Global Five conferences, five continents’ worth of anxiety, one unmistakable pattern: the global pharma industry is being reshaped faster than it can keep up. From Philadelphia to Geneva, Istanbul to Chicago to London, the Shawview Consulting team found the same threads running through every panel and corridor conversation — AI and…
Europe The EU Health Technology Assessment Regulation was implemented in January 2025 to replace 27 fragmented national evaluations with a single Joint Clinical Assessment, run in parallel with EMA review. The idea was simple enough and aimed at giving European patients faster, more equitable access to innovative medicines. In practice, the…
Europe As the European Medicines Agency navigates the most significant expansion of its mandate in a generation, Executive Director Emer Cooke highlights how the regulator is further strengthening its role across the full lifecycle of medicines. Cooke sets out how EMA is enhancing its engagement from early developer support and clinical…
Europe Europe’s long-anticipated shift to a unified Health Technology Assessment framework is no longer theoretical, it is now being tested in practice. As the results from the first Joint Clinical Assessments begin to emerge, Niklas Hedberg describes a system balancing ambition with reality, aligning 27 Member States while managing expectations from…
Europe Europe is rewriting the rules governing medicines, innovation, and industrial competitiveness, with consequences that reach far beyond regulation alone. Pricing pressure from the United States, slower market access, rising administrative complexity, and the global race for biotech leadership are forcing policymakers to decide whether the region will remain a premier…
Global 2025 was a year of volatility for pharma and healthcare. In particular, the speed with which the administration of Donald Trump makes (and often then changes) consequential policy decisions has left industry stakeholders in the US and globally scrambling to fall in line. There are already clear winners and losers…
USA Rob Abbott, CEO of ISPOR—The Professional Society for Health Economics and Outcomes Research (ISPOR) provides an update on the organisation’s activities since taking up the role in 2023, including the launch of a new 2030 strategy and revised mission aimed at integrating HEOR into everyday health policy decision-making. This includes…
Europe The EU’s Health Technology Assessment Regulation (HTAR), which kicked off in January 2025, has launched joint clinical assessments (JCAs) for oncology and advanced therapies; yet six months in, implementation remains rocky, communication is patchy, and the wider impact on access and innovation is still murky. Writing in DIA’s Global Forum…
Denmark Since stepping into the role of Chair of the Danish Medicines Council in early 2025, Birgitte Klindt Poulsen has been navigating the delicate balance between accelerating patient access to innovation and maintaining the rigour of independent, evidence-based evaluation. In this interview, she shares how the Council is adapting to a…
Europe Writing in the June 2025 edition of DIA’s Global Forum Magazine, Finn McCartney, Maria Dutarte, Petra Adámková, and Paola Kruger from the European Patients’ Academy on Therapeutic Innovation (EUPATI) weigh in on how the patient voice is being incorporated into Joint Clinical Assessments (JCA) under the new EU Health Technology…
Europe Lora Fleifel, Director of Global Value Access & Pricing Operations Europe for Oncology at Merck, dissects the promise and pitfalls of the new EU Joint Clinical Assessment (JCA). The JCA aims to harmonise clinical evaluations to help reduce the significant disparities in patient access to innovative treatments that still exist…
Global Writing in the April 2025 edition of DIA’s Global Forum magazine, Christopher Morrison and Richard Xie of RA Capital Management L.P., introduce the recently published cost-effectiveness analyses methodology which incorporates key value elements and drivers that are omitted or incompletely captured in traditional clinical outcome assessments. Accelerating scientific discoveries…
See our Cookie Privacy Policy Here
