hat if you could witness the power of science firsthand?

Imagine the case of Maria, an adolescent girl who takes the stage in front of a crowd full of high school, college, and postgraduate students. Just months ago, she was confronting mortality head-on, her body weakened by leukemia. Now, having no remaining evidence of disease, she shares her extraordinary journey.

n October 2023, the FDA released a revised draft guidance, reshaping the communication landscape between firms and healthcare providers (HCPs) regarding scientific information on unapproved uses (SIUU) of medical products. This guidance supersedes the 2014 version, spotlighting the impact of off-label or separately indicated medical products on clinical decision-making. The update marks a shift by acknowledging the potential use of real-world evidence (RWE) and data (RWD) in providing scientifically sound information on unapproved products. Incorporating electronic health record (EHR) data opens avenues for broader clinical insights, but challenges like data quality variability and reporting bias require careful consideration.

McKinsey Report suggests that Generative AI could unlock potential value of about 2.6 percent to 4.5 percent of annual revenues ($60 billion to $110 billion) annually on the pharmaceutical and medical product industry.

IA Patient Partner John Linnell serves on the Board of Directors for the US COPD Coalition and as an Advocacy Captain for the COPD Foundation, works with the nonprofit Right2Breathe, and has been appointed to the Patient Engagement Collaborative for the FDA. In this interview from our DIA Global Annual Meeting 2023 in Boston, John shares the vision, purpose, and power of his patient advocacy with DIA Scientific Affairs Specialist Maria Paula Bautista Acelas.

ithin a defined period after the initial approval of a medicinal product, many regulatory authorities require the renewal of its marketing authorization to ensure that the medicine’s safety, quality, and efficacy continue to meet the standards set by national regulations.

IA Scientific Affairs Specialist Maria Paula Bautista Acelas discusses the importance of effective patient communication and engagement with DIA Patient Partners and cancer survivors Desiree Walker and Roberta Albany in this interview from our DIA Global Annual Meeting 2023 in Boston. Desiree is a member of the MRCT of Brigham and Women’s Hospital and Harvard’s Collaborative Cross-Industry Glossary for Clinical Research Workgroup and works extensively with the Young Survival Coalition. “My goal has been and continues to be that health equity is not a luxury but it’s an option for all,” she explained. “I’m involved in patient advocacy, but I also do research advocacy as well as legislative advocacy. We need the research, the evidence-based information, because that’s also needed for the policy conversations.”

t the end of the year, it’s time once again for our annual conversation with our DIA Global Forum co-editors for Translational Science and Medicine, Dr. Gary Kelloff, who has more than 40 years of cancer research experience at the US National Cancer Institute; and Dr. Lanny Kirsch, Distinguished Physician-Scientist and SVP of Translational Medicine at Adaptive Biotechnologies. Alberto Grignolo, editor-in-chief of Global Forum, sat down with them to look back and ahead and share their view on which 2023 milestones are likely to make an impact within translational medicine in 2024 and beyond.

e asked members of DIA’s scientific and publications communities to share their predictions for the life sciences in the coming year. All responded creatively, although some responded anonymously. We hope you enjoy reading these predictions now AND revisiting them later to see how many came true in 2024.

he landscape of the life sciences will continue to evolve in 2024, propelled by technological advancements, research breakthroughs, and regulatory adaptations. As we stand in front of 2024, exploring the imminent trends in regulatory affairs, FDA policies, and clinical research becomes paramount. This article aims to illuminate unfolding regulatory developments in drugs, biologics, and medical devices, and their potential impact on clinical trial participant care, regulatory affairs professionals, and public health. By appraising the current landscape of medical product development, it endeavors to present a comprehensive view of the path ahead.

ublication of the European Commission’s (EC) legislative proposal for the review of the general pharmaceutical legislation (GPL) at the end of April 2023 has been heralded as a “once in a generation” opportunity to make medicines more available, accessible, and affordable. The EC considers that the proposals will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry while promoting higher environmental standards. However, the published proposals introduce changes that would have a major impact on the global competitiveness of the EU market as well as erode incentives for investment in innovation.

rom 2018 to April 2022, the regional ECOWAS Joint Assessment Procedure (JAP) under the West Africa Medicines Regulatory Harmonization (WA-MRH) Initiative received twenty-two (22) dossier submissions from manufacturers within and outside the ECOWAS region, a relatively lower number than anticipated.

he knowledge and infrastructure required to unlock rare disease “white spots,” diseases where there is currently no science or translational capability, call for a different strategic paradigm. The mission of the Rare Disease Moonshot is rooted in boosting public-private collaborations.

apan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems fragmented. IITs are categorized as either commercial or noncommercial.