PDA Virus Conference 2024

Wednesday, 26 June CEST

• 08:00 – 17:15

  Registration Open

  Studio 3,4,5,6,7
• 09:00 – 09:05

  Welcome and Introduction

  Salon ABC

  • 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

  Salon ABC

  • 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, to provide 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: ICH Q5A (R2) and the Importance of Viral Safety to the Patient

  Salon ABC

  • 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, to provide 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

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

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

      

      Rick S., Patient Advovate, CSL Behring
      

      I was diagnosed with hemophilia B when I was born. For most of my childhood, I was alone in the hospital receiving frozen plasma treatments and felt ashamed of my condition. But when I was a teenager, a Bruce Lee movie inspired a lifelong love of martial arts. I became a taekwondo champion, but in my 50s, my body couldn’t handle the intense physical activity anymore. Instead, I learned tai chi, which taught me a sense of mindfulness and body connectivity that I hadn’t experienced before. I started teaching meditation and tai chi to others, which helped me learn that this condition isn’t a journey you go through alone. It’s something you share with the people in your life who love you. It took many years, but I’ve learned that this condition isn’t something to be ashamed of. My confidence is a strength I can teach others.

  • 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
      

      Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with the 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 participated as an expert in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed to the drafting of numerous Guidelines and Monographs on viral safety. Further, he is working on several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he has been 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. Before 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 five years of 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 a teaching graduation (Habilitation) in Medical Virology from the University of 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, to provide 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
      

      Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with the 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 participated as an expert in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed to the drafting of numerous Guidelines and Monographs on viral safety. Further, he is working on several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he has been 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. Before 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 five years of 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 a teaching graduation (Habilitation) in Medical Virology from the University of Frankfurt.

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

      

      Rick S., Patient Advovate, CSL Behring
      

      I was diagnosed with hemophilia B when I was born. For most of my childhood, I was alone in the hospital receiving frozen plasma treatments and felt ashamed of my condition. But when I was a teenager, a Bruce Lee movie inspired a lifelong love of martial arts. I became a taekwondo champion, but in my 50s, my body couldn’t handle the intense physical activity anymore. Instead, I learned tai chi, which taught me a sense of mindfulness and body connectivity that I hadn’t experienced before. I started teaching meditation and tai chi to others, which helped me learn that this condition isn’t a journey you go through alone. It’s something you share with the people in your life who love you. It took many years, but I’ve learned that this condition isn’t something to be ashamed of. My confidence is a strength I can teach others.

    • 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 a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from George Washington University, Washington, D.C. She has authored more than 100 publications.

• 10:45 – 11:15

  Networking Coffee Break, Poster Session & Exhibition

  Studio 3,4,5,6,7
• 11:15 – 12:35

  Session 1: Viral Safety of Advanced Therapies

  Salon ABC

  • 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 applications throughout the biologics product lifecycle. A key focus of the team is to develop scientific relevance through thought leadership activities at international conferences, webinars, and writing assignments. Dr. Armstrong has held positions 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 University School of Management. Throughout her career, Alison has been an invited speaker at both national and international conferences, a member of industry 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, Associate Director, CMC Leadership, Alexion/Astrazeneca Rare Disease

      

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

      Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst and has over 7 years of experience in the biotech industry developing biologics manufacturing processes. He got his start supporting commercial manufacturing at Sanofi and has since held roles of increasing responsibility in the process development groups at Bristol Meyers Squibb and LogicBio therapeutics. He is currently serving as an associate director of genomic medicines CMC leadership at Alexion pharmaceuticals.

  • 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 applications throughout the biologics product lifecycle. A key focus of the team is to develop scientific relevance through thought leadership activities at international conferences, webinars, and writing assignments. Dr. Armstrong has held positions 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 University School of Management. Throughout her career, Alison has been an invited speaker at both national and international conferences, a member of industry 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, Associate Director, CMC Leadership, Alexion/Astrazeneca Rare Disease

      

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

      Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst and has over 7 years of experience in the biotech industry developing biologics manufacturing processes. He got his start supporting commercial manufacturing at Sanofi and has since held roles of increasing responsibility in the process development groups at Bristol Meyers Squibb and LogicBio therapeutics. He is currently serving as an associate director of genomic medicines CMC leadership at Alexion pharmaceuticals.

