
    • ECAs help put numbers into perspective, allowing the community to better understand the true value of a new therapy.

 

Designing better studies with ECAs

External controls are not only a tool for analyzing results — they can also improve study design.

  • Feasibility assessments: By examining real-world data or prior trial results, sponsors can estimate expected event rates, patient characteristics, and recruitment timelines. This reduces the risk of under- or over-powered studies.
  • Endpoint selection: Understanding how endpoints behave in historical or real-world settings helps refine choices for the trial, ensuring relevance to both regulators and clinicians.
  • Eligibility criteria: RWD and earlier trial data can reveal which inclusion/exclusion criteria are overly restrictive. Adjusting them can broaden access while maintaining scientific rigor.
  • Sample size planning: By leveraging ECAs, trialists may reduce the number of patients required for an internal control arm, easing recruitment in small populations.

In other words, ECAs can shape trials from the start, rather than being seen only as a “rescue” option after the fact.

 

Sources of external control data

An ECA is only as good as the data it relies on. Broadly, there are three main sources:

  1. Other clinical trials:
    • Prior trials of standard of care treatments can serve as external comparators.
    • Individual patient-level data (IPD) is preferred, but often only summary data is available.
    • These data are typically high quality but may not perfectly match the new study population.
  2. Published studies:
    • Systematic reviews and meta-analyses of the literature can provide comparator data.
    • Useful when IPD is unavailable but limited by reporting standards and heterogeneity across studies.
  3. Real-world data (RWD):
    • Sources include electronic health records, registries, and insurance claims databases.
    • These capture routine clinical practice, reflecting the diversity of real patients.
    • However, RWD often suffers from missing data, variable quality, and lack of standardized endpoints.

Each source has strengths and weaknesses. Often, the best approach is to triangulate across multiple sources, ensuring that conclusions do not rest on a single dataset.

 

The value of earlier clinical trials

Earlier-phase trials (Phase I and II) can be particularly valuable in constructing ECAs. These studies often include control arms, detailed eligibility criteria, and well-captured endpoints.

For rare diseases and oncology, earlier trials may be the only available benchmark. By carefully aligning populations and endpoints, statisticians can extract maximum value from these datasets.

The challenge, of course, is ensuring comparability. Patient populations may differ in prognostic factors, supportive care practices may evolve, and definitions of endpoints may shift over time.

This is where advanced statistical methods become essential.

 

Reducing bias with propensity scoring

One of the key criticisms of ECAs is the risk of bias. Without randomization, patients receiving the experimental therapy may differ systematically from those in the external control.

Propensity score methods are a powerful way to reduce this bias. The idea is simple:

  • For each patient, estimate the probability (the “propensity”) of receiving the experimental treatment based on baseline characteristics.
  • Match or weight patients in the external control group so that their distribution of covariates mirrors that of the trial patients.

This approach creates a “pseudo-randomized” comparison, balancing measured variables. While it cannot eliminate unmeasured confounding, it greatly improves fairness in comparisons.

 

Quantitative bias analysis: Addressing the unmeasured

Even with careful propensity scoring, unmeasured confounding remains a concern. Clinical researchers often ask: What if there are factors we didn’t account for?

This is where quantitative bias analysis (QBA) enters. QBA does not eliminate bias but helps us understand its potential impact.

For example:

  • Analysts can model how strong an unmeasured confounder would need to be to explain away the observed treatment effect.
  • Sensitivity analyses can simulate scenarios with different assumptions about unmeasured variables.

By explicitly quantifying uncertainty, QBA provides transparency. Regulators and clinicians gain confidence that conclusions are robust — or at least, that limitations are clearly understood.

 

The need for experienced statisticians

Constructing an ECA is not a “plug-and-play” exercise. It requires expertise across multiple domains:

  • Data curation: Selecting fit-for-purpose datasets, cleaning and harmonizing variables, and aligning endpoints.
  • Study design: Defining eligibility, follow-up time, and analysis plans that minimize bias.
  • Statistical methodology: Applying techniques like propensity scoring, inverse probability weighting, Bayesian borrowing, and QBA.
  • Regulatory communication: Explaining assumptions, limitations, and sensitivity analyses in language that regulators and clinicians can understand.

