In the imaging field, biomarkers are increasingly being used non-invasively to assess patients' localized disease progression and response to drug candidates. Biomarkers can help determine whether the drug reaches the target, whether it affects biological activity and, if it does, whether that effect leads to the desired clinical outcome. With these trends in mind, our point-of-view reflects insights and discussions from the IBM (Imaging) Biomarker Summit III held in January 2007. This is the third in a series of summits that began in 2005, but for the first time, participants explored a full spectrum of biomarkers, including imaging, genomics and proteomics. As biomarkers become part of the entire developmental process, they can be used to help increase patient-focused precision in medical practice, leading to better risk assessment, diagnosis and treatment. As the Figure shows, biomarkers can impact both clinical development and medical practice. 
While there is widespread recognition of biomarker value, scientific progress continues to outpace acceptance. The following barriers continue to hinder biomarker acceptance: - Resistance to sharing data across independent efforts – Organizations may work on similar research or discover keystone advances, yet resist sharing knowledge because they feel that doing so will jeopardize their competitive advantage.
- Limited biomarker validation – The biomarker development and validation process is necessary, but costly for one company to do in isolation. Innovation takes place in many organizations, and so stakeholders work redundantly on the same effort. Many collaborative forums exist, but these usually involve sharing "safe" information that does not really hasten overall progress.
- Need for new R&D models with greater precision and flexibility – The industry needs an R&D model that supports targeted treatments for specific patient groups, leveraging active clinical knowledge to offset the declining success in new drug development.
- Insufficient interoperability – Traditional data resides in disparate places that often do not easily connect. Factor in imaging biomarkers constituted by terabytes of data and the result is a complex mix of data from which it is difficult to extract new insights.
Discussions at the summit suggest four steps that can be taken to help the industry realize the full potential of imaging biomarkers: - Enable collaboration – Adopt new, more collaborative approaches for biomarker validation, innovation, development and sharing costs.
- Increase biomarker utility – Agree on a validation framework for biomarkers to be part of pivotal decisions within development, medical care and health policy.
- Shift toward information-based medicine – Increase predictability of safety and efficacy to help target treatment based on more informative cohort data and other clinical information.
- Create an interoperable environment – Combine biomarkers with other clinical data. Agree and implement data standards and semantics (i.e., ontologies and rules).
By following this four-step path, companies can use biomarkers to help translate patient-focused research into medical care with valuable precision. How can IBM help?
IBM Life Sciences R&D Transformation Solutions - Unstructured Information Management Architecture (UIMA) - software architecture for developing and deploying unstructured information management (UIM) applications. We can provide our clients a high-level overview of the architecture, introduce its basic components, describe the set of tools that constitute a UIMA development framework, and show them the steps involved in building a simple UIM application, thus highlighting the major UIMA concepts and techniques.
- IBM Medical Image Management Solution (MIMS) - An industry-specific solution offered as an on-demand service that provides an online collaborative environment for the acquisition and management of medical images to support efficient R&D and timely commercialization. MIMS includes a pre-configured industry information model and best practices to support compliance with industry regulations including 21 CFR Part 11, HIPAA, and GCP
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