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10th Workshop on Monoclonal Antibodies - PDA Exchange

Sep 26 - Sep 27, 2017
Berlin, Germany

  • Conference
  • Europe
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Program Highlights

Brochure and Agenda are online now!

Come celebrate with us the PDA Europe
10th Anniversary of the Monoclonal Antobodies Workshop!

The Scientific Program Planning Committee warmly welcomes you to Berlin!

  • Ursula Busse, Co-Chair, Novartis
  • Steffen Gross, Co-Chair, Paul-Ehrlich-Institut
  • Barry Cherney, Amgen
  • Michael De Felippis, Eli Lilly
  • Juan Giménez, Genentech/Roche
  • Ralf Hess, TPL Path Labs
  • Susanne Jörg, Lonza
  • Lutz Mathe, GE Healthcare
  • Martijn van der Plas, Medicines Evaluation Board
  • Falk Klar, PDA Europe

Overview

This year, PDA celebrates the 10th anniversary of the Workshop on Monoclonal Antibodies, taking place in Berlin, Germany, 26 – 27 September, highlighting the achievements of this successful format over the past ten years. The Workshop will be part of the PDA Exchange meeting format. This meeting format combines two meetings in the same place, allowing the audience to swap between the two meetings and attend different sessions with just one meeting ticket. This format gives you the chance to “Meet, Exchange and Connect” with colleagues, peers and professionals from different backgrounds around the globe - see Particles in Injectables Conference in the previous page.

The 10th PDA Europe Monoclonal Antibodies Workshop will once again feature presentations about the latest developments, brought to you by international industry and regulatory experts, including a broad update on regulatory considerations. Aside from presentations, there will be various case studies and panel discussions regarding upstream and downstream process development, control strategy design, antibody related products and technological innovations. Traditionally, PDA Europe's Monoclonal Antibodies Workshop is an event which allows its attendees to interact intensely with colleagues, regulators, industry leaders and experts. So come to Berlin and use this chance to get involved!

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Agenda

  • Tuesday, 26 September 2017

    9:00
    Welcome and Introduction
    Falk Klar, PDA Europe
    Ursula Busse, Co-Chair, Novartis
    Steffen Gross, Co-Chair, Paul-Ehrlich-Institut

    Keynote: 10th Anniversary of the PDA Europe Workshop on Monoclonal Antibodies

    9:10
    Accomplishments of a Decade of mAbs
    Gabriele Dallmann, 1st Chairwoman, Biopharma-Excellence

    Session 1: Regulatory Trends & Updates

    Moderator: Martijn van der Plas, CBG-MEB

    9:40
    Biologics Working Party: Lessons Learned
    Veronika Jekerle, EMA

    10:10
    EDQM on Monographs related to Monoclonals
    Mihaela Buda, EDQM

    10:40
    Comparability 2.0
    Martijn van der Plas, CBG-MEB

    11:15
    Coffee Break, Poster Session & Exhibition

    11:45
    Advancements in ADC Manufacture and Control
    Nathan Ihle, Seattle Genetics

    12:15
    Regulatory Requirements of Antibody-Drug Conjugates -A Chemical Perspective
    Nynke Brouwer, CBG-MEB

    12:45
    Q&A, Panel Discussion

    13:15
    Lunch Break, Poster Session & Exhibition

    Session 2: High Concentration Monoclonal Antibody Products

    Moderator: Michael De Felippis, Eli Lilly

    14:15
    Physical Stability Considerations for High Concentration Formulations
    Wolfgang Friess, University of Munich

    14:45
    Formulation and Dosage Form Design
    Nagarajan Thyagarajapuram, Eli Lilly

    15:15
    Primary Packaging Interactions & Delivery Systems
    Julian Jazayeri, Amgen
    Jean-Christophe Veilleux, California Institute of Technology

    15:45
    Q&A, Discussion

    16:00
    Coffee Break, Poster Session & Exhibition

    16:30
    Delivery System Design
    Susanne Joerg, Lonza

    17:00
    SC Products and Enzyme Co-Formulation
    Claudia Mueller, Roche / Genentech

    17:30
    Q & A, Panel Discussion

    18:00
    End of Day 1

    19:00
    Networking Dinner

    Wednesday, 27 September 2017

    9:00
    Welcome and Introduction
    Falk Klar, PDA Europe
    Ursula Busse, Co-Chair, Novartis
    Steffen Gross, Co-Chair, Paul-Ehrlich-Institut

    Session 3: Advancements in Manufacturing Technologies for Monoclonal Antibodies

    Moderator: Lutz Mathe, GE Healthcare

    9:05
    Overcoming the Challenges – A Decade's Journey in Cell Culture Process Innovation
    Tongtong Wang, Eli Lilly

    9:35
    How to Manage Bioburden: A Case Study from a mAb Production Facility
    Reinhard Braaz, Roche

    10:05
    Addressing the Risks of Bioburden in mAb Downstream Bioprocessing
    Lutz Mathe, GE Healthcare

    10:35
    Q & A, Discussion

    11:00
    Coffee Break, Poster Session & Exhibition

    Session 4: Life Cycle Management

    Moderator: : Ursula Busse, Novartis

    11:30
    ICH Q12: Status of the Lifecycle Management Guideline
    Nanna Kruse, Danish Medicines Agency (DKMA), Expert Working Group

    12:00
    Case Study: Managing Post-Approval Changes
    Brian Mullan, Novartis

    12:30
    Continued Process Verification as a Tool to Support Changes
    Aaron Goerke, Roche

    13:00
    Lunch Break, Poster Session & Exhibition

    Session 5 Specifications & QbD

    Moderator: Steffen Gross, Paul-Ehrlich-Institut

    14:00
    Leveraging Principles of QbD to Establish Clinically Relevant pecifications
    Barbara Rellahan, Amgen

    14:30
    Comparison of Justification of Specifications
    Gerald Gellermann, Novartis

    15:00
    Setting Specifications for Monoclonals – A Regulator's View
    Mats Welin, Swedish Medicines Agency (MPA)

    15:30
    Closing Panel Discussion
    Barbara Rellahan, Amgen
    Gerald Gellermann, Novartis
    Mats Welin, Swedish Medicines Agency (MPA
    Nanna Aaby Kruse, Danish Medicines Agency (DKMA), Expert Working Group

    16:15
    Closing Remarks & Farewell Coffee

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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