    • 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 – 13:50

  Networking Lunch Break & Exhibition

  Studio 3,4,5,6,7
• 13:10 – 13:50

  Guided Poster Walk

  Studio 3,4,5,6,7

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

    

    Sebastian B Teitz, PhD, Consultant, Consultant
    

    Sebastian Teitz graduated from the 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 a liaison for authorities, CROs, and industry consortiums of the biopharmaceuticals industry. At Biopharma-Excellence he consulted developers of new drugs in scientific- & regulatory affairs during all stages to market access and is currently freelancing serving the biopharma community.

  • 13:10 – 13:50

    Enhancing Clinical Safety: Virus-Inactivated Human Platelet Lysate as Alternative to Clinical-Grade FBS

    • Poster Presenter: Roman Goetzke-Braun, PhD, Senior Scientist, PL BioScience

      

      Roman Goetzke-Braun, PhD, Senior Scientist, PL BioScience
      

      Dr. Roman Goetzke-Braun, PhD, a Postdoc in Stem Cell Biology and a Senior Scientist at PL BioScience GmbH, is a distinguished expert in the field. He studied Biotechnology at RWTH Aachen University and completed his doctorate at the Department of Stem Cell Biology and Cellular Engineering at the Helmholtz Institute in Aachen from 2015 to 2019. During his PhD, Dr. Goetzke-Braun specialized in the interaction of induced pluripotent stem cells and mesenchymal stem cells with soft hydrogels, such as human platelet lysate gel. From 2019 to 2021, he pursued postdoctoral research focusing on the self-organization during the differentiation of pluripotent stem cells. Since 2021, he has been a Senior Scientist at PL BioScience in Aachen, where he focuses on developing a safe, viral-inactivated human platelet lysate.

  • 13:10 – 13:50

    Enhancing Clinical Safety: Virus-Inactivated Human Platelet Lysate as Alternative to Clinical-Grade FBS

    • Poster Presenter: Roman Goetzke-Braun, PhD, Senior Scientist, PL BioScience

      

      Roman Goetzke-Braun, PhD, Senior Scientist, PL BioScience
      

      Dr. Roman Goetzke-Braun, PhD, a Postdoc in Stem Cell Biology and a Senior Scientist at PL BioScience GmbH, is a distinguished expert in the field. He studied Biotechnology at RWTH Aachen University and completed his doctorate at the Department of Stem Cell Biology and Cellular Engineering at the Helmholtz Institute in Aachen from 2015 to 2019. During his PhD, Dr. Goetzke-Braun specialized in the interaction of induced pluripotent stem cells and mesenchymal stem cells with soft hydrogels, such as human platelet lysate gel. From 2019 to 2021, he pursued postdoctoral research focusing on the self-organization during the differentiation of pluripotent stem cells. Since 2021, he has been a Senior Scientist at PL BioScience in Aachen, where he focuses on developing a safe, viral-inactivated human platelet lysate.

  • 13:10 – 13:50

    Genedata Selector®: Next Generation Sequencing Based Biosafety Assessment of Biologics in a Validated Environment

    • Poster Presenter: Christoph Bredack, Dr., Business Account Manager, Genedata AG

      

      Christoph Bredack, Dr., Business Account Manager, Genedata AG
      

      Christoph Bredack joined Genedata Basel in 2016. He is responsible for business development and scientific consulting within the Genedata Selector unit. Genedata Selector is an enterprise platform designed to streamline Next-Generation Sequencing (NGS) based applications within the life science industry. Previously, Christoph worked at Roche in Switzerland as Postdoc in the neuroscience department in the Molecular Imaging group. He earned his PhD at the Max-Planck-Institute of Experimental Medicine in Goettingen, Germany, in Molecular Biology and Molecular Neuroscience.

  • 13:10 – 13:50

    Mechanistic Modeling of Minute Virus of Mice Virus-Like Particle Removal by Anion Exchange Chromatography

    • Poster Presenter: Lukas Doering, PhD Student, Rentschler Biopharma SE

      

      Lukas Doering, PhD Student, Rentschler Biopharma SE
      

  • 13:10 – 13:50

    Qualifying and Using Virus Filtration Integrated Into Low- and High-Flux Continuous Processes

    • Poster Presenter: Sherri Dolan, BS Biochemistry, Technical Consultant, Sartorius Stedim North America

      

      Sherri Dolan, BS Biochemistry, Technical Consultant, Sartorius Stedim North America
      

      Sherri Dolan is Technical Consultant for virus clearance working in the Applications and Testing Group at Sartorius Stedim North America. She has been with Sartorius for the past 19 years and has 36 years of experience working in the biopharmaceutical industry holding various positions focusing on downstream purification and clinical manufacturing of monoclonal and bispecific antibodies. She holds a BS degree in Biochemistry and has co-authored 12 publications and 3 book chapters on the topics of membrane chromatography, virus clearance and monoclonal antibody production. She resides in South Carolina, USA.

