22-23 June 2020, Brussels, Belgium
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.
Andy Bailey is a virologist who served 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 Pathogen Safety group of Baxter Healthcare in Vienna, Austria. Over the last 20 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies either in support of products at the UK MHRA, German PEI, French AFFSAPS, US FDA, KFDA (Korea), EMEA and JMHLW (Japan) supporting regulatory submissions for various products. He has extensive experience in regulatory affairs and virus safety issues. Since 2005 he has been the founder and CEO of ViruSure in Vienna, Austria, a company specialising in the virus and prion safety of biopharmaceutical products
Dr. Dehghani is a Principal Scientist at Amgen. His area of expertise is viral and microbial safety evaluation of mammalian cell culture processes. Following his post-doctoral training at the National Institute of Allergy and Infectious Diseases, he joined Amgen, Inc. in 2003 as a member of the Biosafety Development Laboratory.
Currently, he leads the Biosafety Development Laboratory, which is involved with development and assessment of new technologies for detection and identification of adventitious contaminants of mammalian cell culture processes as well as viral clearance assessment studies in both cGMP and development settings.
Houman holds a Ph.D. degree from Michigan State University in Cell and Molecular Biology.
Falk Klar holds a PhD in Applied Physics and has more than 19 years of experience in Quality Assurance and Compliance. Before joining PDA Europe, he worked for the pharmaceutical, biopharmaceutical, and medical device industries, and in clinical research.
Falk joined PDA Europe in 2015 as Senior Director Training & Education. He will develop and extend PDA Europe’s portfolio of training courses and workshops for the parenterals market. Recently, he was appointed General Manager and Vice President PDA Europe.
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.
Dr. Kreil obtained a PhD in Biochemistry from the University of Vienna, Austria, and spent several years on post-doctoral research at the same institution focusing on antiviral immunology and specifically, the role of antiviral antibodies. He then joined Takeda (Immuno/Baxter/Baxalta/Shire), working in the area of Pathogen Safety of biopharmaceuticals, as well as research on virus antibodies and vaccines. He is well-published and has been a frequent international lecturer on the safety of biological medicinal products versus viruses and prions as well as antiviral defense, with particular emphasis on the role of virus antibodies/IVIG and vaccines.
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 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.
Dr. Barone has been at the MIT Center for Biomedical Innovation since 2010. He currently is the Associate Director of two biopharmaceutical industry consortia housed at MIT: the Biomanufacturing Research Program (BioMAN) and the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB). He manages sponsored projects and activities for both BioMAN and CAACB with topics ranging from analysis of media treatment options to risk assessment and risk control for adventitious agent contamination.
Maria is a scientist at Biogen, located in Research Triangle Park, North Carolina. As part of the Analytical Technology department for the Quality Control organization she is responsible for the development and validation of NGS methods and implementing new assays for the global Quality Control Virology group. Maria joined Biogen in 2017 after receiving her Ph.D. in Chemistry from Duke University and completion of a Postdoctoral fellowship at the University of North Carolina at Chapel Hill.
Marc Eloit is Professor of Virology at the Veterinary School of Maisons-Alfort and the head of the Pathogen Discovery laboratory at Institut Pasteur Paris, which is using Next Generation Sequencing as a routine method for discovering new viruses in human patients and animal reservoirs.
He has been a member of the Virus Safety Committee, French Agency of Medicinal Products (1992-2012).
He has served as a consultant to many companies on the field of virus safety of biologicals.
He founded in 2010 Pathoquest, a spin-out of Institut Pasteur dedicated to the identification of pathogens using untargeted Next Generation Sequencing.
He has been its CSO till the end of 2016 and acts currently as a scientific advisor for the company.
Scott Lute has been with the U.S. Food and Drug Administration since 2002 in the Bioprocessing laboratory run by Dr. Kurt Brorson.
Scott received a B.A. in Biology from Boston University and a M.Sc. in Biotechnology at Johns Hopkins University. Over the past 12 years he has extensively studied the viral safety of downstream processing associated with monoclonal antibody manufacturing.
He was an active participant of the PDA Virus Filter Task Force responsible for standardizing the nomenclature of both large and small pore size virus filters, performing much of the lab based development work. His current research topics include PAT tools for mammalian cell culture, and projects improving biotech process virology.
Scott is a member of the American Chemical Society, has won several internal awards from the FDA, and is an author on more than 30 scientific articles and book chapters.
Kathryn Martin Remington is a member of BioReliance’s Field Development Services group and provides U.S. clients with technical and regulatory support.
Kathy came to BioReliance in 2010 from Catalent Pharma Solutions where she established their viral clearance program and managed it for 7 years. Prior to that, Kathy was the Section Head of the Viral Validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in Microbiology from the University of Montana.
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 currently responsible for the business development of Charles River’s viral clearance and virology service worldwide.
Eike Steinmann studied biology at the University Hannover, with emphasis on Virology and Microbiology. After a DAAD scholarship for study at Northeastern University in Boston, he completed his diploma at the Institute for Virology of the Veterinary University of Hannover. For his Ph.D. thesis, Eike Steinmann switched to the Department for Molecular Virology in Heidelberg. Together with Prof. Pietschmann, he was appointed to TWINCORE in 2007.
The research group “Virus Transmission” of Prof. Eike Steinmann is working on molecular and clinical transmission pathways of HCV and HEV causing severe infections in humans. Therefore, new prevention strategies and therapies for these two RNA viruses should be developed. Risks of virus transmission in the environment, especially in the hospital should be identified as well as effective methods for virus inactivation established and validated.
In April 2018, Eike Steinmann was appointed as Director to the Department of Molecular and Medical Virology at the Ruhr-University in Bochum.