This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
第 5 回 JBF シンポジウム プログラム
日時: 2014 年 3 月 6 日(木), 7 日(金)
場所: タワーホール船堀
(口頭発表:5階小ホール、ポスター発表:1 階展示ホール)
総合司会: 小林信博 (第一三共)
3 月 6 日(木)
10:00-10:10 開会の挨拶 奥田 晴宏 (国立医薬品食品衛生研究所)
10:10-10:20 1. JBF 活動報告 間渕 雅成 (田辺三菱製薬)
10:20-11:40 2. BMV ガイダンス/ガイドライン (低分子を中心に)
座長: Mark Arnold(Bristol-Myers Squibb), 松丸 剛久(日本ベーリンガーインゲルハイム)
2.1 日本の BMV ガイドラインの概要 香取 典子 (国立医薬品食品衛生研究所)
2.2 The FDA draft guidance (Webinar) Brian P. Booth (U.S. Food and Drug Administration)
2.3 総合討論
11:40-12:50 ランチョンセミナー
蓬莱:日本ウォーターズ株式会社
瑞雲:サーモフィッシャーサイエンティフィック株式会社
平安:株式会社エービー・サイエックス
12:50-13:30 3. BMV ガイダンス/ガイドライン (LBA を中心に)
座長: Peter van Amsterdam (Abbott), 八幡 憲治 (サノフィ)
3.1 FDA draft Guidance on Bioanalysis: LBA perspectives and Discussion at the Crystal City
V conference Binodh S. DeSilva (Bristol-Myers Squibb)
3.2 The EMA guideline – LBA requirements Michaela Golob (Merck Serono)
13:30-14:30 4. 日本版 BMV ガイドラインの現状
座長:谷口佳隆(東レリサーチセンター), 富樫 一天(住化分析センター)
4.1 医薬品開発における生体試料中薬物濃度分析法(リガンド結合法)バリデーションに関する
ガイドライン(案)の概要 石井明子(国立医薬品食品衛生研究所)
中村隆広(新日本科学)
4.2 製薬企業での低分子 BMV ガイドライン(医薬品開発における生体試料中薬物濃度分析法のバ
リデーションに関するガイドライン)への対応状況について 宮井裕子 (わかもと製薬)
14:30-15:30 5. パネルディスカッション(テーマ: 国際調和)
コーディネーター:工藤 忍(島津テクノリサーチ)
5.1 Current status of Regulated Bioanalysis and contribution of Indian bioanalytical community
to global harmonization efforts Yadav, Manish (APA-India, ALKEM Labs)
5.2 Perspectives on the harmonization of regulated bioanalysis in general
5.3 LC-MS based approaches for bioanalysis of bio-pharmaceuticals
The 5th JBF Symposium Program Date: March, 6-7th, 2014
Venue: Tower Hall Funabori, Tokyo, Japan (Oral presentation:Small hall on 5F, Poster session : Exhibition hall on 1F)
Chair: Kobayashi, Nobuhiro (DaiichiSankyo)
March 6th (Thu.) 10:00-10:10 Opening remarks Okuda, Haruhiro(National Institute of Health Sciences) 10:10-10:20 1. JBF activity report Mabuchi, Masanari (Mitsubishi Tanabe Pharma) 10:20-11:40 2. BMV guidance/guideline (with a focus on small molecules)
2.1 Overview and update of Japan BMV guideline Katori, Noriko (National Institute of Health Sciences)
2.2 The FDA drafted guidance (Webinar ) Booth, P. Brian (U.S. Food and Drug Administration)
2.3 Open discussion
12:40-12:50 Luncheon Seminar
Hourai Nihon Waters Zui-un ThermoFisher Scientific Hei-an AB Sciex
12:50-13:30 3. BMV guidance/guideline (with a focus on LBA)
Chair : Van Amsterdam, Peter (EBF, Abbott), Yahata, Kenji (Sanofi) 3.1 FDA draft Guidance on Bioanalysis: LBA perspectives and Discussion at the Crystal
City V conference DeSilva, Binodh S.(AAPS, Bristol-Myers Squib) 3.2 The EMA guideline – LBA requirements Golob, Michaela (EBF, Merck Serono)
13:30-14:30 4. Japan BMV guideline
Chair : Taniguchi, Yoshitaka (Toray Research Center), Togashi, Kazutaka (Sumika Chemical Analysis Service)
4.1 Summary of the Draft Japanese BMV Guideline for Ligand Binding Assay Ishii, Akiko(National Institute of Health Sciences)
Nakamura, Takahiro(Shin Nippon Biomedical Laboratories) 4.2 Regulatory compliance to Japanese BMV guideline for small molecule in
pharmaceutical companies Miyai, Hiroko(Wakamoto Phama) 14:30-15:30 5. Panel discussion (Theme:Harmony-“All we have to do is dream”)
Coordinator:Kudoh, Shinobu(Shimadzu Techno-Research) 5.1. Current status of Regulated Bioanalysis and contribution of Indian bioanalytical
community to global harmonization efforts Yadav, Manish (APA-India, ALKEM Labs) 5.2. Perspectives on the harmonization of regulated bioanalysis in general 5.3. LC-MS based approaches for bioanalysis of bio-pharmaceuticals
(Break 15:30-16:00)
16:00-18:00 6. Challenge of JBF Discussion Group (DG) Chair&Introduction : Sano, Yoshihisa (Eisai)
6.1 DG2013-01:Preparation of calibration standards and QC samples Igarashi, Harue (GlaxoSmithKline) 6.2 DG2013-02:Recommendation to prepare standard solutions Osumi, Takahiko (Otsuka) 6.3 DG2013-03:Tiered approach for bioanalytical method of metabolites Niwa, Makoto (Nippon Kayaku) 6.4 DG2013-04:Partial validation (change in matrix) Nagao, Akemi (Japan Tobacco) 6.5 DG2013-05:LBA topics (critical reagents, ADA, etc.) Miya, Kazuhiro (Chugai)
18:30-20:00 Banquet (Zui-un, 2F)
March 7th (Fri.) 9:00-11:30 7. Poster session 7.1. DG poster presentation and open discussion
