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PDA Next Generation Sequencing Workshop 2024
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Program Highlights
The agenda preview is now published!
Join this one-day interactive workshop after the PDA Virus Conference 2024, and join the discussion with industry experts on challenges and solutions all around NGS!
Dear Colleague,
We would like to invite you to the PDA Next Generation Sequencing Workshop 2024 to take place on 28 June 2024 in Amsterdam, The Netherlands directly after the PDA Virus Conference 2024.
We look forward to welcoming you!
Sincerely,
The Workshop Leader
Simone Olgiati, Merck KGaA
SCIENTIFIC PROGRAM PLANNING COMMITTEE
- Simone Olgiati, Merck KGaA
- Alison Armstrong, Merck KGaA
- Andy Bailey, ViruSure
- Johannes Bluemel, Paul-Ehrlich-Institut
- Arifa Khan, U.S. FDA
- Sean O'Donnell, Eli Lilly and Company
- Sebastian Teitz, Biopharma Excellence
- Falk Klar, PDA Europe
- Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
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Standard Registration
Member Price
€1.080Non-Member
€1.080
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Friday, 28 June 2024
09:00 Welcome and Introduction |
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Falk Klar, PDA |
Topic 1: Implementation of Next Generation Sequencing in a Regulated Environment | ||||||
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Moderator: Pharmacopoeia Chapter 2.6.41 on High Throughput Sequencing EFPIA’s Perspective on Validation of Next Generation Sequencing for Virus Safety Testing Update on FDA perspective on NGS for Virus Detection 09:55 - 10:25 Coffee Break
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Featured Presenters
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Melissa Alzona, PhD
Merck
Read BioMelissa Alzona, PhD
Merck
Melissa Alzona, PhD, is Associate Scientist in the Innovative Sequencing laboratory at Merck. In her role, she is actively involved in development of molecular-based methods using cutting edge sequencing technologies, with a particular focus on virus detection strategies. She holds a Master Degree in Molecular Biology from the University of Turin and a PhD in Molecular Medicine in collaboration with Merck. During her studies she focused on innovative molecular methods to support Quality Control and to improve the Cell Line Development process, developing strong expertise on both the Droplet Digital PCR and Next Generation Sequencing technologies
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Christoph Bredack, PhD
Genedata
Read BioChristoph Bredack, PhD
Genedata
Christoph Bredack joined Genedata Basel in 2016. He is responsible for the business development and scientific consulting within the Genedata Selector unit. Previously, he 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.
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Elodie Charbaut Taland, PhD
Global Regulatory Affairs, Merck
Read BioElodie Charbaut Taland, PhD
Merck
Elodie Charbaut Taland works as Associate Director in Merck KGaA GRA CMC Regulatory Intelligence team. She has 15 years of experience in biological drug substance process development and manufacturing, covering development products, marketed products, and biosimilars. She is now involved in CMC regulatory intelligence activities, with a focus on advocacy for the introduction of innovative technologies. In this context, she is co-leading the elaboration of the EFPIA position paper on the use of Next Generation Sequencing for virus safety testing. Elodie Charbaut Taland holds an Engineering degree from Ecole Polytechnique, France, and a PhD in Neurosciences from the University Pierre et Marie Curie, France.
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Izabela Fabianska
IDT Biologika
Read BioIzabela Fabianska
IDT Biologika
Dr. Izabela Fabianska is a scientist in the Analytical Development team at IDT Biologika since 2020, where she performs computational analyses of sequencing data. She was involved in the development and validation of the analysis workflows for virus detection and genome identity testing. She studied biotechnology in Poznan, Poland before she joined the International Max Planck Research School (IMPRS) at the Max Planck Institute for Plant Breeding Research in Cologne, Germany. In 2017, she received a PhD degree from the University of Cologne. During her PhD and short post-doc, she did research in plant and soil microbiome including the plant molecular responses to environmental changes, NGS sample preparation, development of NGS data analysis pipeline, and multivariate data analysis.
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Hans Peter Fasching
ViruSure
Read BioHans Peter Fasching
ViruSure
He studied molecular biology with a focus on molecular medicine at the University of Vienna. Hans-Peter started at ViruSure in 2015 as a scientific assistant also performing his master thesis within the company. The title of the thesis was “Development of Real-time PCR assays and application of next generation sequencing for viral safety evaluation of insect cell substrates and derived bioproducts”. After finishing his master’s thesis, he continued working at ViruSure and implemented the Sanger Sequencing service. While at the company, he progressed to become both GMP assay coordinator and GLP study director. Currently he is the deputy head of the molecular biology group and focus on the establishment of NGS services.
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Christophe Lambert, PhD
GSK
Read BioChristophe 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.
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Siemon Ng, PhD
Notch Therapeutics
Read BioSiemon 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.
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Charles Swofford
MIT
Read BioCharles Swofford
MIT
Charley Swofford has been at the Center for Biomedical Innovation at MIT since 2022, where he is the Assistant Director for Biomanufacturing Initiatives. In this role, he manages collaborative sponsored research projects, including investigating ONT sequencing for adventitious agent detection and developing a continuous manufacturing testbed for virus-like particle (VLP) vaccine production. He also supports joint research projects among members of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), a pre-competitive biopharmaceutical industry consortium focused on identifying and sharing best practices to mitigate the risk of adventitious agent contamination in biopharmaceutical manufacturing. Dr. Swofford received his Ph.D. in Chemical Engineering from the University of Massachusetts Amherst in 2014, where he engineered microbes for targeted cancer drug delivery.
Presenters
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Alison Armstrong, PhD
Merck KGaA
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.
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Andy Bailey, PhD
ViruSure
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.
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Johannes Blümel, PhD
Paul-Ehrlich-Institut
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.
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Arifa S. Khan, PhD
U.S. FDA
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.
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Sean Michael O'Donnell, PhD
Executive Director, Eli Lilly and Company
Sean Michael O'Donnell, PhD
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. -
Simone Olgiati, PhD
Merck
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.
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Sebastian B Teitz, PhD
Consultant, Consultant
Sebastian B Teitz, PhD
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.
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For more information about exhibit and sponsorship opportunities, please contact:
Christopher Härtig
Senior Manager Exhibition & Sponsorship
Email
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Amsterdam Marriott Hotel
Stadhouderskade 12Amsterdam, The Netherlands , The Netherlands
PDA recommends the reservation at the following hotel
Amsterdam Marriott Hotel
Stadhouderskade 12
1054 ES Amsterdam
The
Netherlands
PDA Europe has reserved a limited number of rooms by 11 April 2024.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
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