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Committee & Speaker Biographies

Committee & Presenter Biographies

2023 PDA Virus Conference

20 - 21 June 2023

  • Alison Armstrong

    Alison Armstrong, PhD

    Merck KGaA

    Dr Alison Armstrong serves as the Global Head Technical and Scientific Solutions leading a team of scientific and regulatory experts within the Merck BioReliance® testing services business.  This global scientific team provides an understanding of scientific and regulatory application throughout the biologics product lifecycle. A key focus of the team is to develop scientific relevance through thought leadership activities at international conference, webinars and writing assignments. Dr Armstrong has held 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, member of industry forums and has published more than 40 peer-reviewed papers and editorials.

  • Andy Bailey

    Andy Bailey, PhD

    ViruSure

    Andy Bailey specialized 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 27 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products or as an invited speaker at expert workshops. In 2005 he founded ViruSure, now a part of the Asahi Kasei Medical group, with the goal of providing a high quality science based testing service to the biopharmaceutical industry.

  • Johannes Bluemel

    Johannes Blümel, PhD

    Paul-Ehrlich-Institut

    Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products and recombinant DNA products. He participates in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure as a national expert. Further, he is working in several research projects on virus inactivation and virus removal.

    Prior to joining the Paul-Ehrlich-Institut in 1998, Johannes worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics.

    He completed his Diploma in Biology (molecular genetics, microbiology, biophysics and physical chemistry) the University of Freiburg, Germany and received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany. In 2010, he received teaching credential in Medical Virology from the University Frankfurt.

  • Qi Chen

    Qi Chen, PhD

    Genentech

    Qi Chen, Ph.D. is a Staff Scientist in Process Virology, Purification Department, Pharma Technical Development US at Genentech, Inc. She joined the Process Virology group in 2001. Since 2003, she has led this group for viral clearance validation of Genentech’s CHO cell derived mAb and recombinant protein therapeutics. She received her B.Sc in Virology from Wuhan University, M.Sc in Virology from Institute of Virology, Chinese Academy of Medical Sciences in P.R. China. She received her Ph.D in Developmental Genetics from the University of Texas at Austin, and her postdoctoral training in Molecular Oncology at Genentech.

  • Tomoko Hongo

    Tomoko Hongo-Hirasaki, PhD

    Asahi Kasei

    Tomoko Hongo-Hirasaki has worked with Planova virus removal filters for over 25 years. She obtained her Ph.D. of Pharmaceutical Science from Kyushu University for a study of the separation mechanisms of biopolymers on cellulose porous membranes. She specializes in virus evaluation, colloid science, membrane science and biophysics of proteins. She is the lead expert of Evaluation and Analysis in Virus Filtration in the Bioprocess Division as advanced professional system in Asahi Kasei. Her research has focused on virus filtration mechanisms, viral clearance study design, design space studies for virus filtration and the characterization of virus removal membranes. Now she is in charge of global scientific activity and leading scientific publication. She is a member of the Bio-virus Committee of the PDA Japan, and is also active in the field of virus safety.

  • Arifa Khan

    Arifa S. Khan, PhD

    U.S. FDA

    Dr. Arifa S. Khan is Head, Molecular Retrovirology Unit, Division of Viral Products, Office of Vaccines Research and Review, in the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. She moved her retrovirus reseach program from NIAD/NIH to CBER in 1991, where she is currently leading efforts for applications of high-throughput sequencing for endogenous retrovirus and adventitious virus detection for safety evaluation of biologics. Her primary regulatory responsibilities include viral vaccines, including HIV-1, influenza virus 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 licensure of several viral vaccines and development of FDA, ICH, PHS, USP, and WHO documents. Dr. Khan obtained her Ph.D. in Microbiology from the George Washington University, Washington, D.C. She has authored more than 100 publications.

  • Kreil Thomas

    Thomas R. Kreil, PhD

    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.

  • Sean O'Donnell

    Sean O'Donnell, PhD

    Eli Lilly and Company

    Dr. O’Donnell is a Principal Research Scientist in the purification development and virology 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 12 years of industry experience, working in various aspects of viral research and viral safety.

  • Sebastian Teitz

    Sebastian B. Teitz, PhD

    Biopharma Excellence

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

  • David Cetlin

    David Cetlin

    Cygnus Technologies

    David Cetlin is the Senior Director of R&D at Cygnus technologies and the former founder and C.E.O. 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.

  • Noemie Deneyer

    Noémie Deneyer, PhD

    GSK

    Noémie Deneyer is a Senior Manager and Global Subject Matter Expert at GSK, with a focus on Next Generation Sequencing for Quality. In 2019, she started her journey at GSK where she was coordinating scientific projects aiming to deploy novel analytical methods for Quality Control testing. Since January 2021, she joined the Global Quality Control and Product Quality department where Noémie and her team work together to develop and implement Next Generation Sequencing in Quality Control to drive innovation and strengthen product safety. Noémie holds a PhD in Molecular and Cellular Biology from the UCLouvain, Belgium.