In short, ECAs demand both technical skill and strategic judgment. Partnering with experienced statisticians ensures that external controls provide credible, decision-grade evidence rather than misleading comparisons.

 

Final takeaways

External control arms are rapidly becoming an indispensable tool in modern clinical research — especially in oncology and rare diseases, where traditional RCTs often fall short.

They offer:

  • Context for single-arm studies and unbalanced designs.
  • Support for both internal and regulatory decisions.
  • Guidance in study design and feasibility planning.

By leveraging diverse data sources — from earlier trials to real-world evidence — and applying rigorous methods such as propensity scoring and quantitative bias analysis, ECAs can bring clarity and credibility to difficult development programs.

But the value of ECAs depends on how well they are planned and implemented. Done poorly, they risk misleading decisions. Done well, they empower researchers, regulators, and clinicians to make better choices for patients.

As the field evolves, one thing is clear: the expertise of skilled statisticians is the cornerstone of successful ECAs.

 

Interested in learning more?

Join Alexander Schacht, Steven Ting, and Vahe Asvatourian for their upcoming webinar, “Beyond the Standard Clinical Trial in Early Development: When and Why to Consider External Controls” on Thursday, October 16 at 10 a.m. ET:

Addressing Evidentiary Gaps with Advanced Quantitative Methods

By Hoora Moradian, Victor Laliman-Khara, Peter Wigfield, Michael Dolph, and Michael Groff

 

Global health technology assessment (HTA) bodies are setting higher standards for rigorous evidence to support access decisions. In this evolving landscape, generating meaningful health economic (HE) models and indirect treatment comparison (ITC) analysis is critical — particularly in rare and chronic disease settings. However, traditional modeling techniques often fall short, prompting the need for more advanced and adaptable approaches.

Here, we discuss finding the right method for various market access scenarios, given your indication, patient population characteristics, and data gaps.

 

Addressing heterogeneity across multiple studies

Victor Laliman-Khara

Problem: A sponsor has an asset that is entering a crowded market (3rd or 4th entrant), with a significant number of comparators and a related shift in standard of care. While network meta-analyses (NMA) are broadly accepted, one of the challenges is the limited possibility to adjust for between-study heterogeneity. While Matching-Adjusted Indirect Comparison (MAIC) and Simulated Treatment Comparison (STC) exist, they only allow for pairwise comparison, limiting comparative effectiveness to two treatments.

Solution: Population-adjusted indirect comparisons (PAICs) at the aggregate level — such as Multilevel Network Meta-Regression (ML-NMR) and Network Meta-Interpolation (NMI) — are increasingly used to address heterogeneity across multiple studies. These methods are particularly well-suited for situations where population adjustments are necessary across a network of trials, and where standard NMA falls short in accounting for treatment effect modifiers and between-study differences. Unlike traditional approaches such as MAIC or STC, which are limited to pairwise comparisons, ML-NMR and NMI extend the capability to more complex networks, enabling more robust and generalizable estimates.

 

Accurately reflecting treatment sequencing

Michael Groff

Problem: Many clients struggle to accurately reflect treatment sequencing in their decision problem modeling — especially in indications such as chronic inflammation with multiple therapeutic options. Capturing sequences can make it difficult to fully exploit the value proposition of a product, and poor structuring often leads to models that oversimplify the clinical pathway, become overly complex, or drive runaway costs that make the intervention appear less favorable.

Solution: Apply a structured, evidence-based methodology to transparently map and model clinical sequences, ensuring all clinically relevant transitions, such as disease progression, treatment pathways, and health state changes, are incorporated without compromising credibility, usability, or cost realism.

