10th Workshop on Monoclonal Antibodies - PDA Exchange

Berlin, Germany
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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

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!

More information coming soon.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 26 September 2017

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

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

Session 1: Regulatory Trends & Updates

Moderator: Martijn van der Plas, CBG-MEB

Biologics Working Party: Lessons Learned
Veronika Jekerle, EMA

EDQM on Monographs related to Monoclonals
Mihaela Buda, EDQM

Comparability 2.0
Martijn van der Plas, CBG-MEB

Coffee Break, Poster Session & Exhibition

Advancements in ADC Manufacture and Control
Nathan Ihle, Seattle Genetics

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

Q&A, Panel Discussion

Lunch Break, Poster Session & Exhibition

Session 2: High Concentration Monoclonal Antibody Products

Moderator: Michael De Felippis, Eli Lilly

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

Formulation and Dosage Form Design
Nagarajan Thyagarajapuram, Eli Lilly

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

Q&A, Discussion

Coffee Break, Poster Session & Exhibition

Delivery System Design
Susanne Joerg, Lonza

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

Q & A, Panel Discussion

End of Day 1

Networking Dinner

Wednesday, 27 September 2017

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

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

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

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

Q & A, Discussion

Coffee Break, Poster Session & Exhibition

Session 4: Life Cycle Management

Moderator: : Ursula Busse, Novartis

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

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

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

Lunch Break, Poster Session & Exhibition

Session 5 Specifications & QbD

Moderator: Steffen Gross, Paul-Ehrlich-Institut

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

Comparison of Justification of Specifications
Gerald Gellermann, Novartis

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

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

Closing Remarks & Farewell Coffee

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sofitel Berlin Kurfürstendamm

Augsburger Str. 41
Berlin, Germany , Germany

Sofitel Berlin Kurfürstendamm
Augsburger Strasse 41
10789 Berlin
Tel: +49 30 800 999 0
Fax: +49 30 800 999 99
Hotel Website

Just 100m from the Kurfürstendamm Boulevard, Sofitel Berlin Kurfürstendamm has a strikingly modern architecture with its spacious rooms and suites featuring dark woods and high windows.

Restaurant Le Faubourg offers traditional French cuisine and an outdoor terrace overlooking Kurfürstendamm.

Formerly the Hotel Concorde Berlin, the Sofitel Berlin Kurfürstendamm provides a touch of luxury in an Art Deco building. It is near designer boutiques, cultural highlights, the KaDeWe department store, Berlin Zoo, the Theater des Westens, Charlottenburg Palace and the Deutsche Oper Opera House.

Kurfürstendamm Underground Station is just a 3-minute walk from the Sofitel. Buses run directly to Tegel Airport from there.

PDA Europe has reserved a limited number of rooms until the 17th August 2017.

for the PDA Group Rate.

Single Room € 165 per night*
Double Room € 185 per night*

*Rates are per room and night, including the following services and benefits:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • On-site Parking
  • Taxes and Service will apply

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 13 km

  • Bus service, fee: € 2.80 (one way)
  • Estimated taxi fare: € 26

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 23 km

  • Bus service, fee: € 3.40 (one way)
  • Estimated taxi fare: € 48