  • 13:10 – 13:50

    Rapid Detection of Adventitious Agents using Next-Generation Sequencing (NGS) and a Proprietary Analysis Pipeline

    • Poster Presenter: Amber L. Overgard, MSDS, Bioinformatician, Merck KGaA

      

      Amber L. Overgard, MSDS, Bioinformatician, Merck KGaA
      

      Amber Overgard is a bioinformatician in the Omics and Machine Learning R&D department at Merck and has been with the company for 10 years. Her experience includes molecular assay development, validation, and GxP assay data analysis. She has contributed to the successful launch of over 30 molecular assays for a wide variety of stakeholders. Currently, she evaluates complex bioinformatics algorithms, and develops and validates new computational pipelines for various biosafety testing purposes. Amber holds a Bachelor of Science (BS) in Biochemistry, and a Master of Science in Data Science (MSDS) in Bioinformatics and Computational Biology.

  • 13:10 – 13:50

    Recombinant Retrovirus-Like Particles as Non-Infectious Surrogates for Virus Clearance Evaluation in Bioprocess Development

    • Poster Presenter: 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.

  • 13:10 – 13:50

    Risk Mitigation of Usutu Virus Contamination of Raw Materials and Cell Lines for Biopharmaceutical Products by Classical In Vitro Adventitious Virus Assay

    • Poster Presenter: Florian Wrensch, Dr, Senior Scientist, Solvias France

      

      Florian Wrensch, Dr, Senior Scientist, Solvias France
      

      Dr. Wrensch is a Senior Scientist in the Virology department at Solvias France focusing on biosafety and release testing in biologicals and ATMPs. His previous academic experience includes a Postdoc in the Institute for translational medicine and liver disease in Strasbourg, France and a PhD in Virology at the German Primate Center in Göttingen, Germany. Dr. Wrensch has published over 20 papers in peer reviewed journals on Virology and Hepatology.

  • 13:10 – 13:50

    Unexpected Virus Loss During Post-Spike Filtration for Anion Exchange

    • Poster Presenter: Jena M. Daya, MS, Process Development Engineer III, Regeneron Pharmaceuticals, Inc.

      

      Jena M. Daya, MS, Process Development Engineer III, Regeneron Pharmaceuticals, Inc.
      

      Jena Daya is a member of a dedicated Viral Clearance sub-group in Preclinical Manufacturing and Process Development (PMPD) at Regeneron Pharmaceuticals, Inc., New York. Jena has 10 years of experience in the biopharmaceutical industry. She began her career in downstream GMP manufacturing at GSK. In 2016, she joined Regeneron, where she supports viral clearance studies and regulatory filings at every stage of the product lifecycle. Jena holds a B.S. in Chemical and Biomolecular Engineering from Johns Hopkins University, and a M.S. in Chemical Engineering from Villanova University. Outside of work, Jena enjoys all outdoor activities, especially running and hiking.

  • 13:10 – 13:50

    Unlocking the Potential of Multi-Spiking for ATMPs Produced Using Baculovirus-Insect Cell Systems

    • Poster Presenter: Sandra Meier

      

      Sandra Meier
      

  • 13:10 – 13:50

    Utilizing Retrovirus-like Particles (RVLP) to Evaluate Viral Clearance for Multiple Modes of Separation

    • Poster Presenter: 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.

  • 13:10 – 13:50

    Viral Clearance Assessment of Chromatography Steps During Purification of a Biological Using Multi-Virus-Spiking and Specific Infectous Virus Titration Assay

    • Poster Presenter: Yves Barbier, MA, Sales and Marketing Director, TEXCELL FRANCE

      

