Registration has now Opened for Biosimilars & Biobetters USA 2015

Biosimilars & Biobetters USA 2015
16th-17th,November
New Jersey, USA

Early bird offers:Book by 17th July and save $400. Book by 30th of September and save $100 

SMi Group reports (2015.07.07, Iselin, New Jersey, USA): Leading biosimilars experts from Sandoz, MedImmune, Selecta Biosciences, Bristows LLP, BioInsight Inc will meet in Iselin at Biosimilars & Biobetters USA (16th-17th November 2015). Registration to the event is now open

SMi's conference on Biosimilars & Biobetters USA 2015 will be taking place in Renaissance Woodbridge Hotel in Iselin, New Jersey, USA, on the 16th and 17th of November 2015. The 2-day event programme will offer effective strategies and solutions for developing cost effective biosimilars for the future, through a series of exciting discussions, presentations and workshops, delivered by true biosimilar leaders and industry pioneers. For more information please go to www.biosimilars-usa.com/bioequip

This year’s unrivalled speaker line-up includes leading experts representing Sandoz (speaking on their first biosimilar approved by the FDA), ParExel, FDA, Merck Serono SA, Formycon AG, Dr. Reddy’s Laboratories, AGES Regulatory Agency, Janssen R&D, IMS Health, Norwegian Medicines Agency, Harvest Moon Pharmaceuticals USA, