Tagged with Opinion

Europe A new piece in the January 2023 edition of DIA’s Global Forum magazine lays out how a new coalition aims to transform the landscape for rare disease treatments in Europe and beyond.   The knowledge and infrastructure required to unlock rare disease “white spots,” diseases where there is currently no…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

USA Drawing on her experience as rare disease patient advocacy group SYNGAP1 Foundation’s founder and former president, Monica Weldon argues for the need to standardize genomic testing practices, warns against the possible ethical implications of individualized medicine, and makes a cause for a more holistic approach within rare disease communities.  …

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

Global AI is the buzzword du jour across all industries, but what is needed for it to truly make a difference in clinical trials? Writing in December 2023’s DIA Global Forum magazine, Lokavant’s Rohit Nambisan lays out the three essential characteristics for AI impact in clinical research, foregrounding the vital importance…

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…