PDA Virus Conference 2024

Wednesday, 26 June CEST

• 09:00 – 09:05

  Welcome and Introduction

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

    

    Falk Klar, PhD, Parenteral Drug Association
    

    Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
• 09:05 – 09:15

  Welcome from the Co-Chairs

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

    

    Andy Bailey, PhD, CEO, ViruSure GmbH
    

    Andy Bailey specialised in Virology serving for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 28 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

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

    

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

    Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.
• 09:15 – 10:45

  Opening Plenary

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

    

    Andy Bailey, PhD, CEO, ViruSure GmbH
    

    Andy Bailey specialised in Virology serving for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 28 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

  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.

  • 09:15 – 09:45

    The Path to Resilience: Finding Confidence in Yourself and Managing Your Condition

    • Keynote Speaker: Rick S.

      

      Rick S.
      

  • 09:45 – 10:15

    Updates on ICH Q5A (R2)

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

      

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

      SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax: +49 6103 771285 E-mai: [email protected] Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products, recombinant DNA products such as monoclonal antibodies, and advanced therapy medicinal products (ATMPs) for clinical trials and marketing authorization. He participates as expert in EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed in drafting of numerous Guidelines and Monographs on viral safety. Further, he is working in several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he is chairing the group on blood-associated pathogens for the national advisory board “Arbeitskeis Blut” in Germany as well as the Ph. Eur. Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Prior to joining the Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology (molecular genetics, microbiology, biophysics and physical chemistry) in 1991 at the University of Freiburg, Germany. He received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany (1993). In 2010 he received teaching graduation (Habilitation) in Medical Virology from the University Frankfurt.

  • 10:15 – 10:45

    Plenary Discussion

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

      

      Andy Bailey, PhD, CEO, ViruSure GmbH
      

      Andy Bailey specialised in Virology serving for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 28 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

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

      

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

      SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax: +49 6103 771285 E-mai: [email protected] Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products, recombinant DNA products such as monoclonal antibodies, and advanced therapy medicinal products (ATMPs) for clinical trials and marketing authorization. He participates as expert in EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed in drafting of numerous Guidelines and Monographs on viral safety. Further, he is working in several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he is chairing the group on blood-associated pathogens for the national advisory board “Arbeitskeis Blut” in Germany as well as the Ph. Eur. Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Prior to joining the Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology (molecular genetics, microbiology, biophysics and physical chemistry) in 1991 at the University of Freiburg, Germany. He received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany (1993). In 2010 he received teaching graduation (Habilitation) in Medical Virology from the University Frankfurt.

    • Panelist: Rick S.

      

      Rick S.
      

• 10:45 – 11:15

  Networking Coffee Break, Poster Session & Exhibition
• 11:15 – 12:35

  Session 1: Viral Safety of Advanced Therapies

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

    

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

    Dr Alison Armstrong serves as the Senior Director, Global Head Scientific and Regulatory Consultancy leading a team of scientific and regulatory experts within the Merck BioReliance® testing services business. This global scientific team provides an understanding of scientific and regulatory application throughout the biologics product lifecycle. A key focus of the team is to develop scientific relevance through thought leadership activities at international conference, webinars and writing assignments. Dr Armstrong has held positons in Operation leadership, quality management and as a Scientific Director for the biologics business. Dr Armstrong holds a PhD in Molecular Virology from the University of Glasgow and she has a certificate in Advanced Management from Cranfield Unversity School of Management. Throughout her career, Alison has been an invited speaker at both national and international conferences, member of inustry forums and has published more than 40 peer-reviewed papers and editorials.

  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.

  • 11:15 – 11:30

    Viral Safety Strategy for Adeno-Associated Virus Gene Therapy Products

    • Presenter: Nicholas DiGioia

      

      Nicholas DiGioia
      

  • 11:30 – 11:45

    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

      

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

      Amy Bennett joined Charles River in 2010 as a Technician within the Virology department and is now the Manager of Virology Scientific Support Services. She currently oversees assay development within the Virology department as well as technical transfers. Amy has worked on the development and implementation of safety assays for various gene therapy vectors including adenovirus, adeno-associated virus, and lentivirus. She has a Master’s degree in Biology from West Chester University.

