Day 1 :
Keynote Forum
Andras Guttman
SCIEX, USA
Keynote: The glycosylation aspects of biosimilarity
Time : 10:30-11:00
Biography:
András Guttman, MTA - PE Lendulet Professor of Translational Glycomics, directs the Horváth Csaba Laboratory of Bioseparation Sciences in Hungary and leads the application efforts in Sciex in California. His work is focused on capillary electrophoresis and CESI-MS based glycomics and glycoproteomics analysis of biomedical, cell biology and biopharmaceutical, interests. He has close to 300 scientific publications, wrote 35 book chapters, edited 4 textbooks and holds 23 patents. He is on the board of several international organizations, on the editorial boards of a dozen scientific journals, has been recognized by numerous awards and member of the Hungarian Academy of Sciences
Abstract:
Keynote Forum
Fiona M Greer
SGS Life Sciences, Switzerland
Keynote: Establishing finger-print like biosimilarity: Critical characterization steps for biosimilar assessment
Time : 11:20-11:50
Biography:
Abstract:
Keynote Forum
David Ebsworth
Vifor Pharma Ltd, Switzerland
Keynote: Challenges with Non-Biological Complex Drug (NBCD) products and their follow on copies: Complex drugs in a complex environment
Time : 11:50-12:20
Biography:
Abstract:
- Current Challenges in Developing Biosimilars | Analytical Strategies for Biosimilars | Biosimilar Companies and Market Analysis | Regulatory Approach of Biosimilars | Intellectual Property Rights | Emerging Biosimilars in Therapeutics
Location: Olimpica 2, Holiday Inn Rome Aurelia
Chair
Sakae Tsuda
National Institute of Advanced Industrial Science and Technology, Japan
Co-Chair
Kamali Chance
BioSciencesCorp, USA
Session Introduction
Sakae Tsuda
National Institute of Advanced Industrial Science and Technology, Japan
Title: Application of new quality products of type I–III antifreeze proteins and antifreeze glycoprotein
Biography:
Abstract:
Emile Van Corven
Bioceros, Netherlands
Title: Technical challenges in developing biosimilar antibodies
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R Helena Bustos-Cruz
Universidad de La Sabana, Colombia
Title: Bioanalytical methods for biosimilars: An approach
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M. Carme Parés Santilari
European Bio Immune(G)ene Medicine Association, France
Title: The Bio Immune(G)ene medicine and the use of miRNAs to regulate the cell
Biography:
Abstract:
Kurt R Karst
Hyman, Phelps & McNamara, PC., USA
Title: Biosimilars in the United States: A progress report and a peek in to the future
Biography:
Abstract:
Kamali Chance
BioSciencesCorp, USA
Title: How to meet FDA requirements for demonstration of interchangeability?
Biography:
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Theo Christie
National Institute for Health Research, UK
Title: Getting the NHS ready for the biosimilar boom: Shifting attitudes, acceptance and appetites
Biography:
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Biography:
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Fatemeh Torkashvand
Pasteur Institute of Iran, Iran
Title: An in-vitro functional assessment of a biosimilar rituximab and its originator
Biography:
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Yazan Shaban
Hikma Pharmaceuticals, Jordan