PDA Virus Conference 2024

Viral Safety Reloaded - the Finalized ICH Q5A (R2)

Amsterdam, The Netherlands
Ask a Question Exhibitor Standard Contract Clause
Program Highlights

The agenda is out now!

Related PDA Letter Article: Seven Key Takeaways from PDA’s Viral Safety for ATMPs Workshop and Virus Conference Events authored by our Committee Member, Sebastian Teitz, Consultant.

Dear Colleague,

We would like to welcome you to join the PDA Virus Conference 2024  to be held on 26-27 June 2024 in Amsterdam, The Netherlands.

The Implementation of the newly published ICH Q5A into practice is a topic that all of the biopharmaceutical industry is eagerly discussing.  Four main areas have been significantly updated in the new revision which has a major impact on the viral safety strategies for biological products. The revision expands the possibility of using prior knowledge for validation of viral clearance. The scope of the new ICH Q5A has been extended to cover new, advanced therapy, product types such as certain viral vectors (along with their helper viruses used at vector production). The implementation of virus safety principles in continuous manufacturing processes highlights a number of unique challenges which are discussed in new chapters of the guideline. One of the most significant changes in the new revision is the acknowledgment and implementation of advanced technologies such as next-generation sequencing and PCR for virus detection and the potential use of these technologies for replacing commonly used in vivo and in vitro adventitious agent tests.

We are excited to announce that this year's opening plenary talk will include a patient perspective.

Check out the agenda which is intended to initiate and support discussion and professional exchange through the diversity of scientific presentations. Meet exhibitors, listen to poster sessions, and enjoy a lot of networking opportunities.

Join us in Amsterdam to listen to different talks and discuss challenges with our experts.

Sincerely,

The Co-Chairs

Andy Bailey, ViruSure
Sean O’Donnell, Eli Lilly and Company

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Andy Bailey, ViruSure
  • Sean O’Donnell, Eli Lilly and Company
  • Alison Armstrong, Merck KGaA
  • Chakameh Azimpour, Capsida
  • Johannes Blümel, Paul-Ehrlich-Institut
  • David Cetlin, Cygnus
  • Qi Chen, Genentech/Roche
  • Tomoko Hongo-Hirasaki, Asahi Kasei
  • Arifa Khan, U.S. FDA
  • Thomas R. Kreil, Takeda
  • Remo Leisi, CSL Behring
  • Simone Olgiati, Merck
  • Sebastian Teitz, Consultant
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
Featured Sponsors
Become a Sponsor

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

Request Information
Featured Exhibitors
Become an Exhibitor

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

Request Information

Standard Registration

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

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.

Wednesday, 26 June CEST

  • Registration Open

  • Welcome and Introduction

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

  • Welcome from the Co-Chairs

    • Co-Chair: Andy Bailey, PhD, CEO, ViruSure GmbH

    • Co-Chair: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

  • Opening Plenary: ICH Q5A (R2) and the Importance of Viral Safety to the Patient

    • Moderator: Andy Bailey, PhD, CEO, ViruSure GmbH

    Patient safety and eliminating the risk of virus contamination in biologics is at the heart of all regulations relating to virus safety. Understanding the patient perspective and the impact that these life-saving products have on patient quality of life reinforces the importance of guidelines like the ICH Q5A, as well as others relating to virus safety. The presentations in this opening plenary session set the stage for this year’s PDA Virus Conference by reinforcing the importance to the industry of having a well-balanced guideline addressing the key concepts for assuring virus safety.
    • A Patient Perspective: The Path to Resilience: Finding Confidence in Yourself and Managing Your Condition

      • Keynote Speaker: Rick S., Patient Advovate, CSL Behring

    • Updates on ICH Q5A (R2)

      • Regulatory Presenter: Johannes Bluemel, PhD, Head of Virus Safety Section, Paul-Ehrlich-Institut

    • Plenary Discussion

      • Moderator: Andy Bailey, PhD, CEO, ViruSure GmbH

      • Regulatory Panelist: Johannes Bluemel, PhD, Head of Virus Safety Section, Paul-Ehrlich-Institut

      • Panelist: Rick S., Patient Advovate, CSL Behring

      • Regulatory Panelist: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 1: Viral Safety of Advanced Therapies

