12th European Biosimilars Congress April 15-16, 2019 Berlin, Germany

Jane (Xiaoyao) Xiao received her Ph.D. in Analytical Chemistry from University of Wales Swansea, UK. Dr. Xiao currently is president of BioPeak Solutions. She formerly served as Senior Director at Axcel BioPartners, Director of Analytical Sciences at Oncobiologics, Head of Proteomic Lab at Johnson & Johnson and Senior Scientist of Clinical Development Lab at Merck.

Biosimilar similarity assessment and comparability assessment, CQA and CPPs, strategies for reference product and reference standard, specification justification, stability trending and shelf life determination, analytical method development, qualification, validation and life cycle management, biologics physicochemical and biological characterization.

Dr Fiona Greer was a founding Director of M-Scan, contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences. Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered new developments in Mass Spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility where she was appointed VP. With over 35 years experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings and has designed and presented various technical training courses.

Structural analysis of proteins and glycoproteins

Dr. Chow received a B.S. in Mathematics from National Taiwan University, Taiwan, and a Ph.D. in Statistics from the University of Wisconsin, Madison, Wisconsin, USA.

Biostatistics, Biopharmaceutical Statistics, Bioavailability and Bioequivalence Studies

Mr. De la Parra is an entrepreneur focused on Information Technology, Education and Health. He is creative and results-driven and has 16+ years of Digital Strategy experience in architecture and implementation

Neuroscience, Regenerative Medicine, Continued Medical Education, Information & Communications Technology, Biotechnology, Social Development

Dr. Poon is currently the President of Quacell Biotech Ltd. He previously worked for Hisun Biopharm, Merck (SAFC), Roskamp Institute in USA. He completed his Ph.D. in Biological Chemistry at University of Kentucky, and MBA from University of South Florida. He has years of experience in the field of biological therapeutics, analytical research, bioinformatics and proteomics. He has more than 10 years of cell culture experience with focus on biopharmaceutical products.

Biotherapeutics; proteomics, metabolomics, cell line engineering, cell cultures, multivariate analysis, QbD, PAT.

Since August 2014, Professor Naidu is the Minnesota Power Jack F. Rowe Endowed Chair and Professor of Electrical Engineering, at University of Minnesota Duluth, Minnesota, USA. In March 2015, Professor Naidu was awarded Professor-Emeritus status with Idaho State University for "years of service to Idaho State University Community"

Professor Naidu's primary areas of teaching and research include Electrical Engineering, Power and Energy, Biomedical Engineering, Control Systems, Neural Networks, Measurements and Instrumentation, Mechatronics, Guidance and Control in Aerospace Systems, Trajectory Optimization, Aerobraking, Orbital Mechanics, Singular Perturbations and Time Scales (SPaTS) in Control Theory and Applications, Optimal Control Systems, Nonlinear Control Systems, Intelligent Control Systems, Digital Control Systems, Geometric Control Theory and Applications and Modeling, Sensing and Control of Gas Metal Arc Welding (GMAW).

George Wyatt is the Managing Director of Wyatt Health Management, which he founded in 2002 after a very successful 20-year career in the pharmaceutical industry. He held a number of senior positions in the industry, including Director, Market Access and Policy Development for Bristol-Myers Squibb Canada. Prior to being involved in the pharmaceutical sector, Mr. Wyatt was employed with a provincial government and worked both in the bureaucracy and on the political side. Mr. Wyatt holds a B.Sc. from Memorial University of Newfoundland, and an M.B.A. in Marketing and Strategic Management from the Schulich School of Business at York University in Toronto where he won the Graduate Business Council Gold Medal for Academic Achievement. He has also studied health policy at the Faculty of Medicine at the University of Toronto. Company Profile and Biosimilar Leadership.

Wyatt Health Management is a full-service Canadian pricing and reimbursement consultancy. We are the leading agency in Canada for biosimilars. We have extensive experience working with clients from Europe, Asia and the Americas. We pioneered the entry of biosimilars in Canada and have never looked back. We have a team of pharmacologists, health economists, and clinicians ready to meet your needs. Both payers and manufacturers have looked to us to solve the issues associated with biosimilars in Canada. You can count on us too!

He holds the MTA-PE Lendulet professorship in Translational Glycomics and directs the Horváth Csaba Laboratory of Bioseparation Sciences in University of Pannonia (Hungary). His work is focused on capillary electrophoresis and CESI-MS based glycomics and glycoproteomics analysis of biomedical, cell biology and biopharmaceutical, interests. Professor Guttman has more than 290 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.

His research interests include the glycomics and glycoproteomics analysis of biomedical, cell biology and biopharmaceutical.

Christoph Volpers earned a PhD in Molecular Biology from the University of Mainz, Germany, and an MBA from Bradford University, UK, both with Distinction. Chris has almost fifteen years of experience in Intellectual Property and Licensing. Before he joined the patent law firm Michalski Hüttermann & Partners, Dusseldorf/Munich, as Senior Patent Consultant in early 2015, he was Director IP Biologics of the Teva Pharmaceutical Industries/ratiopharm group for six years with global responsibility for innovative biologics and biosimilar products. He is founder of a biopharmaceutical consultancy firm, author of more than 20 publications and a member of the Licensing Executive Society.

Intellectual Property and Licensing

Laszlo Endrenyi is Professor Emeritus of pharmacology and biostatistics in the University of Toronto. He has served the university in various positions including on its Governing Council and as Associate Dean of Graduate Studies. He sat on the Board of Directors of the American Statistical Association and the Canadian Society for Pharmaceutical Scientists; he was a president of the latter and received its Lifetime Achievement Award. Externally, he has served on grant review committees and editorial boards of research journals. He has received several recognitions, including an honorary doctorate from the Semmelweis University of Medicine. He is a Fellow of the Canadian Society for Pharmaceutical Sciences and of the American Association of Pharmaceutical Scientists. Dr. Endrenyi published a book on Kinetic Data Analysis and over 180 research papers. He has advised and widely consulted with industry and regulatory agencies.

Kinetic Data Analysis,pharmacology and biostatistics

Racho Jordanov Co-Founder, President and CEO. Racho Jordanov is a biotech pioneer with more than 30 years of experience building and leading manufacturing operations in development-stage and multi-national biopharmaceutical companies. Mr. Jordanov started his career with Genentech, Inc. in 1981 in San Francisco, where he led the facility start-up and managed on-going commercial manufacturing of the first biotech products to be approved by FDA: insulin and rhGH. Over his 20-year career at Genentech Mr. Jordanov was at the forefront of innovations in biopharmaceutical manufacturing, from introducing the first processes for monoclonal antibody (mAb) production, to establishing Genentech\'s outsourcing capabilities for drug substance, drug product and medical devices, to most recently starting-up new biomanufacturing facilities in the US and Singapore. In addition to Genentech, Mr. Jordanov led North America manufacturing operations for Serono S.A. (now Merck Serono; Switzerland) and served as the Vice President of Manufacturing and Operations for two California-based biotech start-ups: Cholestech and Telios Pharmaceuticals. Mr. Jordanov earned his B.S. in Chemical Engineering from the University of California, San Diego, and an M.B.A. from National University in San Diego.

Biotechnology, Monoclonal antibody (mAb) production, Biomanufacturing,