李自力
美国强生集团杨森制药全球药物研发副总裁,亚太研发中心负责人 医学博士

  李自力博士目前任美国强生集团杨森制药全球药物研发副总裁,负责公司亚太地区药物研发整体战略的制定和实施及1400人的研发团队的管理。

  自力博士有着20年国际药监机构、药业和基金会的工作经历。他于2000年和2015年两次加入美国FDA,任新药临床审评员、审评组长和仿制药部副主任,分管国际合作。期间,直接推动了仿制药标准在ICH框架下的国际协调机制。2017年5月,做为美国FDA代表团的核心成员,直接参与了就中国药监部门加入ICH在北京进行的中美磋商。对中国加入ICH起到了重要作用。他还曾出任默沙东中国医学总监和全球新兴市场药品注册战略策划部执行总监。自力博士在担任美国比尔及梅琳达•盖茨基金会中国办公室副主任期间,推动了中国企业疫苗和仿制药产品WHO预认证的战略规划和支持中国药监部门加入PIC/s的战略探索。同时,他积极推动了中国药监部门和盖茨基金会战略合作框架的建立,为以后的战略人才的引进奠定了基础。

  为了支持新兴市场药品监督机构科学审评能力的提高和体系的现代化,自力博士在2008-13年期间担任美国FDA同仁会国际部联席主席,做了大量的宣传、推动和培训工作。为此,于2013和2014年,分别获得中国国家食品药品管理总局药品审评中心颁发的监管科学特别贡献奖和美国FDA颁发的FDA同仁会特别贡献奖。

  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.