Oxford Global’s 3rd Annual Biosimilars & Biobetters Congress Annouces New Hot Topics

Oxford Global’s 3^rd Annual Biosimilars and Biobetters Congress offers an exclusive opportunity for over 350 biologics experts to exchange their experience, engage in scientific discussions and debate the best practices and solutions to improve the biosimilars industry performance. Join us on 20^th and 21^st April at the Novotel London West, London, UK to hear over 20 presentations and case studies focusing on the key areas of the biosimilars industry.

 

Why this Congress?

Despite having to overcome tight regulatory, business and financial challenges, the biosimilars industry is forecast to be worth up to $25 billion by 2020. The rapid growth of the industry requires biosimilar experts to be at the forefront of knowledge with the current landscape of the industry. Co-located with the 8^th Annual Proteins & Antibodies Congress and the 2^nd Annual Peptides Congress, this Congress is the only one of its kind.

 

The Congress covers key hot topics such as regulatory guidelines, market access initiatives and the challenges and opportunities in developing best in class biosuperiors or biobetter biologics.  Our speaker line-up includes a Vice President from MedImmune and nine Directors from companies such as Merck Serono, Eli Lilly, Sanofi, Baxter, Boehringer Ingelheim and Teva.

 

Oxford Global are pleased to announce the latest Hot Topics, including:

Comparison Between Different Regulatory Guidances And The Pathways To Extrapolation Of Indications       ►   A detailed side-by-side comparison between FDA and EMA Quality and Clinical requirements for development of biosimilars       ►   Extrapolation of indication: from different regulatory points of view Mehrshid Alai-Safar, Senior Director Regulatory Affairs, Baxter

Process For Gaining Scientific Advice From FDA And EMA       ►   Approaches to gain scientific advice from EU Regulators       ►   Gaining Scientific Advice in the US       ►   General meeting guidance       ►   Guidance and meeting types for Biosimilars       ►   Parallel scientific advice from FDA and EMA Benita von Glahn, Head of Regulatory Affairs, Biosimilars, Boehringer Ingelheim

Facilitating Acceptance Of Biosimilars By Clinicians: Education Above All       ►   Understanding analytical comparability and biosimilarity       ►   Appreciating the link between the “totality of evidence” and conditional probabilities       ►   Distinguishing between the absolute versus the relative benefit-risk balance Uwe Gudat, Head of Safety, Biosimilars, Merck Serono

Challenges And Opportunities In Developing Best In Class Biosuperiors Or Biobetter Biologics       ►   Biosuperiors or biobetters: Why?       ►   Identifying the unmet medical needs with marketed biologics or potential biosimilars       ►   How innovations in biologics technologies can be applied in producing best in class biologics       ►   Challenges to establishing the biosuperiority in safety and efficacy or convenience of dosing       ►   Case studies of biosuperior antibody drug conjugates and bispecific biologics Rakesh Dixit, Vice President R&D, Global Head, Biologics Safety Assessment, MedImmune

Insulin Biosimilars Overview       ►   Complexities of biologics/insulin biologic development       ►   Overview of insulin biosimilar/copies landscape       ►   Global Regulatory and other considerations for insulin biosimilars Hootan Khatami, Senior Medical Director, Global Medical Affairs, Sanofi

 

To download the full agenda please visit : http://www.biosimilars-congress.com/download-agenda-marketing/

 

Reserve Your Place Today!

With only a limited number of places available, please contact Steph Punfield on s.punfield@oxfordglobal.co.uk or call on +44(0)1865 248455 today.

 

If you’re looking to present a poster, we have limited spaces available on a strictly first come first served basis. For further information regarding our poster presentations, or to find out more about this or any of our upcoming events, please contact Steph Punfield on s.punfield@oxfordglobal.co.uk or +44(0)1865 248455