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10th Workshop on Monoclonal Antibodies - PDA Exchange

Sep 26 - Sep 27, 2017 |
Sep 27, 2017 |
Sofitel Berlin Kurfürstendamm | Berlin, Germany
  • Conference
  • Europe
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Speaker Biographies

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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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

11:10
Control Strategy
FDA invited

11:40
Coffee Break, Poster Session & Exhibition

12:10
Advancements in ADC Manufacture and Control
Nathan Ihle, Seattle Genetics

12:40
Regulatory Requirements of Antibody-Drug Conjugates -A Chemical Perspective
Nynke Brouwer, CBG-MEB

13:10
Q&A, Panel Discussion

13:30
Lunch Break, Poster Session & Exhibition

Session 2: High Concentration Monoclonal Antibody Products

Moderator: Michael De Felippis, Eli Lilly

14:30
Physical Stability Considerations for High Concentration Formulations
Wolfgang Friess, University of Munich

15:00
Formulation and Dosage Form Design
Nagarajan Thyagarajapuram, Eli Lilly

15:30
SC Products and Enzyme Co-Formulation
Claudia Mueller, Roche / Genentech

16:00
Coffee Break, Poster Session & Exhibition

16:30
Delivery System Design
Susanne Joerg, Lonza

17:00
Primary Packaging Interactions & Delivery Systems
Julian Jazayeri, Amgen
Jean-Christophe Veilleux, California Institute of Technology

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

4 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 30 July 2017
1,345 Euro

After 30 July 2017
1.495 Euro

Nonmember

By 30 July 2017
1.645 Euro

After 30 July 2017
1.795 Euro

Govern./Health Authority/Academic

By 30 July 2017
670 Euro

After 30 July 2017
750 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

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

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 

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3362
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