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CMC Strategy Forum Japan 2020" was held by CASSS (California Separation Science Society) on December 7 and 8, 2020. 2020 is also the year of the spread of the new coronavirus and the first CMC Strategy Forum Japan 2020 was held against the backdrop of travel restrictions around the world. The event was held online for the first time, against the backdrop of travel restrictions in many parts of the world. 102 participants registered not only from Japan but also from Asia, North America, and Europe, and active exchanges of opinions took place on both days.

Background of CMC Strategy Forum Japan

The CMC Strategy Forum was spun off from the Well Characterized Biotechnology Pharmaceutical (WCBP) Symposium in 2002, and after the first meeting in the United States, the Forum has been held in Europe since 2007, Japan since 2012, and Latin America since 2014. At the CMC Strategy Forum, experts from industry, academia, and regulatory agencies spend ample time discussing issues related to the research, development, manufacturing, and regulation of CMC (Chemistry Manufacturing and Control) for biopharmaceuticals. The CMC Strategy Forum in Japan is a forum for companies, academia and regulators to discuss issues related to research and development, manufacturing and regulation of biopharmaceutical CMC (Chemistry Manufacturing and Control).

For the CMC Strategy Forum in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) and the Pharmaceutical Manufacturers Association of Japan (PMAJ) organized a preparatory committee that has spent about a year preparing not only the selection of discussion topics and the direction of discussions, but also the management of the meeting in 2020, which is only possible online.

After welcome comments from Ms. Nadine Ritter of Global Biotech Experts, LLC, who will serve as the representative of CASSS from 2020, and Ms. Hiroyoshi Arai, Director of PMDA's Regulatory Science (RS) Center, lively discussions were held on the following themes The following topics were discussed.

Session 1: Recent Trends in the Regulation of Biopharmaceutical Products

In Session 1, moderated by Mr. Shinichi Okudaira, PMDA Regenerative Medicine Product Review Division, and Ms. Cecilia Tami, Genentech, the regulatory officials from each country presented a wide range of topics on recent regulatory trends, especially for biopharmaceuticals, and on temporary measures and new modality development under COVID-19. The session covered a wide range of topics, including recent regulatory developments, particularly for biopharmaceuticals, as well as temporary measures and new modality development under COVID-19.

Ms. Futaba Honda, Director of the PMDA's Regenerative Medicine Products Review Division, gave an overview of the proposed law to partially revise the Pharmaceutical Affairs Law, designation of pioneering drugs, operation of expedited approval with conditions, operation of the Post-Approval Change Management Protocol (PACMP), and the COVID-19 therapeutic drug. Management of the regulatory review process for COVID-19 drugs was introduced.

Ms. Ragini Shivji of the European Medicines Agency (EMA) introduced the concept of quality of biologics (including vaccines) under COVID-19, and showed the EMA's flexible approach based on risk-benefit and associated data, Discussion on the use of Prior Knowledge/platform data and the need for additional actions to mitigate potential risks through risk assessment were also presented. It was also mentioned that while delays in data submission are acceptable, quality data deemed necessary by the EMA need to be addressed after approval as an item to be noted.

Robin Levis of the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) discussed how to facilitate CMC development while ensuring product quality, He also introduced the development of the Ebola virus vaccine. First, he presented the basic premise that applicants should only be granted approval or Emergency Use Authorization (EUA) for vaccines that can be manufactured using appropriate and well-controlled studies to demonstrate vaccine safety and efficacy, and consistent manufacturing methods. Efforts to ensure the availability of safe and effective vaccines in the event of a public health emergency were also introduced, including the FDA Guidance for Industry: Emergency Use Authorization for Vaccines to Prevent COVIDID, to be issued in October 2020. Vaccines to Prevent COVID-19), which will be issued in October 2020.

Marjorie Shapiro of the FDA Center for Drug Evaluation and Research (CDER) introduced the regulatory approach to CMC development under COVID-19. The presentation covered a wide range of topics, but mainly included an introduction to the FDA's COVID-19 website, the Coronavirus Treatment Acceleration Program, and the pre-IND/IND process. Flexible thinking on neutralizing antibodies in Phase 1 trials and drug repositioning were also introduced.