 

Handling pairwise comparisons in rare disease indications

Hoora Moradian

Problem: Assets in an indication where the referent trial and comparator trial have sparse data and/or heterogeneous populations present a challenge, especially in pairwise comparisons. This is common in rare disease indications, where standard PAIC approaches often struggle to produce reliable insights.

Solution: Apply innovative strategies for pairwise comparisons when traditional methods fall short:

  • G-Computation, a flexible and well-established method, can be applied when there is poor covariate overlap between study populations.
  • MAIC with random forest-based weighting can be used when the overlap is poor and the sample size is very small, delivering improved robustness over traditional methods.

 

Accounting for health equity

Mike Dolph

Problem: Accounting for health inequity is growing in importance in certain areas with a public health focus such as vaccination programs.

Solution: As health systems increasingly prioritize equity-informed decision-making, distributional cost-effectiveness analysis (DCEA) has emerged as an important extension of the traditional cost-effectiveness analysis, reflecting a growing recognition that efficiency alone is not enough to guide healthcare decisions. This approach allows decision-makers to quantify and weigh the trade-offs between improving overall health and reducing health inequalities.

 

Managing immature survival data

Peter Wigfield

Problem: Survival data, particularly in early-stage diseases, are often immature, and the emergence of more effective treatments is likely to prolong this trend.

Solution: State transition models (especially multistate frameworks) offer benefits that are difficult to achieve with conventional partitioned survival methods alone. With real-world evidence evolving rapidly, the relative ease of incorporating external evidence sources is a significant advantage, enabling the real-world value of a product to be realized. However, multiple limitations (particularly related to indirect treatment comparisons and model fits) also need to be considered.

 

Final takeaways

At Cytel, we specialize in solving complex evidence challenges, whether it’s navigating complex markets, rare diseases, or evolving treatment pathways. Our advanced methodologies, including ML-NMR, NMI, structured sequencing frameworks, equity-informed modeling (DCEA), and multistate survival models, empower sponsors to generate credible, realistic, and actionable insights. These tools go beyond traditional approaches to support better decisions and stronger value demonstration.

 

Interested in learning more?

Watch the authors’ recent webinar, “Leveraging the Right Advanced Quantitative Methods to Address Evidentiary Gaps,” on demand:

Breathing Easier: How Wearables Are Revolutionizing Patient-Reported Outcomes in Respiratory Disease

The rise of wearable technology is transforming how clinicians track chronic respiratory diseases like asthma and COPD (chronic obstructive pulmonary disease). Traditionally, managing these conditions has relied heavily on intermittent clinic visits and subjective symptom reports. But what if we could continuously monitor how patients breathe, move, and feel — right from their homes?

Enter wearables: smart devices that collect real-time physiological and behavioral data. These devices typically work in tandem with smartphone apps that prompt patients to complete patient-reported outcome (PRO) measures — allowing for integrated, real-time tracking of a full range of patient-relevant outcomes. When combined, these tools offer a powerful new lens for respiratory health.

 

Why PROs matter in respiratory disease

PROs are essential for understanding the true impact of respiratory disease on daily life. PRO measures like the Asthma Control Test (ACT), COPD Assessment Test (CAT), and modified Medical Research Council (mMRC) Dyspnea Scale help patients communicate their symptoms and limitations. Yet, these snapshots — typically completed during in-clinic visits — often miss the nuances of fluctuating symptoms and the effects of lifestyle or environment.

This is where wearables shine: they offer objective, continuous, real-world data that can complement traditional PROs — typically administered in-clinic on paper or electronically — by adding daily context and physiological insight to self-reported symptoms. By enabling patients to complete PRO measures remotely, often via smartphone apps, paired with real-time wearable data, we gain a fuller, more continuous picture of their health and functioning.

 

What wearables can measure

Modern wearables can track a range of data relevant to respiratory care, including:

  • Physical activity (steps, walking time, exertion)
  • Heart rate and heart rate variability
  • Respiratory rate and breathing patterns
  • Sleep quality and disruptions
  • Environmental exposures (via linked apps or sensors)

While wearables provide continuous physiological data, PROs are typically captured via separate smartphone apps or digital platforms, where patients log symptoms, functioning, or side effects on a scheduled or event-triggered basis.

