Tagged with Cell & Gene Therapy

Global Bayer’s Michael Levy casts his eye over the implications of the advent of cell and gene therapies on pharmacovigilance and patient safety.  Levy examines why these potentially revolutionary new therapies will necessitate a rethinking and adaptation of currently existing pharmacovigilance processes and activities.   While traditional medicines have, without a…

Global The ascent of cell and gene therapies (CGT) is commonly regarded as one of the momentous turning points in the history of the pharmaceuticals industry. Not only do innovative therapies such as CAR-T herald a shift towards genuinely individualized medicine and an exciting new front in the war against cancer,…

Global Emerging cell and gene therapies herald immense clinical value for patients, society, and healthcare systems: carrying the potential to offer life-changing solutions for people with few or no alternative treatments. Given the limited amount of long-term evidence for these therapies due to their relatively recent development, however, bringing them to…

USA Certara’s Ulrich Neumann examines some of the major US market access trends of the past few years, including the innovative financing models required for novel therapies, why cost effectiveness considerations are on the rise, and the impact of the drug policy environment on payer sentiments.   The US reimbursement landscape…

Global Stefan Hendriks, Global Head of Novartis Oncology’s Cell & Gene division outlines the company’s progression to becoming the global leader in cell and gene therapies, the strategy he has put in place for the business, and the key issues of manufacturing and access.   Cell and gene therapies are truly…

Global Rare disease patient advocate Monica Weldon outlines some of the ethical conundrums around embryonic gene editing. With CRISPR technology again in the news as part of the rush to develop COVID-19 treatments and vaccines, Weldon highlights the arguments for and against embryonic gene editing from a patient/parent perspective and makes…

Sweden Anders Blanck of Lif, the trade association for the research-based Swedish pharmaceutical industry, outlines the steps already being put in place for Sweden to become a leading country in the implementation of precision medicine. Blanck highlights the impact of Sweden’s December 2019 Life Science Strategy – which includes initiatives on…

Global On 7 October 2020, the 2020 Nobel Prize in Chemistry was jointly awarded to Emmanuelle Charpentier and Jennifer A. Doudna “for the development of a method for genome editing.” They are the sixth and seventh female chemistry laureates in the history of the prize.   Emmanuelle Charpentier was born in…

Europe Professor Nicolaus Kröger, president of the European Society for Blood and Marrow Transplantation (EBMT) introduces the multi-stakeholder GoCART Coalition and the impact that it stands to have on the cell and gene therapy field in Europe.   It was critical to build a coalition that is win-win for everyone Nicolaus,…

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…