In the panel discussion, Mr. Yasuhiro Araki, Director of the Vaccine Review Division of PMDA, and Mr. Fumihiko Mueshita of Daiichi Sankyo participated in a lively discussion on the handling of communication between regulatory authorities and manufacturers under COVID-19, the status of ad hoc responses, and the handling of national certification for COVID-19 vaccines in Japan. The session was followed by a lively discussion on the handling of communication between regulatory authorities and manufacturers under COVID-19, the status of ad hoc responses, and the handling of national certification in Japan for COVID-19 vaccines.

Panel discussion (Session 1)

Session 2: Implementation of ICH Q12? Where Are We In Japan and Globally?

Session 2, moderated by Dr. Akiko Ishii, Director of Biopharmaceuticals Division, National Institute of Health Sciences, and Dr. Markus Goese of Roche, introduced a wide range of topics for the implementation (Step 5) of ICH Q12 Guideline "Life Cycle Management of Pharmaceutical Products".

Joel Welch, FDA CDER, introduced the preparation of training material in the ICH Implementation Working Group (IWG) for the implementation of ICH Q12 guideline. He also provided a detailed description of the preparations for ICH Q12 implementation at FDA and the Established Conditions Pilot Program that started in 2019. The purpose of this Pilot Program is to evaluate Established Conditions (ECs) proposed by applicants and gain experience in working with applicants to refine ECs and identify an agreed level of ECs for approval. Lessons learned from the Pilot Program were also introduced.

Mr. Yoshinori Kubodera of Chugai Pharmaceutical introduced the experience of actually using the PACMP pilot program, which has been implemented in Japan since 2018, for post-approval modification of a monoclonal antibody (addition of manufacturing facility for the API), and implementing a partial change application after PACMP quality consultation, PACMP GMP consultation, and post-approval interviews. The presentation included issues and suggestions for the implementation of ICH Q12.

Ms. Keiko Funado of GlaxoSmithKline introduced a PACMP mock-up document for domestic submission, which is being prepared by the PACMP working group of the Japan Agency for Medical Research and Development (AMED). This mock-up document reflects Japan's change procedure system while referring to overseas PACMPs, and its structure and contents were explained based on discussions within the AMED WG.

Ms. Satomi Yagi, PMDA New Drug Review Department IV, introduced PMDA's perspective on the implementation of ICH Q12. She indicated that the PACMP pilot program currently under trial has more than 10 use cases, of which approximately 80% are biopharmaceuticals (the remaining 20% are chemical products), although there are some restrictions on the scope of application, etc. She also explained that the PACMP pilot program will start in 2021, and that the PMDA is currently working on the implementation of ICH Q12. In addition, he introduced the concrete direction of the PACMP pilot program, including the plan to expand the scope of application of the PACMP when it becomes officially operational in 2021.

In the panel discussion, Mr. Jean-Louis Robert, ICH Q12 Topic Leader of the EC-EU, first introduced the progress of ICH Q12 implementation in the EU in terms of conformity to the legal framework and challenges. He also explained the structure of the training material (Module) being developed by the ICH Q12 IWG. Thereafter, there was a lively discussion among the regulators and companies on the issues (legal development, ECs, etc.) for the implementation of ICH Q12, as well as the issues for the official operation of PACMP in Japan.

Panel Discussion (Session 2)

Summary

In order to make the panel discussions held after each session presentation as rich as possible even though they were held online, the CMC Strategy Forum Japan 2020 was able to provide a variety of features, including the ability to ask questions in advance, to ask questions immediately via chat, and to "like" questions that have already been asked. The online conference was a unique event in that it featured a number of innovations not seen in previous years.

After the two sessions, Dr. Nadine Ritter of Global Biotech Experts, LLC gave a summary of the forum, and Dr. Wassim Nashabeh of Genentech gave closing remarks.

Dr. Wassim Nashabeh, Genentech

The Pharmaceutical Manufacturers Association of Japan (PMAJ) will continue to support this global conference so that it will continue to be held in Japan in the future and help promote biopharmaceutical R&D and revitalize the CMC field. We look forward to your continued support.

The next CMC Strategy Forum Japan 2021 is scheduled to be held on December 6 and 7, 2021.

(Biopharmaceuticals Committee: Makoto Shinozaki , Masatoshi Yamada, Yoshinori Kubodera, Nao Nakamura, Hirotomo Akahane, Tetsushi Ito)

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