The dynamic landscape of pharmaceutical regulatory affairs is undergoing a transformative paradigm shift propelled by the integration of Artificial Intelligence (AI) and Machine Learning (ML) technologies. This review explores the unprecedented impact of AI and ML on regulatory processes within the pharmaceutical industry. Through a comprehensive analysis of recent advancements, applications, and case studies, the review illuminates how these technologies enhance efficiency, accuracy, and compliance in regulatory affairs. AI and ML play pivotal roles in automating labour-intensive tasks, such as data analysis, document processing, and compliance monitoring. Leveraging advanced algorithms, these technologies enable real-time decision-making and predictive analytics, empowering regulatory professionals to navigate complex frameworks with agility. The review further examines the role of AI-powered tools in optimizing regulatory submissions, accelerating approval timelines, and minimizing risks associated with non-compliance. The review underscores the scalability of AI-driven solutions in handling vast datasets and extracting valuable insights, thereby facilitating proactive regulatory strategies. The synthesis of AI and ML in regulatory affairs also addresses challenges related to data integrity, ensuring the reliability and traceability of information throughout the product lifecycle. By fostering a harmonious collaboration between human expertise and machine intelligence, regulatory professionals can make informed decisions and adapt swiftly to evolving regulatory landscapes.

In recent years, phase separation has emerged as a crucial mechanism for protein functionalization. This process allows proteins to form droplet structures known as biodroplets, which separate oil and water. Biodroplets regulate the spatiotemporal activity and interactions of proteins in the complex intracellular environment. This regulation is vital for maintaining cellular function and adapting to environmental changes. Biodroplets play a significant role in gene expression within cancer cell biology. They enable the compartmentalization of biochemical reactions without relying on membrane-bound organelles. This control is crucial for the rapid and uncontrolled growth of cancer cells. Recent research illuminated how biodroplets influence various aspects of cancer cell biology, including the expression of oncogenes and the efficient nuclear import of oncogenic transcription factors. By forming dynamic and reversible compartments, biodroplets facilitate the precise control of protein interactions and functions necessary for cancer progression. This review summarizes the latest findings on the role of biodroplets in the gene expression system of cancer cells, drawing on recent research by the author. Understanding the mechanisms underlying biodroplet formation and function could open new avenues for targeted cancer therapies and provide insights into disrupting these processes to inhibit cancer cell growth.

Thalidomide, a small-molecule drug, caused a global drug disaster more than half a century ago. Thalidomide derivatives are widely used to treat several hematological cancers. Recent studies have revealed that thalidomide and its derivatives act as protein degraders that bind to cereblon (CRBN), the substrate-recognition receptor of a complex-type E3 ubiquitin ligase, and degrade neo-substrates that are not their original substrates. Furthermore, they are currently being used in proteolysis-targeting chimeras (PROTACs), which are chimeric protein degraders. Protein degraders open up a new mechanism of drug action and proteolysis and have the potential to target various therapeutic proteins, including undruggable proteins. Analysis of drug-dependent protein-protein interactions (PPIs) is crucial for the development and use of this new class of protein degraders. We developed an in vitro and intracellular protein degrader-dependent PPI analysis method using a cell-free protein synthesis system and proximity-dependent biotinylation. Using these analytical methods, we successfully identified several neo-substrates involved in the mechanism of action of thalidomide. Furthermore, we developed thalidomide derivatives and PROTACs with enhanced selectivity for neo-substrates or target proteins involved in the anti-hematological cancer effects. In this paper, we review the history of thalidomide and the research achievements related to protein degraders, as represented by thalidomide derivatives.