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2022 VirusConf-1988x680

2022 PDA Virus Conference

Jun 20 - Jun 21, 2022
Brussels, Belgium

Changing Landscape of Viral Safety - Existing and Advanced Technologies

  • Conference
  • Europe

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Program Highlights

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Meet old friends and gain new ones at the long-awaited return of this popular conference to the in-person format in beautiful Belgium!

Join us for this onsite event to take place just prior to the 2022 PDA Advanced Therapy Medicinal Products Conference!

Overview

Dear Colleagues,

A very warm welcome on behalf of the Scientific Program Planning Committee and PDA.  We are pleased to invite you to join us for the 10th edition of the 2022 PDA Virus Conference to take place as a face-to-face event on 20-21 June 2022 in Brussels/Belgium.

This global meeting is organized in close collaboration with an excellent Scientific Program Planning Committee which includes European and U.S. FDA regulators, industry experts, supplier specialists, and dedicated PDA Europe support.

The overall program is designed to provide an update on regulatory expectations and the scientific framework around the virus safety of plasma-derived and biotechnology medicinal products, as well as the particularly innovative cell- and gene-therapies. 

Similar to earlier events in this long-standing series, current and newly emerging viral threats, viral safety considerations around the selection of low risk starting materials, virus detection and identification methods and strategies, and the design and validation of virus inactivation and removal process will be key topics for discussion. In addition, intensified continuous manufacturing processes and their potential impact on facility design and viral safety will also be considered.

After a sequence of online-only events, forced by the emergence of SARS-CoV-2, the 2022 PDA Virus Conference will provide attendees the unique opportunity to re-gather for interactive discussions and benchmarking, as well as to reinvigorate social interactions. A discussion forum that allows for the direct interaction between industry and regulators will continue to support the wider industry and improve the current understanding and acceptance of new technologies, highlight new and emerging viral risks and explain novel regulatory approaches. 

Panel discussions and ample networking opportunities will complement an impressive scientific program and make it a worthwhile and well-rounded experience for you.

We look forward to meeting you in person in Brussels! 

Sincerely,

The Chairs

Alison Armstrong, Merck KGaA,
Thomas Kreil, Takeda

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Alison Armstrong, Merck KGaA, Chair
  • Thomas R. Kreil, Takeda, Chair
  • Andy Bailey, ViruSure
  • Johannes Blümel, Paul-Ehrlich-Institut
  • Qi Chen, Genentech/Roche
  • Arifa S. Khan, U.S. FDA
  • Sean O’Donnell, Eli Lilly & Company
  • Sebastian Teitz, Asahi Kasei
  • Josh Eaton, PDA
  • Falk Klar, PDA
  • Stefanie Nebelin, PDA, Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Sunday, 19 June

    Welcome Reception proudly brought to you by ViruSure
    19:00 – 21:00

    The Parenteral Drug Association and ViruSure are proud to invite you!
    Meeting Point: Exhibition Hall

    Monday, 20 June

    09:00

    Welcome and Introduction

    • Falk Klar, PDA Europe
    • Alison Armstrong, Merck KGaA
    • Thomas R. Kreil, Takeda

    09:20 I Keynote: New Methods to Ensure Virus Safety in the Production of Biologics
    David E Onions, Norcliffe Partners

    Opening Plenary: Updates from the Regulatory Landscape
    Moderator:
    Alison Armstrong, Merck KGaA, Co-Moderator: Thomas R. Kreil, Takeda

    09:45 I Update on the revision of Guideline ICHQ5A
    Johannes Bluemel, Paul-Ehrlich-Institut

    10:10 I Regulatory Update of Viral Safety
    Scott Lute, U.S. FDA

    10:35 I Q&A, Discussion

    11:05 - 11:35
    Coffee Break, Poster Session & Exhibition

    Session 1: Virus Filtration
    Moderator:
    Sean O'Donnell, Eli Lilly

    11:35 I Visualizing Protein Fouling and its Impact on Parvovirus
    Retention Within Distinct Filter Membrane Morphologies
    Remo Leisi, CSL Behring

    12:00 I A New Reliable Approach to Viral Clearance Study Design from the Amount of Virus Load
    Tomoko Hongo, Asahi-Kasei

    12:25 I Q&A, Discussion

    12:55 - 13:55
    Lunch Break, Poster Session & Exhibition

    Session 2: Preparedness of Biotechnology Industry against Pandemics
    Moderator:
    Johannes Bluemel, Paul-Ehrlich-Institut

    13:55 I Zoonotic Viruses and Humans: Emerging, Pandemic, and Seasonal Patterns of Circulation
    Thomas R. Kreil, Takeda

    14:20 I Dual Sourcing of Raw Materials during the Pandemic
    John Fisher, Genentech/Roche

    14:45 I Q&A, Discussion

    15:15 - 15:45
    Coffee Break, Poster Session & Exhibition

    Session 3: Next Generation Sequencing (NGS) and Virus Detection  
    Moderator:
    Jean-Pol Cassart, GSK

    15:45 I Identification of an Epizootic Hemorrhagic Disease Virus (EHDV) Contamination Event in a Biopharmaceutical Product using a Combination of Adventitious agent Testing and Next Generation Sequencing
    Andy Bailey, ViruSure

    16:10 I Use of Next Generation Sequencing Technology for Broad Virus Screening in Biologically Derived Samples: A Case Study with SARS-CoV-2 Challenge Virus
    Bradley Hasson, Merck KGaA

