ご挨拶

ライフサイエンス業界の皆様におかれましては、来年に迫った、PMDAに対するCDISC標準準拠の電子データ提出に向けて、人材教育や体制、基盤の整備に注力されているところかと存じます。また、レセプト、ClinicalTrials.govなどの臨床試験情報、JADERなどの有害事象情報など、いわゆるビッグ・データ、リアルワールド・データ、オープン・データの活用が現実のものとなってきております。

これらは、Time to marketの短縮、臨床開発の効率化、コスト低減、そして安全対策において非常に期待が大きい取り組みでありますが、準備期間、リソースの制約、経験を考えるとチャレンジングなテーマであるとも認識しております。

この度、国内先進企業様、及び、欧米からのプレゼンターによる先進事例、最新情報のご紹介を行なう、SAS Life Science Forum Japanを開催する運びとなりました。
皆様、お忙しいところかと存じますが、ご参加いただき、課題解決やアクションの加速化に向けたヒントを見つけていただければ幸いです。

主催
SAS Institute Japan株式会社
日時
2015年5月14日(木)10:30~18:40(10:00 受付開始)
会場
東京コンファレンスセンター品川 4F 406
ご対象
製薬会社、CRO、大学、研究機関、病院及びその業務の関係者
参加費用
無料(事前登録制)

協賛企業(50音順)

株式会社タクミインフォメーションテクノロジー 日本メディア株式会社 Business Decision Life Sciences

プログラム

10:00~10:30
受付開始
10:30~10:40
ご挨拶
SAS Institute Japan株式会社
コマーシャル営業本部
本部長 執行役員
松田 博文
10:40~11:20
[同時通訳あり]
Trends and opportunities in Life Sciences : Evaluating how Life Science companies are addressing needs from clinical R&D to regulatory changes and emerging opportunities.
Life science companies around the world are looking at ways to improve their clinical research and development processes. This session will discuss SAS' strategy towards clinical development and the SAS portfolio of offerings as it relates to the data management, clinical analysis and optimization of the R&D process. In addition to the changes companies are making to their tradition R&D area, many companies are focusing on reacting to other external influences. This session will also discuss several of the top areas impacting life science companies including regulatory changes such as clinical trial data transparency and Identification of Medical Products as well as emerging trends such as the evolution of real world data (RWD), the maturation of data visualization and the challenge of understanding and using big data in Life Sciences.
SAS Institute Inc.
Director, Health Care and Life Sciences Global Practice
Industry Leader, Health and Life Sciences, EMEA/AP
Matt Gross
  • 講師概略

    • Matt Gross is the Director of Health Care and Life Sciences Global Practice for SAS Institute based in the United States of America. The Global Practice is responsible for the development of industry solutions. They also work with the industry globally to understand the trends and opportunities where advanced analytics could help address industry challenges and transform the health care ecosystem.

      Matt is currently heading up an emerging business unit focused on working with Life Science organizations in Europe, Middle East, Africa and the Asia Pacific Region.

      For thirty years, Matt has worked with and analytics in the healthcare and life sciences industries. Prior to joining SAS, he worked in senior roles with top healthcare and life sciences organizations such as Johnson & Johnson, Pfizer and McKesson Health Solutions where he provided strategic direction and led development efforts around their analytic-based initiatives.

      Matt's recent focus is on transparency throughout the health care and life sciences industries. He has been spearheading SAS' efforts in clinical trial data transparency and works with companies around the world to understand the needs and opportunities for data sharing.
      Matt Gross is the Director of Health Care and Life Sciences Global Practice for SAS Institute based in the United States of America. The Global Practice is responsible for the development of industry solutions. They also work with the industry globally to understand the trends and opportunities where advanced analytics could help address industry challenges and transform the health care ecosystem.

      Matt is currently heading up an emerging business unit focused on working with Life Science organizations in Europe, Middle East, Africa and the Asia Pacific Region.

      For thirty years, Matt has worked with and analytics in the healthcare and life sciences industries. Prior to joining SAS, he worked in senior roles with top healthcare and life sciences organizations such as Johnson & Johnson, Pfizer and McKesson Health Solutions where he provided strategic direction and led development efforts around their analytic-based initiatives.

      Matt's recent focus is on transparency throughout the health care and life sciences industries. He has been spearheading SAS' efforts in clinical trial data transparency and works with companies around the world to understand the needs and opportunities for data sharing.