When patients report increased fatigue or shortness of breath, wearables can confirm whether activity levels dropped, sleep was disrupted, or physiologic stress markers changed — giving clinicians a fuller picture of disease impact and progression.

 

Applications in COPD and asthma

One of the most promising areas for wearables in respiratory care is pulmonary rehabilitation (PR). PR is a cornerstone therapy for COPD and increasingly recommended for severe asthma. However, adherence and engagement outside clinical settings can be challenging.

Wearables like Fitbit or Garmin devices are being used in PR programs to:

  • Monitor daily activity levels
  • Set and track exercise goals
  • Deliver motivational feedback
  • Correlate physical activity trends with PROs such as dyspnea and fatigue

Recent studies suggest that integrating wearables into PR not only boosts patient motivation but also correlates with improved self-reported symptoms and quality of life.

Another area of growth is early detection of exacerbations. New wearable patches and multi-sensor systems can detect subtle changes in respiratory rate, coughing, or oxygen saturation — sometimes days before a patient would seek help. When combined with self-reported symptoms like increased breathlessness or wheezing, these alerts could trigger early intervention and reduce hospitalizations.

 

Case in point: A digital lifeline for COPD patients

In one pilot program, COPD patients were equipped with a wearable sensor that tracked activity, respiratory patterns, and heart rate. They also submitted weekly symptom reports via an app. When wearable data indicated decreased activity and rising respiratory rate, and the patient-reported worsening breathlessness, clinicians were alerted and could intervene early — often adjusting treatment or scheduling a check-in before an exacerbation worsened.

This “digital safety net” approach is gaining traction as a way to personalize care and improve outcomes, especially in vulnerable or remote populations.

 

Challenges to widespread use

Despite their promise, wearables in respiratory care face several hurdles:

  • Data integration: Many devices still don’t seamlessly connect with electronic health records (EHRs).
  • Clinical validation: While feasibility is proven, more large-scale trials are needed to show that wearable-enhanced PRO monitoring improves long-term outcomes.
  • Implementation: Providers may require training in how to teach their patients to utilize wearables and the associated smartphone apps that collect PRO data, meaning that time spent on these activities should be considered billable.
  • Equity and access: Not all patients have smartphones, internet access, or feel comfortable using digital devices — particularly older adults, those in underserved or rural communities, and individuals facing technological or connectivity barriers.
  • Privacy and regulation: Health data from consumer-grade devices must be handled securely, and many wearables are not yet classified as medical devices.

 

The road ahead

With increasing support from healthcare systems, regulators, and tech companies, the future looks bright for wearable-assisted respiratory care. Remote patient monitoring is now reimbursable in countries like the U.S., and smart integration with PRO tools is making these technologies more usable and impactful.

As clinicians and researchers continue to validate these tools, we can expect wearables — and the PRO data they pair with — to become a routine part of respiratory disease management. Smartphone apps are now central to this ecosystem, not just for data capture but for delivering care.

Trustworthy AI in Action: Predicting Stroke Risk Transparently with Claims-Based Machine Learning

In recent years, deep learning and large neural networks have garnered most of the attention in the machine learning (ML) community. Their ability to model complex, high-dimensional data is indeed impressive. But in healthcare — where decisions can have serious consequences and interpretability is paramount — simpler, transparent models like logistic regression still have an important role to play.

Not every problem requires a black box. When it comes to predicting disease risk using structured data, such as insurance claims, traditional models can offer accuracy and insight.

 

Claims databases: An untapped resource for disease risk prediction

Claims databases are an increasingly valuable source of real-world data (RWD). Unlike clinical trial data, which is highly controlled but limited in scale and scope, administrative claims datasets cover millions of lives over multiple years, reflecting real patient behavior and care patterns.

