Featuring

14th Biosimilars Global Congress 2019 Europe

Days
Hours
Minutes
Seconds

25th-26th November 2019
Hilton London Olympia, London, UK

Venue

Hilton London Olympia

Address

380 Kensington High St, Kensington, London W14 8NL

Phone

020 7603 3333

Biosimilars Global Congress

Biosimilars market in Europe, having reached the most advance stage in the process globally is still continuously gathering strength. In the recent year alone, 19 biosimilar therapeutic medicines had been granted marketing authorization, which brings over 40 EC-approved biosimilar products in the current market. Europe is bound to have another remarkable year of biosimilar approvals and launches in this coming year with EMA’s pipeline of biosimilar candidate reviews rapidly increasing.

The 14th Biosimilars Global Congress, will cover a diverse range of topics that addresses the Strategies, Innovations and Collaborations for Sustainable Biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

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Biosimilars market in Europe, having reached the most advance stage in the process globally is still continuously gathering strength. In the recent year alone, 19 biosimilar therapeutic medicines had been granted marketing authorization, which brings over 40 EC-approved biosimilar products in the current market. Europe is bound to have another remarkable year of biosimilar approvals and launches in this coming year with EMA’s pipeline of biosimilar candidate reviews rapidly increasing.

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. 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.

The 14th Biosimilars Global Congress, will cover a diverse range of topics that addresses the Strategies, Innovations and Collaborations for Sustainable Biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

We are honoured to welcome you to London in November!

Jocelyn Raguindin
Jocelyn Raguindin

Jocelyn is Conference Director at Paradigm Global Events (PGE). She has over 15+ years experience in organizing pharma-industry conferences and has been at the helm of every PGE conference since 2013. Jocelyn is based in London, UK.

Gain Latest Insights on:

  • Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to themarket
  • Know the strategies in place in developing and manufacturing biosimilars
  • Establishing and integration of biosimilarity and comparability into developing Biosimilars
  • Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
  • 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

TARGET AUDIENCE:

  • Pharmaceutical and Biotech Companies
  • Pharma Associations & Societies
  • Biotechnology Experts/Business Entrepreneurs
  • Research and Development Scientists
  • Intellectual Property Attorneys
  • Ph.D. and Post Doctorate Scholars

Who Should Attend:

This Conference is designed for Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:

¨ Follow on Biologics/Biosimilars

¨ Biologics/Biotechnology/ Biogenerics

¨ Biopharmaceuticals/ Biotherapeutics

¨ Legal Affairs

¨ Pricing and Reimbursement

¨ Clinical Immunology

¨ Regulatory Compliance

¨ Research & Development

¨ Preclinical and Clinical Development

¨ New Product Development

¨ Quality Affairs/ Quality Control

¨ Principal Scientist

¨ Pharmacovigilance

¨ Chief Scientific Officer

¨ Drug Safety & Risk Management

Who Attends

Biosimilars Global Congress provides a unique platform for the convergence of stakeholders in the biosimilars industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organizations, biosimilar developers as well as regional and local manufacturers. Our event delegates include Chief Executives, Executive Directors, Vice Presidents, Heads, Team Leaders & Managers from a range of organisations including..

