Tagged with therapy

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…

USA Astellas has steadily developed its immuno-oncology (IO) pipeline via both organic and inorganic means in recent years, with its early-phase IO projects now overseen by industry veteran Peter Sandor, the company’s SVP and IO Primary Focus Lead. Sandor explains the variety of exciting IO approaches in development at Astellas, how…

Singapore MSD is set to inject an additional USD 500 million into its existing Singapore manufacturing operations with two new facilities to produce vaccines and biologics. One of the new plants will turn out MSD’s immunotherapy for cancer and its human papillomavirus (HPV) vaccine for the Asia-Pacific region. The reason we…

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…

Spain In 2021, a hospital in Barcelona managed to get approval for the first European-developed CAR-T cell therapy. Aided by a little girl and her mother, a team of doctors at the Hospital Clinic Barcelona moved early to learn from the American physician that pioneered the treatments, did not take no…

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…