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The "CMC*1 Strategy Forum Japan 2021" was held by CASSS (California Separation Science Society) for three days from December 6 to 8, 2021. Although the forum was held online, as in 2020, due to the spread of the new coronavirus, approximately 90 participants registered from 13 countries in Asia, North America, and Europe, as well as Japan, and actively exchanged their opinions.

Background of CMC Strategy Forum Japan

The CMC Strategy Forum was spun off from the Well Characterized Biotechnology Pharmaceutical (WCBP) Symposium in 2002, with the first meeting held in the United States, followed by Europe from 2007, Japan from 2012, Latin America from 2014, and At the CMC Strategy Forum, experts from industry, academia, and regulatory authorities spend ample time discussing issues related to the research and development, manufacturing, and regulation of biopharmaceutical CMCs to promote mutual understanding and resolution of challenges. The CMC Strategy Forum in Japan is a forum for the discussion of CMC strategy in the biopharmaceutical industry.

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 spent about a year in preparation, including not only the selection of discussion topics and the direction of discussions, but also the management of the unique online conference in 2021.

After welcome comments from Ms. Nadine Ritter of Global Biotech Experts, who will serve as the representative of CASSS from 2021, and Mr. Hiroyoshi Arai, Director of PMDA, discussions started on the following themes.

Session 1: Recent Trends in the Regulation of Biopharmaceutical Products

In Session 1, moderated by Mr. Shinichi Okudaira of PMDA's Regenerative Medicine Product Review Division and Ms. Cecilia Tami of Genentech, regulatory officials from each country presented a wide range of topics on recent regulatory developments, especially for biopharmaceuticals, and on temporary responses under the new coronavirus infection (COVID-19). The presentation covered a wide range of topics, including recent regulatory developments, particularly for biopharmaceuticals, and temporary measures under COVID-19.

Ms. Ryoko Naruse of the PMDA's Regenerative Medicine Products Review Department gave an outline of the partial revision of the Pharmaceuticals and Medical Devices Act (Pharmaceuticals and Medical Devices Act), the operation of the Post-Approval Change Management Protocol (PACMP), minor changes to approved items, and the COVID-19 treatment. Management of regulatory review for COVID-19 treatment was introduced.

Cassandra Overking, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), presented on key regulatory considerations for COVID-19 vaccine development and the management of regulatory review for COVID-19 therapeutics, She also discussed lessons learned from the pandemic with regard to Emergency Use Authorization (EUA).

Emily (Xianghong) Jing, Center for Drug Evaluation and Research (CDER), FDA, presented on the COVID-19 Expedited Drug Development Program and EUA, COVID-19 neutralizing antibody drug in Phase I clinical trials, and the CMC requirements for the COVID-19 neutralizing antibody drug. He introduced the flexibility of CMC requirements for entering trials, CMC information required for EUA applications, and management of CMC changes after EUA.

Mr. Jason Turpin of Health Canada presented on the COVID-19-related issues with Health Canada, the Australian Department of Health's Therapeutic Goods Administration (TGA)*2 , SwissMedic, the Health Sciences Authority (HSA) of Singapore, and the UK's Medicines and Healthcare Products Regulatory Agency (MHPCA). The Access Consortium with the Medicines and Healthcare products Regulatory Agency (MHRA), the implementation of ICH Q12, and international collaboration on regulatory matters were introduced.

During the panel discussion, there was a lively discussion on the challenges and lessons learned during the pandemic and the implementation of ICH Q12. In particular, there were active discussions on communication between regulatory authorities and companies and between regulatory authorities during a pandemic, handling GMP inspections and reviews, setting validity periods based on limited stability test results, raw material shortages, and other issues.

Session 2: Continuous Manufacturing of Biologics

Session 2, moderated by PMDA Quality Specialist Yoshihiro Matsuda and BioMarin's Erik Fouts, covered a wide range of topics related to the serial production of biopharmaceuticals.