AbbVie Canada – Abbvie – Abzena – AGES MEA – Alliance for Safe Biologics – Amgen Inc – Applied Photophysics Ltd – Arecor – Avalere Health – AstraZeneca – Barclays – Bates White – Baxalta Inc – Baxalta US Inc – Baxter Healthcare – Benchworks Inc – Biocad Brazil – Biocad Russia – Bioeq – BioFactura Inc – Biogen Idec – Biogen International GmbH – Biogen – Biologics Consulting Group Inc – BIOMEDICA – BioPharm Insight – Biopharmaspec Inc – BioVirtus – BioWorld Today – Bird and Bird – Boehringer Ingelheim – Bristol Myers Squibb – Caprion – Cardinal Health – Charles River Laboratories – Chatfield Pharmaceuticals Ltd – CIMA Industries SA – Cipla Ltd – Clearside Biomedical – Clinigen CTS – CMC Biologics A/S – COFEPRIS – Consumer Health Forum of Australia – Cook Pharmica LLC – Deutsche Bank – Dr. Reddy’s Laboratories – Drinker Biddle & Reath – Durbin Global – Dyadic International (USA) Inc – EMD Millipore – EMD Serono – ENCB-IPN – Epirus Biopharmaceuticals – Eurofins Lancaster Laboratories – FirstWord – Fresenius Kabi – Fujifilm Diosynth Biotech – Fujifilm Kyowa Kirin Biologics Co. Ltd – GE Healthcare Life Sciences – Genentech – Geolab Pharmaceutical Industry – Glyconex – Granzer Regulatory Consulting & Services – Grupo Farmaceutico Somar – GSK – Hanwha Biologics – Hanwha Chemicals – Harvest Moon Pharmaceuticals – Hospira Inc – IMS Health – Innovent Biologics Inc – Intra – Cellular Therapies Inc – inVentiv Health Clinical – Janssen Inc – JHL Biotech Inc Taiwan – KLJ Associates – Lake Partners – Libbs Farmaceutica – Lifescience Dynamics – Lonza Biologics PLC – Lupin Pharmaceuticals India – mAbXience – Medimmune – Merck & Co – Merck Biosimilars – Merck Millipore – Merck Serono – Merck Sharp & Dome Ltd – Merck – Merckle GmbH – Milliman – MITSUBISHI GAS CHEMICAL COMPANY INC – Momenta Pharmaceuticals Inc – Multipharma – Mylan – Myoderm – Napp Pharmaceuticals – Nippon Kayaku Co Ltd – NIPTE – Norwegian Medicines Agency – Novo Nordisk – Omnicare Pharma GmbH – Orygen Biotechnologica – PARAXEL International – Patheon – PCI Pharma Services – Pfizer Inc – Plexus Ventures Limited – PPD – PRA Health Sciences – PRA International – Probiomed S.A de C.V – Protagen Protein Services GmbH – Qually Corporacion S.A de C.V – Queens University – Ratiopharm – Roche Farmaceutica – Sanape LLC – S &Oz Inc. (a Novartis Company) – Sciex Separations – SciMentum – SGS Group Ltd (USA) – SGS Life Sciences Services – SGS M-Scan Ltd – Shanghai CP Guojian Pharmaceutical Co Ltd – Spectrum Paharmaceuticals – SPL – Stefantech Systems Inc – Sterne Kessler Goldstein & Fox P.L.L.C – Sughrue Mion PLLC USA – Sun Pharmaceuticals Industry Ltd – Taylor Wessing LLP – Teva Pharmaceuticals – Texcell – Therapeutic Proteins International LLC – Toxikon Europe – Transformity – University Alkharh EDU – Virdispharma – Voisin Consulting Life Sciences – West Pharmaceutical Services Inc – Woodley Bio Reg Ltd – Wyatt Health Management – YAKUMED – Ypsomed AG – ZOTEK King Lai Co. Ltd (KunShan)

Syu-Yi Su

Principal Scientist, Department of Physical Chemistry Characterization, Technical Development Biosimilars, Novartis

Shu-Yi Su is the principal scientist in the Department of Physical Chemistry Characterization at the Technical Development Biosimilars Novartis.  She received her Ph.D in Statistical Genetics from Imperial College London and did her post-doctoral training at the University of California San Francisco. Prior to joining Novartis, she worked as bioinformatics scientist at European Molecular Biology Laboratory. Dr. Su has extensive experience in statistical modelling, analysis, computation and software development.

Louis Boon

Chief Scientific Officer, Bioceros

Dr. Boon received his Ph.D. in Biochemistry at the University of Amsterdam. In 2003 he was one of the founders of Bioceros BV were he currently hold a position of CSO. In addition, he held position as CSO for 4AZA Bioscience NV, FF Pharma and VP Preclinical for PanGenetics BV and Tanox. Dr. Boon is author of over 290 papers in international scientific journals in the field of medical biotechnology.

 

Bioceros generates production cell lines and production processes for the industry and used its proprietary CHOBC® platform and its SPOT™ technology to generate a portfolio of cell lines producing biosimilar monoclonal antibodies. Since the acquisition of Bioceros by EPIRUS in 2015, he extended this expertise and developed a complete process modulation toolbox to fit biosimilar CQAs. After the acquisition of Epirus NL by the Polpharma Biologics group in June 2016, he has continued to work on biosimilar development and innovative new molecular antibody entities, which now within the Polpharma Biologics group can be progressed to GMP production and clinical testing.

Cecil Nick

Vice President (Technical) PAREXEL

Gained BSc (Hons) in Biochemistry from University of Cape Town and has been working in regulatory affairs and clinical development for over 30 years; for the last 25 years focused on biological medicines. Particular expertise in monoclonals and biosimilars, having worked on over ten such programs and participated extensively in Industry and International meetings on the subject.

 

Joined PAREXEL in February 2001 and has been involved with issues relating to clinical development, regulatory submissions, biosimilars, orphan drugs and training. In the last five years alone has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft development plans which are effective, highly efficient and achievable with extensive experience in the field of inflammatory disease.

 

Cecil has particular expertise in regulatory, biotechnology and clinical development and is a well-known expert on biosimilarity and comparability. Most recently Cecil has been extensively involved in the development of monoclonal biosimilars and has supported a number of global marketing applications. He has been a frequent international speaker and author on the topic of biosimilars and comparability.

Dr. Steinar Madsen

Medical Director, Norwegian Medicines Agency

Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.

He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework. Dr. Madsen is also engaged in the Agency’s drug information service, with a special interest in the safe use of drugs.