These databases include information on diagnoses, procedures, prescriptions, and demographics — elements that, while lacking granular clinical detail, can still reveal important patterns in disease progression and risk. The scale of these datasets allows for robust statistical modeling, even for rare outcomes.

 

The case for explainable machine learning in claims-based risk prediction

When working with claims data, models like logistic regression, Lasso, or Ridge regression are not just sufficient — they are often ideal. These models:

  • Produce coefficients that quantify the relationship between features and outcomes.
  • Allow for transparent understanding of why a prediction was made.
  • Are easier to validate and communicate to clinicians, payers, and regulators.

In contrast, deep learning models often deliver slightly higher accuracy at the cost of interpretability — a trade-off that may not be acceptable in regulated healthcare environments.

 

A real-world example: Predicting stroke risk with claims data

In a recent study, Cytel used data from over 2.5 million insured individuals to predict the risk of stroke hospitalization. Using only claims-based features such as age, medication use, comorbidities (e.g., diabetes, hypertension), and health service utilization, we compared the performance of several models, including:

  • Logistic Regression
  • Regularized linear models (Lasso and Ridge)
  • XGBoost (a state-of-the-art ML algorithm)

The results? All models achieved similar predictive performance, with area under the ROC curve (AUC) values around 0.81. Logistic regression — simple, explainable, and well-established — performed on par with XGBoost, demonstrating that advanced complexity wasn’t necessary to achieve meaningful predictive power.

 

Transparency enables trust and action

What sets models like logistic regression apart is their explainability. Stakeholders can see precisely how risk factors like atrial fibrillation, hypercholesterolemia, or age contribute to predicted stroke risk. This level of clarity is essential not only for clinicians making decisions, but also for data governance, compliance, and patient communication.

In a time when “black box” AI models are under increasing scrutiny, explainable models offer a pragmatic path forward — especially when paired with large-scale real-world datasets like claims data.

 

Keep it simple, keep it transparent

Healthcare doesn’t just need powerful algorithms — it needs trustworthy ones. As our study shows, standard machine learning models remain highly relevant, especially when applied to well-structured real-world data. Claims databases, in particular, offer a rich foundation for developing these models and making preventive healthcare smarter, earlier, and more accessible.

Enhancing the Reliability of Indirect Treatment Comparisons: The Role of Key Opinion Leaders

ITCs are essential for comparing two or more interventions when head-to-head randomized controlled trials (RCTs) are unavailable. In cases where patient-level data are available for at least one study, population-adjusted methods, such as matching-adjusted indirect comparison (MAIC) or simulated treatment comparison (STC), can be used to adjust for differences in treatment effect modifiers (TEMs) and prognostic variables (PVs) across study populations. Typically, relevant TEMs and PVs are identified through literature reviews, statistical approaches, and expert opinion.

To ensure the accurate identification and clinical relevance of TEMs and PVs, sponsors often consult with key opinion leaders (KOLs), improving the reliability of the ITC results. However, despite the critical and nuanced insight they can provide, the role of KOLs remains unstructured in formal guidance.

Here, we discuss the need for guidelines that outline when and how to integrate KOL input for better-informed healthcare decision-making.

 

The uncharted role of KOLs in ITCs

Health technology assessment (HTA), specifically in the context of ITCs, is an area driven largely by quantitative methods. Yet, the qualitative nuance provided by clinical experts, or KOLs, is indispensable. KOLs offer insights into TEMs and PVs that might otherwise elude purely data-driven models.

 

Current guidance documents

Limited structured guidance from HTA bodies and professional societies leads to inconsistent KOL engagement. Current guidance documents for conducting ITCs (e.g., the NICE methods manual1 and DSU TSD 182) emphasize identifying potential TEMs via expert discussion but leave practical KOL engagement strategies underdefined.

 

Guidance from non-payer organizations

The lack of guidance from non-payer organizations is also evident. The Cochrane Handbook3 discusses both methodological strengths and pitfalls of potential bias when treatments or populations vary in subtle but clinically important ways. However, the guidance is primarily focused on quantitative data synthesis rather than the integration of qualitative insights.

