Tagged with Cell & Gene Therapies

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…

UAE CSL Behring – which specalises in plasma-derived, and recombination therapeutic products – has undergone significant expansion in the Middle East and Africa (MEA) region in recent years under Hassan Herrou. He explains why building partnerships with the relevant authorities as well as patient associations is vital to fostering access in…

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…

Switzerland Vincent Gruntz looks at the market dynamics for oncology in Switzerland, where an increasingly cost-conscious approach is being taken to reimbursement and pricing, his experience of bringing CAR-T therapies to the country, and the challenges and opportunities of ‘virtual’ product launches.   Once you have seen a patient – that…

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…