Info

years

Figure 1 Sequential R&D process. (From Peter Corr, IBM Imaging Biomarkers Summit I, Palisades, New York, December 15-17 2007.)

Decision n

IND Submission NDA Submission

Figure 2 Decision gates (milestones) to manage sequential R&D processes. (From Terry McCormick, Kathleen Martin, and M. Hehenberger, IBM Institute for Business Value, The evolving role of biomarkers: focusing on patients from research to clinical practice, July 2007, http://www.ibm.com/industries/healthcare/doc/jsp/resource/ insight/.)

IND Submission NDA Submission

Figure 2 Decision gates (milestones) to manage sequential R&D processes. (From Terry McCormick, Kathleen Martin, and M. Hehenberger, IBM Institute for Business Value, The evolving role of biomarkers: focusing on patients from research to clinical practice, July 2007, http://www.ibm.com/industries/healthcare/doc/jsp/resource/ insight/.)

Novartis have realized that biomarker-enabled R&D has to be organized differently (personal communication from Werner Kroll, January 2007). In particular, there is an increasing emphasis on parallel processes and accelerated "proof-of-concept" in humans to "learn" quickly and to "confirm" (i.e., conduct extensive clinical trials) only if the learning is yielding promising results (Figure 3). A high - 1 evel depiction of this new approach can also be found in the IBM Pharma 2010 report [2].

It is the role of IT standards and architectures to support business strategies and to enable their implementation. IT standards relevant in this context are:

• Data standards proposed by the Clinical Data Interchange Standards Consortium (CDISC) [8] such as:

• SEND (Standard for Exchange of Nonclinical Data) covering animal data

Figure 3 Parallel biomarker-enabled processes up to preclinical development. (From Terry McCormick, Kathleen Martin, and M. Hehenberger, IBM Institute for Business Value, The evolving role of biomarkers: focusing on patients from research to clinical practice, July 2007, http://www.ibm.com/industries/healthcare/doc/jsp/resource/ insight/.)

Figure 3 Parallel biomarker-enabled processes up to preclinical development. (From Terry McCormick, Kathleen Martin, and M. Hehenberger, IBM Institute for Business Value, The evolving role of biomarkers: focusing on patients from research to clinical practice, July 2007, http://www.ibm.com/industries/healthcare/doc/jsp/resource/ insight/.)

• SDTM (Study Data Tabulation Model) covering human data

• ODM (Operational Data Model) covering study data including EDC-generated data

• ADaM (Analysis Data Model) covering analysis data sets

• HL7 Clinical Document Architecture (CDA) [9]

• DICOM (Digital Imaging and Communications in Medicine) to transmit medical images [10]

• Janus Data Model [11] developed by FDA and IBM [in a collaborative research and development agreement (CRADA)] and implemented by NCI (National Cancer Institute) and the FDA

A comprehensive overview of relevant standards along with associated Web sites is shown in Figure 4.

Based on the technical challenges for integrating a diverse set of data sources for a biomarker- based clinical data submission, we propose an IT architecture (Figure 5 [12]) that addresses a majority of those requirements. Although this architecture includes software products and assets belonging to IBM, one can logically extend it to fit other vendor products as well. Our approach is to present a general-purpose platform for managing clinical submissions of patient data, enhanced with genomic and imaging data.

Psidev.sourceforge.net

Microarray Gene Expression Data Society: MAGE Standard

Clinical Data Interchange Standards Consortium

Joint project of CDISC and HL7, based on FDA Guidance. IBM co-founded in Nov. 2003

ANSI Accredited Standards Committee (ASC) X12N : EDI and XML standards

HUPO Proteo rnios Standards Initiative

Global Grid Forum: Life Sciences Grid standards

BioMoby www.biomoby.org

Bionformatics metadata standards

Pharmaco-genomios Standards Initiative

HUPO Proteo rnios Standards Initiative

Pharmaco-genomios Standards Initiative

DICOM Medical.nema.org

BioMoby www.biomoby.org

Bionformatics metadata standards

Figure 4 Health care and life sciences standards organizations.

Health Level Seven: Hospital/clinical data standards

Healthcare

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