The PRISMA guidelines4 stress the need for transparent reporting when combining evidence across comparisons, but no tools or frameworks are proposed for capturing qualitative contributions.

A 2023 review5 of methodological approaches for identifying TEMs in ITCs highlighted that available guidance largely focused on statistical methods for adjusting TEMs rather than systematic and comprehensive processes for identifying TEMs. In addition, only 17 of 511 (3.3%) ITCs included in the review presented a description of the selection process for TEMs.

 

Bridging the gap: Methodological and procedural challenges

The current landscape is marked by a reliance on ad hoc approaches. KOL input on ITCs is often collected on an “as-needed” basis — sometimes late in the process — which may result in missed opportunities to refine study protocols early on. Without structured guidance from HTA bodies and professional societies, engagement with KOLs remains inconsistent. This gap underscores a broader tension: the need to honor the nuance of clinical insights while adhering to statistical rigor. It has been suggested that solicitation of KOL input should occur during the early, formative phases of the research process within a pre-specified framework.6 Late-stage involvement and integrating KOL input post-hoc  — after the core design and analysis decisions have been made — can introduce bias and risks the integrity of the ITC.

Several methods for structured expert input, such as the Delphi technique or nominal group processes, have been proposed in adjacent fields, but these are rarely applied in the context of ITCs.7 The consequence is a reliance on unstructured interviews or informal consensus-building, which can introduce subjectivity and reduce reproducibility.

 

Looking forward: Harmonizing expert input with methodological standards

The way forward lies in bridging the divide between clinical intuition and methodological precision. The development of clear guidelines that outline when and how to integrate KOL input would be a significant step toward enhancing the reliability of ITCs. One promising approach is the early engagement of KOLs in, for example, structured Delphi panels or advisory boards during the protocol development stage. Codifying this process would ensure that expert insights inform the research from the outset, rather than serving as an afterthought.

HTA bodies, regulatory agencies, and academic methodologists should prioritize the collaborative creation of comprehensive guidelines to address the following key aspects of KOL consultation for ITCs:

  • Selecting KOLs: Defining objective, transparent eligibility criteria to ensure that only the most appropriate clinical experts contribute their insights.
  • Timing: Detailing when during the research process expert opinion should be solicited — ideally early on to influence study design and TEM identification.
  • Question types: Guiding the formulation of questions that address specific knowledge gaps related to TEMs and PVs in the ITC.
  • Integration protocols: Outlining systematic methods for incorporating and reporting KOL insights, ensuring this information is subject to the same transparency standards as quantitative data.

The accurate identification of TEMs can significantly influence the reliability of ITC outcomes. Without consistent frameworks, there’s a risk that KOL input is either underutilized or inconsistently applied, affecting both the credibility and applicability of findings. The lack of guidance highlights the need to explore effective approaches in the absence of standardized methodologies for KOL engagement. Addressing this gap is essential for improving the reliability of ITC results and supporting informed healthcare decision-making.

 

Upcoming webinar

Our Evidence, Value, and Access team will be hosting the upcoming webinar, “Navigating the First Year of EU JCA Implementation: Updates, Methodological Insights, and Bridging Local HTA Realities,” on July 10 at 10 am ET. Register today to reserve your spot!

Career Perspectives: A Conversation with Angie Raad-Faherty

In this latest edition of our Career Perspectives series, we had the pleasure of speaking with Angie Raad-Faherty, Director, EVA Health Economics. Angie shares her journey from a background in applied mathematics and biology to a career in health economics. In this interview, she shares emerging trends in health economics and RWA, expertise that will be essential for the future of drug development, the importance of mentorship, and much more.

 

Can you give us a little background on your career so far? What inspired you to pursue an education in applied mathematics and biology, and how did that lead to a career in health economics?

My career journey has really been shaped by a deep passion for both mathematics and biology. Even back in high school, I loved the logic and problem-solving side of math, but I was equally fascinated by biology, especially in understanding how diseases affect the human body.

