Dr. Changlin Dou Appointed IFPMA ICH M18 Task Force Lead Expert

Recently, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), as a standing observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), announced the list of experts for its new ICH working groups. Dr. Changlin Dou, R&D President and Chief Operating Officer at Boan Biotech, has been appointed by IFPMA as its Lead Expert for the ICH M18 Task Force. In this role, he will lead the drafting, formulation, and revision of relevant guideline documents.

Acting as the secretariat of ICH, IFPMA represents the pharmaceutical industry at the international level. It works closely with public health stakeholders in the UN system, including the World Health Organization, World Intellectual Property Organization, and the World Trade Organization. It also partners with governments, global health organizations, non-governmental organizations, civil society, patient groups, international hospital organizations, global foundations, and research and academic institutions.

In May of this year, the ICH Assembly was held in Madrid, Spain, where it adopted two new topics: E23 "Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines", and M18 "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs". The next ICH Assembly will take place in Singapore this November, during which 12 working groups will convene in parallel. The leaders of the M18 and E23 working groups will attend in person to discuss the next steps for these new topics, with the aim of promoting greater international harmonization of regulatory guidelines.

Dr. Changlin Dou, R&D President and Chief Operating Officer at Boan Biotech, said: "I’m honored to join the task force and take part in the development and revision of ICH guidelines. I am also proud to be a voice of China’s pharmaceutical sector on the global stage and to help bridge the communication between the pharmaceutical industry in China and international regulatory bodies and industry peers. Rooted in China, Boan Biotech aspires to become a 'leading biopharmaceutical company'. We look forward to working with industry colleagues to accelerate the alignment of China’s industry with international standards, helping shorten drug development timelines and drive global pharmaceutical innovation."