  • 11:45 – 12:00

    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

      

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

      David received his PhD from Rensselaer Polytechnic Institute and has been in QC Virology with Regeneron Pharmaceuticals since graduating in 2015. David initiated the development of NGS based assays for adventitious agent GMP testing. He now leads a team of 10 researchers continuing the work to modernize QC Virology testing in the GMP space. Currently we are exploring techniques to use the real-time nature of nanopore sequencing to supplement adventitious agent detection assays in an effort to replace traditional compendial methods. Additionally, we are supporting efforts in the cell and gene therapy space to use nanopore sequencing to further characterize AAV drug products.

  • 12:00 – 12:35

    Q&A, Discussion

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

      

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

      Dr Alison Armstrong serves as the Senior Director, Global Head Scientific and Regulatory Consultancy leading a team of scientific and regulatory experts within the Merck BioReliance® testing services business. This global scientific team provides an understanding of scientific and regulatory application throughout the biologics product lifecycle. A key focus of the team is to develop scientific relevance through thought leadership activities at international conference, webinars and writing assignments. Dr Armstrong has held positons in Operation leadership, quality management and as a Scientific Director for the biologics business. Dr Armstrong holds a PhD in Molecular Virology from the University of Glasgow and she has a certificate in Advanced Management from Cranfield Unversity School of Management. Throughout her career, Alison has been an invited speaker at both national and international conferences, member of inustry forums and has published more than 40 peer-reviewed papers and editorials.

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

      

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

      Amy Bennett joined Charles River in 2010 as a Technician within the Virology department and is now the Manager of Virology Scientific Support Services. She currently oversees assay development within the Virology department as well as technical transfers. Amy has worked on the development and implementation of safety assays for various gene therapy vectors including adenovirus, adeno-associated virus, and lentivirus. She has a Master’s degree in Biology from West Chester University.

    • Panelist: Nicholas DiGioia

      

      Nicholas DiGioia
      

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

      

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

      David received his PhD from Rensselaer Polytechnic Institute and has been in QC Virology with Regeneron Pharmaceuticals since graduating in 2015. David initiated the development of NGS based assays for adventitious agent GMP testing. He now leads a team of 10 researchers continuing the work to modernize QC Virology testing in the GMP space. Currently we are exploring techniques to use the real-time nature of nanopore sequencing to supplement adventitious agent detection assays in an effort to replace traditional compendial methods. Additionally, we are supporting efforts in the cell and gene therapy space to use nanopore sequencing to further characterize AAV drug products.

• 12:35 – 14:05

  Networking Lunch Break & Exhibition
• 13:50 – 14:05

  Guided Poster Walk

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

    

    Sebastian B. Teitz, PhD, Consultant, Consultant
    

    Sebastian Teitz graduated from University of Cologne with a diploma in Genomic Imprinting. He followed this with a PhD in the Analysis of O-glycosylated Proteins. Sebastian has previously worked at Fred Hutchinson Cancer Research Center (Seattle, WA), looking into Cytomegalovirus and its Role in Graft vs. Host Disease and Transplant Rejection; and at NewLab BioQuality / Charles River as the Project Manager of Virus Clearance Studies. Within Asahi his focus is on virus- & pathogen safety, supporting customers & internal entities technically and scientifically, and being liaison for authorities, CROs and industry consortiums of the biopharmaceuticals industry. At Biopharma-Excellence he consultined developers of new drugs in scientific- & regulatory affairs during all stages to market access and is currently freelancing serving the biopharma community.
• 13:50 – 14:05

  Interactive Questionnaire Session

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

    

