Bayer Business Services社のトランスフォーメーションサイエンスチームでプロジェクトマネージャーを務めるIvana Adams博士は、次のように述べています。「古いシステムを維持しようとするのではなく、環境とアーキテクチャーを変革しようと考えました。既存のプロセスは依然として手作業によるところが多く、人的ミスを招きかねない状態だったのです。」
バイエルでは、Talend Data Integrationに加えて、Talend ESBを展開しました。Talend ESBはデータリポジトリを接続するミドルウェアとして機能しますが、ユーザーからは認識されません。データはオンプレミスのOracleデータレイクに投入されますが、バイエルはこのデータレイクをクラウドに移行する予定です。
バイエルは、高度な分析用にSASシステムに接続し、Oracle Life Sciences Data Hubを使用して臨床データを保存しています。Karapitプロジェクトのビジネスリーダー兼データオーナーであるStefan Glotz氏は、次のように述べています。「Karapitの最重要目標は、適切なデータを適切な人々に読み取り可能な形式で提供することです。クリーンで検証済みの追跡可能な臨床データを使用することで、医薬品開発
In addition to Talend Data Integration, Bayerdeployed Talend ESB, which serves as middleware that connects data repositories, but is invisible to users. German software developer QuinScape GmbH helped Bayerdeploy the Talend-powered Karapit framework,which the company is using to integrate several clinical databases and support the pharmacokinetics dataflow and biosampling parts of the drug development process. The data flows into an on-premises Oracle data lake, which Bayer has plans to move into the cloud. For advanced analytics, Bayer connects with an SAS system, and uses Oracle Life Sciences Data Hub to store clinicaldata.“The overarching goal of Karapit is todeliver the right data to the right people in a format they can read,” says Stefan Glotz, Business Lead and Data Owner of the Karapit project.
Understanding pharmacokinetics data to optimize drug doses The role of pharmacokinetics (PK) in drug discovery can be described simply as the study of “what a body does to a drug,” and includes the rate and extent to which drugs are absorbed into the body and distributed to the body tissues. It also includes the rate and pathways by which drugs are eliminated from the body by metabolism and excretion.
Understanding these processes is extremely important for prescribers because they form the basis for the optimal dose regimen and explain the inter-individual variations in the response to drug therapy.
Questions researchers study include: What is the drug concentration in the body? How much time does it take to absorb or eliminate that substance? How many milligrams of an active substance should we put in a tablet? Is it interacting with foods or other drugs?
“Quality data and speed matter in this place,” says Glotz. “Having this slim, microservices-based architecture allows us to add new features quickly, and in a compliant way. By dividing the task into small projects, we can move more quickly to connect data sources and get access to key data more efficiently.”
Bayer also receives the benefits of higher-quality data, and of being able to track everything that happens to the data, including where it’s coming from and where it’s going. “We’ve had three GxP-validated releases since the project started,” says Glotz, “and with the first one, we hadcomplete information about biosamples in-house.” He says the data is in a central repository, has been verified for quality, and includes a complete audit trail that automatically tracks all changes.
“Being able to connect and reconciliate pharmacokinetics and biosampling data so rapidly means we can accelerate the entire process of determining the proper dose for a drug and its interactions with other drugs,” he says.
“Having clean, verified,traceable clinical datasaves us time in drugdevelopment, and mostimportantly, facilitatesGxP compliance to ensureour products are safe forpatients.”
