Tagged with car-t

Hong Kong Haematological oncologist Dr Raymond Liang, gives his take on the adoption and challenges of CAR-T therapy in Hong Kong, the necessity of collaboration with mainland China for patient referrals and clinical trials, and the evolution of both Hong Kong’s hospital and regulatory infrastructure, which point to a brighter future for…

United Kingdom The recent FDA decision to investigate the serious risk of patients developing new cancers after treatment with CAR-T therapies may have created some bad press around cell and gene therapies, but AstraZeneca has continued to consolidate its ambitions in the area with the acquisition of China-based cell therapy biotech, Gracell…

Hong Kong Novartis, one of the world’s largest biopharma companies, has secured approval and market access for two of its most advanced cell and gene treatments in Hong Kong. The firm’s territory head, Derek Chang, highlights how early access to innovative therapies in the Hong Kong-Greater Bay Area (GBA) can unlock winning…

Belgium Janssen has the lofty aim of reaching USD 60bn dollars in sales by 2025, an 8bn increase on the 2021 figure, despite some high-profile losses of exclusivity and the spin-off of its consumer healthcare branch. This massive growth plan involves both existing products as well as new CAR-T and autoimmune…

Belgium Back home in Belgium after a stellar stint in Big Pharma, Dr Paul Stoffels* is now looking to reshape the future of cancer care with the biotech he helped co-found in 1999, Galapagos. In an exclusive conversation with PharmaBoardroom, Dr Stoffels outlines his excitement about a new CAR-T delivery model that…

Belgium Maria Fernanda Prado highlights some of the lessons drawn from her extensive experience in emerging markets which remain applicable in her current role as Janssen’s managing director for the Benelux region. Belgium, the home country of Dr Paul Janssen, continues to be a significant part of the company’s global operations,…

Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…

Spain Dr Manel Juan is part of the team behind the development of the first European CAR-T-cell therapy to treat multiple myeloma, the second most common type of blood cancer. As head of immunology at the Hospital Clinic Barcelona, he walks us through his personal journey with the project, the challenges…

Italy Gilead Sciences’ vice president and general manager for Italy, Valentino Confalone, outlines the company’s tumultuous pandemic journey in one of the first global epicentres; the role that Italy played in the early studies of remdesivir as a treatment against severe COVID-19 disease; how Gilead is working to eliminate viral Hepatitis…

Global As complex cutting-edge therapies come online, industry sponsors are increasingly looking to engage with patients, caregivers, and advocacy groups earlier and more broadly in the drug development process to better understand their needs. However, as the below insights from four of Novartis Oncology’s patient engagement leads show, successfully integrating patient…

Global One of the enduring conundrums around ground-breaking and potentially paradigm-shifting treatments such as CAR-T is the ever-thorny question of how fast to move them to market when the promise seems so great, but the evidence remains so patchy.   So far, top tier regulators such as the US FDA and…