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

    David Cetlin is the Senior Director of R&D at Cygnus technologies and the former founder and CEO of MockV Solutions, Inc. MockV Solutions, acquired by Cygnus Technologies in March of 2020, was dedicated towards establishing and commercializing a novel series of BSL-1 compatible viral clearance prediction kits. These kits are designed to benefit downstream purification process scientists as they develop, characterize, and validate their downstream purification processes. Prior to MockV, David helped develop, characterize, and validate several monoclonal antibody purification processes at Human Genome Sciences and has worked with various separation techniques including all modes of column chromatography, tangential flow filtration, nano-filtration. During his time at HGS, David routinely designed and executed process related studies including resin lifetime studies, viral clearance studies, design of experiment (DOE) studies, etc. He also participated in the technology transfer of several processes to manufacturing scale cGMP facilities, provided on-site support during cGMP campaigns and conducted investigational studies to support deviations . He also explored and introduced new technologies and ideas to his purification team including a single pass mode of operating tangential flow filtration, a salt tolerant ion exchange membrane, and a pre-protein A depth filter for improving protein A lifetime.
• 14:05 – 15:25

  Session 2: Virus Testing

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

    

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

    Thomas R. Kreil, PhD Associate Professor of Virology Vice President, Global Pathogen Safety Beyond his work at Takeda, he is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.

  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.

  • 14:05 – 14:20

    TBA

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

      

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

      Bradley Hasson is the Director of Lab Operations for Next Generation Sequencing Services at Merck KGaA. Brad leads a global team of Scientists, laboratory technicians and bioinformaticians that perform NGS-based testing services in support of product characterization, adventitious agent detection and product release for biologically derived products worldwide. He has over 20 years of industry experience, including 16 years developing, validating and commercializing molecular-based methods for the purposes of biosafety testing and characterization in a variety of biologically derived products.

  • 14:20 – 14:35

    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

    • Presenter: Oliver Klepsch

      

      Oliver Klepsch
      

  • 14:35 – 14:50

    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
      Head of Pathogen Discovery Laboratory, Institut Pasteur, Institut Pasteur

      

      Marc Eloit, Prof DVM PhD, Founder and Scientific Advisor PathoQuest
      Head of Pathogen Discovery Laboratory, Institut Pasteur, Institut Pasteur
      

      Marc Eloit is Professor of Virology at the Veterinary School of Maisons-Alfort and the head of the Pathogen Discovery laboratory at Institut Pasteur (Paris). He has been a member of the Virus Safety Committee, French Agency of Medicinal Products (1992-2012). He founded PathoQuest in 2010, a spin-out of Institut Pasteur dedicated to the identification of pathogens using untargeted Next Generation Sequencing. He has been its CSO till the end of 2016 and acts currently as a scientific advisor for the company.

  • 14:50 – 15:25

    Q&A, Discussion

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

      

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

      Thomas R. Kreil, PhD Associate Professor of Virology Vice President, Global Pathogen Safety Beyond his work at Takeda, he is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.

    • Panelist: Oliver Klepsch

      

      Oliver Klepsch
      

    • Panelist: Marc Eloit, Prof DVM PhD, Founder and Scientific Advisor PathoQuest
      Head of Pathogen Discovery Laboratory, Institut Pasteur, Institut Pasteur

      

      Marc Eloit, Prof DVM PhD, Founder and Scientific Advisor PathoQuest
      Head of Pathogen Discovery Laboratory, Institut Pasteur, Institut Pasteur
      

      Marc Eloit is Professor of Virology at the Veterinary School of Maisons-Alfort and the head of the Pathogen Discovery laboratory at Institut Pasteur (Paris). He has been a member of the Virus Safety Committee, French Agency of Medicinal Products (1992-2012). He founded PathoQuest in 2010, a spin-out of Institut Pasteur dedicated to the identification of pathogens using untargeted Next Generation Sequencing. He has been its CSO till the end of 2016 and acts currently as a scientific advisor for the company.

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

      

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

      Bradley Hasson is the Director of Lab Operations for Next Generation Sequencing Services at Merck KGaA. Brad leads a global team of Scientists, laboratory technicians and bioinformaticians that perform NGS-based testing services in support of product characterization, adventitious agent detection and product release for biologically derived products worldwide. He has over 20 years of industry experience, including 16 years developing, validating and commercializing molecular-based methods for the purposes of biosafety testing and characterization in a variety of biologically derived products.