After completing my undergraduate degree, I took a graduate course that focused on disease mathematical modeling. This experience was pivotal, as it introduced me to the concept of integrating mathematical techniques with biological applications. I realized that my skills in mathematics could be effectively applied to address complex health-related issues, leading me to the field of health economics. I feel really fortunate that my background in applied mathematics and biology allows me to look at health problems from both a quantitative and biological lens.

 

In your current role, you balance leadership, coaching, and hands-on research. How do you manage this mix, and is it important for your job satisfaction to stay involved in both areas?

In my current role, I’ve found a rhythm that really works for me — balancing leadership, coaching, and hands-on research. Clear communication and thoughtful delegation are key, but I also make it a point to stay close to the actual work. I think it’s really important to empower my team to take ownership of their projects, while also being available to guide and support them when needed. What I’ve realized is that staying involved in the hands-on side of things isn’t just good for the work, it’s important for me personally. It keeps me engaged, helps me stay up to date with what’s happening in the field, and allows me to contribute in a meaningful way. Plus, it helps create a collaborative atmosphere where people feel supported and encouraged to try new things. That balance between leading and doing is what makes my role fulfilling. It not only makes me a more effective leader, but also helps us deliver stronger results as a team.

 

What do you like best about your role, and about working at Cytel?

What I love about my role is the opportunity to make a real difference in patients’ lives. By supporting my clients, I’m able to contribute to bringing innovative, cutting-edge treatments to patients in need.

I also enjoy the unique challenges that come with each project — no two are ever the same. Every new project is a chance to learn something new, whether it’s about a different disease area or an emerging therapy.

And finally, one of the things I truly value about working at Cytel is the people. I get to engage with a variety of clients and work on diverse projects and indications, but just as importantly, I’m surrounded by incredibly smart, driven, and supportive colleagues. It makes the work both meaningful and enjoyable.

 

In your opinion, which skills are critical to a function as a research consultant at Cytel?

I believe both hard and soft skills are critical for a research consultant in the HEOR field in general and at Cytel. On the hard skills side, strong technical skills in HEOR methods, evidence synthesis, and understanding HTA requirements is essential — especially since expectations and requirements differ between HTA bodies.

Soft skills are just as important, like critical thinking, flexibility, and clear communication. In my experience working on HTA submissions for both countries, I learned it’s not just about building strong models but also explaining the results clearly to different audiences and adapting based on local needs.

Success really depends on balancing technical excellence with the ability to collaborate and adjust strategies based on specific client and agency expectations.

 

Given how quickly the field of health economics evolves, continuous learning is crucial. Are there any skills or areas of expertise you’re currently focusing on that you believe will be key to the future of drug development in 2025 and beyond?

Absolutely, continuous learning is not just beneficial, it’s essential in our field to stay ahead of the curve in areas that will define the next decade of drug development and market access. While technical skill development is ongoing, my focus is also on strategic foresight. Right now, I’m particularly focused on three key areas:

  • First, the integration of real-world evidence into economic models. We’re seeing increasing acceptance from HTA bodies to go beyond clinical trial data. As such, building rigorous frameworks for incorporating real-world data, while maintaining methodological transparency is a top priority.
  • Second, understanding how machine learning and artificial intelligence can be leveraged in health economics. There’s huge potential here, but it’s critical we align these innovations with HTA standards and ensure that models remain transparent, logically sound, and valid for reimbursement decisions.
  • Finally, I’m very focused on global HTA alignment. As frameworks become more interconnected, strategically aligning value messages and evidence packages across jurisdictions will be key to driving efficiency and access.

 

Are there any emerging trends in health economics and RWA that excite you right now?

Absolutely, there are several exciting developments in health economics that I find particularly inspiring.

One major trend is the increasing use of real-world data earlier in the drug development process to inform trial design, support regulatory decision-making, and identify unmet needs or specific patient populations.

