CHAPTER 3:Introduction: The Cardinal Role of Biobanks and Human Biospecimen Collections in Biomarker Validation: Issues Impeding Impact of Biomarker Research Outcomes

Chapter 3 highlights the value of biobank collections for biomarker development and validation, specifically providing an overview of critical issues in the biobanking pathway that impact biomarker research results. The chapter commences with an overview of the biobank-biomarker collaborative landscape in an effort to elucidate, key planning considerations for enhancing biomarker validation and research. Universal challenges in biospecimen collection and utilization are discussed. Four key areas of dysfunction are outlined: unsustainable biobanking operational models, difficulties in locating and accessing quality biospecimens with appropriate associated data, inefficient research business practices (resulting in inability to engage in timely collaborations) and limited prevalence of suitable biospecimen collections. Recommendations are presented as to how these critical challenges may be ameliorated. Thoughts are then offered as to how biospecimen and biomedical research practices may be improved to optimize and accelerate incidence of relevant biomarker research outcomes.