Welcome to CMC Strategy Forum Japan 2020

On behalf of the CASSS Board of Directors and the CMC Strategy Forum Global Steering Committee, we would like to extend to you a warm welcome to the eighth meeting of the CMC Strategy Forum Japan 2020.

We are very pleased that with the strong support from the Pharmaceuticals and Medical Devices Agency (PMDA Japan), as well as the Japan Pharmaceutical Manufacturers Association (JPMA), and with the continued organization by CASSS and the support from the United States Food and Drug Administration, that we are continuing with the CMC Strategy Forum Japan 2020. Due to the current situation with COVID-19 (also known as coronavirus) outbreak, this forum will now take place virtually. Each session will still include live speaker presentations and panel discussions. This means that you will have the opportunity to login and view each session, ask questions of the speakers and panel members, as well as interact with other attendees.

Workshop session one “Recent Trends in the Regulation of Biopharmaceutical Products” will be held on Monday, 7 December 2020 starting at 9:00 am Japan Standard Time (JST). Topics that will be discussed are: how communications being handled between the Sponsor and each Health Authority during COVID-19; what are the options for accelerated CMC development of prophylaxis / treatment of COVID-19; and what are the regulatory opportunities and challenges when new modalities are utilized.

Workshop session two “Implementation of ICH Q12 – Where Are We in Japan and Globally? will be held on Tuesday, 8 December 2020 starting at 9:00 am Japan Standard Time (JST). Topics that will be discussed include: a case study of the Japan PACMP pilot program for a biotech product will be introduced, as well as the PACMP mock-up document prepared by the AMED PACMP working group.

The success of the CMC Strategy Forum Japan will depend on your active participation in discussing and raising issues pertaining to the development of biologics. We encourage you to participate whole-heartedly in the panel discussions that have been designed to stimulate exchange of ideas and information.

We would like to thank the speakers and the panel members who are giving generously of their time and resources and to you for your attendance. We would also like to acknowledge the generosity of our program partners for the continued support of the Forum series: Biogen; F. Hoffmann-La Roche Ltd. and Merck Research Laboratories. We are grateful for the expert management from CASSS and the audio-visual expertise of Michael Johnstone from MJ Audio-Visual Productions. Their experience and guidance in the preparation of this Forum has been invaluable.