• 15:25 – 15:55

  Networking Coffee Break, Poster Session & Exhibition
• 15:55 – 17:15

  Session 3: Novel Approaches and Digitization

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

    

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

    Dr. Arifa S. Khan is Head, Molecular Retrovirology Unit, Division of Viral Products, Office of Vaccines Research and Review, in the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. She moved her retrovirus reseach program from NIAD/NIH to CBER in 1991, where she is currently leading efforts for applications of high-throughput sequencing for endogenous retrovirus and adventitious virus detection for safety evaluation of cell substrates and biologics. Her primary regulatory responsibilities include viral vaccines, including HIV-1, influenza virus, RSV and SARS-COV-2. Dr. Khan also provides expert consultation on viral safety and testing to OTAT/CBER and CDER. Dr. Khan has been involved in licensure of several viral vaccines and development of FDA, ICH, PHS, USP, and WHO documents. She is currently the FDA Deputy Topic Lead in the Expert Working Group updating the ICH Q5A(R2). Dr. Khan obtained her Ph.D. in Microbiology from the George Washington University, Washington, D.C. She has authored more than 100 publications.

  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.

  • 15:55 – 16:10

    A Deep-Learning Classifier of Adventitious Agents

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

      

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

      Tom de Man is head of the Omics and Machine Learning R&D department at Merck, supporting the BioReliance® services portfolio. His department develops and validates multi-omics bioinformatics algorithms for adventitious agent testing. Previously, Tom has worked at the US Centers for Disease Control and Prevention (CDC) and various academic institutions, which provided him with a broad set of professional skills. His expertise includes comparative genomics, software development, and (GxP) data analysis. Tom has authored over 20 peer-reviewed manuscripts on various molecular and bioinformatics topics, including pathogen detection and characterization. He holds a Bachelor (BSc) as well as Master of Science (MSc) in Bioinformatics.

  • 16:10 – 16:25

    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

      

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

      Dr. Eleonora Widmer is the Head of Global Pathogen Safety of CSL, with a scope of plasma-derived products, recombinants, gene therapy and vaccines. She holds an MD from the University of Bern, Switzerland, and a Ph.D. in Molecular Microbiology from the University of Lausanne, Switzerland. Prior experience includes clinical settings as well as at the Federal Office of Public Health of Switzerland. She has been working at CSL for 15 years in the fields of Quality Control and Pathogen Safety.

  • 16:25 – 16:40

    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

      

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

      Maria Farcet is Head of Cell Culture, Virus Models & Serology at Global Pathogen Safety, Takeda, Austria. In her 15+ years career in this field she gained profound expertise in virology and virus safety of medicinal products. She currently oversees research and development projects on emerging viruses that are of interest to the safety of medicinal products as well as the establishment and operation of virus test systems to enable virus reduction studies, virus testing and immunoglobulin neutralization assays, under GMP/GLP.

  • 16:40 – 17:15

    Q&A, Discussion

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

      

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

      Dr. Arifa S. Khan is Head, Molecular Retrovirology Unit, Division of Viral Products, Office of Vaccines Research and Review, in the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. She moved her retrovirus reseach program from NIAD/NIH to CBER in 1991, where she is currently leading efforts for applications of high-throughput sequencing for endogenous retrovirus and adventitious virus detection for safety evaluation of cell substrates and biologics. Her primary regulatory responsibilities include viral vaccines, including HIV-1, influenza virus, RSV and SARS-COV-2. Dr. Khan also provides expert consultation on viral safety and testing to OTAT/CBER and CDER. Dr. Khan has been involved in licensure of several viral vaccines and development of FDA, ICH, PHS, USP, and WHO documents. She is currently the FDA Deputy Topic Lead in the Expert Working Group updating the ICH Q5A(R2). Dr. Khan obtained her Ph.D. in Microbiology from the George Washington University, Washington, D.C. She has authored more than 100 publications.

