9th bi - annual BIOSIMILARS GLOBAL CONGRESS 2016 EUROPE | 26th - 28th Sepetember 2016 | Hilton London Kensington Hotel | London UK www.biosimilarscongress.com
Paradigm Global Events are once again proud to announce our 9th - bi annual BIOSIMILARS GLOBAL CONGRESS 2016 EUROPE.
Biosimilars is a type of biological product that is similar to another drug, which has already been approved by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy.
The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.
However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.
In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.
KEY INDUSTRY EXPERTS
Prof. Andrea Laslop, Head of Scientific Office. AGES- Austria
Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics, Japan
Roman Ivanov, Vice President, Research and Development, Biocad, Russia
Ray Cresswell, Vice President, Legal Counsel, GlaxoSmithKline
Ming Wang, Vice President, Diabetes Disease Area Leader, Janssen, USA
Dr. Fiona Greer, Global Director, Biopharma Services Development, Life Sciences, SGS
Martin Bluggel, CEO, Co-Founder, Protagen Protein Services GmbH
Dr. John Snyder, Research Fellow, Group Leader, Eurofins
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency
Dr. Ekkehard Brockstedt, Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG
Rodeina Challand, Biosimilars Consultant, formerly PRA International
James Kent, PrescQIPP – Secondary Care Lead, Director of Pharmacy,Southend Hospital
Olga Zielińska, Senior Specialist, Organizational and Legal Unit, Department of Drug Policy and Pharmacy, Ministry of Health, Poland*
Alex Kudrin, Independent Biopharmaceutical Consultant, formerly VP, Head of Global Development, Celltrion
Thomas Felix, Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen, Inc., USA
Dr. Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency
Gain Latest Insights on;
Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market
Know the strategies in place in developing and manufacturing biosimilars in emerging markets
Establishing and integration of biosimilarity and comparability into developing Biosimilars
Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing
Study the pre-clinical and clinical challenges associated with the development of biosimilars
The importance of establishing partnerships and successful collaboration for Biosimilars business
Learn the latest updates, trends and current Biosimilars market situations in different regions
What does the future hold for Biosimilars and Biologics
Network with experts and leading drug developers, regulators and investors in the industry
Who should attend?
Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:
Follow on Biologics/Follow on Proteins/Biosimilars
Pricing and Reimbursement
R & D
Preclinical and Clinical Development
New Product Development
Quality Affairs/ Quality Control
Chief Scientific Officer
Drug Safety & Risk Management
Process Control and Analytical Technologies
Marketing & sales
Legislation and Policy Advice
Drug and Safety Assessment
We look forward to having you be part of the event!