    • Moderator: Alison Armstrong, PhD, Senior Director, Global Head Scientific and Regulatory Consultancy , Merck KgAG

    With the advance of treatments for novel therapies, the impact on virus safety remains a core consideration. Gene therapy delivery systems have shown great promise and this session, with strong reference to adenovirus-associated virus (AAV) products, will examine platform manufacturing processes that focus on safety in upstream and downstream parameters. Also testing capabilities for the detection of replication-competent virus, again showcasing AAV, have been complex and challenging, and proposed solutions will be provided. The introduction of molecular-based technologies in viral safety testing, and long-read nanopore Next Generation Sequencing ( NGS) used for the characterization of critical quality attributes for rAAV products will also be discussed.
    • Viral Safety Strategy for Adeno-Associated Virus Gene Therapy Products

      • Presenter: Nicholas DiGioia, Associate Director, CMC Leadership, Alexion/Astrazeneca Rare Disease

    • The Design, Development, and Validation of Platform Methodology for Replication Competent Adeno Associated Virus

      • Presenter: Amy Bennett, MS, Manager of Virology Scientific Support Services, Charles River Laboratories

    • Harnessing Next-Generation Long-Read Nanopore Sequencing for Critical Quality Attribute Testing of rAAV Products in a GMP Environment

      • Presenter: David R. Van Houte, PhD, Manager - QC Virology, Regeneron Pharmaceuticals

    • Q&A, Discussion

      • Moderator: Alison Armstrong, PhD, Senior Director, Global Head Scientific and Regulatory Consultancy , Merck KgAG

      • Panelist: Amy Bennett, MS, Manager of Virology Scientific Support Services, Charles River Laboratories

      • Panelist: Nicholas DiGioia, Associate Director, CMC Leadership, Alexion/Astrazeneca Rare Disease

      • Panelist: David R. Van Houte, PhD, Manager - QC Virology, Regeneron Pharmaceuticals

  • Networking Lunch Break & Exhibition

  • Guided Poster Walk

    • Moderator: Sebastian B. Teitz, PhD, Consultant, Consultant

  • Interactive Questionnaire Session

    • Moderator: David Cetlin, MS, Senior Director, R&D, Cygnus Technologies

  • Session 2: Virus Testing

    • Moderator: Thomas R. Kreil, PhD, Vice President, Global Pathogen Safety, Takeda

    Conceptually, the benefits of using agnostic and highly sensitive methods for the detection of adventitious viruses have been welcome for several years. Technical, quality-assurance and regulatory hurdles have, however, not led to broad implementation across the biotechnology industry. With recent changes in the regulatory landscape, this may now change, with the ultimate goal to replace technically outdated methods still widely in use and ultimately to improve the breadth of adventitious virus detection.
    • Temperature Check: Adoption and Challenges of NGS Implementation from the CRO Perspective

      • Presenter: Bradley Hasson, MBA, Director of Lab Operations for NGS, Merck KGaA

    • Approaches for Accelerated Adventitious Virus Testing and Follow-Up-Strategies for Rapid Differentiation of Replicating Viral Infections from Inert Viral Sequences in Viral Vector Vaccines and Raw Materials

    • Transcriptomic NGS assay of cells: detection range and sensibility for the 71 human, porcine, and bovine rodent viruses to be detected by the MAP/RAP/HAP, 9CFR, and PCR regulatory assays

      • Presenter: Marc Eloit, Prof DVM PhD, Founder and Scientific Advisor PathoQuest, PathoQuest

    • Q&A, Discussion

      • Moderator: Thomas R. Kreil, PhD, Vice President, Global Pathogen Safety, Takeda

      • Panelist: Oliver Klepsch

      • Panelist: Marc Eloit, Prof DVM PhD, Founder and Scientific Advisor PathoQuest, PathoQuest

      • Panelist: Bradley Hasson, MBA, Director of Lab Operations for NGS, Merck KGaA

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 3: Novel Approaches and Digitization