      Yves Barbier, MA, Sales and Marketing Director, TEXCELL FRANCE
      

      After a master's degree in microbiology and immunology, I joined Florence Colbère-Garapin's laboratory in the medical virology unit headed by Professor Florian Horaud at the Pasteur Institute to study the persistence of the virus responsible for Poliomyelitis. In 1993, I joined the Texcell service laboratory of the Pasteur Institute as a virology research engineer to develop viral safety tests using PCR tools to secure biological products and to study industrial processes regarding their capacity to inactivate and/or eliminate viruses: 'viral validation'. After 6 years spent carrying out viral security experiments supervised by my mentors such as Professor Françoise Barré-Sinoussi, Nobel Prize winner in Medicine and Director of Studies using retroviruses, then a 6-month stay in the United States, I held the position of Business Development Manager at Texcell. In 2002, having become Deputy Director of the laboratory, I had the chance to initiate the spin-off of the laboratory from the Institut Pasteur and to participate in the creation of Texcell SA as co-founders and Vice President, Sales and Marketing. After developing commercial activity in Europe, the United States and then Asia, and completing an MBA Executive Management at ESSEC in 2018-2019, I am currently responsible for strategic commercial development. For more than 32 years in the environment of viral safety of health products of biological origin, and having the chance to have followed all the evolution of regulations and guidelines in terms of safety, I am asked to carry out assessments on all types of products of biological origin developed by our customers, and also to give courses to future students of biotechnology engineers or pharmacists on the current regulations on recombinant proteins and monoclonal antibodies.

  • 13:10 – 13:50

    Viral Vectors Inside an Isolator - Approaches to Minimize Their Associated Risks

    • Poster Presenter: Maximilian Mittelviefhaus

      

      Maximilian Mittelviefhaus
      

• 13:50 – 14:05

  Interactive Questionnaire Session

  Salon ABC

  • 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

  Salon ABC

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

    

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

    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.

  Salon ABC

  • 14:05 – 14:20

    Temperature Check: Adoption and Challenges of NGS Implementation from the CRO Perspective

    • 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, MSc, Research Associate, Next Generation Sequencing, IDT Biologika GmbH

      

      Oliver Klepsch, MSc, Research Associate, Next Generation Sequencing, IDT Biologika GmbH
      

      Oliver Klepsch is a scientist in the analytical development team at IDT Biologika since 2020. His primary research field is the development and implementation of advanced analytical methods for specific detection of adventitious virus infection for conduction of viral safety evaluations. Oliver received his master of science in biosystems engineering from the University of Magdeburg, Germany and investigated the molecular mechanisms of the signal transduction of the cellular inflammatory response in collaboration with the University of Magdeburg, Germany and the Hebrew University of Jerusalem, Israel.

  • 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, PathoQuest

      

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

      Marc Eloit served as a Professor of Virology at the Veterinary School of Maisons-Alfort and held the position of Head of the Pathogen Discovery Laboratory at Institut Pasteur Paris until October 2023. He is deeply involved in virus discovery and the safety of biologicals. He has published a large number of scientific papers in the field of virology. He was member of the Virus Safety of Medicinal Products Committee, French Agency of Medicinal Products (1992-2013). In 2010, he founded PathoQuest, a spin-out of Institut Pasteur dedicated to the comprehensive testing of biologicals using untargeted Next Generation Sequencing (NGS). Serving as its Chief Scientific Officer (CSO) till 2016, he currently acts 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
      

      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, MSc, Research Associate, Next Generation Sequencing, IDT Biologika GmbH

      

      Oliver Klepsch, MSc, Research Associate, Next Generation Sequencing, IDT Biologika GmbH
      

      Oliver Klepsch is a scientist in the analytical development team at IDT Biologika since 2020. His primary research field is the development and implementation of advanced analytical methods for specific detection of adventitious virus infection for conduction of viral safety evaluations. Oliver received his master of science in biosystems engineering from the University of Magdeburg, Germany and investigated the molecular mechanisms of the signal transduction of the cellular inflammatory response in collaboration with the University of Magdeburg, Germany and the Hebrew University of Jerusalem, Israel.

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

      

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

      Marc Eloit served as a Professor of Virology at the Veterinary School of Maisons-Alfort and held the position of Head of the Pathogen Discovery Laboratory at Institut Pasteur Paris until October 2023. He is deeply involved in virus discovery and the safety of biologicals. He has published a large number of scientific papers in the field of virology. He was member of the Virus Safety of Medicinal Products Committee, French Agency of Medicinal Products (1992-2013). In 2010, he founded PathoQuest, a spin-out of Institut Pasteur dedicated to the comprehensive testing of biologicals using untargeted Next Generation Sequencing (NGS). Serving as its Chief Scientific Officer (CSO) till 2016, he currently acts 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

  Studio 3,4,5,6,7

  Studio 3,4,5,6,7
• 15:55 – 17:15

  Session 3: Novel Approaches and Digitization

  Salon ABC

  • 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 a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from 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.

