As Vice Present of Global Drug Development in Janssen Pharmaceuticals, J&J Group, USA, Dr. Li is currently responsible for the formulation and implementation of the company's overall strategy for drug development in the Asia Pacific region, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region.
Dr. Li has 20 years of working experience in international drug administration agency, industry and foundation. He joined US Food and Drug Administration (FDA) twice in 2000 and 2015, serving as the clinical reviewer for new drugs, review team lead and associate director at the office of generic drugs, in charge of the international collaboration. He promoted the international coordination mechanism of generic drug standards under the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) framework. In May 2017, he participated in China-US consultation in Beijing for China’s National Medical Products Administration’s (NMPA) membership in ICH, as a core member of US FDA delegation. He played a critical role in China’s membership in ICH. Dr. Li used to work for Meck as well, as China Medical Director and executive director of Drug Registration Strategic Planning for global emerging market. During his tenure as Deputy Director of the China Office of the Bill & Melinda Gates Foundation, he promoted the strategic planning of WHO pre-certification for Chinese companies’ vaccines and generic products, and supported the strategic exploration of China’s drug regulatory authority to join PIC/s. Meanwhile, he actively promoted the establishment of the strategic cooperation framework between China's drug regulatory authority and the Gates Foundation, laying the foundation for the introduction of strategic talents in the future.
In order to support the improvement of the scientific review capability and the modernization of the system in the drug supervision agencies in emerging markets, Dr. Li cooperated with some former colleagues of the FDA to establish the International Department of the FDA Peer Association in 2008 and co-chaired during 2008-2013, doing a lot of publicity, promotion and training. To recognize his contribution, Dr. Li received the Special Award for Regulatory Science from the Center for Drug Evaluation of China’s NMPA and FDA Distinguished Alumni Award issued by the US FDA in 2013 and 2014 respectively.