Skip To The Main Content
2021 VirusConference-1988x680

2021 PDA Virus Conference

Acceleration of Biotechnology and Applications Due to Pandemic Pressure

Jun 21 - Jun 22, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe
Program Highlights

Join us for the 2021 PDA Virus Conference to be held on 21-22 June as an Online Event!

We are proud to welcome regulatory representatives from EDQM, U.S. FDA, Paul-Ehrlich-Institut along with a distiguished panel of industry experts and academia.

This event will be immediately followed by the 2021 PDA Advanced Therapy Medicinal Products Conference, package offers are available!

Overview

Dear Colleagues,

We would like to warmly invite you to join us for the 2021 PDA Virus Conference!

Given the (virus-caused!) current circumstances and difficulties of long-term planning, the conference will take place as a Virtual Event, facilitated by an online platform that will allow for remote participation and presentation!

These truly global meetings are organized by PDA, in close collaboration with an excellent scientific organizing committee which includes members of European regulatory agencies as well as the U.S. FDA. The program is designed to provide an overview and updates on regulatory expectations and scientific matters related to virus and TSE safety of biotechnology, plasma-derived and cell- and gene-therapy medicinal products.

As in previous years, current and emerging viral threats, viral safety considerations around the selection of raw and starting materials, virus detection and identification methods and strategies, and the design and validation of virus inactivation and removal process will be discussed.

The PDA Europe Virus Conference reliably provides attendees a unique opportunity for interactive discussion and benchmarking. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain novel regulatory approaches.

Panel discussions and ample networking options will complete an impressive program and make it into a worthwhile and well-rounded learning experience for you!

We warmly invite you to join us online next summer!

Sincerely,

The Chairs

Johannes Blümel, PhD, Paul-Ehrlich-Institut
Thomas R. Kreil, PhD, Takeda

SCIENTIFIC PROGRAM PLANNING COMMITTEE

Johannes Blümel, Paul-Ehrlich-Institut, Chair
Thomas R. Kreil, Takeda, Chair
Alison Armstrong, Merck KGaA
Andy Bailey, Virusure
Qi Chen, Genentech/Roche
Houman Dehghani, Allogene Therapeutics
Arifa S. Khan, US FDA
Mehran Rafigh, Sartorius Stedim Biotech
Sebastian Teitz, Asahi Kasei
Sean O’Donnell, Eli Lilly & Company
Josh Eaton, PDA
Falk Klar, PDA Europe
Teresa Schubach, PDA Europe, Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Monday, 21 June 2021

    Module I: Opening & Regulatory Updates
    12:00-14:00 CEST

    11:00 - 12:00 CEST - Conference Platform Opens: Set up Your Profile, Enjoy the Exhibition & Poster Session
    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs Johannes Blümel, Paul-Ehrlich-Institut
    Thomas Kreil, Takeda
    Luck is Not a Strategy: Emerging Viruses, and What Should be Learned from SARS-CoV-2 Thomas Kreil, Takeda

    Regulatory Updates
    The first version of ICH Q5A was published in 1997 to regulate the Viral Safety Evaluation of Biotechnology
    Products Derived from Cell Lines of Human or Animal Origin, then with a focus on interferons, monoclonal antibodies and recombinant DNA-derived products. A quarter of a century later, cell- and gene-based products, i.e. advanced therapies, now hold the promise of transforming medical practices, potentially offering cure rather treatment of medical conditions. The regulatory framework to support making theses advancements of biomedical research available to patients at adequate virus safety margins will be discussed.

    Moderators: 
    Johannes Blümel, Paul-Ehrlich-Institut
    Thomas Kreil, Takeda
    Updates on the Revision of ICH Q5A Johannes Blümel, Paul-Ehrlich-Institut
    Updates on the Recent OTAT Guidance Ramjay Vatsan, U.S. FDA
    The Approach of the European Pharmacopoeia to Adventitious Agents Testing Gwenael Cirefice & 
    Laurent Mallet, EDQM
    LIVE Panel Discussion, Q&A Johannes Blümel, Paul-Ehrlich Institut
    Thomas R. Kreil, Takeda
    Gwenael Ciréfice, EDQM
    Laurent Mallet, EDQM
    Ramjay Vatsan, U.S. FDA
    Stefan Hepbildikler, Roche 
    Marie Murphy, Eli Lilly & Company

    Break and Virtual Exhibition
    14:00-15:00 CEST

    Module II: Applications of Next Generation Sequencing, New Technologies, and Virus Detection
    15:00-16:30 CEST

    Applications of Next Generation Sequencing, New Technologies, and Virus Detection
    Adventitious viral contaminants are a major safety concern for biopharmaceutical manufactures; therefore, biopharmaceutical products undergo extensive adventitious agent testing to ensure that they are free of viral contamination. Traditional adventitious viral testing involves the use of cell culture or animals to detect viral contamination.  More recently, molecular techniques have been developed to detect adventitious virus yielding faster turnaround times and broader viral detection than the traditional methods.  In this session we will hear about molecular techniques such as next generation sequencing, and their potential to replace or supplement traditional adventitious virus tests.

