his June in San Diego (California), DIA simultaneously celebrates 60 years at the forefront of global life sciences and embarks on a journey to explore uncharted territories.

ost-approval changes (PACs) are an essential part of product lifecycle management to ensure continuous supply of life-saving medicines in case of increased demand, to support continuous improvement and optimization of the manufacturing process, to remain state-of-the-art with analytical techniques, and to ensure continuity to comply with the updated regulatory requirements. However, bringing chemistry, manufacturing, and controls (CMC) changes through global health authority (regulatory) systems can be a complex, lengthy process that can take several years. At the same time, PACs represent a large proportion of regulatory submissions and their timely approval is critical to maintaining and ensuring continuous supply of quality medicinal products.

n February 2024, the nonprofit industry association Accumulus Synergy announced the launch of its initial cloud-based information and data exchange platform through a regulatory reliance pilot project. This is in line with the overall mission of Accumulus to dramatically accelerate critical therapies to citizens of the world by using technology to simplify regulatory interactions and by bringing forward the much-anticipated concept of “a dossier in the cloud” to support real-time information exchange between those that develop medicines and those that review and approve them.

ong-term retention of patients in clinical trials is both difficult and costly, which is challenging in an era in which drug development costs are increasing while success rates decrease. High dropout rates are likely to compromise study power and lead to trial failure, which can have catastrophic financial implications for drug developers. Clinical trial dropout can exceed 30% in pivotal phase 3 trials, and nearly 85% of trials fail to retain enough patients. Recruiting a single clinical trial patient can cost nearly $7,000, and the cost to replace patients that have dropped out is nearing $20,000. High dropout rates also place additional burdens on study recruitment, as failing to recruit sufficient numbers of patients is itself a cause of clinical trial failure.

atient and public involvement (PPI), or patient engagement (PE), is a positive development that aligns with broader patient empowerment movements. People affected by health conditions should have a say in the decision-making processes that will impact them. Moreover, when patients are involved in developing and testing new healthcare solutions, outcomes should be more patient-centered. Why has this knowledge not yet been translated into widespread action? This article explores why we seem stuck on the PPI adoption curve and how to get moving again.

he reviewer of cancer research history can only marvel at the acceleration of drug discovery and development plus the multimodal and multidisciplinary innovations. The landscape imagines incredible potential, while maintaining ethical guidelines. Here, cancer treatment advances are explored with the future of artificial intelligence (AI) and machine learning (ML).

n October 1964, a group of pharmaceutical and medical communication and information professionals gathered in Philadelphia (PA) for conversations which culminated in the formation and inaugural meeting of the Drug Information Association (DIA) in Washington, DC, on October 9, 1965.

IA: We are celebrating 60 years of DIA, and you’re one of the luminaries and a former DIA President. Let’s begin at the beginning: Please introduce yourself, your career, and your current work.

n 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year.

lthough open innovation in drug research and development has long been recognized as important in Japan, it has not yet become widely adopted practice, and there are significant gaps in understanding and expectations between academia and pharmaceutical companies. For example, when there is an excellent research outcome, academia seeks recognition and research grants for subsequent research through publication of the outcome; whereas pharmaceutical companies generally tend to keep the research results confidential to maintain their competitive edge. This article discusses current gaps and primary challenges to resolving them, aims to deepen understanding of the issues that both parties face, and proposes measures for improvement.