FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Research Project

The participant will be involved in the review of biologics license applications (BLAs) approved in recent 10 years (2015-2025) to identify biomarkers which have been used in diagnosis and assess the biomarker roles and associated bioanalytical methods to identify the landscape of a bioanalysis gap. This analysis could provide the scientific rationales for the appropriateness of bioanalysis of biomarker in different roles to fill out the gap and improve the drug development efficacy when using biomarkers and thus expand the usage of biomarker to more drug development and thus to expedite the drug development overall and bring more drugs to patients early.

Learning Objectives

• Learn the FDA database navigation system
• Learn how the biomarker assists the drug development process
• Master the bioanalysis of PD biomarker guidance and best practice in industry
• Understand the scientific considerations in regulatory decision making

Mentor

• Xiulian Du
• Yow-Ming Wang

Citizenship Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Qualifications

• Currently pursuing or have received a Master's or Doctoral degree in Life Health and Medical Sciences
• Have lived in the United States for at least 36 out of the past 60 months

Application Process

• All documents must be in English or include an official English translation
• One educational or professional recommendation
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• An application
• Transcripts – Click here for detailed information about acceptable transcripts

Contact Information

• If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

Benefits

• Monthly stipend commensurate with educational level and experience
• Participation in FDA ethics training

Background Investigation

Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

ORISE GO Mobile App

The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!