  Salon ABC

  • 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 a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from 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

• 08:00 – 17:30

  Registration Open

  Studio 3,4,5,6,7
• 09:00 – 09:01

  Welcome to Day 2

  Salon ABC

  • 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, to provide 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.

  Salon ABC
• 09:02 – 10:15

  Session 4: Virus Inactivation and Virus Removal

  Salon ABC

  • 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.

  Salon ABC

  • 09:02 – 09:15

    Inactivation of Hepatitis E Virus by Terminal Dry Heat Treatment

    • Presenter: Thomas Unterkircher, PhD, GLP Study Director, Octapharma Biopharmaceuticals, Virus and Prion Validation

      

      Thomas Unterkircher, PhD, GLP Study Director, Octapharma Biopharmaceuticals, Virus and Prion Validation
      

      Dr. Thomas Unterkircher acts as GLP study director at Octapharma’s Virus and Prion Validation department. Thomas joined the department in 2017 as a scientist. In his current role, he supervises virus validation studies for plasma derived medicinal products. Furthermore, he is the responsible project leader for gene-technological matters and a subject matter expert for the Plasma Master File. He oversees the assay development (NAT and infectivity based methods) and is responsible for virus and prion related matters concerning selected Octapharma products. After Thomas’ master’s degree in molecular biology at the University of Innsbruck, Austria, he worked in brain cancer research receiving a PhD in molecular medicine from the University of Ulm, Germany, and a postdoc fellowship from the University hospital of Freiburg, Germany.

  • 09:15 – 09:30

    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

      

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

      Daniel Strauss is Director of the Research and Development group at Asahi Kasei Bioprocess America in Glenview, Illinois, as well as a Lead Expert in biomanufacturing at Asahi Kasei Medical. His work focuses on providing data to better understand the capabilities of Planova virus filters and on providing solutions to allow customers to efficiently provide safe biotherapeutic products to their patients. Danny received a Ph.D. in Biochemistry from the University of Colorado, Boulder in 2005. He then completed his post-doctoral research in the viral clearance group at Genentech, Inc. and worked as a Research Scientist in the viral clearance group at Eli Lilly until starting with AKBA in 2012. He is a member of ACS and PDA, as well as an active participant in the MAST Center and BioPhorum.

  • 09:30 – 09:45

    Virus Safety of Medical Devices Utilizing Animal Materials

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

      

      Ursula Lauer, PhD, Senior Product Specialist, TÜV SÜD Product Service GmbH
      

      Name: Dr. rer. nat. Ursula Lauer Role: Senior Product Specialist, Medical Device Lead Auditor and Technical Certifier at Notified Body Company: TÜV SÜD Product Service GmbH Studying biology at University of Kaiserslautern focusing on biotechnology, cell biology and zoology. I did my PhD thesis in a joined research project with a Global Pharmaceutical and Diagnostic Company working in the field of natural compounds for inhibition of platelet aggregation in animal and human blood and investigation of signaling pathways in bovine and human thrombocytes. Having finished my thesis, I worked as post doc at university and later for several years as a scientist and project leader in biotechnology industries. During this work I obtained further specific experience with animal and human cells and antibodies. In 2003 I joined TÜV SÜD Product Service. My responsibilities at TÜV are performance of conformity assessments for non-active medical devices utilizing animal origin materials or human blood derivatives. Examples for those devices are absorbable soft tissue implants, antibody solutions, immune adsorbers, scaffolds for tissue engineering, biological heart valves. One major aspect related with these kinds of assessments is virus and TSE safety of animal and human origin including human blood derivatives utilized.

  • 09:45 – 10:15

    Q&A, Discussion

    • 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.

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

      

      Ursula Lauer, PhD, Senior Product Specialist, TÜV SÜD Product Service GmbH
      

      Name: Dr. rer. nat. Ursula Lauer Role: Senior Product Specialist, Medical Device Lead Auditor and Technical Certifier at Notified Body Company: TÜV SÜD Product Service GmbH Studying biology at University of Kaiserslautern focusing on biotechnology, cell biology and zoology. I did my PhD thesis in a joined research project with a Global Pharmaceutical and Diagnostic Company working in the field of natural compounds for inhibition of platelet aggregation in animal and human blood and investigation of signaling pathways in bovine and human thrombocytes. Having finished my thesis, I worked as post doc at university and later for several years as a scientist and project leader in biotechnology industries. During this work I obtained further specific experience with animal and human cells and antibodies. In 2003 I joined TÜV SÜD Product Service. My responsibilities at TÜV are performance of conformity assessments for non-active medical devices utilizing animal origin materials or human blood derivatives. Examples for those devices are absorbable soft tissue implants, antibody solutions, immune adsorbers, scaffolds for tissue engineering, biological heart valves. One major aspect related with these kinds of assessments is virus and TSE safety of animal and human origin including human blood derivatives utilized.

