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)…
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…
Asia-Pacific Asia has experienced a biotech boom in the past five years. In 2020, almost 50 percent of the region’s clinical trials were led by biotechs and by 2025, biotech-led clinical trials will far exceed those led by Big Pharma, according to IQVIA. However, the region’s biotechs face a myriad of…
Asia-Pacific Asia-Pacific, as home to 50 percent of the world’s new cancer cases each year and with deaths caused by cancer expected to increase by 36 percent by 2030, has a pressing need for more patient-centric, data-driven, value-based, and precise solutions in oncology. Additionally, Asian cancer patients’ healthcare needs can differ…
Singapore Kevin Zou highlights Novartis Oncology’s footprint and priorities in the diverse Asia-Pacific region, the challenges of introducing cutting-edge cell and gene therapies, how the company works with regulators and payers in Singapore and beyond, and why Asian representation in clinical trials is of vital importance moving forward. Technology has…
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