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11th Workshop on Monoclonal Antibodies

Nov 27 - Nov 28, 2018
Seville, Spain

Applications of Prior Knowledge to Monoclonal Antibody Discovery, Development and Commercialization

  • Conference
  • Europe

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Program Highlights

This year, the conference will be part of the PDA Europe Exchange Series and held in parallel to the Pharmaceutical Freeze Drying Technology Conference. 

Speakers from International Regulatory Agencies will be presenting on site and available for Q&A and discussions!

  1. US:FDA
  2. Europe: EDQM
  3. Germany: Paul-Ehrlich-Institut
  4. The Netherlands: Medicines Evaluation Board
  5. Spain: AEMPS
  6. UK: NIBSC/MHRA

Make sure to take advantage of this 2-for-1 Exchange Series Event and review both conference agendas in the download brochure!

 
Call for Abstracts

Overview

Dear Colleagues,

On behalf of the program planning committee and PDA, we are pleased to invite you to attend the 2018 PDA Europe 11th Workshop on Monoclonal Antibodies, to be held 27-28 November 2018 in Seville, Spain.

Since the first licensed product in 1986, monoclonal antibodies have dominated the field of biopharmaceuticals with more than 70 approved products and hundreds more currently undergoing clinical evaluation for a variety of diseases.  Market evaluations for monoclonal antibodies predict no decline in interest for many years to come. 

The knowledge gained over decades of discovery research, development and manufacturing has enabled tremendous advancements in the commercialization of therapeutic monoclonal antibodies. In addition to fully human and humanized monoclonal antibodies, new related modalities have been introduced such as antibody fragments, Fc-fusions, bi-specifics and antibody drug conjugates all aimed at improving pharmacological properties.   Technology improvements in expression systems, cell culture and downstream purification have increased efficiency and productivity. The ability to apply common unit operations across multiple monoclonal antibodies has allowed manufacturers to develop platform processes and in turn accumulate substantial knowledge applicable to future molecules in their portfolios.  Many companies are now adopting continuous manufacturing approaches to further streamline production and reduce operating expenses.

The regulatory environment has kept pace with these achievements by supporting innovation and ensuring patient access to novel monoclonal antibody products. Various guidance documents have been published outlining regulatory expectations. In addition, regulatory frameworks have been established to enable the commercialization of biosimilar monoclonal antibody products.

With so much accumulated knowledge related to monoclonal antibodies, the focus is now on how best to make use of all the information.  The term Prior Knowledge is applied to describe this wealth of information and the subject is a hot topic amongst industry and regulators.  For this reason, the program planning committee selected Prior Knowledge as the theme for this year’s workshop.  Objectives for the workshop are to answer key questions on how product and process knowledge is being captured and transferred, and more importantly, how is the knowledge being utilized to drive continuous improvements and sustain further advancements for this therapeutic class.

The workshop program consists of sessions covering a variety of topics related to Prior Knowledge from research, development, manufacturing and regulation.  Through presentations, case studies and panel discussions, workshop participants will learn the latest trends in the application of Prior Knowledge to monoclonal antibodies.  In addition to the planned sessions, the program will provide abundant opportunities for networking and exchange of ideas with regulators and industry leaders.  We look forward to welcoming you at the workshop in Spain!

Sincerely,
The Co-Chairs,

Michael de Felippis, PhD., Eli Lilly, Chair
Martijn van de Plas, PhD., Medicines Evaluation Board, Chair

Agenda

  • Tuesday, 27 November 2018

    9:00
    Welcome: Opening Remarks & Introductions
    Falk Klar, PDA Europe
    Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
    Michael De Felippis, Workshop Chair,Eli Lilly

    09:15 - 09:45
    Keynote: Regulatory Perspective on Prior Knowledge
    Martijn van der Plas, Medicines Evaluation Board

    09:45 - 12:45
    Session 1: Regulatory Updates
    Moderator: Martijn van der Plas, Medicines Evaluation Board

    09:45
    Microbial Control Strategies in the Manufacturing of Monoclonal Antibodies: Lessons Learned and Moving Forward
    Patricia Hughes, US FDA

    10:15
    Regulatory Updates on Biological Medicinal Products
    David Pérez Caballero, AEMPS

    10:45 – 11:15
    Coffee Break, Poster Session & Exhibition

    11:15
    The European Pharmacopoeia Approach to Monoclonal Antibodies
    Emmanuelle Charton, EDQM

    11:45
    Industry Perspective on Product Specific Monographs
    Barry Cherney, Amgen