    • Moderator: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

    Artificial intelligence (AI), machine learning (ML), deep learning (DL), and robotics are the latest buzzwords being applied to biologics and emerging technologies. Computer-based strategies are being developed to overcome the challenges of intensive labor in big data analysis and human bias in the interpretation of results from biological assays. Presentations in this session will show the promise of a DL model for the detection of adventitious agents and automation of infectivity assays using AI. Additionally, the use of a virus-specific PCR assay to replace infectivity assays for rapid investigations of bioreactor contamination will be presented.
    • A Deep-Learning Classifier of Adventitious Agents

      • Presenter: Tom J.B de Man, MSc, Head of Omics and Machine Learning R&D, Merck KGaA

    • Automation of Virus Detection Assays Used in Virus Clearance Studies: From Liquid Handling to the Use of Machine-learning and Artificial Intelligence in Analyzing Cytopathic Effects

      • Presenter: Eleonora Widmer, PhD, MD, Executive Director Global Pathogen Safety, CSL Behring

    • Adventitious Agent Testing for MMV: How Much Do We Really Know?

      • Presenter: Maria R. Farcet, PhD, Director, Cell Culture, Virus Models & Serology, Global Pathogen Safety, Takeda

    • Q&A, Discussion

      • Moderator: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

      • Panelist: Tom J.B de Man, MSc, Head of Omics and Machine Learning R&D, Merck KGaA

      • Panelist: Eleonora Widmer, PhD, MD, Executive Director Global Pathogen Safety, CSL Behring

      • Panelist: Maria R. Farcet, PhD, Director, Cell Culture, Virus Models & Serology, Global Pathogen Safety, Takeda

  • End of Conference Day 1 & Networking Event

Thursday, 27 June CEST

  • Registration Open

  • Welcome to Day 2

    • Co-Chair: Andy Bailey, PhD, CEO, ViruSure GmbH

    • Co-Chair: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

  • Session 4: Virus Inactivation and Virus Removal

    • Moderator: Remo Leisi, PhD, Head of Breakthrough Technologies & Technical Innovation, Global Pathogen Safety, CSL

    • Moderator: Tomoko Hongo, PhD, Lead Expert, Bioprocess Division, Asahi Kasei Medical Co., Ltd.

    The incorporation of effective virus clearance steps represents a major pillar for ensuring virus safety of therapeutic products that are based on biologically derived materials. This session will discuss the application and contribution of virus inactivation and removal in various cases: Heat inactivation of Hepatitis E virus (HEV), which has emerged as a relevant concern for plasma-derived medicinal products; strategies for implementing effective virus filtration in continuous manufacturing; and safety considerations related to the use of animal materials in medical devices.
    • Viral Clearance Validation of Continuous Virus Filtration: Adapting Alternate Approaches to a New Manufacturing Paradigm

      • Presenter: Daniel Strauss, PhD, Director of Research and Development, Asahi Kasei Bioprocess America

    • Virus Safety of Medical Devices Utilizing Animal Materials

      • Presenter: Ursula Lauer, PhD, Senior Product Specialist, TÜV SÜD Product Service GmbH

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 5: Next Generation Sequencing

    • Moderator: Simone Olgiati, PhD, Head of Innovative Sequencing & Bioinformatics Group, Merck

    The updated ICH Q5A (R2) promotes the adoption of Next Generation Sequencing (NGS) technologies to either supplement or replace the traditional viral safety tests. This session will explore the performances of NGS in detecting viruses across various sample types, employing different sequencing technologies and testing approaches. The speakers will present data on NGS sensitivity for virus detection and comparative data against in vivo and in vitro tests, thereby providing new insights into NGS capabilities.
    • Evaluation of Next Generation Sequencing Performance for in vitro Detection of Viruses in Biological Products

      • Academic Presenter: Ken Kono, PhD, Chief, National Institute of Health Sciences

    • Head-to-Head Comparison of NGS with in Vivo Animal Assays and in Vitro Cell Culture Assays for Adventitious Virus Detection

      • Regulatory Presenter: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

    • High-Throughput Sequencing (HTS) Transcriptomics Analysis for the Detection of Viral Contaminants in Cells Used for Manufacturing of Biologics

      • Presenter: Noémie Deneyer, PhD, Molecular Biology Lead, GSK

    • Q&A, Discussion

      • Moderator: Simone Olgiati, PhD, Head of Innovative Sequencing & Bioinformatics Group, Merck

