PDA Virus Conference 2025

CEST Daylight Time (UTC +2:00)

• 09:00 – 09:05

  Welcome and Introduction

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 09:05 – 09:15

  Welcome from the Co-Chairs

  • Co-Chair:

    

    Chakameh Azimpour, PhD
    Director - Virology and Microbiological Sciences, EMD MilliporeSigma

  • Co-Chair:

    

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

• 09:15 – 11:10

  Opening Plenary

  • Moderator:

    

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

  Viral safety of all biopharmaceutical products is at the forefront of ensuring patient safety. In this opening session of the PDA Virus Conference 2025, attendees will hear a patient's experience taking biopharmaceutical products and from a doctor who treats patients needing these critical treatments. There will also be presentations from regulators about using high throughput sequencing for viral safety testing, followed by a regulatory update from the US FDA.

  • 09:15 – 09:40

    Title to be Announced

    • Keynote Speaker:

      

      Merete Schmiegelow
      

  • 09:40 – 10:05

    Update from European Pharmacopeia -Testing HTS Document

    • Regulatory Presenter:

      

      Johannes Bluemel, PhD
      Head of Virus Safety Section, Paul-Ehrlich-Institut

  • 10:05 – 10:30

    Regulatory Updates

    • Regulatory Presenter:

      

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

  • 10:30 – 11:10

    Q&A, Discussion

    • Moderator:

      

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

    • Regulatory Panelist:

      

      Johannes Bluemel, PhD
      Head of Virus Safety Section, Paul-Ehrlich-Institut

    • Regulatory Panelist:

      

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

    • Panelist:

      

      Merete Schmiegelow
      

• 11:10 – 11:40

  Networking Coffee Break, Poster Session & Exhibition

• 11:40 – 12:55

  Session 1: Viral Safety in Manufacturing

  • Moderator:

    

    Andy Bailey, PhD
    CEO, ViruSure GmbH

  The expanded section on platform data and prior knowledge in the new ICH Q5A (R2) guidelines provides a more detailed understanding of how such data can be leveraged in regulatory submissions for biopharmaceutical products. Much has been learned over the years, particularly in low pH inactivation and virus filtration. Continuous bioprocessing presents challenges in understanding how the virus load might change throughout the campaign. This session will focus on the application of platform and prior knowledge in case studies of manufacturing processes.

  • 11:40 – 11:55

    A Case Study: Leveraging “In-House” Platform Data for Prior Knowledge Application in Low PH Viral Inactivation, Viral Reductive Filtration, and Evaluation of Resin Reuse

    • Presenter:

      

      Rasika Nawimanage, PhD
      Scientist, Teva Pharmaceuticals

  • 11:55 – 12:10

    A Predictive Modeling Tool to Quantitate Virus Contamination Risk in Integrated Continuous Bioprocessing

    • Presenter:

      

      Ushma Mehta, MS
      Senior Regulatory Expert, MilliporeSigma

  • 12:10 – 12:25

    Establishing Virus Filtration Design Space for Process Optimization and Utilization as Prior Knowledge: Perspectives on Filtration Characteristics and Virus Removal Performance

    • Presenter:

      

      Chie Hashikawa-Muto
      

  • 12:25 – 12:55

    Q&A, Discussion

    • Moderator:

      

      Andy Bailey, PhD
      CEO, ViruSure GmbH

    • Panelist:

      

      Chie Hashikawa-Muto
      

    • Panelist:

      

      Ushma Mehta, MS
      Senior Regulatory Expert, MilliporeSigma

    • Panelist:

      

      Rasika Nawimanage, PhD
      Scientist, Teva Pharmaceuticals

• 12:55 – 13:10

  LIVE Guided Poster Walk

  • Moderator:

    

    Michael Lasse, PhD
    Head of Product Management Filtration Consumables, Sartorius

• 13:10 – 14:10

  Networking Lunch Break, Poster Session & Exhibition

• 14:10 – 14:25

  Interactive Questionnaire Session

  • Moderator:

    

    David Cetlin, MS
    Senior Director, R&D, Cygnus Technologies

• 14:10 – 15:35

  Session 2: Emerging Pathogen Detection

  • Moderator:

    

    Sebastian B. Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  As the biopharmaceutical industry continues to advance, the ability to rapidly detect and mitigate emerging viral threats remains a critical priority. This session will explore cutting-edge strategies for early pathogen detection, risk assessment, and control, with a focus on novel and emerging challenges. Attendees will discover the emerging global trends in novel pathogen identification, delve into the unique challenges of pathogen elimination in xenotransplantation and finally stay abreast with cutting-edge developments in virus detection methodologies. As laid forth in PDAs Technical Report 71.