7.1.1 DG2013-01:Preparation of calibration standards and QC samples 7.1.2 DG2013-02:Recommendation to prepare standard solutions 7.1.3 DG2013-03:Tiered approach for bioanalytical method of metabolites 7.1.4 DG2013-04:Partial validation (change in matrix) 7.1.5 DG2013-05: LBA topics (critical reagents, ADA, etc.)
7.2. BMV Guideline/Guidance Comparison for Small Molecule 7.3. Draft Japanese BMV guideline for ligand binding assay
11:30-11:45 Closing Remark (Small hall, 5F) ・On the Day 1, the sessions No. 4 and 6 are spoken in Japanese along with presentation slides provided in English. A translation service in one way from Japanese to English is provided. Consecutive translation in two ways (English to Japanese, Japanese to English) is provided only Q&A session. ・On the Day 2, the poster session is performed in Japanese.
Summary of the Draft Japanese BMV Guideline for Ligand Binding Assay Akiko Ishii1, Takahiro Nakamura2 1 National Institute of Health Sciences, 2 Shin Nippon Biomedical Laboratories, Ltd.
LBA ガイドライン案の概要、LBA ガイドライン(案)作成にお
ける議論-JBF 案に対するコメントを中心に
JBF LBA ガイドラインタスクフォース
Summary of the Draft BMV Guideline for LBA, Comments on the JBF working draft of the LBA Guideline JBF LBA Guideline Task Force リガンド結合法(Ligand Binding Assay, LBA)に関する生体試料中薬物濃度分析法バリデー
Panel Discussion: Harmony‐“All what we have to do is dream?” Shinobu Kudoh1, Mark Arnold2, Binodh DeSilva2, Michaela Golob3, Daniel Tang4, Peter van Amsterdam5, Manish S.Yadav6 1JBF/Shimadzu Techno-Research, 2AAPS/BMS Co., Ltd., 3EBF/Merck Serono, 4CBF/ICON, 5EBF/Abbott, 6 APA-India/Alkem Labs Ltd.
Harmonization, the final frontier…..This is a panel discussion with representatives of various bioanalytical communities spread across the globe. As members of Global Bioanalysis Consortium (GBC), they have been actively discussing and exchanging their best practices and share a continuing mission to explore new sciences and technology and to seek out consensus in regulated bioanalytical practices. Faster delivery of safer and more efficacious medicines and medications to patients and medical practices in need is a common mission of the pharmaceutical industry. Many of us consider that harmonized common practices and regulations minimize the duplication in bioanalysis that has been and will be playing an important role in the studies undertaken to elucidate and understand the safety and efficacy profiles of drugs or drug candidate compounds. From 2011, bioanalytical scientists who were supportive of the idea of the GBC began comprehensive discussions on necessary regulations under the globalized circumstance in complex drug discovery and development processes by standing on the scientific and technical advancements made since FDA Guidance in 2001. The mission of the GBC is to merge existing or emerging bioanalytical guidance or guidelines to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries. Its goals and objectives needed to be slightly modified due to the delay of a long waited the revise of the FDA guidance document that was finally announced late last year and Crystal City V meeting that followed. GBC decided that the publication on the consensus reached in each harmonization team should have been made in place of having global conferences. In the meantime, EMA guideline came into effect in 2011. It fills some gaps between the FDA guidance and the increasing demands with advancement in science and technology that impact many bioanalysts working either on small or large molecular drugs. Japan’s guideline on chromatographic bioanalysis was issued last year. It comes into effect next April and the one on ligand binding assays (LBA) has completed the final stage for public comments and reflection. Brazil’s ANVISA also issued their own guideline on BA/BE in the interim period. Our Chinese colleagues are now preparing their own guidelines. With many changes in regulated bioanalysis after starting the GBC activities, this is a good occasion to discuss the status of bioanalysis and GBC activities. Within a limited time, this panel discussion is going to focus on 2 topics as follow after the introduction of Indian bioanalytical community’s and APA-India’s contribution to GBC activities. The theme of Harmony - “All we have to do is dream” is derived from a song of The Everly Brothers, a famous duo for beautiful harmony,
although our efforts might feel like “a bridge over troubled water”. Yet, we are sure that what we are doing is for a reality and a virtuous act for patients and medical practices in need.
