Tagged with CELL &

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…

Global The Alliance for Regenerative Medicine (ARM) brands itself as the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. ARM’s latest sector snapshot details the cell and gene therapy approvals list for 2022, as well as the number of…

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,…

Hong Kong With the global market for cell and gene therapy (CGT) products set to skyrocket in the coming years, Hong Kong is looking to get in on the action with the opening of a new Advanced Therapy Products (ATP) Good Manufacturing Practice (GMP) Centre earlier this month.   Leveraging the city’s…

Korea Founder and CEO of GeneMedicine, Dr Chae-Ok Yun, explains how the company, specialised in oncolytic virus development, has progressed since we last interviewed her two years ago, with one of its candidates getting close to phase II clinical trials and the construction of a new manufacturing facility that will enable…

China Due in part to an increasingly encouraging regulatory environment, China continues to strive for progress in cell and gene therapies (CGT). In fact, according to a 2021 Nature study, CAR T-cell therapy clinical trials in China have accounted for over 50% of registered CGT studies worldwide. Currently, over 200 CAR-T…

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…