  • 14:25 – 14:40

    Novel Pathogens: Global Trends and Strategies for Their Prevention and Control

    • Presenter:

      

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

  • 14:40 – 14:55

    Xenotransplantation: Elimination of Potential Pathogens from Living Organ Donors, A New Challenge

    • Academic Presenter:

      

      Joachim Denner, PhD
      Head of laboratory, Institute of Virology, Freie Universität Berlin

  • 14:55 – 15:05

    Updates from PDA Technical Report 71 - Emerging Methods for Virus Detection
  • 15:05 – 15:35

    Q&A, Discussion

    • Moderator:

      

      Sebastian B. Teitz, PhD
      Senior Development Scientist, Novo Nordisk

    • Academic Panelist:

      

      Joachim Denner, PhD
      Head of laboratory, Institute of Virology, Freie Universität Berlin

• 16:05 – 17:20

  Session 3: Speed Talks - Virus Testing

  • Moderator:

    

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

  Virus Testing of Biologics has substantially evolved over the last decade based on the technological advancement and increasing application of next generation sequencing/high throughput sequencing (NGS/HTS) for Viral Safety purposes. This Session provides both background and specific examples on how NGS/HTS have been implemented in alignment with modernized regulatory guidelines. The presenters will share their experience, key lessons-learned, and innovations regarding the development and validation of NGS/HTS in a GxP environment.

  • 16:05 – 16:15

    Enhanced Detection of Adventitious Viruses in Biological Products Using High-Throughput Sequencing

    • Presenter:

      

      Song Sun, PhD
      Unit Head of High-throughput Sequencing, Sanofi

  • 16:15 – 16:25

    Developing and Validating GAMP 5 Bioinformatics Software in a GMP-Regulated Environment

    • Presenter:

      

      Jared Richardson, PhD
      Staff Bioinformatics Scientist, Regeneron Pharmaceuticals

  • 16:25 – 16:35

    Automated Virus NGS for GMP Testing: Bioinformatic Considerations & Hit Criteria

    • Presenter:

      

      Jesper Storm Jensen
      

  • 16:35 – 16:45

    10-Year Retrospective of Biological Testing Using NGS: From Past Achievements to Routine Clinical Batch Release Control

    • Presenter:

      

      Marc Eloit, Prof DVM PhD
      Founder and Scientific Advisor PathoQuest, PathoQuest

  • 16:45 – 17:20

    Q&A, Discussion

    • Moderator:

      

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

    • Panelist:

      

      Marc Eloit, Prof DVM PhD
      Founder and Scientific Advisor PathoQuest, PathoQuest

    • Panelist:

      

      Jared Richardson, PhD
      Staff Bioinformatics Scientist, Regeneron Pharmaceuticals

    • Panelist:

      

      Song Sun, PhD
      Unit Head of High-throughput Sequencing, Sanofi

    • Panelist:

      

      Jesper Storm Jensen
      

• 17:20 – 22:00

  End of Conference Day 1 & Networking Event

CEST Daylight Time (UTC +2:00)

• 09:00 – 09:05

  Welcome to Day 2

  • Co-Chair:

    

    Chakameh Azimpour, PhD
    Director - Virology and Microbiological Sciences, EMD MilliporeSigma

  • Co-Chair:

    

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

• 09:05 – 10:30

  Session 4: Sustainable Manufacturing

  • Moderator:

    

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

  The topic of sustainable manufacturing is viewed through the optimization of the whole product lifecycle and aligns with the generation of manufactured products that use processes to minimize negative environmental impacts and conserve energy and natural resources. The presentations in this session will touch on restrictions of synthetic chemicals, Per- and polyfluoroalkyl substances (PFAS), which pose a challenge to biopharmaceutical manufacturing and directly impact PFAS raw materials including virus filtration devices, and in addition, the relevance of environmental aspects of virus care pathways will be highlighted.

