TFS boosts neuroscience trials with Nordic data and AI
In an interview with BioStock, Anne-Marie Nagy, PhD, Head of Internal Medicine and Neuroscience at TFS HealthScience, shed light on how the company leverages Nordic data, AI and decentralised settings to navigate the challenges of clinical trials in a complex space.
– Neuroscience is one of the most dynamic and rapidly-evolving fields of drug development, yet it comes with a high risk of failure, Dr. Nagy said, reflecting the persistent challenges of pushing neuroscience forward.
As a global CRO, TFS HealthScience operates across a wide therapeutic landscape, helping drug developers improve their success rates. The company specialises in fields such as dermatology, internal medicine, neuroscience, oncology and hematology, and ophthalmology. With 28 years in the pharmaceutical industry, Anne-Marie Nagy has seen the neuroscience field evolve significantly during her career, but there is still more to come.
– Despite major advancements, there remains a significant unmet need, and the market continues to grow. In fact, the Global CRO market for neuroscience drugs is expected to reach $15 billion globally by 2025 and is projected to grow at a compound annual growth rate (CAGR) of 10 per cent during the next 5 years. This growth is mainly driven by the increasing prevalence of neurological disorders and the consequent demand for specialized research and development services. The cutting-edge innovations, such as AI and data analytics, are streamlining operations, making CRO services even more appealing, thereby supporting the market growth.
Dr. Nagy says that there are many reasons that neuroscience drugs remain high-risk but emphasises the limited understanding of the pathophysiology behind neurodegenerative diseases and the intricate and subjective nature of CNS endpoints. Therefore, it is critical that data is collected consistently in these complex clinical trials. In this regard, the experience and guidance that TFS offers, can play an important role in ensuring successful outcomes.
Nordic data and biobanks – a boost to neuroscience research
TFS’s headquarters are located in Lund, Sweden, and looking specifically at the Nordic context, Dr. Nagy notes that it offers a unique advantage in terms of data. Here, national registries record individuals from birth to death, linking comprehensive, longitudinal data via personal identification numbers. This integrated and intricate system enables detailed analyses of risk factors for neurodegenerative diseases such as Alzheimer’s – providing an invaluable resource for neuroscience research. Moreover, there is a strong culture of collecting biological samples and store them in biobanks, thus supporting future genetic analyses and refined trial designs.
– In the Nordics, we benefit from a highly organised and reliable data infrastructure that supports groundbreaking neuroscience studies, Nagy says.
This infrastructure, combined with TFS’s expertise, creates a powerful synergy for advancing neuroscience research. The region’s comprehensive health registries and biobanks enable researchers to access high-quality, longitudinal data, which is invaluable for studying neurological conditions. This data-driven approach helps mitigate some of the risks associated with neuroscience drug development, offering a clearer path to understanding disease mechanisms and evaluating treatment efficacy.
Addressing the challenges of drug development
Still, neuroscience drug development is notoriously challenging, not least in the Nordics with its own set of conditions. Firstly, site capabilities and patient recruitment can be an issue as the Nordic population is limited. Secondly, these are highly developed countries, which translates to a costly setting for running trials compared to e.g. Eastern Europe.
Another issue is a high number of unreported trials, which according to Dr. Nagy, can be explained by a lack of awareness of the regulatory framework for reporting results combined with limited resources at smaller companies, particularly in the currently strained economic environment. With these factors in mind, TFS has set out to support the industry.
– With our comprehensive insight in the system and its regulation, TFS can help sponsors overcome these hurdles. We operate to ensure transparent, ethical practices and providing extensive resources for effective data reporting and assist smaller life science companies to meet regulatory requirements and thus contribute valuable, publicly available results to advance scientific research, Dr. Nagy says.
Managing the risk of failure with AI
Dr. Nagy also emphasises that the high failure rates in this space are often due to the heterogeneity of patient population in CNS and lack of qualitative enpoints which are clinically meaningful. Unlike other therapeutic areas, neuroscience trials frequently grapple with unclear or inconsistent endpoints leading to high placebo response and/or unconclusive results. TFS addresses these challenges by leveraging its deep understanding of the field, combined with advanced AI tools to analyse data more effectively.
– We use an integrated platform from our preferred partner MEDIDATA to collect the data in real time, which means that any data outliers can be spotted and investigated immediately, not saving significant time but guaranteeing a high quality in data generation. Thus, using AI accelerates trials and reduces risk by quickly identifying inconsistencies in data, allowing for swift action. It is the future, says Dr. Nagy.
AI plays a transformative role in TFS’s approach, enabling the company to identify patterns and insights that might otherwise be missed. By integrating AI with robust clinical trial design, TFS can optimise trial protocols, improve patient recruitment, and enhance data interpretation. This multidisciplinary strategy not only reduces the risk of failure but also accelerates the pace of innovation in neuroscience.
Decentralised trials are trending
Another important trend in the neuro space is the shift towards decentralised trials (DCTs). The DCT concept means that patients can participate in studies from home using devices such as wearables and sensors. Reducing the need for frequent hospital visits means better patient access, retention, and data compliance, all while decreasing costs. For neurological studies, DCTs offer particularly significant benefits in the form of improved patient recruitment, greater diversity, and enhanced real-time monitoring. Such trials reduce screening failures, allow broader participation, and improve knowledge with real-world data – something that the regulatory authorities are requiring more frequently.
The future of neuroscience
Looking ahead, Dr. Nagy remains optimistic about the future of neuroscience, but she acknowledges that significant unmet needs persist. The growing prevalence of neurodegenerative diseases, such as Alzheimer’s and Parkinson’s, underscores the urgency of developing effective treatments. TFS’s strategic focus on combining Nordic data resources, biobanks, and AI positions the company to make meaningful contributions to this field.