    Moderators:
    Sean O’Donnell, Eli Lilly & Company
    Arifa Khan, U.S. FDA

    A Collaborative Spiking Study Using Model Viruses for Assessing HTS for Broad Adventitious Virus Detection in a Viral Vaccine Seed
    Siemon Ng, Sanofi Pasteur
    NGS for Adventitious Agent Detection: Analysis Options and Consequences Devon Ryan, Genedata
    Evaluation of RNA Next-Generation Sequencing (Transcriptomics Analysis) to Replace In-Vivo Tests for Assessing the Viral Safety of Cells Marc Eloit, Pathoquest
    Horst Ruppach, Charles River
    Novel Approaches to Degenerate PCR to Minimize Viral Risk Mitigation in Biologics Products Alison Armstrong, Merck KGaA

    LIVE Q&A, Discussion

    Break & Virtual Exhibition
    16:30 - 17:00 CEST

    Module III: Advanced Virus Detection Interest Group Session
    17:00-18:00 CEST

    Advanced Virus Detection Interest Group (AVDTIG) Session
    The AVDTIG is an international effort focused on standards and standardization of next generation sequencing technologies for adventitious virus detection in biologics. The group has scientific discussions and collaborations to address technical and bioinformatics challenges in the NGS workflow, with the goal of facilitating broad applications of NGS for viral safety.  The session will include brief presentations on the background, ongoing activities, and achievements of the IG, and the status of ongoing collaborative studies for evaluating virus detection using NGS. The session will close with a member panel for audience Q&A and discussion. 

    Moderators:
    Arifa Khan, U.S. FDA
    Jean-Pol Cassart, GSK Vaccines

    Welcome and Introductions Arifa Khan, U.S. FDA
    Interest Group Background and Activities Jean-Pol CassartGSK Vaccines
    Updates on Collaborative Studies  Maria Bednar, Biogen
    Siemon Ng, Sanofi Pasteur
    Noemie Deneyer, GSK
    Alessia Bachmann, Merck KGaA

    LIVE Group Discussion, Q&A

    Arifa Khan, U.S. FDA 
    Jean-Pol Cassart, GSK Vaccines
    Maria Bednar, Biogen
    Siemon Ng, Sanofi Pasteur
    Noemie Deneyer, GSK
    Alessia Bachmann, Merck KGaA
    Simone Oligiati, Merck KGaA

    LIVE Interactive Poster Lounge
    18:00 - 19:30 CEST

    Engage in a live Q&A opportunity with our Poster Presenters in a separate video chat room!


    Alternative Detergent Viral Inactivation –
    Julia Bach, Amgen 

    Implementation of Virus Filtration Unit Operations and Evaluation of Viral Clearance Under Challenging Process Conditions –
    Alexander Schwartz, Sartorius Stedim

    Advancing Bioprocess Operations from Pressure to Pump: Scalability of Pump-Based Virus Filtration –
    Daniel Strauss, Asahi Kasei

    A Non-Redundant, Reference Virus Database (RVDB) for Adventitious Virus Detection in Biologics using High-Throughput Sequencing (HTS) Technologies -
    Pei-Ju Chin, U.S. FDA

    Chromatography Based Purification of Retrovirus Spikes –
    Rahul Fadnis, Syngene International Limited

    Agenda subject to change without notice

  • Tuesday, 22 June 2021

    Module IV: Viral Inactivation & Removal
    12:00-13:45 CEST

    11:00 - 12:00 CEST - Conference Platform Opens: Enjoy the Exhibition & Poster Session

    Viral Inactivation & Removal
    Virus clearance remains one of the key pillars supporting the virus safety of biological products. There is much we are still learning about what constitutes a robust virus removal or inactivation step. In this session we will gain insights into one of the key steps, virus filtration, both from a regulatory as well as a mechanistic perspective. Much can also be gleaned from data mining, and the FDA Office of Biotechnology Products database provides a unique insight into which steps have demonstrated robust and effective clearance over a wide range of products. Additional mechanistic insights into the partitioning of viruses over anion exchange chromatography can help in optimizing specific chromatography steps for the effective removal of even parvoviruses.  

