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Webcast | Virtual

Event Title
FDA Grand Rounds – Clinical Omics Biomarker Discovery and Validation in Precision Medicine Applications
April 9, 2026


Date:
April 9, 2026
Time:
12:00 p.m. - 1:00 p.m. ET

To Attend

For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov

Speaker

Richard Beger, Ph.D.


Richard Beger, Ph.D. 
Branch Chief
Division of Systems Biology
National Center for Toxicological Research
Office of the Chief Scientist
U.S. Food and Drug Administration

About the Speaker

Dr. Beger received his Ph.D. in biophysics from Purdue University in 1991 and completed postdoctoral training in nuclear magnetic resonance at Wesleyan University and Johns Hopkins University School of Medicine before joining NCTR’s Division of Chemistry in 1998. He is currently the Branch Chief of the Omics, Modeling, Imaging and Chemistry (OMIC) Branch in the Division of Systems Biology, a diverse group of scientists working in the fields of metabolomics, proteomics, tissue imaging, and chemical modeling of toxicological and disease endpoints. Dr. Beger has been involved with metabolomics data quality since 2015 and was part of a group of scientists that started the metabolomics quality assurance and quality control consortium (mQACC) in 2018 He was on the coordinating committee of mQAAC from 2019-2022, including the chair of mQACC in 2022. Dr. Beger won the 2016 Society of Toxicology translational impact award for developing translational approaches to improve drug safety, disease detection/management, and human health. He has authored more than 190 published manuscripts including over 70 manuscripts in metabolomics, over 20 manuscripts in chemical activity modeling, over 10 manuscripts in proteomics, and systems biology and personalized medicine, 14 employee invention reports, and six patents.

About the Presentation

This lecture will provide an overview of Systems Biology omics and biomarker concepts with four examples of omics analyses of human blood samples. The examples include metabolomics and miRNA analysis of serum during acetaminophen-induced liver toxicity, proteomic analysis of serum to predict kidney recovery from dialysis, baseline proteomics analysis of blood from patients receiving doxorubicin treatment, and method for discovery and validation of miRNA-proteins pairs in plasma associated with respiratory disease.

Learning Objectives

  1. Discuss the use of samples collected at baseline and during treatment to provide predictive phenotype omics biomarkers.
  2. Understand how correlation of proteomics technologies can be used for analytical validation.  
  3. Describe methods to analyze and interpret miRNA and proteomics data. 

Continuing Medical Education (CME) Credit

As CME credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CME credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CME credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation.

Accreditation Statement

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Johns Hopkins University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This regularly scheduled series has been approved for a 52-week cycle beginning October 23, 2025.

Other Credits

Reciprocity exists with the following boards that accept AMA PRA Category 1 Credits™ from organizations accredited by the ACCME:

  • American Nurses Credentialing Center
  • American Academy of Nurse Practitioners National Certification Program
  • National Commission on Certification of Physicians Assistants
  • Psychologists: JHUSOM is authorized by the Maryland State Board of Examiners of Psychologists as a provider of continuing education. The JHUSOM maintains responsibility for this program.
  • Social Workers: The Maryland Board of Social Work Examiners certifies that this program meets the criteria for 1 credit hour of Category 1 of continuing education for social workers licensed in Maryland. The JHUSOM is an approved sponsor of the Maryland Board of Social Work Examiners for continuing education credits for licensed social workers in Maryland.

These professionals should submit their transcript to their respective boards to convert their credits to CEUs.

Policy on Presenter and Provider Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the presenter globally disclose conflicts of interest and any discussion of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place to identify and mitigate relevant conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education.

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