I’m also really encouraged by the growing emphasis on patient-centered outcomes and health equity. There’s a broader recognition that value goes beyond traditional metrics like QALYs or ICERs. Incorporating factors like caregiver burden, and access disparities is making economic evaluations more holistic and aligned with real-world impact. Another area that particularly interests me is the use of surrogate outcomes. Being able to translate clinical endpoints into meaningful modeling endpoints is crucial, especially when long-term outcomes are difficult to measure directly.

Lastly, the advancement of AI and machine learning is a trend I’m closely following. These technologies are opening doors to deeper insights and faster analyses of complex, unstructured data. While we still need to ensure transparency and methodological rigor, the potential to uncover patterns and generate predictive insights is incredibly exciting. Overall, it’s a dynamic time in our field, and these trends are not only transforming how we work but also reinforcing the importance of continuous learning and adaptability.

 

Could you share a project you’ve worked on that you’re particularly proud of, and why?

Every project I’ve worked on in health economics has felt important to me, because each one represents a chance to help patients access innovative therapies. But the project that stands out most is actually the very first HTA submission I worked on early in my career. It was for early prostate cancer therapy. We were able to build a strong case for both the clinical value and the cost-effectiveness of the therapy, and seeing it approved and knowing it would change lives was incredibly powerful. That experience stayed with me and really shaped my passion for HEOR, showing me how our work can directly contribute to patient access and better outcomes.

 

As someone completing a PhD in applied mathematics and with a leadership role in RWA — both areas where women are underrepresented — what advice would you give to young women or girls aspiring to enter STEM fields?

STEM is full of tough questions and complex challenges — but that’s exactly what makes it so rewarding and interesting. Diverse thinking drives better science, more inclusive solutions, and ultimately, stronger outcomes in healthcare. And that’s exactly what our field needs. Also, mentorship and community are important. Throughout my journey, having people around me who believed in my potential, even when I didn’t yet see it myself, made a huge difference. That kind of support helps build the confidence not just to grow, but to lead. STEM needs more women not just participating, but shaping its future, and I encourage every young woman to see herself as part of that transformation.

 

Have you had a female mentor during your education or career? How did that impact you? Would you be open to mentoring women yourself in the future?

Yes, I had the privilege of working with my supervisor, Dr. Jane Heffernan, during my graduate studies. Her guidance and support were instrumental in shaping my academic and professional development. She provided valuable insights and encouragement, which significantly impacted my confidence and skills in my field.

In the future, I would be open to mentoring women myself, as I believe in the importance of supporting the next generation of professionals and fostering an inclusive environment in academia and beyond.

 

As a remote employee, how do you maintain a healthy work-life balance? What strategies work for you, and do you feel supported by Cytel in this regard?

To maintain a healthy work-life balance while working from home, I believe two key factors are essential. First, establishing a consistent routine with clearly defined working hours and scheduled short breaks throughout the day is crucial. This structure helps me stay productive while also allowing time to recharge. Second, creating a designated workspace that is separate from my everyday home activities is vital. This physical distinction not only enhances my focus but also aids in mentally transitioning between my professional and personal life. I appreciate that Cytel supports this balance through its flexible working hours, which further enables me to manage my responsibilities effectively.

 

What are your main interests outside of work?

Outside of work, I really enjoy getting outside for walks and hikes with my dogs — it’s one of my favorite ways to unwind. I also love spending time in the kitchen, whether I’m baking something sweet or trying out a new dish from a different cuisine. It’s my way of relaxing and getting a little creative.

 

Finally, what’s one piece of career advice you wish you had received earlier?

A key piece of career advice that holds significant value is to prioritize networking and relationship-building within your industry. This includes not only connecting with colleagues beyond your immediate team but also engaging with clients. Cultivating a robust professional network can unlock new opportunities, provide essential support, and offer valuable insights that can greatly influence your career path. Additionally, actively engaging with mentors and peers fosters continuous learning and personal growth, making networking an essential component of career development that is often underestimated.