2021 PDA Virus Conference

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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!

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!


The Chairs

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


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

More information coming soon.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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.

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.

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. 

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

Day 2

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.  

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. 

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.

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

Agenda is subject to change.

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