    16:35 I NGS Contribution to Virus Discovery:
    Bat Coronaviruses related to SARS-CoV-2 and Infectious for Human Cells
    Marc Eloit, Institut Pasteur

    17:00 I Q&A, Discussion

    17:30 | End of Conference Day 1 and Networking Event

  • Tuesday, 21 June

    08:00

    Welcome to Day 2

    • Alison Armstrong, Merck KGaA
    • Thomas R. Kreil, Takeda

    Interest Group Morning Session: Advanced Virus Detection Technologies Interest Group (AVDTIG) Session
    Moderator:
    Arifa Khan, U.S. FDA

    08:00 I Updates on Next Generation Sequencing Activities and Achievements
    Jean-Pol Cassart, GSK

    Session 4: Viral Inactivation
    Moderator:
    Andy Bailey, ViruSure

    09:00 I Detergent-based Virus Inactivation: Development and Evaluation of an Alternative for Triton X-100
    Johanna Kindermann, Takeda

    09:20 I Identification of an Environmentally friendly Detergent as a Replacement for Triton X-100 in Virus Inactivation
    Sean O'Donnell, Eli Lilly

    09:40 I Transitioning Low pH Mediated Viral Inactivation in Bioprocessing from Batch to Continuous Mode
    Corinne Miller, MilliporeSigma

    10:00 I Q&A, Discussion

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

    Session 5: Viral Clearance
    Moderator:
    Sebastian Teitz, Asahi Kasei

    11:00 I A Database for Virus Clearance Data for Improved Virus Validation Programs
    Moritz Bennecke, Genentech

    11:20 I Efficient Hepatitis E Virus (HEV) Production in Tissue Culture and its Application in Inactivation studies
    Daniel Todt, Ruhr Uni Bochum

    11:40 I Characterizing a Novel Parameter Affecting Low pH Viral Inactivation
    Jena Daya, Regeneron

    12:10 I Q&A, Discussion

    12:40 - 13:40
    Lunch Break, Poster Session & Exhibition

    Closing Plenary: Industry Forums
    Moderator
    : Alison Armstrong, Merck KGaACo-Moderator: Thomas R. Kreil, Takeda

    13:40 I Interactive Questionnaire

    13:50 I Update on PDA's Technical Report #41 on Virus Filtration
    Sebastian Teitz, Asahi Kasei

    14:05 - 14:35
    Coffee Break, Poster Session & Exhibition

    14:35 I Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility  
    Paul Barone, Massachusetts Institute of Technology

    15:00 I Closing Panel Discussion with Regulatory and Industry Speakers

    15:45 I Conference Summary by the Chairs
    Alison Armstrong, Merck KGaA
    Thomas R. Kreil, Takeda

    16:00 I Closing Remarks & Farewell
    Falk Klar, PDA Europe

    16:10 I| End of Conference

    Agenda is subject to change without notice, Speakers are invited, pending confirmation

Highlighted Speakers

Johannes Blümel
Johannes Blümel
Paul-Ehrlich-Institut
Jean-Pol Cassart
Jean-Pol Cassart
GlaxoSmithKline Vaccines
Jena Daya
Jena Daya
Regeneron
Tomoko Hongo
Tomoko Hongo
Asahi Kasei
Thomas R. Kreil
Thomas R. Kreil
Takeda
Scott Lute
Scott Lute
Food and Drug Administration
Corinne Miller
Corinne Miller
MilliporeSigma
Daniel Todt
Daniel Todt
Ruhr University Bochum

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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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.

Tangla Hotel Brussels

Avenue Emmanuel Mounier 5
Brussels, Belgium

Make a Reservation
Tangla Hotel Brussels
  • Accommodations

    Tangla Hotel Brussels
    Avenue Emmanuel Mounier 5
    1200 Brussels
    Belgium
    Tel: +32 2775 2508

    Single Room € 160 per night*
    Double Room upon request*

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

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    PDA Europe has reserved a limited number of rooms until 01 May 2022. 

    The PDA block of rooms are available on a first come basis and must be secured by the deadline included above to receive the PDA rate. After this date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    The Tangla Hotel Brussels is located in Sint-Lambrechts-Woluwe, a neighbourhood in Brussels, and is near the airport and near the boardwalk.

How to Get Here

By Air

The main airports for Brussels are Brussels Zaventem Airport (BRU) and Brussels South Charleroi (CRL). Tangla Hotel Brussels Airport shuttle : 10 € per traveler upon reservation only from Monday through Friday.

By Car

Tangla Hotel Brussels can easily be reached by car. When calculating your commuting time, take into account that there are roadworks on the Nearby Woluwesteenweg that can cause slightly heavier traffic during rush hours. Take the highway E 40 (Brussels-Liège), take Exit 20 Kraainem and follow the signs for "UCL - St-Luc" or take the ring Road, Exit 2 "Wezembeek-Oppem" and follow signs for "UCL – St Luc/ Tangla Hotel Brussels". The hotel is opposite the windmill you encounter.

Other Options

Walking distance from metro station to hotel : 7 minutes. Nearest station: Alma

Directions

Registration Fees

Early Registration
Registration Type Price by 24 April 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Early Career Professional (Member) €845

Regular Registration
Registration Type Price after 24 April 2022
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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