    12:15
    Panel Discussion with Regulatory Representatives
    David Pérez Caballero, AEMPSr
    Patricia Hughes, US FDA
    Emmanuelle Charton, EDQM
    Mihaela Buda, EDQM
    Steffen Groß, Paul-Ehrlich-Institut
    Martijn van der Plas, Medicines Evaluation Board
    Barry Cherney, Amgen

    12:45 – 13:45
    Lunch Break, Poster Session & Exhibition

    13:45 – 15:30
    Session 2: Bioassays – Trends, Development and Expectations
    Moderator: Mihaela Buda, EDQM

    13:45
    Regulatory Perspective on Bioassays
    Mihaela Buda, EDQM

    14:15
    International Standards for Bioassay Calibration
    Sandra Prior, NIBSC Speaker

    14:45
    Stability Indication of Bioassays
    Gael Debauve, UCB Speaker

    15:15
    Q&A, Discussion

    15:30 – 16:00
    Coffee Break, Poster Session & Exhibition

    16:00 – 18:00
    Session 3: Drug Products, Formulation and Delivery
    Moderator: Susanne Joerg, LONZA

    16:00
    Challenges of Low Dose Administration MABEL Dosing Approaches)
    Monika Geiger, LONZA

    16:30
    A QbD Approach to Formulation Robustness
    Christine Wurth, Roche

    17:00
    Innovation Drug Delivery Systems for Biopharmaceuticals
    Thomas Schönknecht, SHL Group

    17:30
    Panel Discussion

    18:00
    End of Conference Day 1

    18:30
    Networking Event

    Wednesday, 28 November 2018

    9:00
    Welcome
    Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
    Michael De Felippis, Workshop Chair,Eli Lilly

    09:05 – 10:30
    Session 4: Process Development and Manufacturing
    Moderator: Brian Mullan, Novartis

    09:05
    A Systematic Approach to Control System Updates of Established Products
    Jan Pollmann, Roche

    09:30
    Manufacturing a Therapeutic Fab for High Concentrations - Filtration and Viscosity Challenges
    Marc Pompiati, Roche

    09:55
    Application of ‘-Omics’ Technologies in MAbs Manufacturing
    Niall Barron, University College Dublin

    10:20
    Q&A, Discussion

    10:30 – 11:00
    Coffee Break, Poster Session & Exhibition

    11:00 – 13:00
    Session 5: Control Strategies
    Moderator: Michael De Felippis, Eli Lilly

    11:00
    Use of Prior Knowledge in Establishing Control Strategies
    Barbara Rellahan, Amgen

    11:30
    Leveraging the Learnings of 10 Years of Developing Control Strategies Post ICH Q8 Part II
    Felix Kepert, Roche

    12:00
    Application of Prior Knowledge to Drug Substance Process Development
    Theresa Ahern, Eli Lilly

    12:30
    Q&A, Discussion

    13:00 – 14:00
    Lunch Break, Poster Session & Exhibition

    14:00 - 15:00
    Session 6: Post-Approval Life Cycle Management
    Moderator: Juan Gimenez, Genentech/Roche

    14:00
    Can ICH Q12 Unlock Manufacturing Innovation?
    Ursula Busse, Novartis

    14:25
    QRM Application to Biopharma Operations in the Q12 Era
    Jose Menezes, 4Tune Engineering

    14:50
    Q&A, Discussion

    p>15:00 – 15:30
    Coffee Break, Poster Session & Exhibition

     

    15:30 – 16:30
    Closing Plenary: Biosimilar Variations & Biosimilar Product Development
    Moderator: Steffen Gross, Paul-Ehrlich-Institut

    15:30
    Biosimilar Development
    Michelle Frazier, Coherus BioScience

    15:55
    Structure-function Relationships for GP2015/Erelzi
    Robert Mayer, Novartis

    16:20
    Q&A, Discussion

    16:30
    End of Conference and Farewell
    Falk Klar, PDA Europe
    Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
    Michael De Felippis, Workshop Chair,Eli Lilly

Additional Information

  • Call for Abstracts

    Call for Abstracts is Closed! Thank you!

    Download Call for Papers

    Call for Papers/Abstracts is available now.

    Download

    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • 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:

    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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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.

MELIÁ SEVILLA

Calle Dr. Pedro de Castro 1
Seville, Spain

How to Get Here

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By Car

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Directions

Registration Fees

Regular Price

3 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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 14 October 2018
1.395 Euro

After 14 October 2018
1.595 Euro

Nonmember

By 14 October 2018
1.695 Euro

After 14 October 2018
1.895 Euro

Govern./Health Authority/Academic

By 14 October 2018
700 Euro

After 14 October 2018
800 Euro

All fees given in Euro and excluding VAT (21%)

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.

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