Ms. Kyoko Sakurai of PMDA's Regenerative Medicine Products Review Department introduced the contents of the ICH Q13 Guideline Draft, which became Step 2 in July 2021. She also introduced that public comments on the Step 2 document are being collected in Japan and other countries, and that Step 4 is scheduled to be completed in November 2022.

Mr. Shinichi Okuhira of PMDA's Regenerative Medicine Products Review Department introduced the contents of the "Point to Consider for Continuous Production of Biopharmaceuticals" document (Nippon PDA Journal of GMP and Validation, Vol. 23 (2021), No. 1, p. 13-22), which was reviewed in a joint research by the Japan Agency for Medical Research and Development (AMED). The contents of the document were introduced.

Rebecca Berger of Sanofi introduced the company's development of continuous production of biopharmaceuticals. In this presentation, she also introduced the company's objectives for enhancing serial production, process development, collaboration with regulatory authorities, and the design philosophy of the manufacturing facility.

Ms. Lucy (Liuquan) Chang of Merck introduced the company's background, regulatory outlook, technological challenges, and regulatory strategy for promoting continuous production of biopharmaceuticals.

In the panel discussion, Mr. Tetsuhiro Yanagida of Chugai Pharmaceutical and Mr. Andrew Chang of Novo Nordisk joined to discuss the continuous production of biopharmaceuticals. In particular, there were active discussions among the authorities and companies on topics related to the continuous production of biopharmaceuticals, including Process Dynamics, Residence Time Distribution, Process Analytical Technology (PAT), bioburden control, process validation, productivity, and mitigation of environmental impact. The session was followed by a lively discussion among the authorities and companies.

Session 3: Challenges of Vaccine and Biotherapeutic Therapies for COVID-19

In Session 3, moderated by Dr. Akiko Ishii of the Division of Biopharmaceuticals, National Institute of Health Sciences and Dr. Frank Montgomery of AstraZeneca, the panelists discussed the development of vaccines and antibody drugs against COVID-19, which have received special exception approval in Japan, and the regulatory perspective on how to accelerate CMC development in new modalities. He also introduced strategies to cope with the accelerated development of CMC in new modalities and the regulatory flexibility of CMC regulations, such as expedited review.

David Cirelli of Pfizer introduced the use of novel platform analysis technology for rapid COVID-19 vaccine development and considerations for approval in Japan, as the COVID-19 vaccine has also received special exception approval in Japan. Julia O'Neill of Moderna presented on accelerating mRNA vaccine development, and Nancy Kavanaugh of AstraZeneca presented on challenges and lessons learned in accelerating global development of COVID-19 vaccines. Mr. Kavanaugh also spoke about the challenges and lessons learned in accelerating global development of COVID-19 vaccine. In addition, Mohammed Shameem of Regeneron and Maren Willcockson of Genentech presented on the so-called cocktail antibodies of COVID-19, which have received the same special approval, and Lonaprev (generic name: casiribimab (genetical recombination)/ (generic name: casiribimab (genetical recombination)/imdevimab (genetical recombination)) as a Case Study, and introduced their efforts from bench-top to approval in record time. In addition, Mr. Motoaki Mitsugi of the PMDA's Vaccine and Other Drugs Review Division introduced the flexibility of regulatory requirements for CMC review of vaccines under COVID-19.

During the panel discussion, many questions were raised by the audience, and there were heated discussions between the government and the industry, especially on the concept and strategy of granting an efficacy period for a drug product over a wide time horizon, taking into account the potential impact from the development stage to the post-marketing period.

Closing Remarks

In order to enhance the content of the panel discussions that followed each session, the "CMC Strategy Forum Japan 2021" was also managed in an innovative manner, including the use of chat rooms for immediate questions and a "like" function for support of questions. After the three sessions, Dr. Wassim Nashabeh of Genentech gave a summary of the forum and closed the meeting.

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 2022 is scheduled to be held on December 5-6, 2022.

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

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