he T cells circulating in an individual’s blood represent a record of their prior immune exposures. Reading that record is an elusive goal but an important one: knowing prior immune exposures can predict future risk of severe disease or inform treatment decisions. Through our immunosequencing platform, we have amassed a database of T-cell repertoires from tens of thousands of individuals. Along with our partners at Microsoft, we’ve harnessed that enormous database to learn a great deal about a person’s exposure history from a sample of their blood.

n today’s fast-paced pharmaceutical industry, generative AI (Gen AI) is rapidly emerging as a transformative tool, much like Excel revolutionized business operations in its early days. Organizations can build a dynamic, evolving portfolio of AI capabilities for the drug development lifecycle. This article introduces a Gen AI capabilities maturity model to guide companies through the stages of AI implementation from simple foundational tasks to highly complex, data-driven workflows. We emphasize the importance of treating AI use cases as living products, evolving with business needs and technological advancements, while also addressing common challenges, such as managing expectations and leveraging existing data structures for AI optimization. This article provides a robust framework and real-world paradigms to help pharmaceutical organizations unlock Gen AI’s potential—an indispensable read for those aiming to lead in digital innovation.

rtificial intelligence (AI) has already begun transforming the healthcare industry, with applications ranging from diagnostics to drug discovery and personalized medicine. The global healthcare AI market, valued at $19.27 billion in 2023, is expected to grow at an annual rate of 38.5% through 2030, according to Grand View Research.

echnology is awesome … until it isn’t, at which point, it’s downright exasperating.

his is the first in a series of articles introducing perspectives from the public and private sectors on identifying and addressing challenges in adopting innovative trial approaches into clinical evidence generation and FDA’s medical product approval processes.

n an era where artificial intelligence (AI) is revolutionizing healthcare and clinical research, regulatory bodies are racing to keep pace. The European Union’s Artificial Intelligence Regulation 2024/1689 represents a watershed moment in AI regulation, with potentially far-reaching implications for the global clinical research community. What will be the regulation’s impact on clinical trials, and how might stakeholders navigate this new regulatory landscape?

ustralia’s Therapeutic Goods Administration (TGA) has been busy warning consumers about the dangers of accessing medicines from online sites outside of Australia. Several problematic products have recently been identified: For example, African Vigorous Max Strength and Ziyinzhuangyang tablets (both of which contain sildenafil not listed on the label), counterfeit ivermectin, and counterfeit Ozempic pens (which contain insulin, and are most likely relabelled insulin pens).

lease enjoy this look back at the most-read Global Forum articles in 2024.

lobal Forum contributors revisit their 2024 predictions for translational medicine, technology and the life sciences, and regulatory science, and in several cases reframe these 2024 predictions for 2025.

number of expert sources shared with Global Forum their additional predictions on new topics for 2025. They are grouped by contributor or contributing organization.

isk management is one of the cornerstones of effective project management. The generally recognized benefits of effective risk management include improvements to decision-making, increased confidence in projections, and increased probability of achieving project goals. It has been the authors’ experience, however, that risk management activities at the beginning of a therapy’s lifecycle are not always as robust or well-structured as they are later in the drug development lifecycle. This is a problem.

takeholder management is an established cornerstone of project management and is a process clearly detailed in resources such as the Project Management Body of Knowledge (PMBOK). Additionally, pharmaceutical and biotech companies routinely describe expectations for stakeholder management in their operating procedures and business processes. Yet, stakeholder management too often fails to meet expectations and creates unnecessary risks.