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

      

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

      Daniel Strauss is Director of the Research and Development group at Asahi Kasei Bioprocess America in Glenview, Illinois, as well as a Lead Expert in biomanufacturing at Asahi Kasei Medical. His work focuses on providing data to better understand the capabilities of Planova virus filters and on providing solutions to allow customers to efficiently provide safe biotherapeutic products to their patients. Danny received a Ph.D. in Biochemistry from the University of Colorado, Boulder in 2005. He then completed his post-doctoral research in the viral clearance group at Genentech, Inc. and worked as a Research Scientist in the viral clearance group at Eli Lilly until starting with AKBA in 2012. He is a member of ACS and PDA, as well as an active participant in the MAST Center and BioPhorum.

    • Panelist: Thomas Unterkircher, PhD, GLP Study Director, Octapharma Biopharmaceuticals, Virus and Prion Validation

      

      Thomas Unterkircher, PhD, GLP Study Director, Octapharma Biopharmaceuticals, Virus and Prion Validation
      

      Dr. Thomas Unterkircher acts as GLP study director at Octapharma’s Virus and Prion Validation department. Thomas joined the department in 2017 as a scientist. In his current role, he supervises virus validation studies for plasma derived medicinal products. Furthermore, he is the responsible project leader for gene-technological matters and a subject matter expert for the Plasma Master File. He oversees the assay development (NAT and infectivity based methods) and is responsible for virus and prion related matters concerning selected Octapharma products. After Thomas’ master’s degree in molecular biology at the University of Innsbruck, Austria, he worked in brain cancer research receiving a PhD in molecular medicine from the University of Ulm, Germany, and a postdoc fellowship from the University hospital of Freiburg, Germany.

• 10:15 – 10:45

  Networking Coffee Break, Poster Session & Exhibition

  Studio 3,4,5,6,7

  Studio 3,4,5,6,7
• 10:45 – 12:00

  Session 5: Next Generation Sequencing

  Salon ABC

  • Moderator: Simone Olgiati, PhD, Head of Molecular Biology Technology & Innovation, Merck

    

    Simone Olgiati, PhD, Head of Molecular Biology Technology & Innovation, Merck
    

    Dr. Simone Olgiati is head of the Molecular Biology Technology & Innovation Unit, leading a team of scientists and bioinformaticians within the Healthcare sector of Merck. This unit applies a solid expertise on advanced molecular methods to support the manufacturing and quality control of biotechnological products by developing and validating innovative analytical methods for a variety of applications, mostly in the fields of viral safety and genetic characterization. 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 (lately 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.

  Salon ABC

  • 10:45 – 11:00

    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

      

      Ken Kono, PhD, Chief, National Institute of Health Sciences
      

      Ken Kono is Chief of Viral Safety Section in the Division of Cell-Based Therapeutic Products, National Institute of Health Sciences (NIHS), Japan. He is responsible for viral safety of cell-processed therapeutic products. He is working in several research projects on assessment of viral safety using Next Generation Sequencing technologies. Prior to joining the NIHS in 2011, Kono worked at Osaka University where he performed basic research on host factors involved in HIV replication.

  • 11:00 – 11:15

    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

      

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

      Dr. Arifa S. Khan is a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from George Washington University, Washington, D.C. She has authored more than 100 publications.

  • 11:15 – 11:30

    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

      

      Noémie Deneyer, PhD, Molecular Biology Lead, GSK
      

      Noémie Deneyer is a Senior Manager and Associate GSK Fellow working as Molecular Biology Lead at GSK, with a focus on innovative analytical technologies including NGS. Noémie holds a PhD in Molecular and Cellular Biology from the UCLouvain, Belgium. In 2019, she started her journey at GSK where she was coordinating scientific projects aiming to deploy novel analytical methods for Quality Control testing. In January 2021, she joined the Global Quality Control department where Noémie and her team worked together to develop and implement Next Generation Sequencing in Quality Control to drive innovation and strengthen product safety. Since May 2024, Noémie joined the Manufacturing Sciences & Technology department where she is leading the strategical deployment of new analytical technologies and ensuring connections between Analytical R&D and Quality groups for molecular biology applications. Noémie is also involved in different external working and interest groups such as the AVDTIG where she had the chance to increase her engagement by becoming a co-chair in 2023.

