Conference Agenda

Biosimilars Global Congress 2019 Europe

Day 1: 25th November 2019

Challenges, Trends and Opportunities

  • Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies, market drivers and challenges
  • Changing market dynamics within the Biosimilars market
  • What are the recent biosimilar market trends and development to date
  • Useful guidelines for players to understand and define their strategies more efficiently in order to keep themselves ahead of their competitors
  • Emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.

Moderator:

Yariv Hefez, VP, Global Head Oncology Marketed Products, Merck Group

  • Performance of latest biosimilars
  • Challenges facing the sector
  • Future Biosimilar Opportunities

Aurelio Arias, Senior Consultant, Thought Leadership, IQVIA

  • National and International developments in biosimilar medicines
  • How well versed are pharmacists today in the world of biosimilars?
  • Importance of Physician and Patients input in shaping international standards for biosimilars
  • Policies in place to encourage physicians / pharmacist collaboration
  • Harmonizing global standards to ensure safety and efficacy of biosimilars

10:40 am - Morning Networking& Refreshment Break

Challenges, Trends and Opportunities

  • What impression does recent changes in regulation, science & production technologies on future patterns of production
  • Issues to overcome to increase uptake of biosimilars
  • How to generate enough interest and enthusiasm for biosimilars

  • Most common approach for challenging the RBP’s patent
  • Biosimilars Patent strategies and considerations
  • What are the anticipated new litigations?

1:10 pm - Networking Lunch

Innovations, Clinical Considerations and Manufacturing

  • USP technology for efficient DSP
  • Accelerating specific productivity by SPOT™ for titre increase
  • Extending sustainability of CHOBC® by SLIM™ technology
  • Advantages of SLIM™ technology developed by metabolic engineering

Louis Boon, Chief Scientific Officer, Bioceros

  • An overview on data analytics and digitalization
  • Discuss what are the challenges
  • User cases that we have implemented

Syu-Yi Su, Principal Scientist, Novartis

Anita Krishnan, Director and Head, Analytical R&D and CMC, Kashiv Biosciences LLC

3:40 pm - Afternoon Networking & Refreshment Break

  • Identifying specific product associated with adverse events
  • Importance of product naming for biosimilars traceability
  • Establishing full characterization of immunogenicity profile
  • Continues post-post marketing surveillance is critical for effective risk management

Rene Anour, Sr. Clinical Expert, Head of National Scientific Advice, AGES*

  • The importance of a careful design of the analytical similarity study program
  • A state-of-the-art analytical similarity study meeting current regulatory requirements
  • Scientific and methodological considerations on the process of attribute
  • Case Examples

  • Challenges and obstacles faced by manufacturers in developing biosimilars
  • How to overcome challenges, increase development success and optimize result
  • Techniques in bringing the next generation of Biosimilars to the market
  • Reducing capital investment and creating cost effective and scalable manufacturing operations

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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)