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

      

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

      Tom de Man is head of the Omics and Machine Learning R&D department at Merck, supporting the BioReliance® services portfolio. His department develops and validates multi-omics bioinformatics algorithms for adventitious agent testing. Previously, Tom has worked at the US Centers for Disease Control and Prevention (CDC) and various academic institutions, which provided him with a broad set of professional skills. His expertise includes comparative genomics, software development, and (GxP) data analysis. Tom has authored over 20 peer-reviewed manuscripts on various molecular and bioinformatics topics, including pathogen detection and characterization. He holds a Bachelor (BSc) as well as Master of Science (MSc) in Bioinformatics.

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

      

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

      Dr. Eleonora Widmer is the Head of Global Pathogen Safety of CSL, with a scope of plasma-derived products, recombinants, gene therapy and vaccines. She holds an MD from the University of Bern, Switzerland, and a Ph.D. in Molecular Microbiology from the University of Lausanne, Switzerland. Prior experience includes clinical settings as well as at the Federal Office of Public Health of Switzerland. She has been working at CSL for 15 years in the fields of Quality Control and Pathogen Safety.

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

      

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

      Maria Farcet is Head of Cell Culture, Virus Models & Serology at Global Pathogen Safety, Takeda, Austria. In her 15+ years career in this field she gained profound expertise in virology and virus safety of medicinal products. She currently oversees research and development projects on emerging viruses that are of interest to the safety of medicinal products as well as the establishment and operation of virus test systems to enable virus reduction studies, virus testing and immunoglobulin neutralization assays, under GMP/GLP.

• 17:15 – 22:00

  End of Conference Day 1 & Networking Event

Thursday, 27 June CEST

• 09:00 – 09:01

  Welcome to Day 2Welcome to Day 2Welcome to Day 2Welcome to Day 2

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

    

    Andy Bailey, PhD, CEO, ViruSure GmbH
    

    Andy Bailey specialised in Virology serving for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 28 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

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

    

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

    Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.
• 09:02 – 10:15

  Session 4: Virus Inactivation and Virus Removal

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

    

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

    Remo Leisi is Head of Breakthrough Technologies & Technical Innovation within Global Pathogen Safety at CSL, which has a scope of plasma-derived products, recombinants, gene therapy and vaccines. He received his PhD in Molecular Virology at the University of Bern and further focused his studies on underlying molecular mechanisms in virus clearance steps as Postdoctoral Researcher in collaboration with CSL.

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

    

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

    Tomoko Hongo-Hirasaki have been working on Planova virus removal filters for over 30 years. She is the lead expert of virus filtration in the Bioprocess Division of Asahi Kasei Medical Co., Ltd. She received her PhD in Pharmaceutical Sciences from Kyushu University for her research on separation mechanisms of biological macromolecules on porous cellulose membranes. Her areas of expertise include virus evaluation, colloid science, membrane science, and protein biophysics. At Asahi Kasei, she led a group in the R&D department that evaluated and analyzed the performance of virus removal filters, conducting study on filtration removal mechanisms, developing evaluation and analysis technology, and studying the characteristics of virus removal membranes. She is currently responsible for global scientific activities and leads global scientific publications. She is a member of the Bio-Virus Committee of PDA Japan and leader of the Virus Safety Subcommittee. Also she is serving on the board member of the Japanese Society for Virus Safety Research of Biologics.

  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.
• 10:15 – 10:45

  Networking Coffee Break, Poster Session & Exhibition
• 10:45 – 12:00

  Session 5: Next Generation Sequencing

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

    

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

    Dr. Simone Olgiati is head of the Innovative Sequencing & Bioinformatics Group, leading a team of scientists and bioinformaticians within the Healthcare sector of Merck. This group applies a solid expertise on high-throughput sequencing to support the manufacturing and quality control of biotechnological products by developing and validating innovative analytical methods for the detection of viral contaminants and other NGS-based applications. Dr. Olgiati holds a MSc in Biology from the University of Insubria (Italy) and a PhD in Human Genetics from the Erasmus Medical Center (the Netherlands). Before moving to Merck (Italy) in 2019, he held a bioinformatic position at Cergentis, building competencies on the genetic analysis of recombinant cell lines with the TLA technology. Moreover, he served as bioinformatician at BlueBee (currently part of Illumina), focusing on diagnostic analyses of NGS data in cloud-based environments. His professional journey allowed him to develop expertise in Big Data analytics and a broad view of NGS applications in both diagnostics and industry.