11:20~12:00
SAS® Clinical Data Integration(CDI)を利用したSDTM作成プロセスの紹介
弊社では2012年末よりCDISCに関する調査及び社内標準プロセスの見直しを始め、2015年より全新規試験においてSDTM及びADaMの作成を開始した。本発表ではSAS® Clinical Data Integration(CDI)を使用したSDTM作成の実現にあたり、DMが行った対応を中心に弊社の新社内プロセスを紹介する。合わせて、SDTM作成を効率的に行うための今後の課題や構想についても触れたい。
株式会社中外臨床研究センター(CCRC)
バイオメトリクス部
久保 真紗美 氏
12:00~13:20
ランチョンセッション 調整中
13:20~14:00
∫[社内データ×社外データ]dt=ビッグデータ
社内に蓄積されたデータは利用時期が過ぎれば寝かされていることがほとんどである。
基本的にデータは生ものであるが、組み合わせによりその価値が生き返る可能性がある。いくつかの事例とともに、そのコンセプトを紹介する。
塩野義製薬株式会社
解析センター
データサイエンス部門
北西 由武 氏  惟高 裕一 氏
14:00~14:40
[同時通訳あり]
SAS Life Science Analytics Framework, a new name for SAS Drug Development and a robust extensible foundation for analyses of clinical and therapy-related information
SAS Life Science Analytics Framework (based on the SAS® Drug Development foundational platform) provides an integrated and clinically compliant repository to store the SDTM and ADaM warehouse data, a SAS analytics engine to drive clinical queries and analyses and a secure lockbox for all important standardized submission-related clinical data. While SAS Life Science Analytics Framework, as the market-leading clinical platform, serves the operational submission during development of a new compound, therapy or device, it can also support other business processes in the pharmaceutical company such as responding to regulatory queries across trials and therapeutic areas, sharing of clinical trial data and analyses results across departments within the company or between external CRO's and the pharmaceutical sponsor. During this presentation, we will focus on the capabilities of the current version and the roadmap of SAS Life Science Analytics Framework. We will explain that the extensive web services Application Programming Interface is heavily used by organizations to extend the solution according to clinical trial processes and operational needs.
SAS Institute Inc.
SAS Health and Life Sciences Global Practice, principal industry consultant
Mark Lambrecht, PhD
  • 講師概略

    • Mark Lambrecht, PhD, is a principal industry consultant at SAS and is a member of the SAS Health and Life Sciences Global Practice that sets out the strategic direction of its life sciences and CDISC solutions and provides industry domain knowledge to colleagues and customers. He is member of the European CDISC Coordinating Committee.

14:40~15:00
休憩
15:00~16:20
[同時通訳あり]
SAS Drug Development and CDmation in action:
Efficient standards libraries and study management modules on a robust clinical analytics platform

With the evolution of clinical data standards, metadata standards management has become all the more important and finding ways to better store, access, and manage metadata is regarded as a priority by most life sciences companies. During this presentation, Peter and Stephen will explain the benefits companies can get from a Data Standards Library and a Metadata Repository. They will focus on how several companies are using CDmation and in particular, how it can seamlessly integrate with SDD/LSAF.
SAS Institute Inc.
SAS Health and Life Sciences Global Practice, principal industry consultant
Mark Lambrecht, PhD
  • 講師概略

    • Mark Lambrecht, PhD, is a principal industry consultant at SAS and is a member of the SAS Health and Life Sciences Global Practice that sets out the strategic direction of its life sciences and CDISC solutions and provides industry domain knowledge to colleagues and customers. He is member of the European CDISC Coordinating Committee.

Business & Decision
Chief Operating Officer
Peter Van Reusel 氏
  • 講師概略

    • Peter is the Business Unit Director CRO Services, based in Brussels, Belgium. He is also Chief Operating Officer, responsible for group operations. Peter started his career in a large pharma company as a database analyst. His team is specialized in CDISC data standards and Biometrics services. Peter is a CDISC CDASH & SDTM trainer, delivering courses across Europe. Peter is also the chair of the CDISC E3C committee.

Business & Decision
Director of Biometrics Consultancy
Stephen Bamford 氏
  • 講師概略

    • Stephen is the Director of Biometrics Consultancy where he spends his time on both consultancy and advising on a suite of eApplication software. Stephen started his career at Pfizer and during these 12 years, he led the analysis & reporting of numerous international clinical trials as well as on 6 global submissions. After leaving Pfizer, Stephen worked at 2 CROs prior to joining BDLS. Stephen founded PhUSE in 2004 and is now the EU Events Director.

16:40~18:40
懇親会

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アクセス

東京コンファレンスセンター品川
東京都港区港南 1-9-36 アレア品川 3F-5F
JR品川駅港南口(東口)より徒歩2分

お問い合わせ先

SAS Institute Japan株式会社
SASセミナー事務局
TEL: 03-6273-0525
(受付時間 : 10:00-18:00、土日祝除く)

E-mail: jpnseminar@sas-event.com

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