      • Panelist: Noémie Deneyer, PhD, Molecular Biology Lead, GSK

      • Regulatory Panelist: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

      • Academic Panelist: Ken Kono, PhD, Chief, National Institute of Health Sciences

  • Networking Lunch Break, Poster Session & Exhibition

  • Interactive Questionnaire Session

    • Moderator: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

  • Session 6: Sustainability

    • Moderator: Sebastian B. Teitz, PhD, Consultant, Consultant

    In the bio/pharmaceutical sector, achieving sustainability and lowering environmental impact can present a difficult challenge when balancing corporate and environmental interests. According to The Underswell Foundation, while sustainability is a complex and urgent topic, it is also one of the biggest economic opportunities of our lifetime! This plenary will reflect on the efforts of companies to replace the Triton X-100 with environmentally friendly alternatives. Presentations will focus on eco-friendly & biodegradable alternatives used in continuous processes and identifying an alternative with similar impact on process performance & protein stability.
    • The Development of a Sustainable Alternative Detergent to Triton X-100

      • Presenter: Russell van Buskirk, Senior Principal Scientist, Amgen

    • Eco-Friendly Detergent Inactivation and Clearance for a Hybrid-Continuous Process for Biologics Manufacturing

      • Presenter: Derek Pacheco, Scientist I, Just-Evotec Biologics

  • Networking Coffee Break, Poster Session & Exhibition

  • Passport Raffle

  • Closing Plenary: Regulatory Perspectives and Novel Therapies

    • Moderator: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

    Viral safety is required for biopharmaceutical products and is always evolving as new product types are manufactured. In this session, we will hear an update on viral safety from the FDA and hear about viral safety for xenotransplantation. The session will conclude with an expert panel of regulators and industry members who will give their perspectives on viral safety.
    • Center for Drug Evaluation and Research Updates on Viral Safety

      • Regulatory Presenter: Sarah A. Johnson, PhD, Senior Biologist, OPQ, CDER, U.S. FDA

    • Virus Safety of Xenotransplantation

      • Academic Presenter: Joachim Denner, PhD, Head of laboratory, Institute of Virology, Free University Berlin

    • Plenary Discussion

      • Moderator: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

      • Regulatory Panelist: Sarah A. Johnson, PhD, Senior Biologist, OPQ, CDER, U.S. FDA

      • Regulatory Panelist: Arifa S Khan, PhD, Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

      • Regulatory Panelist: Johannes Bluemel, PhD, Head of Virus Safety Section, Paul-Ehrlich-Institut

      • Academic Panelist: Joachim Denner, PhD, Head of laboratory, Institute of Virology, Free University Berlin

      • Panelist: Thomas R. Kreil, PhD, Vice President, Global Pathogen Safety, Takeda

  • Co-Chairs Conference Summary

    • Co-Chair: Andy Bailey, PhD, CEO, ViruSure GmbH

    • Co-Chair: Sean Michael O'Donnell, PhD, Executive Director, Eli Lilly and Company

  • Closing Remarks & Farewell

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

Posters

Agenda is subject to change.

