SEP 30, 2015 1:30 PM PDT

Biomarkers: An Auspicious Beginning and a Portentous Future?

Speaker
  • Co-Director, Complex Adaptive Systems Initiative, Director, Transformative Healthcare Networks, Professor, School of Life Sciences, Arizona State University (ASU)
    BIOGRAPHY

Abstract

Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the foundation for “precision medicine”, biomarkers do represent an unparalleled “value proposition”, as they are central to transitioning from a 20th century “one size fits all” approach to healthcare to a 21st century molecularly based model. Based on individual patient molecular (and other) biomarkers, this model would connect research to patient care in a seamless process. Early in the history of biomarkers, in areas such as cardiovascular disease and cancer, it appeared that the discovery and development of successful disease biomarkers might indeed be a straightforward process. However, that vision has proven elusive. Although to date, literally thousands of biomarkers exist in the literature as “discovered”, in the specific case of protein biomarkers, the FDA has approved less than one per year since 1993. This lack of validated biomarkers also contributes to the dismal success rate of late stage clinical trials in oncology and other complex diseases. Large-scale projects in whole genome sequencing (such as The Cancer Genome Atlas and other international efforts) are producing unprecedented – and often unmanageable – multi-dimensional data sets in cancer and other diseases. These efforts promise to inform and enable biomarker discovery by identifying the molecular changes associated with complex diseases. Questions as to whether these molecular changes are causative or merely associated with a given disease generally remain unanswered; and it undoubtedly take time to understand the intricacies of genomic and other molecular changes that characterize complex diseases. In parallel to these profound scientific questions that underlie biomarker science, there are real problems associated with the discovery and development of biomarkers that require a unified effort by the affected communities to achieve real solutions. For example, the lack of standards for biomarker discovery and development in areas ranging from the relevance of the original clinical question, to the quality of biospecimens, to the provenance of data and appropriate analytics all contribute to biomarker failure. Furthermore, end-to-end regulatory pathways for biomarker qualification and validation have lacked specificity in terms of required evidentiary standards. The FDA is currently addressing many of these issues through its increased emphasis on community engagement in biomarker qualification. Assuming that knowing the molecular underpinnings of complex diseases will enable success in the discovery of clinically relevant biomarkers, most, if not all, of the other problems are solvable. The National Biomarker Development Alliance (NBDA) is a non-profit, multidisciplinary and trans-sector network organization that is dedicated to achieving solutions to many of the systemic problems that plague the field. The presentation will focus on the state of the biomarker field and progress by the the NBDA and other efforts to create end-to-end biomarker discovery and development approaches dedicated to patient benefit.


Show Resources
You May Also Like
APR 01, 2021 8:00 AM PDT
C.E. CREDITS
APR 01, 2021 8:00 AM PDT
Date: April 01, 2021 Time: 8:00am (PST), 11:00am (EST) Generating therapeutic antibodies is far more challenging than obtaining antibodies that merely recognize their targets. Engineering po...
MAY 11, 2021 10:00 AM PDT
C.E. CREDITS
MAY 11, 2021 10:00 AM PDT
Date: May 11, 2021 Time: 10:00zm PDT Your samples are some of the most valuable assets in the laboratory. After spending countless hours on extraction and preparation, your conclusions could...
FEB 24, 2021 10:00 AM PST
C.E. CREDITS
FEB 24, 2021 10:00 AM PST
DATE: February 24, 2021 TIME: 10am PST Automated lab instruments such as liquid handlers and cell sorters are increasingly common in all types of laboratories, driving fast results for labor...
MAR 16, 2021 10:00 AM PDT
C.E. CREDITS
MAR 16, 2021 10:00 AM PDT
Date: March 16, 2021 Time: 10:00am (PST) Scientific progress and breakthroughs today are often too expensive for most institutions to acquire. Each year, the National Institutes of Health (N...
JAN 21, 2021 8:00 AM PST
JAN 21, 2021 8:00 AM PST
Date: January 21, 2021 Time: 8:00am (PST), 11:00am (EST) Today, critical reagent characterization is a key component in the overall workflow to establish robust ligand binding assays (e.g.,...
MAY 18, 2021 7:00 AM PDT
MAY 18, 2021 7:00 AM PDT
Date: May 18, 2021 Time: 7:00am PDT, 10:00am EDT Proteins encoded by mutant genes in cancers can be processed and presented on tumor cell surface by human leukocyte antigen (HLA) molecules,...
SEP 30, 2015 1:30 PM PDT

Biomarkers: An Auspicious Beginning and a Portentous Future?


Specialty

Research And Development

Gene Expression

Dna

Big Data

Cancer Research

Tumor

Biomarkers

Cancer

Earth Science

Oncology

University

Gene Sequencing

Drug Discovery

Mass Cytometry

Cell Culture

Geography

Asia50%

Europe50%

Registration Source

Website Visitors100%

Job Title

Student50%

Medical Laboratory Technician50%

Organization

Manufacturer - Other50%

Academic Institution50%


Show Resources
Loading Comments...
Show Resources
Attendees
  • See more