1. Perspectives on the harmonization of regulated bioanalysis in general What is our goal (if it exists), How we can achieve it, What are the difficulties and Their overcoming ways towards our goal
2. LC-MS based approaches for bioanalysis of bio-pharmaceuticals Current situation in each community Present technical hurdles A short-ranged perspective
As this panel discussion will be proceeded in bilingual mode of English and Japanese, all gathering at this program should not hesitate to join in the conversations and enjoy with the panelists, who agreed to boldly go for its harmonization where no one has gone before, for a delivery of safer and efficacious medicines and medications to patients and medical practices as early as possible.
Program No.
5
Current status of Regulated Bioanalysis and contribution of Indian bioanalytical community to global harmonization efforts
Manish S. Yadav APA-India, Alkem Laboratories Limited
Representing the first generation of Bioanalysts of India, our generation witnessed various era of progress of Bioanalysis named as Pre-regulations, Post regulations and Dynamic Era. Pre-regulation era can be distinguished by developments prior to 1990s i.e. AAPS/FDA workshops and subsequent reports thereof. As such there were no mandatory guidelines for the conduct of bioanalysis in pre-regulation era, and often sponsors used to provide and enforce their own set of acceptance criteria to evaluate the Bioanalytical method validation. Post-regulation era distinguished by series of Crystal City (CC) workshops on bioanalysis in 1990 and 2000 organized by AAPS and FDA. The outcome and workshop reports eventually led to the release of the first regulatory guidance by US Food and Drug Administration known as US FDA guidance in May 2001 [4] and thereby, the bioanalytical community was equipped with a sound tool to execute their day to day job. From there on, the last decade named as dynamic era has witnessed a significant and notable progress in Regulated Bioanalysis (RegBio) due to better understanding of bioanalytical science, allied sciences and technological advancements. This continuous and prevalent evolution in science requires additional or upgraded quality measures and regulatory guidance. Learning out of decade long progress and genuine innovations are invaluable and such level of improvisations transform the nature of RegBio into a highly dynamic entity. Moreover, with the release of three major regulatory guidelines on BMV e.g. EMEA, 2011, ANVISA, 2012 and draft USFDA, 2013 in the last three years has generated tremendous interest in RegBio. In the current economy, bioanalysis has become global but several guidance documents remain localized, thereby posing additional burden on bioanalytical practitioners with almost no or insignificant value addition to the quality, conduct or data of bioanalysis. This scenario demands global harmonization of bioanalytical guidance to complement globalized bioanalytical practices from the practitioners as well as the regulators. This talk will emphasize not only on the need of a common BMV and bioanalysis guidance but also the efforts and contribution of global and Indian Bioanalytical practitioners. To cope with the pace of scientific advancement and dynamic nature of bioanalysis, it is imperative to have a harmonized and common regulatory guidance like ICH-GCP to conduct the routine bioanalytical operations thus avoid duplicity of data and aid to quality, reliability and consistency of bioanalytical data generated and submitted to various regulatory agencies for drug approval purpose. Key words: LC-MS/MS assays, Bioanalysis, Harmonized and Common BMV guidance, Global Bioanalysis Consortium, Indian Bioanalytical Community, APA-India.
BMV Guideline/Guidance Comparison for Small Molecule Tazutaka Togashi, Japan Bioanalysis Forum Steering Committee Sumika Chemical Analysis Service, Ltd. 2013 年 9 月に FDA BMV ガイダンスの改訂版ドラフト 1) が発表された。同年 7 月には日本に
おいて「医薬品開発における生体試料中薬物濃度分析法のバリデーションに関するガイドラ
イン」(通称、低分子BMVガイドライン)2) が発表されており、遡ること 2011年には EMA BMV
した低分子 BMV ガイドラインの 3 極比較した資料を用いて、FDA, EMA および日本のガイド
ラインについて各々の違いを詳細に解説する。
1) Bioanalytical Method Validation: Guidance for Industry (Draft guidance). FDA (September, 2013): http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf
3) Guideline on Bioanalytical Method Validation. EMA (July, 2011): http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
Hourai: High throughput sample preparation and new separation technology for limited amount of samples. Shunya, Sasaki,Reiko, Iizuka (Nihon Waters K.K.)
Zui-un: Quantification of Large Molecules by a High Resolution/Accurate Mass Based Approach Kazunobu Yamamoto (ThermoFisher Scientific K.K.)
Hei-an: Method development for quantification of antibody drug using LC/MS/MS Amane Sakurai (Toray Research Center, Inc.)