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…

China Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.  …

Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, critiques the draft EU Pharma Regulation from a VC perspective, arguing that the continent’s status as a medical innovation hub is at risk if the EU…

Global Regular contributor Brendan Shaw* casts his eye over the recently announced 2023 WHO Essential Medicines List, how it reflects growing pharmaceutical innovation, and why maintaining a ‘seat at the table’ for the pharma industry in these discussions will be crucial to meeting global healthcare access goals.   Recently, the World…

Global Smart manufacturing has become a key component of today’s industrial evolution and unlocked unprecedented efficiencies and quality enhancements. Smart Manufacturing expert Eric Whitley outlines the specific benefits of smart manufacturing for the pharmaceutical industry, illustrating these benefits with industry case studies.   Smart manufacturing has entered the world of modern…

Global Merck KGaA’s Marco Rauland and Kaushal Kishore examine how artificial intelligence and machine learning can best be applied in pharmaceutical pricing and market access. Noting the significant uptake of such tools in other aspects of the pharma value chain, Rauland and Kishore speculate how they might come to revolutionise pricing…

Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, launches a critique of current pharmaceutical policies across the EU, arguing that constant cost-containment measures, over-regulation, and bureaucracy are leading to drug shortages and acting as…