EBE at BIO International Convention 2018
4 June 2018, room 207, level 2, from 13:00h to 14:15h: Going Global with Biosimilars: How are Biosimilars Regulated Around the World Today
Biosimilar medicines provide an opportunity to increase competition for biologic medicines that have lost exclusivity, thus improving patient access to existing and innovative treatment, increasing physician treatment choice and generating savings for health systems. Most active substances in biological medicines are proteins. They can differ in size and complexity and can have a degree of variability in the molecules of the same active substance. Therefore, the traditional approaches to developing generic medicines are not appropriate.
In the EU a regulatory pathway for approving biosimilar medicines has been in place since 2003, followed by US pathways. Developers of biosimilars must demonstrate through comprehensive studies with the ‘reference’ biologic. Some of the challenges continue beyond market approval. This session explores how other world regions approach biosimilars.
Barbara Freischem, Executive Director at EBE – European Biopharmaceutical Enterprises (moderator)
Daniela Marreco CerqueiraAssessora, Gabinete do Diretor Presidente – GADIP, Agência Nacional de Vigilância Sanitária atANVISA
Il Ung Oh, Senior Scientific Officer at the National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea
Elizabeth de Somer, Interim CEO at Medicines Australia
Thomas Felix, Medical Director, Global R&D Policy at Amgen
5 June 2018, @ the European Commission Stand, from 15:30h to 16:00h: Europe – open for business
Here we will discuss how Europe and its Member States support biopharma companies seeking to establish their business in Europe.
Participants so far are Elmar Nimmesgern, Deputy Head of Unit, Innovative and Personalised Medicine at European Commission, Andre Guedel, Head International HQs Cluster at KPMG and a third speaker to be confirmed.
7 June 2018, Room 259A, Level 2, from 9:00 AM–10:15 AM – Successful launch and site selection in Europe – Investments, pipeline and cluster comparison
This session will provide an overview and comparison of what’s happening in Europe regarding Venture Capital Investments, development of therapeutic pipelines and number of companies. The new report by KPMG and Venture Valuation “Site Selection in Europe 2018” will be presented. The short presentation of the report will be followed by a panel discussion with key stakeholders of the European Biotech Industry to discuss the state of the industry and future developments
Patrik Frei, CEO & Founder at Venture Valuation
Barbara Freischem, Executive Director at EBE – European Biopharmaceutical Enterprises
Andre Guedel, Head International HQs Cluster atKPMG
Mr. Brady Hugget, Business Editor at Nature Biotechnology
Michelle Lock, Senior Vice President & Head of Europe at Sage Therapeutics