Japan Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data, say J&J’s Yumi Wakabayashi and Vicky Han in October 2023’s DIA Global Forum magazine. With appropriate efforts to ensure…

Global Shawview Consulting’s Brendan Shaw looks back on a sombre United Nations High Level Meeting on Universal Health Coverage in New York last month, as stakeholders reflected on the long road still to travel if the goal of securing UHC for the world’s population by 2030 is to be met. Shaw…

Global Merck’s Kaushal Kishore attempts to illustrate why pharma companies have struggled to crack what he calls “the Gross to Net (GtN) code.” He outlines the maturity journey for a pharma commercial and pricing organisation which can lead to maturity on the GtN topic, and highlights a successful example that can…

Global Claudia Martínez, generic & biosimilar medicines programme manager at the Access to Medicine Foundation, draws from a recent AMF report to outline what more generics companies can be doing to ensure greater access to their essential products. Martinez argues that for people living in low-and middle-income countries (LMICs), generic and…

Global Ahead of the 78th session of the United Nations General Assembly (UNGA78), IFPMA Director General Thomas Cueni underscores the need for pandemic preparedness plans to support innovation and equity. Global leaders must ensure science and innovation can again deliver at record speed and scale while supporting voluntary partnerships and enabling…

Global Patents can be an excellent way to demonstrate value, not only showing that a technology is protected but also how promising it can be when it eventually comes to market. Here, William Mansfield of LexisNexis® Intellectual Property Solutions outlines how ‘patent analytics’ can help identify pharma’s top performers today as…

Brazil The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This…

China Writing in the September 2023 edition of DIA’s Global Forum magazine, Shuting Li of Anhui Jimin Cancer Hospital and Xinfang Fan of Bayer Health Care Ltd. examine how Chinese clinical trials are increasingly focusing on patient engagement and patient centricity.   In recent years, with the Chinese government’s vigorous support…

Europe The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a new initiative made up of industry association the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), molecular diagnostics firms Exact Sciences and Guardant Health, sequencing platform provider Illumina, and drugmakers MSD and Novartis. Here, the coalition lays out its aims…

Global The rise of niche therapies is shaping a more tailored engagement model, driven by data and AI, writes Florian Schnappauf, vice president of enterprise commercial strategy at Veeva Europe.   Last year, orphan drugs accounted for more than a third of Europe’s new drug approvals, and the number of gene…

USA With office occupation rates on the slide and the life sciences industry’s demand for lab space on the rise, the repurposing of existing offices into medical laboratories has become an important new asset class, writes Liz Chen, a lab planner at HGA Life Science + Advanced Technology Group’s San Diego…

Americas Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED).   The need for further regulatory…