03/13 Keynote Speech of Lawyer Chia-Feng Lu (呂家鋒)
The Platform for Research and Inspiration in Regulatory Science sincerely invites you to actively participate in the Keynote Speech of Lawyer Chia-Feng Lu!
Topic: The impact of Food and Drug Omnibus Reform Act of 2022 (“FDORA”) and Inflation Reduction Act (“IRA”) on the biopharmaceutical industry Lecture outline:
The every-five-year Drug User Fee Act came to an end in December 2022. The Food and Drug Omnibus Reform Act, also known as FDORA, will have an impact on clinical trials, cell and gene therapy, supply chains, and real-world data applications in the United States (US). Meanwhile, the Inflation Reduction Act (IRA) introduces the first mechanism for the US government to intervene in drug price negotiations. Lawyer Chia-Feng Lu, who was involved in the negotiation of these two bills in Washington, DC, will discuss the key points and impacts on the biopharmaceutical industry. This speech will primarily focus on FDORA. If time permits, it will also address the potential impact of IRA on biotech licensing negotiations and investment strategies. Speaker: Chia-Feng Lu / Greenberg Traurig - Senior Partner in Washington, D.C. and Tokyo/Osaka area Speaker profile：Lawyer Lu specializes in biopharmaceutical and emerging technology businesses. He participates in emerging technology regulatory legislation, as well as negotiates licensing and mergers and acquisitions of cutting-edge technologies. Lawyer Lu has been involved in the world's first global licensing negotiation for immunotherapy, the acquisition of the division of cellular and gene therapies, as well as the development or launch strategies of three Nobel Prize-winning drugs. In addition, he provides consultation on biotech policies for the government agency.