Presenters

  • Alison Armstrong, PhD

    Senior Director, Global Head Scientific and Regulatory Consultancy , Merck KgAG

    Moderator
    Read Bio
  • Andy Bailey, PhD

    CEO, ViruSure GmbH

    Co-Chair
    Moderator
    Read Bio
  • Amy Bennett, MS

    Manager of Virology Scientific Support Services, Charles River Laboratories

    Panelist
    Presenter
    Read Bio
  • Johannes Bluemel, PhD

    Head of Virus Safety Section, Paul-Ehrlich-Institut

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • David Cetlin, MS

    Senior Director, R&D, Cygnus Technologies

    Moderator
    Read Bio
  • Tom J.B de Man, MSc

    Head of Omics and Machine Learning R&D, Merck KGaA

    Panelist
    Presenter
    Read Bio
  • Melanie Decker

    Parenteral Drug Association

    Moderator
  • Noémie Deneyer, PhD

    Molecular Biology Lead, GSK

    Panelist
    Presenter
    Read Bio
  • Joachim Denner, PhD

    Head of laboratory, Institute of Virology, Free University Berlin

    Academic Panelist
    Academic Presenter
    Read Bio
  • Nicholas DiGioia

    Associate Director, CMC Leadership, Alexion/Astrazeneca Rare Disease

    Panelist
    Presenter
    Read Bio
  • Marc Eloit, Prof DVM PhD

    Founder and Scientific Advisor PathoQuest, PathoQuest

    Panelist
    Presenter
    Read Bio
  • Maria R. Farcet, PhD

    Director, Cell Culture, Virus Models & Serology, Global Pathogen Safety, Takeda

    Panelist
    Presenter
    Read Bio
  • Bradley Hasson, MBA

    Director of Lab Operations for NGS, Merck KGaA

    Panelist
    Presenter
    Read Bio
  • Tomoko Hongo, PhD

    Lead Expert, Bioprocess Division, Asahi Kasei Medical Co., Ltd.

    Moderator
    Read Bio
  • Sarah A. Johnson, PhD

    Senior Biologist, OPQ, CDER, U.S. FDA

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Arifa S Khan, PhD

    Supervisory Microbiologist, DVP, OVRR, CBER, U.S. FDA

    Moderator
    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Falk Klar, PhD

    Parenteral Drug Association

    Committee Member
    Read Bio
  • Oliver Klepsch

    Panelist
    Presenter
  • Ken Kono, PhD

    Chief, National Institute of Health Sciences

    Academic Panelist
    Academic Presenter
    Read Bio
  • Thomas R. Kreil, PhD

    Vice President, Global Pathogen Safety, Takeda

    Moderator
    Panelist
    Read Bio
  • Ursula Lauer, PhD

    Senior Product Specialist, TÜV SÜD Product Service GmbH

    Presenter
    Read Bio
  • Remo Leisi, PhD

    Head of Breakthrough Technologies & Technical Innovation, Global Pathogen Safety, CSL

    Moderator
    Read Bio
  • Sean Michael O'Donnell, PhD

    Executive Director, Eli Lilly and Company

    Co-Chair
    Moderator
    Read Bio
  • Simone Olgiati, PhD

    Head of Innovative Sequencing & Bioinformatics Group, Merck

    Moderator
    Read Bio
  • Derek Pacheco

    Scientist I, Just-Evotec Biologics

    Presenter
    Read Bio
  • Rick S.

    Patient Advovate, CSL Behring

    Panelist
    Read Bio
  • Daniel Strauss, PhD

    Director of Research and Development, Asahi Kasei Bioprocess America

    Presenter
    Read Bio
  • Sebastian B. Teitz, PhD

    Consultant, Consultant

    Moderator
    Read Bio
  • Russell van Buskirk

    Senior Principal Scientist, Amgen

    Presenter
    Read Bio
  • David R. Van Houte, PhD

    Manager - QC Virology, Regeneron Pharmaceuticals

    Panelist
    Presenter
    Read Bio
  • Eleonora Widmer, PhD, MD

    Executive Director Global Pathogen Safety, CSL Behring

    Panelist
    Presenter
    Read Bio

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.

PDA recommends the reservation at the following hotel

Amsterdam Marriott Hotel
Stadhouderskade 12
1054 ES Amsterdam 
The Netherlands

PDA Europe has reserved a limited number of rooms by 11 April 2024.

Please note that this special rate is subject to availability, as there is a city fair during this time.

Book your room at the PDA Group Rate via the above-mentioned reservation button.

How to Get Here
By Air

The hotel is only 13,4 km away from the airport. Public transportation or taxis will bring you to it. It takes around 20 minutes by car and 35 minutes by train.

By Car On site parking is not available.
Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILG. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to [email protected], stating the event code DEAPILG.

Book Flight
Special Deutsche Bahn Train Fares
Deutsche Bahn Train logo

Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

Book Train
Area Attractions

Experience a well-deserved escape at the hotel in Netherlands, Amsterdam. The Amsterdam Marriott Hotel is surrounded by stunning canals and exquisite architecture boasting an unparalleled city centre location across from the Leidseplein, just moments from Amsterdam's iconic attractions. Walk to the Anne Frank House, the Van Gogh Museum, Rijksmuseum and Vondelpark as well as upscale shopping, fine dining and entertainment destinations.