  • 11:30 – 12:00

    Q&A, Discussion

    • Moderator: Simone Olgiati, PhD, Head of Molecular Biology Technology & Innovation, Merck

      

      Simone Olgiati, PhD, Head of Molecular Biology Technology & Innovation, Merck
      

      Dr. Simone Olgiati is head of the Molecular Biology Technology & Innovation Unit, leading a team of scientists and bioinformaticians within the Healthcare sector of Merck. This unit applies a solid expertise on advanced molecular methods to support the manufacturing and quality control of biotechnological products by developing and validating innovative analytical methods for a variety of applications, mostly in the fields of viral safety and genetic characterization. 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 (lately 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.

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

      

      Noémie Deneyer, PhD, Molecular Biology Lead, GSK
      

      Noémie Deneyer is a Senior Manager and Associate GSK Fellow working as Molecular Biology Lead at GSK, with a focus on innovative analytical technologies including NGS. Noémie holds a PhD in Molecular and Cellular Biology from the UCLouvain, Belgium. In 2019, she started her journey at GSK where she was coordinating scientific projects aiming to deploy novel analytical methods for Quality Control testing. In January 2021, she joined the Global Quality Control department where Noémie and her team worked together to develop and implement Next Generation Sequencing in Quality Control to drive innovation and strengthen product safety. Since May 2024, Noémie joined the Manufacturing Sciences & Technology department where she is leading the strategical deployment of new analytical technologies and ensuring connections between Analytical R&D and Quality groups for molecular biology applications. Noémie is also involved in different external working and interest groups such as the AVDTIG where she had the chance to increase her engagement by becoming a co-chair in 2023.

    • 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 a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from George Washington University, Washington, D.C. She has authored more than 100 publications.

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

      

      Ken Kono, PhD, Chief, National Institute of Health Sciences
      

      Ken Kono is Chief of Viral Safety Section in the Division of Cell-Based Therapeutic Products, National Institute of Health Sciences (NIHS), Japan. He is responsible for viral safety of cell-processed therapeutic products. He is working in several research projects on assessment of viral safety using Next Generation Sequencing technologies. Prior to joining the NIHS in 2011, Kono worked at Osaka University where he performed basic research on host factors involved in HIV replication.

• 12:00 – 13:00

  Networking Lunch Break, Poster Session & Exhibition

  Studio 3,4,5,6,7

  Studio 3,4,5,6,7
• 13:00 – 13:15

  Interactive Questionnaire Session

  Salon ABC

  • 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.

  Salon ABC
• 13:15 – 14:00

  Session 6: Sustainability

  Salon ABC

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

    

    Sebastian B Teitz, PhD, Consultant, Consultant
    

    Sebastian Teitz graduated from the 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 a liaison for authorities, CROs, and industry consortiums of the biopharmaceuticals industry. At Biopharma-Excellence he consulted 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.

  Salon ABC

  • 13:15 – 13:30

    The Development of a Sustainable Alternative Detergent to Triton X-100

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

      

      Russell van Buskirk, Senior Principal Scientist, Amgen
      

      Russell Van Buskirk is a Senior Principal Scientist of Bioprocess Development at Amgen. For the past 20 years, Russell has led the teams in the product development of many early-stage and late-stage commercial protein therapeutics. His work includes cell culture and purification development, viral clearance studies, as well as regulatory filings for investigational new drug applications as well as marketing applications. Russell holds a Bachelor of Science degree in Medical Microbiology from California State University.

  • 13:30 – 13:45

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

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

      

      Derek Pacheco, Scientist I, Just-Evotec Biologics
      

      Derek Pacheco is a scientist at Just-Evotec Biologics where he specializes in developing robust purification processes for Mab-like molecules using high throughput screening and bench-scale evaluation. During his tenure at Just-Evotec Biologics, Derek has been a champion of developing alternative options for the hybrid-continuous platform process by interrogating both resins and solutions that can broaden the platform capabilities. Derek holds a B.S. in molecular, cellular, and developmental biology from University of Washington.

  • 13:45 – 14:00

    Q&A, Discussion

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

      

      Sebastian B Teitz, PhD, Consultant, Consultant
      

      Sebastian Teitz graduated from the 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 a liaison for authorities, CROs, and industry consortiums of the biopharmaceuticals industry. At Biopharma-Excellence he consulted developers of new drugs in scientific- & regulatory affairs during all stages to market access and is currently freelancing serving the biopharma community.

