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10th Workshop on Monoclonal Antibodies - PDA Exchange

Sep 26 - Sep 27, 2017
Berlin, Germany

  • Conference
  • Europe
Closed
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.

Got a Question? We have answers

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Travel

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

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

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

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

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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