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An Interview with Biosimilars Industry Leader Mehrshid Alai-Safar, Senior Director Regulatory Affairs, Baxter

Hits:3295   Date: 12/12/2014

Oxford Global Conferences are proud to present the 3rd Annual Biosimilars & Biobetters Congress, taking place at the Novotel London West on the 20th and 21st April 2015. The congress is an exclusive opportunity for over 350 biologics experts to exchange their experiences, engage in scientific discussions and debate the best practices and solutions to improve the biosimilars industry performance. The two day congress is co-located with our 2nd Annual Peptides Congress and our  8th Annual Proteins and Antibodies Congress .In the lead up to the 3rd Annual Biosimilars & Biobetters Congress we caught up with one of our keynote speakers, Mehrshid Alai-Safar, Senior Director Regulatory Affairs, Baxter  to ask her about the regulatory landscape of the biosimilars and biobetters industries…
Despite having to overcome tight regulatory challenges the biosimilars industry is rapidly moving. In your opinion, what is the key driving force behind this rapid growth?
“The opportunities are immense and there are different paths to the finish line. Healthcare should be made more affordable and offering to patients and healthcare providers.”
How are the current biosimilars regulations affecting the industry and are there some new regulations researchers should be aware of?
“The field is evolving very rapidly. The regulatory requirements – although different – are converging to some degree. The Quality and analytical biosimilarity assessment requirements will be something to keep an eye on. For example the sensitivity of analytical methods to detect differences vs clinical results will become more and more evident. I personally think that the regulators will be asking for a much more extensive analytical comparison and the tools are there and becoming more sophisticated.”
At our 3rd Annual Biosimilars & Biobetters Congress you will be sharing with us your experience in different regulatory guidelines, primarily FDA and EMA. Could you highlight some of the most important differences to these two guidelines? How do the different guidelines affect the industry in different locations?
“Interchangeability is the first thing that comes to my mind. That is in FDA’s guidance documents but not something that is regulated by EMA, and this can potentially impact the design of clinical trials. Also, there are differences in clinical requirements for certain types of biosimilars. In the past few months we have seen some differences in extrapolation of indication between EMA and Health Canada. We are all interested to see how FDA evaluates the same product.”
If you would like to hear more from Mehrshid Alai-Safar, she will be presenting her research on the “Comparison Between Different Regulatory Guidances And The Pathways To Extrapolation Of Indications” on the 20th April 2015 in the Biosimilars and Biobetters stream.
Oxford Global Conferences are proud to announce the following speakers for The 3rd Annual Biosimilars & Biobetters Congress:
Rakesh Dixit, Vice President R&D, Global Head, Biologics Safety Assessment, MedImmune will explore the challenges and opportunities in developing best in class biosuperiors or biobetter biologics
Ayse Baker, Director of Combination Products and Medical Devices, Sanofi will show the balance between technological innovations and regulatory requirements
Chetak Buaria, Director – Alliance Management (Biosimilars), Merck Serono, will address market access challenges and opportunities in emerging markets
For a full list of our congress speakers and to download the agenda please visit:
For further information or to enquire about available discounts please contact Steph Punfield on or phone us on +44(0)1865 248455.
1. Steph Punfield. Marketing Executive. +44(0) 1865 248455.  
2. Oxford Global Conferences produces cutting edge congresses and summits for the Life Sciences Industry.
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