  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.
• 12:00 – 13:00

  Networking Lunch Break, Poster Session & Exhibition
• 13:00 – 13:15

  Interactive Questionnaire Session

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

    

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

    Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.
• 13:15 – 14:15

  Session 6: Sustainability

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

    

    Sebastian B. Teitz, PhD, Consultant, Consultant
    

    Sebastian Teitz graduated from University of Cologne with a diploma in Genomic Imprinting. He followed this with a PhD in the Analysis of O-glycosylated Proteins. Sebastian has previously worked at Fred Hutchinson Cancer Research Center (Seattle, WA), looking into Cytomegalovirus and its Role in Graft vs. Host Disease and Transplant Rejection; and at NewLab BioQuality / Charles River as the Project Manager of Virus Clearance Studies. Within Asahi his focus is on virus- & pathogen safety, supporting customers & internal entities technically and scientifically, and being liaison for authorities, CROs and industry consortiums of the biopharmaceuticals industry. At Biopharma-Excellence he consultined developers of new drugs in scientific- & regulatory affairs during all stages to market access and is currently freelancing serving the biopharma community.

  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.
• 14:15 – 14:45

  Networking Coffee Break, Poster Session & Exhibition
• 14:45 – 14:50

  Passport Raffle

  • Moderator: Melanie Decker, Parenteral Drug Association

    

    Melanie Decker, Parenteral Drug Association
    
• 14:50 – 16:20

  Closing Plenary

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

    

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

    Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.

  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.

  • 14:50 – 15:15

    Center for Drug Evaluation and Research Updates on Viral Safety

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

      

      Sarah A Johnson, PhD, Senior Biologist, OPQ, CDER, U.S. FDA
      

      Sarah Johnson is a Senior Biologist in the Office of Biotechnology Products and a member of the CDER Manufacturing Science & Innovation Center of Excellence. She has been with CDER/OPQ/OBP since 2015. Over the past years she has extensively studied various aspects of recombinant protein manufacturing focusing on regulatory concerns associated with the emerging manufacturing technologies and the viral safety of downstream bioprocessing. Her current research topics include aspects of advanced manufacturing with a focus on continuous bioprocessing to provide regulatory support for the CDER Emerging Technology Program submissions. She has won several internal scientific awards from the FDA and is an author on numerous scientific articles related to biotechnology manufacturing.

  • 15:15 – 15:40

    Virus Safety of Xenotransplantation

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

      

      Joachim Denner, PhD, Head of laboratory, Institute of Virology, Free University Berlin
      

      Dr. Joachim Denner, Dir. u. Prof. a.D., Institute of Virology at the Free University Berlin, studied biochemistry, specialization virology. Beginning with his diploma he worked on retroviruses, first leukemia viruses of mice, later human endogenous retroviruses, simian and human immunodeficiency viruses (HIV). His laboratories at the Paul Ehrlich Institute and the Robert Koch Institute (RKI) worked on vaccine development against HIV-1, porcine endogenous retroviruses (PERVs) and Koala retrovirus. He also worked on the mechanism how retroviruses cause immunosuppression. He has authored more than 200 original articles and 100 reviews and book chapters. Dr. Denner works as reviewer for many scientific journals and foundations. From 2017 until 2020 he worked as Robert Koch Fellow at the RKI and since than in the Institute of Virology at the Free University Berlin. Since 1997 he is involved in research on PERVs and virus safety of xenotransplantation. The development of highly sensitive methods for the detection of potential zoonotic and xenozoonotic porcine viruses is an essential part of these investigations

  • 15:40 – 16:20

    Plenary Discussion

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

      

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

      Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.

