With the drug patent cliff continuing to cast a long shadow over biopharma, the industry is radically reinventing itself by embracing globalization and focusing on innovation and operational excellence. Most importantly, biopharma organizations are expanding externalized collaborative relationships beyond traditional boundaries and creating flexible networks of researchers — some in-house, others with industry and academic partners, research institutes and contract research organizations. These networks are increasing in size and complexity with many combining numerous partners with diverse project objectives. Externalized projects like this raise important data security and project management challenges.
Partners need to exchange scientific data pertaining to chemical and biological structures along with information resulting from experiments, biological assays and ADMET studies. In a world used to doing this through some form of document management or file exchange, incompatible data formats have become a significant issue, along with the need to prepare and curate files manually and meet required data quality standards. Multi-partner teams struggle to produce common views and reports on project data with time-consuming and error-prone reporting often resulting in poor decisions. Finally, today’s collaborations are fluid, and many companies struggle with the dynamics of project lifecycles, where quickly spinning projects up and down is a requirement.
Working in a cloud-based information management and collaboration workspace provides a level of business agility and security that is not available with server-based, on-premises infrastructure. Operating in the cloud means organizations can get up and running in days rather than weeks or months, and with minimal IT involvement. Most importantly, by sharing a common collaborative space, scientists can spend less time performing mundane data preparation and manipulation tasks and can focus more closely on the scientific aspects of their project workflow.
Understandably, data security is top of mind for organizations collaborating in the cloud. Existing standards like the ISO/IEC 27001 certification standard for information security management can help ensure that cloud-hosted systems offer strong data safeguards for globally networked drug research.
SUPPORT THE END-TO-END PROJECT LIFECYCLE
From rapid project spin up through supporting research workflows and ultimately, closing out a project, the cloud workspace supports end-to-end collaboration dynamics throughout the project lifecycle. New collaborations and individual partners can be added and removed quickly. All data is live and data exchange occurs in real time. The security model should protect each participant’s intellectual property while controlling and auditing access and ensuring that all project team members see only the information they need and are authorized to access. Intellectual property should be held in a secure “neutral zone” until ownership is clear. This is important because there are many contractual models for collaboration and some do not resolve the ownership of intellectual property until final results are known. Finally, the cloud system should connect with in-house systems to enable data synchronization with existing on-premises applications, enabling scientists to see in-house and networked data from their preferred environments.
With no software to manage and no hardware to maintain, organizations gain improved operational excellence in globally networked research with significantly reduced IT cost and effort through the ability to access integrated hosted applications supporting a range of scientific workflows.
• Collaborative Project Management. Virtual teams should be able to access, search and share real-time project information and stay in touch using social networking.
• Experiment and IP Capture. The system should include a low-cost-of-ownership electronic lab notebook that enables sponsors and network partners to share experimental methods and results.
• Custom Business Rules and Integration. The system should facilitate the creation and management of scientific services, implement standard business rules and enable integration between cloud and on-premises systems so that data flows from one environment to the other.
• Data Analysis and Visualization. The system should include scientific analysis, visualization and charting capabilities, enabling scientists to construct and automate informative workflows from pre-built services in chemistry, biology, imaging and other scientific domains.
• Publishing and Sharing Services. Ideally, a hosted collaboration space should function as an open portal where team members can publish and share scientific services, best practice approaches and research tools within the larger scientific community.
For many organizations, cloud adoption will be a staged process in which scientists collaborate using both in-house (on-premises) systems and a hosted collaboration system. The cloud workspace should support this hybrid environment in which data flows between on-premises and hosted applications. For example, a design team should be able to start an experiment in an on-premises ELN and then transfer the information to the cloud for execution at a partnering organization; or molecules registered into a cloud database should be automatically synchronized into an organization’s on-premises corporate registration system.
THE EUROPEAN LEAD FACTORY
A cloud-based collaboration workspace is currently being used by the European Lead Factory (ELF) project — a pan-European drug discovery consortium of 30 commercial and academic partners. Backed by the Innovative Medicines Initiative (IMI), the goal of the project is to facilitate the collaborative, high-throughput screening of previously safeguarded, high quality corporate small molecule compounds against novel biological targets to advance the discovery of new drug lead molecules. In 2015 the ELF announced the synthesis of more than 50,000 new, high-quality compounds based on public proposals.
The ELF’s successful, open innovation model would not have been possible without the ability to give external researchers access to screening compounds that were normally locked behind company firewalls, while assuring the compound owners that their intellectual property was secure. The ELF addressed this challenge by giving all members shared access to chemistry and biology project data within a secure, cloud-based information management and collaboration environment. Biological data has been restricted to the target owner, and chemical structures are generally not disclosed. Instead, early stages of decision-making use derivative data from the compounds. Once the compound list has been reduced to a few hundred molecules, structures are revealed to certain team members for follow-up studies and allocation to the Qualified Hit List.
The ELF cloud system provides a project data and documents repository; an electronic lab notebook for capturing, accessing and sharing experimental information; interactive visualization, analysis and scientific authoring capabilities; and a social portal for progress reporting and team discussions. The secure, ISO/IEC 27001-certified system is scalable (able to support 20 organizations, over 500,000 compounds and millions of assay results) and has been deployed with minimal organizational impact. One of the beneficiaries of this project said that access to ELF has fast-forwarded their oncology drug discovery work by several years.
Although the ELF is currently focused on life sciences research, overall cloud solutions will eventually extend to the entire innovation lifecycle from product ideation to manufacturing. The cloud environment offers life science research organizations great potential for increased agility and best-of-breed resourcing, while also providing extensibility beyond traditional industry boundaries to rapidly impact patient outcomes. Ultimately, the cloud shows great promise for empowering life science organizations to adopt and leverage new scientific discoveries and open technological innovation.