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Biotherapeutics (NEU)

2016 APEC Biotherapeutics Centers of Excellence Pilot Training

September 13 - 16, 2016 Northeastern University, Boston, United States
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Phase 2: Comparability Throughout the Life-Cycle
Day 1: Tuesday, September 13, 2016
Session 1: Welcome and Introduction
08:00-08:30 Breakfast Available at Elliott Hall
08:30-09:00 Registration
09:00-09:15 Opening Remarks
Congratulatory Remarks
David Luzzi (NEU)
Yeowon Sohn (AHC) - Video
09:15-09:30 Critical Concepts from Phase 1-Introduction to Biologics Jared Auclair (NEU)
09:30-09:40 Group photo and coffee break
Session 2: Control of the Product I Hands-on Training
09:40-10:30 Why comparability is needed-changes including post-approval variation for biologics Sunny Zhou (NEU)
10:30-11:30 How to do Comparability: ICH Q5E Jared Auclair (NEU)
Dieter Schmalzing (Roche)
11:30-13:00
    • 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)
Jeffery Agar
13:00-14:00 Lunch at Elliott Hall
Session 3 Lecture
14:00-15:00 Hands-on Training Cont. from Session 2 Jared Auclair (NEU)
Jeffrey Agar (NEU)
15:00-15:30 Coffee Break
15:30-17:30 How to do Comparability: Interpretation of the data, risk-based understanding of changes Dieter Schmalzing (Roche)
17:30-18:00 Acceptance Criteria; statistical considerations Jeffery Agar (NEU)
18:00-20:00 Opening Reception at the Hilton Garden Inn, 5 Wheeler Rd., Burlington, MA
Day 2: Wednesday , September 14, 2016
Session 4: Risk based understanding of categorization of changes Hands-on Training
08:30-09:00 Breakfast Available at Elliott Hall
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)
Jeffery Agar (NEU)
12:00-12:30 Group Discussion on Intact Mass Analysis Jared Auclair (NEU) facilitate
12:30-13:30 Lunch at Elliott Hall
Session 5: Understanding "Comparability" and "Similarity" Case Studies
13:30-14:00 Understanding "Comparability" and "Similarity"
    • Lecture Highlights:
      • As defined in different regions (FDA, EMA, WHO, etc.)
Karen Hauda (Novo Nordisk)
14:00-14:45 Understanding "Comparability" and "Similarity"
CMC, Quality and General Clinical Considerations
- "Totality of the Evidence" - An FDA Perspective
Michael Stern (Covington & Burling, FDA AA)
14:45-15:15 Coffee Break
15:15-16:00 Understanding "Comparability" and "Similarity"
Structure Function Analysis and Clinical Pharmacology
      • Utility of Clinical Pharmacology information in determining Biosimilars
Sundar Ramanan (Amgen)
16:00-16:30 Understanding "Comparability" and "Similarity"
Getting into clinical trials:
      • Are they really necessary?
      • Biosimilars and small-molecule generics - twin sisters or remote second cousins?
      • Introduction to cases and break-out group work
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
16:30-17:30 Understanding "Comparability" and "Similarity"
Case 1: Human insulin biosimilar
      • Break-out group work
      • Discussion in class
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
Karen Hauda (Novo Nordisk)
Wrap-up session
17:30-18:30 Concluding Remarks on Comparability Throughout the Life-Cycle Jeffery Agar (NEU)
18:30-20:00 Dinner Lecture at Elliott Hall

2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Phase 3: Clinical Considerations for the Assessment for Biosimilars
Day 3: Thursday, September 15, 2016
08:30-09:00 Breakfast Available at Elliott Hall
09:00-09:30 Opening/ Introduction to Phase 3 Jangik Lee (SNU)
09:30-10:30 General Clinical Considerations in the Development of Biosimilars - Putting it all together
Case 2: Long-acting insulin analogue biosimilar
      • Break-out group work
      • Discussion in class
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
Karen Hauda (Novo Nordisk)
10:30-12:00 General Clinical Considerations in the Development of Biosimilars - Putting it all together
Case 3: Monoclonal antibody (infliximab) biosimilar
      • Break-out group work
      • Discussion in class
Jens Heisterberg (Novo Nordisk, Former EMA CHMP Rapporteur)
12:00-13:00 Lunch at Elliott Hall
13:00-15:00 Group Project (2-3 subgroups)
Examples:
 - Should the first human study be a     traditional Phase 1 trial or a PK/PD     comparability trial with the reference?
 - What are important ingredients in a     confirmatory Phase 3 trial?
Moderator: Jangik Lee (SNU)
15:00-15:30 Coffee Break
15:30-17:00 Group Project (2-3 subgroups); Cont.
Examples:
 - Should the first human study be a     traditional Phase 1 trial or a PK/PD     comparability trial with the reference?
 - What are important ingredients in a     confirmatory Phase 3 trial?
Moderator: Jangik Lee (SNU)
Day 4: Friday, September 16, 2016
08:30-09:00 Breakfast Available at Elliott Hall
09:00-10:30 Considerations of Immunogenicity in Determining Biosimilar
 - With case studies
Cornelia Ulm (Merck Biosimilars)
Martin Ullmann (Merck Biosimilars)
10:30-11:00 Coffee Break
11:00-12:30 Extrapolation of Indication
 - Principles of indication extrapolation
 - Evidences required (analytical,     nonclinical, clinical, etc.)
 - With case studies
Regulatory Perspective:
Jian Wang (IPRF BWG, Health Canada)
Industry Perspective:
Nathan Doty (Abbvie/IFPMA)
Case Study:
Alex Kudrin (Celltrion)
12:30-13:30 Lunch at Elliott Hall
13:30-14:30 Post approval monitoring
 - EMA requirements
 - FDA requirements
 - With case studies
Matthew Thompson (Pfizer) with
Kristin Boggio (Pfizer)

Sreedhar Sagi (Sandoz)
14:30-15:00 Coffee Break
15:00-18:00 Group Project (2-3 subgroups) Presentations Moderator: Jangik Lee (SNU)
18:00-18:30 Wrap up and Conclusion Jared Auclair (NEU)
18:30-20:30 Closing Dinner at the Concord’s Colonial Inn, 48 Monument Square, Concord, MA