USA Access works when all pieces are in place. Hearing directly from patients about what diagnosis or how a treatment impacts their lives is meaningful to everyone involved Scott Weintraub, Head of US Business at Alexion, AstraZeneca Rare Disease, discusses how his experience across commercial leadership, strategy, and rare disease innovation…
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…
Lebanon Dr Ali Taher, MD, PhD, FRCP, has spent more than three decades shaping the understanding and treatment of thalassemia. As Associate VP for Academic Centers at the American University of Beirut (AUB) and Director of the Naef K. Basile Cancer Institute, he has integrated high-level research with clinical excellence. Trained…
USA Duane Barnes, President of Sobi North America, outlines how the company has rapidly expanded its presence in the region to become a key player in rare diseases, growing its US business more than twenty-fold over the past decade. He discusses Sobi’s strong focus on haematology and immunology, the company’s upcoming…
Europe Advanced Therapy Medicinal Products (ATMPs) – encompassing gene therapies, somatic-cell therapies, and tissue-engineered products – have been regulated in the European Union under a dedicated framework since 2009. As of 2025, the European Medicines Agency (EMA) has authorised close to 20 ATMPs (below), most of them gene therapies for rare…
Europe As China and the US attract an increasing share of commercial clinical trials, Europe is fighting to reclaim its spot as a global research leader. While Europe has world-class hospitals and experienced regulators, it has struggled with a complicated and fragmented approval system that has pushed trial sponsors elsewhere. To…
Saudi Arabia Osama Braiwish leverages over 26 years of industry experience across the Gulf region and Saudi Arabia. He joined Bristol Myers Squibb (BMS) in 2024, drawn to the company’s commitment to addressing significant unmet medical needs in oncology, hematology, immunology, cardiovascular and neuroscience. In his first few months at BMS, Braiwish…
Europe While Europe has lost some of its global share of clinical trials to China and the US, it remains a clinical research stronghold. Three years into the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to transform how trials are initiated, designed, and run across the…
Europe The EMA’s Pre-Accession Assistance Program (IPA) helps EU candidate and potential candidate countries align their medicines regulations with EU standards through training, capacity-building, and policy support. As a new op-ed in the February 2025 edition of DIA’s Global Forum magazine outlines, an impact assessment of IPA II (2020-2023) showed significant…
Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond. The Road…
Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…
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