Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites July 19 - 20, 2022

Virtual | Virtual

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• Date: July 19 - 20, 2022
• Day1: Tue, Jul 19 9:00 AM - 4:10 PM ET
• Day2: Wed, Jul 20 9:00 AM - 3:20 PM ET

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Topics & Presentations Day 1	Speakers
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Welcome & Session 1
Welcome by Office of Study Integrity and Surveillance (OSIS)	Sean Kassim, PhD Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) |CDER
Keynote	ShaAvhrée Buckman-Garner, MD, PhD Director Office of Translational Sciences (OTS) | CDER
OSIS - Introduction, Mission, Vision	Tahseen Mirza, PhD Associate Director for Regulatory Affairs OSIS | OTS | CDER
Good Laboratory Practice (GLP) 101 - Regulation and Basic Studies	Zhou Chen, MD, PhD Team Lead, GLP Team Division of New Drug Study Integrity (DNDSI) OSIS | OTS | CDER
GLP Compliance Program	Erin McDowell Biologist DNDSI | OSIS | OTS | CDER
Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies Compliance Program	Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER
GLP Related Guidance Update: Pathology Peer Review and Whole Slide Imaging	Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER
Session One Questions & Answer Panel	Sean Kassim, Tahseen Mirza, Zhou Chen, Erin McDowell, Lynda Lanning
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 2
Bioavailability (BA) and Bioequivalence (BE) Studies supporting NDAs under the 505(b)(2) and ANDA under the 505(j) Application Pathways	Yiyue (Cynthia) Zhang, PhD, RAC Senior Staff Fellow, BE Team DNDSI | OSIS | OTS | CDER
In Vitro BE Studies	Monica Javidnia, PhD Staff Fellow, BE Team Division of Generic Drug Study Integrity (DGDSI) OSIS | OTS | CDER
Immunogenicity	Kara Scheibner, PhD Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER
Session Two Questions & Answer Panel	Yiyue (Cynthia) Zhang, Monica Javidnia and Kara Scheibner
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 3
Inspecting Clinical BA/BE Studies	Xingfang Li, MD, RAC Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER
Inspecting BE Studies with Clinical Endpoints	Xikui Chen, PhD Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER
Overview of Reserve Samples	Li-Hong Yeh, PhD Interdisciplinary Scientist, BE Team DNDSI | OSIS | OTS | CDER
Session Three Questions & Answer Panel	Xingfang Li, Xikui Chen, and Li-Hong Yeh
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 4 & Closing
In Vivo Studies	Gopa Biswas, PhD Team Lead, BE Team DNDSI | OSIS | OTS | CDER
In Vitro Studies	Sripal Mada, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER
Immunogenicity Studies	Kara Scheibner, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER
Session Four Questions & Answer Panel	Gopa Biswas, Sripal Mada, and Kara Scheibner
Day One Closing	Brian Folian, MS, JD Deputy Office Director OSIS | OTS | CDER

 

Topics & Presentations Day 2	Speakers
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 1
GLP Case Study	Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER Zhou Chen, MD, PhD Team Lead, GLP Team DNDSI | OSIS | OTS | CDER
Question & Answer	Lynda Lanning and Zhou Chen
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 2
Animal Rule Case Study	Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER Yiyue (Cynthia) Zhang, PhD, RAC Senior Staff Fellow, BE Team DNDSI | OSIS | OTS | CDER
Question & Answer	Lynda Lanning and Yiyue (Cynthia) Zhang
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 3
Clinical BA/BE Case Study	Doug Pham, PharmD, JD Associate Director for Clinical Policy OSIS | OTS | CDER
Question & Answer	Doug Pham
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 4
Analytical BA/BE Case Study	Sarmistha Sanyal, PhD Chemist, BE Team DGDSI | OSIS | OTS | CDER
Question & Answer	Sarmistha Sanyal
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 5
In Vitro BE Case Study	Gajendiran Mahadevan, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER
Question & Answer	Gajendiran Mahadevan
Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 6 & Closing
Immunogenicity Case Study	Amanda Lewin, PhD Team Lead, BE Team DGDSI | OSIS | OTS | CDER
Day Two Closing	Sean Kassim, PhD Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) |CDER

 

Agenda

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ABOUT THIS WORKSHOP

This workshop will:

• Describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS)
• Identify the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection
• Provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability (BA) -Bioequivalence (BE) , In Vivo Analytical BA/BE
• Engage attendees to work through case studies representative of the above programs.

INTENDED AUDIENCE

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

TOPICS COVERED

• Overview of Good Laboratory Practice (GLP), Animal Rule (AR), Compliance Programs (CPs) and inspections
• Guidance updates – Pathology Peer Review and Whole Slide Imaging
• OSIS BA/BE Program that includes BA Studies 505(b)2, BE studies, In Vitro BE studies and immunogenicity studies
• Expectations during BA/BE Inspections – Immunogenicity, Clinical CP, Clinical Endpoints and Analytical Studies
• Reserve sample requirements
• Case studies representing the different compliance programs.

FDA RESOURCES

• Regulations
  1. Regulation Part 320 – Bioavailability and Bioequivalence Requirements
• Related Guidance
  1. Bioanalytical Method Validation (BMV) Guidance for Industry
  2. Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
  3. Good Laboratory Practice for Nonclinical Laboratory Studies
• Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations