heckpoint inhibitor therapy with ipilumumab, nivolumab, pembrolizumab, or similar antibodies has produced outstanding clinical responses in some patients with advanced carcinomas or melanomas. However, most patients are resistant to checkpoint inhibitors because their immune responses are blocked by an immunosuppressive tumor microenvironment (TME). Resistance is characterized by a lack of immune cells infiltrating tumors, stromal macrophages and fibroblasts that release pro-metastatic cytokines, and immune cells that are exhausted and dysfunctional. To address this resistance, we focus on a process called immunogenic cell death (ICD) that rejuvenates antitumor immunity and changes the TME to an antitumor state.

lain language summaries (PLS) of publications form part of the wider democratization of science, enabling a broader audience to access and potentially understand scientific and healthcare research. However, many practical questions around these important summaries remain: what types of PLS should we be writing, which publications should have a PLS, and where should PLS be published? Three key sets of recommendations for PLS were released in 2021. This article explores what these recommendations mean in a practical sense and what more is required to further the development of PLS in terms of support and guidance.

OVID-19 transformed many aspects of pharmacovigilance (PV) practice and reshaped the future of drug and vaccine development. Collaborative efforts between many stakeholders, especially pharmaceutical companies and regulatory bodies, made it possible to develop and approve safe and effective COVID-19 vaccines in a short period. The adverse event (AE) collection process evolved due to the enormous number of safety reports received globally in 2021, resulting, for example, in a shift toward automation (artificial intelligence) in handling safety data to reduce the chance of human error in the process, and in a number of important regulatory changes around the world.

ustralia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was made available for final, widespread community and stakeholder feedback. Final public consultations closed on March 2, 2022.

ver the past five years, China’s pharmaceutical innovation industry has experienced what has been called the Cambrian explosion: significant acceleration in the launch of innovative products, rapid expansion in the number of R&D pipelines, and increasing capital investment in R&D.

o meet the challenges of new requirements for R&D talent in the context of global pharmaceutical innovation trends, pharmaceutical R&D innovation leaders in China must exhibit strategic thinking, efficient cross-departmental communication and collaboration, and an agile working model in addition to their drug-development expertise.

he protection of natural persons in relation to the processing of personal data is a fundamental right in the European Union. Data privacy regulations support these fundamentals. However, the right to protection of personal data is not an absolute right: e.g., it must be balanced against other fundamental rights, in accordance with the principle of proportionality.

eal-world data (RWD) and real-world evidence (RWE) are increasingly used to inform regulatory decisions around the world. As a rapidly evolving regulatory topic, current discussions including regulators and industry highlight the need to clarify the regulatory standards for data quality, acceptable data sources, and analytical methods that support expanded use of RWE in assessing product efficacy/effectiveness and demonstrating its benefits, as well as evaluating product safety. This article presents the results of a 2021 survey organized by industry associations in Brazil to assess the local regulatory environment and use of RWE/RWD studies in regulatory submissions to ANVISA, as well as the challenges and learnings from multiple companies.

ver the past few decades, advances in technology have resulted in progressive automation in every industry. This trend has also touched the scientific writing community. Programmed automation features can be found even in the world’s most popular word processor and a gold standard in the writing industry, Microsoft Word^TM. It is evident that progress in artificial intelligence and deep learning will result in substantial automation of how scientific documents are created.