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

• Regulations
  • Regulation Part 320 – Bioavailability and Bioequivalence Requirements

• Related Guidance
  • Bioanalytical Method Validation (BMV) Guidance for Industry
  • Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples

• FDA’s June 17, 2019 Webinar Topic Videos
  • Bioanalytical Method Validation (BMV) Panel Discussion
  • Accuracy and Precision in Bioanalysis: Review of Case Studies
  • The Finalized Method Validation Guidance: What’s New for NDAs and BLAs
  • Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections
  • Bioanalytical Inspections: Overview and Case Studies