Tagged with therapy

Switzerland Genomic medicine expert Professor Thomas D. Szucs explains what ignited his interest in the field and how payers and authorities are adapting to the strain on resources that genomic medicine can contribute to. Professor Szucs also evaluates the sustainability of personalized medicine and China’s rapid progress in the field.  …

Europe The EMA’s Head of Advanced Therapies Dr Ana Hidalgo-Simon outlines Europe’s evolving regulatory framework for regenerative medicines, how it differs from those in the USA and Asia, ethical and pricing challenges, and why global regulatory harmonization and collaboration is crucial.   For advanced therapies, market approval is not the end…

China While cell and gene therapies are all the rage now, a little known fact is that the world’s first approved gene therapy actually came from a Chinese company – in 2003! Gendicine® was a gene therapy for the treatment of haemophilia B. While China mostly lost the advantage of that…

Opinion Novartis Oncology’s Emanuele Ostuni (lead author) and Karin Blumer draw on their experience commercialising CAR-T therapies to make the case for the myriad benefits of collaborative, as opposed to command, leadership, the impact of company and team culture on the innovation journey, and why we must not confuse collaboration with…

China Following a recent capital injection of USD 67 million, Chinese biotech EdiGene is set to advance its pipeline in gene editing treatments and therapies as it becomes a clinical-phase company. The company’s CEO spoke to PharmaBoardroom about how Edigene’s technology platforms differ from those of other firms, and why the…

Japan Toshio Fujimoto, MBA, MD of Japan’s Shonan Health Innovation Park looks at how a technology developed in Japan over a decade ago is poised to drive major medical advances and new treatments.   Here’s what we know today and what we’ll need to do tomorrow to benefit from the promises…

USA Certara’s Ulrich Neumann looks at the challenges that payment models for cell and gene therapy (CGT) have faced, the multiple models now under development, and why an open and collaborative approach among US healthcare stakeholders is needed if the significant legal and practical barriers are to be overcome.   The…

Norway Photo: Sofia Linden / Oslo Cancer Cluster Oncologist Jon Amund Kyte shares some of the groundbreaking immunotherapy research that he and his team is conducting at Oslo University Hospital. Kyte also explores how Norway can better develop its clinical footprint and what his hopes for the future of experimental cancer…

Japan Dr Ken-ichiro Hata, representative director and chairperson of Japan’s Forum for Innovative Regenerative Medicine (FIRM) outlines the organisation’s mandate, how Japan has been able to cultivate one of the world’s most mature regenerative medicine ecosystems, and highlights key challenges including regulatory misalignment across Asia and the need for better manufacturing…

Novartis Ameet Mallik, Executive VP and Head of Oncology for the US at Novartis Oncology highlights the company’s culture of ‘curious, inspired, and unbossed,’ how Novartis differentiates itself in a highly competitive oncology landscape, learnings from recent product launches, and how Novartis is working to make its CAR-T therapy more accessible…

Cell & Gene Therapy The completion of the Human Genome Project (HGP) in April 2003 with the publication of the first human genome sequence is probably one of the most significant landmarks in humanity’s quest for knowledge, costing USD three billion across 13 years. But even after nearly two decades, we have barely scratched…

Novartis In late 2019 Novartis hit the headlines in Belgium after it refused to grant access to its one-off gene therapy Zolgensma® for the ultra-rare muscle-wasting disease spinal muscular atrophy (SMA) to Pia Boehnke, a Belgian child.   With Zolgensma® at that point having not yet been authorised by the European…