USA Almost ten months into his presidency, Joe Biden has announced his pick to lead the US Food and Drug Administration (FDA). If confirmed by the Senate, the nominee, Dr Robert Califf, would become commissioner for a second time after leading the agency for almost a year at the end of…
USA Melanie Croce-Galis, RN, MPH explains the specificities of her work as patient engagement lead for Novartis Oncology in the US market, where significant disparities in patient access to information and to care throw up several challenges. Croce-Galis also outlines the work being done around CAR-T therapies and why integrating and…
USA Susan L. Lang outlines how pharma companies can navigate drug formulary exclusions, numbers of which have been rising in recent years, and ensure that newly FDA approved medicines can make it to consumers. The pipeline for new therapies at the Food and Drug Administration mostly consists of novel brand…
USA Paediatric oncologist Navin Pinto, MD outlines the current use and potential of CAR-T therapies in his field, including the manufacturing challenges that still need to be addressed. Dr Pinto also explains how the work of his CAR-T team at the University of Washington School of Medicine could provide proof of…
USA Claire Saxton and Lauren Kriegel of Cancer Support Community, the largest professionally led non-profit network of cancer support worldwide, discuss how cancer patient and caregiver perspectives need to be better integrated into the treatment process. This is an especially prescient issue for next-generation cell and gene therapies such as CAR-T…
USA The National Organization for Rare Disorders (NORD) is set to host its annual Rare Diseases and Orphan Products Breakthrough Summit on October 18-19th. Ahead of the Summit, the Chair of NORD’s Board of Directors Kay Holcombe explains its significance for cross-stakeholder interaction and learning and why we are entering “a…
USA PhRMA’s Lori Reilly warns that, as US policymakers seek to reduce drug prices, they must avoid policies that reduce access and choice. America is the centre of cutting-edge biopharmaceutical innovation. Not only are many of the latest treatments and cures developed in labs by researchers across the United States,…
USA Dr Sam Volchenboum outlines the progress that has been made in the paediatric oncology field in recent years and his hopes for its future. Dr Volchenboum also explains the important role that data will play in the new era of targeted and personalised therapies and the impact of the work…
Global Bill Sibold, Executive Vice President and Head of Sanofi Genzyme, highlights the achievements of the company’s Rare Humanitarian Program over the last 30 years, bringing treatments to patients in developing countries with lysomal storage disorders who would otherwise not have access. Sibold outlines the persistent obstacles facing people with rare…
USA John M. O’Brien, recently appointed president and CEO of the US National Pharmaceutical Council, calls for innovation in benefit design reform to match the unparalleled speed and ingenuity with which the biopharmaceutical industry developed vaccines and therapeutics to combat the COVID-19 pandemic. The biopharmaceutical industry developed COVID-19 vaccines and…
Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…
USA In his latest PharmaBoardroom piece, John Singer looks at Biogen’s marketing campaign for its new Alzheimer’s drug, extending and linking the controversy to the grander strategic themes reshaping the ‘drug market’ as a whole, including the impact of the internet on cognitive change, the unmet need for a different premise for…
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