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Biotherapeutics (SNU)

2016 APEC Biotherapeutics Centers of Excellence Pilot Training

November 8 - 11, 2016 Seoul National University, Seoul, Korea

Part 1: Introdction to Biologics - Online

Part 2: Comparability throughtout the Life-Cycle
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 1: Tuesday, November 8, 2016 - training to be held at Waters
Session 1: Welcome and Introduction
09:00-09:30 Registration
09:30-09:45 Opening Remarks
Congratulatory Remarks
Jangik Lee (SNU)
David Luzzi (NEU)
Yeowon Sohn (AHC)
- Video
09:45-10:00 Critical Concepts from Phase 1-Introduction to Biologics Jared Auclair (NEU)
10:00-10:20 Group photo and coffee break
Session 2: Control of the Product Hands-on Training
10:20-11:10 Why comparability is needed-changes including post-approval variation for biologics Sunny Zhou(NEU) - Skype
11:10-12:00
    • Highlights:
      • Characterization (Mass Spec, Structural, Other): HDX, NMR, AUC, IMS, DLF, etc.; Method Validation; Stability; Control of the Process; Data Analysis: best practices and common errors
    • Hands-on Training:
      • Introduction to Instrumentation and capabilities
          - High Pressure Liquid Chromatography      (HPLC) and Aggregation
      • HPLC Analysis of an Ab (and aggregates)
      • Data Analysis: best practices and common errors
In this hands-on training we will introduce the attendees to HPLC and preform an aggregation analysis of a mAb (water standard). We will introduce the attendees to analyzing antibody aggregates using the stand-alone UPLC system as well (with PDA)). In this part of the training the students will be divided in groups for data analysis on EMPOWER.
Jared Auclair (NEU)
12:00-13:00 Lunch
13:00-14:50 Hands-on Training Cont. Jared Auclair (NEU)
14:50-15:10 Coffee Break
Session 3: Risk based understading of categorization of changes Lecture
15:10-17:10 How to do Comparability: ICH Q5E, Interpretation of the data, risk-based understanding of changes Kowid Ho (Roche)
17:10-17:40
    • Acceptance Crteria; statistical considerations
      • Quality Aspects
Jeffery Agar (NEU) -Video
18:00- Dinner (place located in 5 minutes by walking from the classroom)
Day 2: Wednesday , November 9, 2016 - training to be held at Waters
Session 4: Risk based understanding of categorization of changes Hands-on Training
09:00-12:00
    • Hands-on Training:
      • Intact Mass Analysis by direct infusion and LC-MS
      • Categorization of Changes
      • In this hands-on training we will introduce the attendees to the instrumentation and preform an intact mass analysis of a mAb (waters standard). We will compare direct infusion to the LC-MS data. The instrumentation used (TUV-UPLC-MS): Waters H-Class quaternary solvent manager, sample manager, column manager (two column version), UV detector (TUV), and Xevo-G2S. (Time permitting we will introduce the attendees to analyzing antibody aggregates using the stand-alone UPLC system as well (with PDA)). In this part of the training the students will be divided in group for data analysis on UNIFI 1.8.1; how to calculate an intact mass of an Ab (heavy chain, light chain, intact antibody). Ideally UNIFI will have the intact mass workflow installed.
Jared Auclair (NEU)
12:00-12:30 Group Discussion on Intact Mass Analysis Jared Auclair (NEU)
12:30-13:30 Lunch
13:30-14:00 Quality elements of Biosimilar development-importance of structure/function relationship Sundar Ramanan (Amgen)
14:00-15:00 Biosimilar Development & Life-cycle management CASE STUDY
Part 1: Analytical Similarity Assessment of Remsima
part 2: Post-approval changes for Remsima
Jae Hwee Park (Celtrion)
Session 5: Biosimilar Development Site Visit
15:00-16:00 Trip to Celltrion, Songdo(transportation time)
16:00-18:00 Touring the Celltrion Manufacturing Site
18:00- Dinner


Part 3: Clinical Considerations for the Assessment for Biosimilar
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 3: Thursday, November 10, 2016
Session 6: General Regulation in Biosimilar Development
09:00-09:10 Openning/ Introduction to Part 3 Jangik Lee (SNU)
09:10-09:30 Comparison of Biosimilar Guidelines Jangik Lee (SNU)
09:30-10:15
    • Biosimilar Regulations
      • United States
Michael Stern (Convington & Burling, FDA AA)
10:15-10:35 Coffee Break
Session 7: Clinical Elements of Biosimilar Development
10:35-11:00 Understanding the difference between Comparability and Similarity Sundar Ramanan (Amgen)
11:00-12:00 Considerations of Immunogenicity in Determing Biosimilar With case studies Daniel F Alvarez (Pfizer)
12:00-13:00 Lunch
13:00-14:00
    • Lecture: Getting into clinical trials
      • Clinical trial methodology with specific emphasis on biosimilars
      • Why are clinical trials necessary in the evaluation of the benefit-risk balance of biosimilars?
Introduction to cases and break-out group work
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
Session 8: Case Studies and Discussion
14:00-15:00
    • Case1 : Human insulin biosimilar
      • Break-out group work
      • Discussion in class
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
15:00-15:20 Coffee Break
15:20-16:20
    • Case2 : Insulin analog for biosimilar
      • Break-out group work
      • Discussion in class
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
16:20-18:20 Group Projects(2-3 subgroups)
  - Examples: filgrastim, infliximab, etanercept
  - Design a First-in-human Study for the Development of a Biosimilar Product
  - Design a Supportive Safety and Efficacy Study
Moderators:
Jangik Lee (SNU)
Day 4: Friday , November 11, 2016
09:10-09:55 PK, PD, General considerations in efficacy, safety, and immunogenicity Alex Kudrin (Celltrion)
Session 9: Extrapolation of Indication
09:55-10:15 Extrapolation of Indication Case Study:
Alex Kudrin (Celltrion)
10:15-10:40 Coffee Break
10:40-12:10 Extrapolation of Indication (Cont.)
  - Principles of indication extraploation
  - Evidences required (analytical, nonclinical, clinical, etc.)
With case studies
Regulatory Perspective
Kyung-Tak Nam (IPRF BWG, MFDS)
Industry Perspective:
Thomas Schreitmueller (IFPMA)
12:10-13:30 Lunch
Session 10: Post approval monitoring
13:30-14:20 Post approval monitoring
  - EMA requirements
  - FDA requirements
With case studies
Sreedhar Sagi (Sandoz)
Session 11: Wrap Up
14:20-15:20 Group Project (2-3 subgroups) Discussion Moderators:
Jangik Lee (SNU)
15:20-15:40 Wrap up and Conclusion Jangik Lee (SNU)
15:40-15:50 Closing Remark Roadmap Champion