  • 09:05 – 09:25

    Per- and Polyfluoroalkyl Substances (PFAS) - The Industry’s Next Triton X-100? - Insights on How to Maintain and Create Regulatory Compliant Manufacturing Processes

    • Presenter:

      

      Fritjof Linz, PhD
      Head of Product Management Excellence, Sartorius Stedim Biotech GmbH

  • 09:25 – 09:45

    Sustainability in Virus Care Pathways

    • Presenter:

      

      Frederik van Deurs
      

  • 09:45 – 10:00

    Updates from PDA Technical Report 83 Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response

    • Presenter:

      

      Houman Dehghani, PhD
      Vice President, Cabaletta Bio

  • 10:00 – 10:30

    Q&A, Discussion

    • Moderator:

      

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

    • Panelist:

      

      Houman Dehghani, PhD
      Vice President, Cabaletta Bio

    • Panelist:

      

      Fritjof Linz, PhD
      Head of Product Management Excellence, Sartorius Stedim Biotech GmbH

    • Panelist:

      

      Frederik van Deurs
      

• 10:30 – 11:00

  Networking Coffee Break, Poster Session & Exhibition

• 11:00 – 12:20

  Session 5: Viral Safety of ATMPs

  • Moderator:

    

    David R. Van Houte, PhD
    Senior Manager - QC Virology, Regeneron Pharmaceuticals

  In the dynamic landscape of Advanced Therapy Medicinal Products (ATMPs), ensuring viral safety is crucial for safeguarding patient health and adhering to regulatory standards. This session will focus on the viral safety challenges and solutions specific to the development and manufacturing of Adeno-associated virus (AAV) gene therapies. We will hear from two engaging talks on mitigating viral and TSE risks during manufacturing, and explore chromatographic techniques to enrich AAV capsids while focusing on viral safety.

  • 11:00 – 11:25

    Identification and Mitigation of Viral and Transmissible Spongiform Encephalopathy (TSE) Risks for the Manufacture of an Adeno-Associated Virus (AAV) Gene Therapy – A Case Study

    • Presenter:

      

      Denis Klochkov
      

  • 11:25 – 11:50

    From Full Capsid Enrichment to Virus Safety: Chromatographic Solutions for AAV Processing

    • Presenter:

      

      Julio Miguel Huato
      

  • 11:50 – 12:20

    Q&A, Discussion

    • Moderator:

      

      David R. Van Houte, PhD
      Senior Manager - QC Virology, Regeneron Pharmaceuticals

    • Panelist:

      

      Julio Miguel Huato
      

    • Panelist:

      

      Denis Klochkov
      

• 12:20 – 13:20

  Networking Lunch Break, Poster Session & Exhibition

• 13:20 – 16:30

  Closing Plenary

  • Moderator:

    

    Chakameh Azimpour, PhD
    Director - Virology and Microbiological Sciences, EMD MilliporeSigma

  This session will start with an insightful talk on the impact of Virus-like particle selection on determination of Residence Time Distribution Determination for Continuous Viral Inactivation Reactors, followed by an opportunity to join the discussion with distinguished virus safety experts from both industries as well as regulatory agencies for a lively discussion. Participants then have an opportunity to join interactive round table discussions around the topics of primary interest, such as experiences with validation of NGS for viral safety, use of platform knowledge, alternative strategies and continuous processing, and viral safety of ATMPs.

  • 13:20 – 13:45

    Impact of Virus-like particle selection on determination of Residence Time Distribution Determination for Continuous Viral Inactivation Reactors

    • Regulatory Presenter:

      

      Scott Lute, M.Sc.
      Senior Biologist, U.S. FDA

  • 13:45 – 14:30

    Closing Plenary Discussion

    • Moderator:

      

      Chakameh Azimpour, PhD
      Director - Virology and Microbiological Sciences, EMD MilliporeSigma

    • Regulatory Panelist:

      

      Scott Lute, M.Sc.
      Senior Biologist, U.S. FDA

• 14:30 – 15:00

  Networking Coffee Break, Poster Session & Exhibition

• 15:00 – 16:05

  Interactive Round Table Session

• 16:05 – 16:10

  Passport Raffle Announcement

• 16:10 – 16:15

  Best Poster Presentation

• 16:15 – 16:25

  Co-Chairs Conference Summary

  • Co-Chair:

    

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

  • Co-Chair:

    

    Chakameh Azimpour, PhD
    Director - Virology and Microbiological Sciences, EMD MilliporeSigma

• 16:25 – 16:30

  Closing Remarks & Farewell

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 16:30 – 16:30

  End of Conference