  • John Fisher

    John Fisher

    Genentech

    John Fisher is a Senior Principal Engineer in Process Virology, Purification Department, Pharma Technical Development US at Genentech Inc., a Member of the Roche Group. He joined Genentech in 2012 and currently leads the group responsible for virus clearance validation of Genentech’s clinical and commercial therapeutics. John has 15 years of experience in virus safety related roles including positions in Purification Development, Manufacturing Sciences, and Process Virology. He specializes in virus filtration technologies and strategies for virus segregation in manufacturing facilities. He obtained a Bachelors of Science in Chemical Engineering from the University of California, at Berkeley.

  • Bradley Hasson

    Bradley Hasson

    MilliporeSigma

    Bradley Hasson is the Director of Lab Operations for Next Generation Sequencing Services at Merck KGaA. Brad leads a team of Scientists, laboratory technicians and bioinformaticians that perform NGS-based biosafety testing services in support of product characterization and release worldwide. He has 15 years of experience developing and implementing molecular-based methods for the purposes of Adventitious Agent Detection in a variety of biologically derived products.

  • Sarah Johnson

    Sarah Johnson, PhD

    U.S. FDA

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

  • Christophe Lambert

    Christophe Lambert, PhD

    GSK

    Christophe Lambert is Associate Director in Data Science at GSK Vaccines in Belgium. He graduated B.Sc. and M.Sc. in Chemistry and was awarded PhD in bioinformatics from the University of Namur (Belgium) in 2003 for the automated prediction of protein 3D structures and for the automated bacterial genome annotation. In 2003, Dr. Lambert co-founded a company providing expert bioinformatics services to pharmaceutical, biotech and agrofood companies. In 2006, he also co-founded BioWin, the Health competitiveness cluster of Wallonia (Belgium), bringing together stakeholders participating in innovative projects and/or education in the fields of Health biotechnology and medical technologies. He joined GSK in 2014 to provide expertise in protein 3D structure, HTS data analysis and manage the development of an analysis pipeline for Adventitious Virus Detection. Since 2016, Dr. Lambert is the leader of the AVDTIG Subgroup D exploring bioinformatics pipelines and reviewing best practices and perspectives about using HTS for virus detection.

  • Remo Leisi

    Remo Leisi, PhD

    CSL Behring

    Remo Leisi leads the Translational Research and Innovation team 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.

  • Ng Siemon

    Siemon Ng, PhD

    Notch Therapeutics

    Dr. Siemon Ng is the Senior Director, Analytical Development and Quality at Notch Therapeutics and is responsible for developing and implementing the analytical strategy for Notch’s iPSC-derived immunotherapies.

    Dr. Ng has extensive experience with analytical development including next generation sequencing and NGS data analysis, digital PCR, qPCR, and other molecular and immunological techniques. Dr. Ng is an active member of the PDA Advanced Virus Detection Technologies Interest Group and has participated in multiple collaborative studies involving the use of NGS. Prior to joining Notch Therapeutics in 2022, Dr. Ng was the Head of the Molecular Biology Centre at Sanofi Pasteur, Analytical Sciences for vaccine development.

    Dr. Ng completed his PhD at Simon Fraser University studying the Atlantic salmon genome. Subsequently, he worked on mouse genomics at The Jackson Laboratory. In 2008, Dr. Ng moved to Toronto to study the genomic landscape of stem cells at the Ontario Institute for Cancer Research and later joined Sanofi Pasteur in 2011.

  • Simone Olgiati

    Simone Olgiati, PhD

    Merck

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

  • Horst Ruppach

    Horst Ruppach, PhD

    Charles River

    Dr. Horst Ruppach studied Chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House, Frankfurt.

    He has 25 years of experience in the field of virology. His expertise is in virus safety testing and virus/prion clearances studies requested for all biopharmaceuticals and medical devices using animal or human derived materials.

    He is a proven expert for technical and regulatory aspects of virus safety testing and virus/prion clearances studies.

  • Wenbo Sai

    Wenbo Sai, PhD

    Center for Drug Evaluation

    Dr. Wenbo Sai, holds a doctorate in Microbiology and Biochemical Pharmacy of China Pharmaceutical University and has been a reviewer in Pharmacy Department of Biological Products of Center for Drug Evaluation since 2017. He has mainly engaged in pharmaceutical professional technical evaluation of products of recombinant biotechnology and advanced treatment, and drafted normative technical documents such as Guidelines for Platform Process Validation of Viral Removal and Inactivation of Recombinant Biotechnology Products. He is now involved in the revision of issues of ICH Q5A (R2) as an expert.

  • Hironobu Shirataki

    Hironobu Shirataki

    Asahi Kasei

    Dr. Shirataki graduated physics department of Hokkaido University in Japan and got the Doctor of Science by the study of polymer physics. He has a lot of carriers in the research and development as an employee of Asahi Kasei Co., ltd. Currently he is a Senior Consultant of scientific affairs at Asahi Kasei Medical and mainly studying the virus filter and column chromatography for the protein purification and virus reduction.