Tagged with Opinion

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Europe Pfizer’s David Isom and Monica Mihedji, writing in the November 2023 edition of the DIA’s Global Forum magazine, examine how the European Medicines Agency is attempting to integrate the use of artificial intelligence in its regulatory work.   Regulators are advancing information technology and data modernization initiatives to drive more…

Global Dr Vivienne Marshall, senior director of the Center for Advanced Therapies at the South Texas Blood & Tissue Center, part of BioBridge Global, outlines some of the major barriers to wider adoption of cell and gene therapies: complexity, variability, and the lack of robust standards. Dr Marshall also highlights the…

South Africa Dr Benji Pretorius, the founder of Erada Technology Alliance and a malaria survivor himself, shares his insights into why the development of a truly effective malaria vaccine will only succeed in combating the world’s number one killer if it is integral to a ubiquitous, efficacious diagnostic programme.   Malaria, a…

China After four years away, Brendan Shaw recently returned to China to attend the ChinaBio Innovation and Investment Conference in Suzhou. Although geopolitical tensions, the fallout from COVID-19, and local market challenges have dampened stakeholder optimism around China somewhat in the last few years, Shaw feels that the country still has…

Australia Richard Day of the University of New South Wales, writing in the October 2023 edition of DIA’s Global Forum magazine, looks at updates to the health technology assessment (HTA) processes in Australia and New Zealand   In April 2023, the Australian Department of Health and Aged Care launched an independent Health…

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 Mohamed Meshref M.D, PhD is a Professor of Oncology at Cairo University and Regional Medical Director at Boehringer Ingelheim for India, Middle East, Turkey & Africa (IMETA). Here, Prof. Meshref discusses the importance of an ‘early medical affairs mindset’ within the pharma industry whereby medical affairs personnel engage much earlier…

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…