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

      

      Sarah A Johnson, PhD, Senior Biologist, OPQ, CDER, U.S. FDA
      

      Sarah Johnson is a Senior Biologist in the Office of Biotechnology Products and a member of the CDER Manufacturing Science & Innovation Center of Excellence. She has been with CDER/OPQ/OBP since 2015. Over the past years she has extensively studied various aspects of recombinant protein manufacturing focusing on regulatory concerns associated with the emerging manufacturing technologies and the viral safety of downstream bioprocessing. Her current research topics include aspects of advanced manufacturing with a focus on continuous bioprocessing to provide regulatory support for the CDER Emerging Technology Program submissions. She has won several internal scientific awards from the FDA and is an author on numerous scientific articles related to biotechnology manufacturing.

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

      

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

      Dr. Arifa S. Khan is Head, Molecular Retrovirology Unit, Division of Viral Products, Office of Vaccines Research and Review, in the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. She moved her retrovirus reseach program from NIAD/NIH to CBER in 1991, where she is currently leading efforts for applications of high-throughput sequencing for endogenous retrovirus and adventitious virus detection for safety evaluation of cell substrates and biologics. Her primary regulatory responsibilities include viral vaccines, including HIV-1, influenza virus, RSV and SARS-COV-2. Dr. Khan also provides expert consultation on viral safety and testing to OTAT/CBER and CDER. Dr. Khan has been involved in licensure of several viral vaccines and development of FDA, ICH, PHS, USP, and WHO documents. She is currently the FDA Deputy Topic Lead in the Expert Working Group updating the ICH Q5A(R2). Dr. Khan obtained her Ph.D. in Microbiology from the George Washington University, Washington, D.C. She has authored more than 100 publications.

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

      

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

      SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax: +49 6103 771285 E-mai: [email protected] Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products, recombinant DNA products such as monoclonal antibodies, and advanced therapy medicinal products (ATMPs) for clinical trials and marketing authorization. He participates as expert in EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed in drafting of numerous Guidelines and Monographs on viral safety. Further, he is working in several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he is chairing the group on blood-associated pathogens for the national advisory board “Arbeitskeis Blut” in Germany as well as the Ph. Eur. Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Prior to joining the Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology (molecular genetics, microbiology, biophysics and physical chemistry) in 1991 at the University of Freiburg, Germany. He received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany (1993). In 2010 he received teaching graduation (Habilitation) in Medical Virology from the University Frankfurt.

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

      

      Joachim Denner, PhD, Head of laboratory, Institute of Virology, Free University Berlin
      

      Dr. Joachim Denner, Dir. u. Prof. a.D., Institute of Virology at the Free University Berlin, studied biochemistry, specialization virology. Beginning with his diploma he worked on retroviruses, first leukemia viruses of mice, later human endogenous retroviruses, simian and human immunodeficiency viruses (HIV). His laboratories at the Paul Ehrlich Institute and the Robert Koch Institute (RKI) worked on vaccine development against HIV-1, porcine endogenous retroviruses (PERVs) and Koala retrovirus. He also worked on the mechanism how retroviruses cause immunosuppression. He has authored more than 200 original articles and 100 reviews and book chapters. Dr. Denner works as reviewer for many scientific journals and foundations. From 2017 until 2020 he worked as Robert Koch Fellow at the RKI and since than in the Institute of Virology at the Free University Berlin. Since 1997 he is involved in research on PERVs and virus safety of xenotransplantation. The development of highly sensitive methods for the detection of potential zoonotic and xenozoonotic porcine viruses is an essential part of these investigations

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

      

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

      Thomas R. Kreil, PhD Associate Professor of Virology Vice President, Global Pathogen Safety Beyond his work at Takeda, he is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.

• 16:20 – 16:35

  Co-Chairs Conference Summary

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

    

    Andy Bailey, PhD, CEO, ViruSure GmbH
    

    Andy Bailey specialised in Virology serving for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 28 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

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

    

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

    Dr O’Donnell is an Executive Director in the Virology and purification development group at Eli Lilly and Company. He has been a member of this department since 2012 and has been responsible for cell bank testing and viral clearance studies to support manufacturing. Dr. O’Donnell has over 16 years of industry experience, working in various aspects of viral research and viral safety.
• 16:35 – 16:40

  Closing Remarks & Farewell

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

    

    Falk Klar, PhD, Parenteral Drug Association
    

    Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.

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