THOUGHT LEADERSHIP

© 2015 BRUCE PHARR | SCIENCE & TECHNOLOGY MARKETING

www.brucepharr.com

Flexible Standardization: The Future of Human Biobank Management Informatics

BACKGROUND  

In late 2013, I was retained by Remedy Informatics to analyze market requirements and develop a product roadmap for a Biobank Management System (BMS), author a white paper, and develop and deliver thought-leader presentations at leading biomedical informatics conferences. Following is the presentation I delivered at Bio-IT World. It is derived from the white paper, and it describes the benefits and advantages of a BMS that combines standardization with flexibility.

Flexible Standardization The Future of Human Biobank Management Informatics  

Bruce Pharr | Vice President, Life Sciences Research Systems

Bio-IT World Conference | April 30, 2014

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Flexible Standardization Biobank History Timeline

Today, biobanks are producers, not just static foundations, of advances in disease and therapeutic research as well as drug discovery and development.

Flexible Standardization Biospecimen Lifecycle and Biobank Management Informatics

Biobank management informatics extends beyond the biobank to include critical pre-analytical data that ensures

accurate analytical results and efficient business operations.

Flexible Standardization Remedy Informatics Biobank Management System (BMS)

Flexibility and standardization of biospecimen, donor, and business information management through:

‒  Best practices (mapped to international standards) ‒  Ontology ‒  Configuration ‒  Interoperability

Flexible Standardization Remedy Informatics Biobank Management System Architecture

Flexible Standardization BMS International Standards (and Regulatory Requirements)

Flexible Standardization Specimen Track BMS Requirements Model Mapped to Standards

Flexible Standardization Harmonized Standards for Informed Consent Forms Requirement

Flexible Standardization Harmonized Standards for Security: Log Requirement

Flexible Standardization Mosaic™ Ontology – Purpose-Specific Structured Data Model

‒  Predefined, Standardized Terminology ‒  Domain-Specific Mapped Relationships ‒  Permissible Values and Validation Rules

Flexible Standardization Mosaic Ontology – Domain Standards for Terminology

Flexible Standardization Mosaic Ontology – Predefined, Standardized Terminology

Flexible Standardization Mosaic Ontology – Domain-Specific Mapped Relationships

Flexible Standardization Mosaic Ontology – Permissible Values and Validation Rules

Flexible Standardization Mosaic Ontology – Standardized, Extensible Disease Registries

Flexible Standardization Specimen Track BMS Configurable Artifacts

Flexible Standardization Configuration

Configure (administrator)

Visualize and Utilize (user)

Flexible Standardization Interoperability

Flexible Standardization The Future of Human Biobank Management Informatics

1.  Biobanks are producers, not just static foundations, of advances in disease and therapeutic research as well as drug discovery and development.

2.  Biobank management informatics includes: a.  Biospecimen information management b.  Donor information management c.  Business information management

3.  For the foreseeable future, biobank management informatics will require: a.  Best practices mapped to applicable standards b.  Flexibility when standards and research applications change

4.  Remedy Informatics’ Specimen Track™ Biobank Management System combines flexibility and standardization through:

a.  Best practices (mapped to applicable international standards) b.  Ontology c.  Configuration d.  Interoperability

ABOUT BRUCE PHARR I live in the San Francisco Bay Area with my wife and son. I hike in the Santa Cruz Mountains, eat good food, drink good wine, root for the SF Giants, and indulge a passion for the arts.

I serve as a strategic advisor, senior consultant, and contract corporate executive with innovative science and technology companies in life sciences, healthcare, energy storage, instrumentation, and semiconductors.

I have a track record of helping companies create competitive advantage, grow revenue and market share, and increase enterprise value. And I’ve contributed to several successful M&A events. I am a subject matter expert in basic, translational, and clinical research systems. I have led or contributed to the development of market and product requirements for biomedical, genomic, and NGS products, written thought-leader white papers, case studies, and articles for leading online and print publications, and developed and delivered presentations at major biomedical conferences.

I served as VP, Life Sciences Research Systems at Remedy Informatics in 2013 and 2014. At Remedy, I analyzed market requirements, developed a product roadmap for a Biobank Management System (BMS), authored a white paper, and developed and delivered thought-leader presentations at leading biomedical informatics conferences describing the benefits and advantages of a BMS that combines standardization with flexibility.