Biomarkers 101

Planned in cooperation with the ASHP Section of Clinical Specialists and Scientists

ACPE Activity Number: 0204-0000-19-004-H04-P
Release Date
: February 13, 2019
Expiration Date: February 13, 2022
Activity Type: Knowledge-based
CE Credits: 1.0 hour, no partial credit
Activity Fee: Members – Free / Non-Member – Not Available

This activity is a recording from a live webinar and those that claimed credit for the live webinar should not claim CE for this activity.

Activity Overview

Measurable entities called biomarkers can be indicative or predictive of disease, infection or even medication effectiveness. This activity will provide an introduction to the use of biomarkers in a clinical pharmacist’s practice. Participants will learn what a biomarker is as well as their history. Additionally, participants will get a better understanding of the FDA categorizing system for biomarkers and the FDA approval process for their clinical use. The FDA’s BEST (Biomarkers, EndpointS and other Tools) resource guide will be discussed. PDL-1 as well as several other biomarkers will be presented to demonstrate the approval process and how biomarkers can be utilized and evaluated in a clinical pharmacist’s practice.


The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Target Audience

This continuing pharmacy education activity is designed forall clinical pharmacists to expand their knowledge of biomarkers and the application of biomarkers into their clinical practice.  

Learning Objectives

  • Discuss ASHP’s policy recommendation on the use of biomarker in clinical practice.
  • Review the definitions and history of biomarkers.
  • Explain the BEST Resource for biomarkers.
  • Describe the FDA approval process for the clinical use of biomarkers.
  • Discuss how the pharmacist would utilize a biomarker such as PDL-1 in clinical practice.

Schedule of Activities

  • Discuss the ASHP’s policy recommendation and FDA approval process on the use of biomarker clinical practice.


  • Ali Roberts, Pharm.D., BCPS, Medical Liaison II, Guardant Health, Brentwood, TN
  • Martha J. Roberts, B.S.Pharm., Pharm.D., BCCCP, Clinical Pharmacist, Kent Hospital,Warwick, RI


In accordance with the ACPE's and ACCME's Standards for Commercial Support, anyone in a position to control the content of an educational activity is required to disclose to the accredited provider their relevant financial relationships. In accordance with these Standards, all potential conflicts of interests have been resolved. An individual has a relevant financial relationship if he or she (or spouse/domestic partner) has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the activity content over which the individual has control.

As defined by ACCME, a commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The Standards for Commercial Support do not consider providers of clinical service directly to patients to be commercial interests.

  • All planners, presenters, reviewers, and ASHP staff of this session report no financial relationships relevant to this activity.

Methods and CE Requirements

This activity consists of recorded faculty slides presentations, active learning activities, discussion, and handouts. Participants must participate in the entire activity to claim continuing pharmacy education credit online at ASHP eLearning Portal. Follow the prompts online to complete the evaluation, claim credit and view the statement of credit within 60 days of completing the activity.

Per ACPE requirements, CPE credit must be claimed within 60 days of being earned.