Flexibility to partner can shorten path to more robust, promising pipeline

With key patents worth a projected $30 billion in revenue pegged to expire between 2010 and 2013, pharmaceutical companies are looking for ways to improve the effectiveness and efficiency of their drug discovery and development programs. Many are turning to partnering and outsourcing as key strategies to boost R&D productivity, enhance operational agility, lower costs and accelerate product pipelines. Partnering can mean many things — from sponsoring basic research at a university lab, to collaborating with a biotech to speed the discovery of early-stage compounds, or outsourcing R&D projects to a contract research organization (CRO).

Today’s rapidly proliferating CROs offer specialized knowledge and know-how in target biology, synthesis, screening, pharmacokinetics, pharmacodynamics and analytical characterization projects, to name just a few capabilities. As such, they provide an excellent opportunity for R&D organizations to improve operational efficiency and productivity. However, communication and information sharing across geographical and corporate boundaries are critical to successful partnering and CRO collaboration. The challenge is that numerous scientific disciplines working in different geographic locations and time zones (and often guided by dissimilar business rules) need to work together in designing and executing experiments — and they need to do this seamlessly and efficiently in order for the relationship to result in productivity gains.

Enterprise ELNs

Although traditional paper notebooks may be tried-and-true, they are difficult to share across global boundaries, and one illegible entry can stop an experiment in its tracks. More importantly, they tend to create knowledge silos that are difficult to manage, access, contrast and compare. With individual scientists often following their own inclinations in documenting experiments and capturing results, paper notebooks can provide problematic support of regulatory requirements, especially for organizations working in both regulated and non-regulated environments.

The new center for workflow coordination and information exchange is the electronic laboratory notebook (ELN). The focal point of the work day, it is the place where design, execution, analysis, reporting and sharing of experiments takes place. However, with today’s challenging R&D landscape, discipline-specific ELNs devoted to the ad hoc requirements of different chemistry and biology domains present their own challenges, since they contribute to the proliferation of knowledge silos, information sharing obstacles, multiple user interfaces, inconsistent or inaccurate data, inconsistent processes and skyrocketing costs of ownership. Challenges such as these have led companies to turn to single, enterprise ELNs that foster collaboration, drive efficiencies and lower costs.

Free flow of electronic information within and across organizations moves products efficiently from lab to plant. An enterprise ELN helps to accomplish this by offering a centralized data repository and infrastructure for capturing, accessing and sharing experimental data, while also supporting the diverse needs of different disciplines without extensive customization. Customizable workflows, complimented with fine-grained security, enable scientists in different organizations to take responsibility for individual parts of an experiment. At the same time, centralized document management, workflow focus and secure infrastructure significantly enhance an outsourcing organization’s ability to adjust resources dynamically, to collaborate effectively with global partners and CROs, and to accomplish more with less.

Building virtual research teams

Since virtual research teams work best when there is operational transparency between the outsourcing organization and the CRO site, it makes sense for outsourcing organizations to engage CROs in long-term partnerships, getting them involved early in the R&D process, and establishing clear protocols for exchanging information and materials. Such engagement and partnership streamlines the exchange of information, activities and materials, since they are sharing consistent experimental procedures, processes and results in real time. This means that scientists at each location can respond with agility to changing experimental conditions and requirements.

The challenges involved in successfully integrating CRO scientists into a virtual global research team can be significantly lessened when the outsourcing organization extends and leverages an enterprise ELN into the CRO, with work requests and tasks that are built and managed using a shared ELN infrastructure. However, it is important to keep in mind that deploying an enterprise ELN across global organizations and CROs places added infrastructure requirements. For example, the system must support:

• coordinated workflows across geographic and business boundaries
• experiment authoring by multiple authors (and sometimes, authors working within different companies)
• experiment capture and access across the globe and between business networks
• secure control of read and write access at experiment and experiment section levels
• regulated and unregulated lab documentation procedures, as appropriate

A flexible, configurable and extensible enterprise ELN should be able to meet these technical requirements while also addressing the workflow information challenges faced by scientists every day on both sides of the virtual research continuum. Thus equipped, scientists can quickly advance their common projects by answering such questions as:

• What experiments do I run next?
• What are the latest results from our experiments?
• What experiments have been carried out before?
• What experiments were successful?
• What could we fine-tune to get better results next time?
• What is the history of a set of experiments?
• How can I improve my work based on other scientists’ research?