    Moderators: 
    Andy Bailey, ViruSure
    Mehran Rafigh, Sartorius Stedim
    2021 Retrospective Analysis of the OBP Viral Clearance Database
    Scott Lute, U.S. FDA
    Impact of the Isoelectric Point of Model Parvoviruses on Viral Retention in Anion Exchange Chromatography Eleonora Widmer, CSL Behring
    Mechanistic Insights into Flow-Dependent Virus Retention in Different Nanofilter Membranes Remo Leisi, University of Bern/CSL Behring
    Predicting Viral Clearance using BSL-1 Mock Virus Particle Surrogates: Concept and Utilization for Biopharmaceutical Applications David Cetlin, Cygnus Technologies

    LIVE Q&A, Discussion

    Break and Virtual Exhibition
    13:45-14:45 CEST

    Module V: Considerations on Continuous Processing and Facility Design
    14:45-16:00 CEST

    Considerations on Continuous Processing and Facility Design
    Continuous processes offer the potential to transform the manufacture of biotherapeutic products through improvements to efficiency, cost and quality. Likewise, recent considerations to facility design, some including continuous manufacturing concepts, propose similar benefits to availability and quality of biopharmaceuticals.  This session reflects on challenges such as small-scale validation, explores unique risk profiles of the presented facility designs and looks into the use of modular and prefabricated manufacturing environments. 

    Moderators:
    Alison Armstrong, Merck KGaA
    Sebastian Teitz, Asahi Kasei

    Case Study: A Holistic Approach to Virus Risk Assessment and Controls in a DS SUT Ballroom Facility John Fisher, Genentech
    Rapid Delivery of a Modular Prefabricated Facility for COVID Vaccine Manufacturing Dennis Powers, G-Con Manufacturing
    Virus Filtration Today: Applying Scientific Understanding to Advance New Guidelines and Processes Sebastian Teitz, Asahi Kasei

    LIVE Q&A, Discussion

    Break & Virtual Exhibition
    16:00-16:30 CEST

    Module VI: Learnings from the Pandemic for Viral Safety & Closing
    16:30-18:30 CEST

    Learnings from the Pandemic for Viral Safety
    The SARS -CoV-2 pandemic showed how important it is to have safety barriers in place, up-front before a new virus emerges.  In this session we will learn how sate of the art technologies including next generation sequencing and in-depth experience with plasma proteins has assisted the pharmaceutical industry in ensuring viral safety of biological medicinal products as well as rapidly developing active and passive immunization.

    Moderators:
    Johannes Blümel, Paul-Ehrlich-Institut
    Andy Bailey, ViruSure

    SARS-CoV-2 and the Safety of Plasma-Derived and Cell-Based Medicinal Products Jens Modrof, Takeda
    A Metagenomic Analysis to Further Inform the Viral Risk Assessment for Rapid Development of a Candidate COVID-19 Vaccine Vanessa Sarathy, MSD
    Development of Antibody-based COVID-19 Treatment Options Maria Farcet and Michael Karbiener, Takeda
    SARS-CoV-2: The Virus that Changed the Way the World Looked at QC Testing Sarah Sheridan, Merck KGaA

    LIVE Panel Discussion, Q&A

    Johannes Blümel, Paul-Ehrlich-Institut
    Andy Bailey, ViruSure
    Jens Modrof, Takeda
    Vanessa Sarathy, MSD
    Maria Farcet, Takeda
    Michael Karbiener, Takeda
    Sarah Sheridan, Merck KGaA
    Paul Barone, Massachusetts Institute of Technology
    Conference Summaries by the Chairs

    Johannes Blümel, Paul-Ehrlich Institut
    Thomas R. Kreil, Takeda

    Closing Remarks & Farewell Falk Klar, PDA Europe 

    Agenda subject to change without notice

Registration Fees

Register Now
Registration Type Price after 25 APR 2021
Member €1.595
Non-Member €1.895
Govern./Health Authority/Academic/
Young Professional (Member)
€600


Package Prices to book both the Virus and ATMPs Conference

Registration Type Price after 25 APR 2021
Member €2.690
Non-Member €2.990
Govern./Health Authority/Academic
Young Professional (Member)
€1.140

All fees given in Euro, excluding VAT – please contact [email protected] to register for the package offer.

Got a Question? We have answers

Contact Us
Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially