Working across a range of Phase I, II, and III trials as well as numerous possible indications, our Project-Based Services (PBS) teams have specialists in many areas. In order to enhance expertise among colleagues, foster knowledge-sharing, and stay up to date on recent developments in the field, Cytel has developed a collaborative workstream initiative that brings together experts with shared statistical and therapeutic area interests.

Michaela Šedová, Biostatistics Director with PBS, moderates the neurology workstream. In this interview, Michaela discusses how these initiatives enable colleagues to share and grow their experience and skills, and how this behind-the-scenes work benefits sponsors.

Michaela, what inspired the creation of Cytel’s new workstreams that focus on specific therapeutic areas and methodologies?

We are a team of biostatisticians working within Cytel PBS. Most of our contracts are limited to specific projects, typically involving one or several related studies. This means that we handle a diverse range of trials — be it Phase I, II, or III, and on any possible indication. Our work includes trials conducted by small biotech companies that lack in-house statisticians, requiring substantial methodological and statistical input from our team, and from large pharmaceutical companies with more specific and focused requirements.

Given the wide range of disease areas, statistical methodologies, and operational aspects we encounter, it’s impossible to be experts in every domain. Instead, we tend to specialize in certain areas. The workstream initiative brings together colleagues with shared statistical and therapeutic area interests and provides a platform to share recent developments, enhance expertise, and foster knowledge-sharing within the company.

Companies sometimes overlook the wealth of experience and skills their employees possess, simply because they lack opportunities to use them. At Cytel, our workstream initiative helps us uncover such talents and foster expertise in specialized methodological and therapeutic areas.

Could you walk us through the focus of these new workstreams, and share some of the key activities involved?

Cytel PBS has set up workstreams focused on varied disease indications (neurology, oncology, type 2 diabetes/cardiovascular) and methodological aspects or regulatory know-how (statistical methodology, rare diseases, Phase I studies, submissions of new drug applications).

The objectives of the workstreams vary depending on their focus, though they all follow recent developments in their field and corresponding regulatory guidelines. Some workstreams have started creating internal standards (e.g., SAPs, table shells) and trainings to support other statisticians, or have documented experiences with specific statistical methods. The objective is to centralize the information and build a structured way of knowledge-sharing.

Workstream meetings and groups are an ideal forum to discuss specific topics and share opinions with colleagues. Some workstreams are also involved in sales and optimization initiatives. Externally, workstream members may attend and prepare presentations for conferences or workshops.

How do these workstreams integrate with the existing clinical biometrics services we offer?

Each statistician within PBS has the opportunity to contribute to one or more workstreams. It is a platform that helps to provide peer-to-peer support among individuals involved in specific projects. Overall, the workstreams aim to support and to improve our existing services.

How do our clients benefit from these workstreams?

At the request-for-proposal stage, clients are often interested in our experience within a specific topic. The workstreams help not only to summarize and provide feedback on such experiences, but within the platform, we can develop and maintain shared knowledge at the highest level within that particular area. We can easily ensure stability, suitable study specific assignments, and swift back-ups, if needed. Additionally, less-experienced statisticians — whether junior or new to the field — gain the broader support provided by the workstream, offering them guidance. Consequently, our clients benefit from this direct and indirect therapeutic area and methodology expertise.

Now, you moderate the neurology workstream. Can you share some of your activities?

The neurology workstream has two main areas of interest:

• Multiple sclerosis (MS)
• Alzheimer’s disease/Parkinson’s disease

These diseases are complex, which is why it’s essential to understand their etiology, development, and symptoms to comprehend typical endpoints and analyze them appropriately. Therefore, we have prioritized mapping, maintaining, and expanding the expertise we have gained through collaborations with various clients, primarily well-established pharmaceutical companies that have already marketed several products and are developing other compounds, as well as smaller biotech companies. The neurology workstream has created a few sets of training slides for biostatisticians who are new to the indication. We also collaborate with Cytel’s business development department on a better description of our capability for clients.

Could you be more specific and share examples?

For now, the focus is on MS and Alzheimer’s/Parkinson’s disease endpoints and statistical methodologies used to analyze them. Team members often bring varied experiences to each focus area. For instance, some colleagues have conducted numerous analyses on relapses, which are recurrent events that may require “qualification” or can have different competing risks — aspects that potentially need to be considered in the analysis. Another example is composite endpoints, such as NEDA (no evidence of disease activity), where different clients may adopt slightly different approaches. Additionally, we work with tools designed to measure levels of disability, cognitive function, and patient-reported outcomes (PROs) collected through questionnaires. These are typically repeated measures, analyzed based on specific manuals.

Can you share an example of a client engagement where your workstream made an impact?

The workstreams operate behind the scenes. For instance, we have long-term clients for which we run numerous exploratory analyses in the medical affairs area. These are often requested on short notice and are difficult to plan. The workstream enables us to remain flexible, distributing the workload among several team members and involving colleagues who would otherwise require significantly more time for onboarding.

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