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

      

      Derek Pacheco, Scientist I, Just-Evotec Biologics
      

      Derek Pacheco is a scientist at Just-Evotec Biologics where he specializes in developing robust purification processes for Mab-like molecules using high throughput screening and bench-scale evaluation. During his tenure at Just-Evotec Biologics, Derek has been a champion of developing alternative options for the hybrid-continuous platform process by interrogating both resins and solutions that can broaden the platform capabilities. Derek holds a B.S. in molecular, cellular, and developmental biology from University of Washington.

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

      

      Russell van Buskirk, Senior Principal Scientist, Amgen
      

      Russell Van Buskirk is a Senior Principal Scientist of Bioprocess Development at Amgen. For the past 20 years, Russell has led the teams in the product development of many early-stage and late-stage commercial protein therapeutics. His work includes cell culture and purification development, viral clearance studies, as well as regulatory filings for investigational new drug applications as well as marketing applications. Russell holds a Bachelor of Science degree in Medical Microbiology from California State University.

• 14:00 – 14:30

  Networking Coffee Break, Poster Session & Exhibition

  Studio 3,4,5,6,7

  Studio 3,4,5,6,7
• 14:30 – 14:35

  Passport Raffle

  Salon ABC

  • Moderator: Melanie Decker, Parenteral Drug Association

    

    Melanie Decker, Parenteral Drug Association
    

  Salon ABC
• 14:35 – 16:00

  Closing Plenary: Regulatory Perspectives and Novel Therapies

  Salon ABC

  • 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.

  Salon ABC

  • 14:35 – 14:50

    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 since 2015. Over the past years, she has extensively studied various aspects of recombinant protein manufacturing focusing on regulatory concerns associated with 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 of numerous scientific articles related to biotechnology manufacturing.

  • 14:50 – 15:15

    Virus Safety of Xenotransplantation

    • Academic Presenter: Joachim Denner, PhD, Head of laboratory, Institute of Virology, Freie Universität Berlin

      

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

  • 15:15 – 16:00

    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 since 2015. Over the past years, she has extensively studied various aspects of recombinant protein manufacturing focusing on regulatory concerns associated with 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 of 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 a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as 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. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from 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
      

      Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with the 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 participated as an expert in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed to the drafting of numerous Guidelines and Monographs on viral safety. Further, he is working on several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he has been 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. Before 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 five years of 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 a teaching graduation (Habilitation) in Medical Virology from the University of Frankfurt.

    • Academic Panelist: Joachim Denner, PhD, Head of laboratory, Institute of Virology, Freie Universität Berlin

      

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

      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: Rick S., Patient Advovate, CSL Behring

      

      Rick S., Patient Advovate, CSL Behring
      

      I was diagnosed with hemophilia B when I was born. For most of my childhood, I was alone in the hospital receiving frozen plasma treatments and felt ashamed of my condition. But when I was a teenager, a Bruce Lee movie inspired a lifelong love of martial arts. I became a taekwondo champion, but in my 50s, my body couldn’t handle the intense physical activity anymore. Instead, I learned tai chi, which taught me a sense of mindfulness and body connectivity that I hadn’t experienced before. I started teaching meditation and tai chi to others, which helped me learn that this condition isn’t a journey you go through alone. It’s something you share with the people in your life who love you. It took many years, but I’ve learned that this condition isn’t something to be ashamed of. My confidence is a strength I can teach others.

• 16:00 – 16:15

  Co-Chairs Conference Summary

  Salon ABC

  • 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, to provide 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.

  Salon ABC
• 16:15 – 16:25

  Closing Remarks & Farewell

  Salon ABC

  • 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.

  Salon ABC

Posters

• Roman Goetzke-Braun, PhD, Senior Scientist, PL BioScience

• Christoph Bredack, Dr., Business Account Manager, Genedata AG

• Lukas Doering, PhD Student, Rentschler Biopharma SE

• Sherri Dolan, BS Biochemistry, Technical Consultant, Sartorius Stedim North America

• Amber L. Overgard, MSDS, Bioinformatician, Merck KGaA

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

• Florian Wrensch, Dr, Senior Scientist, Solvias France

• Jena M. Daya, MS, Process Development Engineer III, Regeneron Pharmaceuticals, Inc.

• Sandra Meier

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

• Yves Barbier, MA, Sales and Marketing Director, TEXCELL FRANCE

• Maximilian Mittelviefhaus