Nikolai Brun is a rare regulator who has rolled up his sleeves and successfully helped bring a therapy to market. He was part of a team at Genmab that discovered one of the first monoclonal antibodies for treating cancer.  Nikolai was previously the Chief Medical Officer (CMO) of the Danish Medicines Agency, and has recently gone back into industry, as the CMO of the Swedish biotech company, Affibody. In this Vital Health Podcast, Nikolai Brun outlines why Europe’s biopharmaceutical sector is falling behind the rest of the world's and how the proposed EU pharmaceutical legislation, while containing many good ideas, may harm the sector instead. The podcast also highlights how the continuing decline in clinical trials in the EU should be setting off alarm bells in Brussels, even if the reaction of many bureaucrats implies that they don’t see this as a concern or a priority. This podcast was made possible with the support of EFPIA - The European Federation of Pharmaceutical Industries and Associations.    00:00:41 - EU Pharmaceutical Legislation Proposal: AMR and EMA Review Timelines00:03:46 - Europe's Loss of Competitiveness: Regulatory Sandbox and Real-World Data00:07:34 - Regulatory Data Protection Linked to Access to All 27 Member States 00:12:03 - Development of COVID-19 Vaccines: The Regulatory Challenges 00:15:45 - AMR Incentives 00:20:45 - Europe Losing Ground vis-à-vis the USA 00:24:42 - Global Share of Clinical Trials 00:31:37 - Regulatory Sandbox 00:35:21 - Forced Access to All 27 Member States and Incentives  00:41:40 - Regulators’ Skills Gap 00:48:19 - Europe and Value-Based Healthcare 00:49:50 - Unmet Medical Needs and Accelerated Procedures 00:55:57 - The Best Place to Start to Improve the European System 00:58:36 - Advanced Therapies Development: The Case of China See omnystudio.com/listener for privacy information.