Centralized storage and security

Deploying an enterprise ELN minimizes IT setup time, facilitates system management and enhances integration across partnering teams. The outsourcing organization defines consistent business rules for managing experimental protocols and data capture and deploys the resulting experiment templates to the CRO via a central server. The organization then has the freedom to push additional projects to the CRO with the assurance that they will be carried out in a consistent manner. On the other side of the virtual divide, the CRO always has instant access to the latest templates without having to waste time with costly software reinstallations.

Cost and maintenance are critical issues for most CROs, which typically function with reduced operating margins and lean IT resources. CRO desktop installations utilizing a virtual desktop emulation environment, such as Citrix server, can minimize deployment and ongoing support costs for both CROs and their outsourcing partners. A virtual desktop emulation environment also facilitates remote access where bandwidth is limited, as the emulation environment transmits screens/keystrokes instead of data files. More importantly, this configuration enables outsourcing organizations to maintain their intellectual property at the corporate location and provide as-needed access to CROs.

Effective CRO enablement requires an informatics infrastructure that can be “turned on” to enable CRO collaboration and then shut down at the end of the engagement, ideally requiring a minimal footprint within the CRO. This approach helps the CRO, which gains advanced scientific informatics technology without the burden of added infrastructure costs, and also benefits the outsourcing organization, which gains the ability to select different CRO partners depending on its research needs. The ELN security model also must be capable of restricting CRO scientists to only appropriate repositories and folders. For example, outsourcing scientists may have permission to view all corporate repositories including the CRO repository, while CRO scientists can only access repositories associated with specific contract research projects. Such fine-grained security restricts projects, experiments and field-level data to appropriate eyes, once again protecting critical intellectual property. Another essential security requirement is the implementation of appropriate security details to enable operation in a 21 CFR Part 11 compliant environment that supports electronic signatures, good laboratory practices and audit trails with secure document versioning.

Integrated workflows and access

The following simple example illustrates how the enterprise ELN enables secure, authorized workflows while also minimizing information exchange delays from data capture through analysis and reporting.

In this scenario, scientists at the outsourcing organization initiate an experiment and clone it into the CRO repository after clearing out any proprietary information that is not appropriate for the CRO scientists to see. A synthesis request can be created using ELN messaging or a document workflow, enabling the CRO scientists to access the experiment directly from their inbox. They then check out the experiment, execute the reaction and record the procedure. They can access any section of the experiment and add new sections during editing to capture relevant analytical data as needed; meanwhile, scientists at the requesting organization can monitor progress at the CRO.

When the experiment is complete, the CRO scientists check it back into the CRO repository and route it back to the requesters. The experimental protocol enables the scientists at the outsourcing organization to mark the CRO experiment as complete and to remove the CRO scientists’ permissions to the experiment, thereby protecting intellectual property. The outsourcing scientists can then take advantage of configurable reporting templates to create and distribute required reports supporting project team collaboration.

Conclusion

As R&D organizations accelerate the pace and extent to which they outsource R&D operations to CROs, their primary strategic issue is how to increase productivity. A multidisciplinary, enterprise ELN can be used internally across the enterprise, as well as worldwide across business ventures, making it possible for scientists to collaborate effectively on multistage projects while concurrently building upon the successful methodologies and collective results of others. Deployment across partnering organizations offers the opportunity to reinvent outsourcing relationships and to make global partnerships more productive by ensuring that virtual research teams are sharing information efficiently, communicating effectively and, most importantly, working off the same virtual page.

John McCarthy is VP, Product Management Strategy, at Symyx Technologies. He may be reached at editor@ScientificComputing.com.