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Speech | Other

Event Title
Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations
June 30, 2020


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Presentation Title Speaker
Keynote Address

ShaAvhrée Buckman-Garner
Director
Office of Translational Sciences (OTS)

Bioanalytical Method Validation: History, Process, and Regulatory Perspectives Patrick Faustino
Lab Chief
Division of Product Quality Research (DPQR)
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ)
Regulated Bioanalysis for Large Molecules Jinhui Zhang
Chemist
Division of Product Quality Research (DPQR)
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ)
Regulated Bioanalysis for Small Molecules Diaa Shakleya
Senior Pharmacologist
Division of Product Quality Research (DPQR)
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ)
Panel Discussion for Office of Pharmaceutical Quality Session Patrick Faustino
Jinhui Zhang
Diaa Shakleya
Office of Clinical Pharmacology (OCP) Session: Drugs and Biologics Sriram Subramaniam
Senior Clinical Pharmacology Reviewer
Division of Cancer Pharmacology | OCP
Office of Clinical Pharmacology (OCP) Session: Biosimilars Salaheldin Hamed
Acting Biosimilars Lead
Division of Cancer Pharmacology | OCP
Bioanalysis of Unstable Analytes in Pharmacokinetic Bioequivalence Studies Submitted in ANDAs Zhen Zhang
Bioequivalence Reviewer
Office of Bioequivalence | OGD
Common Deficiencies for Study Sample Reanalysis in Pharmacokinetic Bioequivalence Studies Submitted in ANDAs Tian Ma
Bioequivalence Reviewer
Office of Bioequivalence | OGD
Bioanalysis of Endogenous Compound in Pharmacokinetic Bioequivalence Studies Submitted in ANDAs Zhen Zhang
Bioequivalence Reviewer
Office of Bioequivalence | OGD
Panel Discussion for Office of Generic Drugs Session Zhen Zhang
Tian Ma
Overview of Immunogenicity Inspections Melkamu Getie-Kebtie
Reviewer
Division of Generic Drug Study Integrity | OSIS
Considerations on ex vivo Conversion of Prodrugs During Bioanalysis Xiaohan Cai
Reviewer
Division of Generic Drug Study Integrity | OSIS
Bioanalysis of the dried blood spot (DBS) by mass spectrometry for the FDA regulated clinical studies Yiyue (Cynthia) Zhang
Senior Staff Fellow
Division of New Drug Study Integrity | OTS
What meta-analysis can tell you about the performance of bioanalytical methods Ruben Ayala
Lead Pharmacologist
Division of New Drug Study Integrity | OTS
CREST Site Selection Model Overview Gabriel Davila
Interdisciplinary Scientist
CREST Team | OSIS
Panel Discussion for Office of Study Integrity and Surveillance Session (OSIS) Session Melkamu Getie-Kebtie
Xiaohan Cai
Cynthia Zhang
Ruben Ayala
Gabriel Davila
Case Study Session: Bioanalytical Approaches to Mitigate Issues Identified During BE Clinical Site Inspection Arindam Dasgupta
Deputy Director
Division of New Drug Study Integrity | OTS

This training is focused on presenting an overview of how FDA’s Center for Drug Evaluation and Research approaches different issues in bioanalysis. The audience will gain a deeper and broader understanding of how bioanalysis must be performed to adequately support regulated activities and how FDA performs bioanalysis to further the agency’s mission and support regulated industry. Attendees will have the opportunity to learn firsthand how the offices that review and conduct bioanalysis conduct their work in this field.

Topics Covered

  • Bioanalytical method validation: history, process, and regulatory perspectives
  • Regulated bioanalysis for large molecules
  • Regulated bioanalysis for small molecules
  • Biosimilars
  • Drugs and biologics
  • Bioanalysis of unstable analytes
  • Repeat analysis
  • Endogenous compound bioanalysis
  • Overview of immunogenicity inspections
  • Considerations on ex vivo conversion of prodrugs during bioanalysis
  • Bioanalysis of the dried blood spot (DBS) by mass spectrometry for the FDA regulated clinical studies
  • What meta-analysis can tell you about the performance of bioanalytical methods
  • Office of Study Integrity and Surveillance’s (OSIS) Collaboration, Risk Evaluation and Surveillance Team (CREST) Site Selection Model Overview
  • Case study: bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection

LEARNING OBJECTIVES

Gain a better overall understanding of FDA’s requirements and processes for reviewing studies supported by regulated bioanalysis including:

  • Describe the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
  • Describe the Office of Clinical Pharmacology’s expectations for 505b2 applications.
  • Explain the Office of Generic Drug’s Office of Bioequivalence documentation needs for bioanalysis used in bioequivalence studies.
  • Understand how the Office of Testing and Research develops bioanalytical methods.
  • Participate in a workshop that will engage attendees to work through an example case study in bioanalysis regulation.

INTENDED AUDIENCE

This event is intended for:

  • Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data
  • Researchers involved in regulated bioanalysis
  • Sponsors planning studies involving bioanalysis
  • Industry professionals associated analytical laboratories that involve bioanalysis

FDA RESOURCES

 
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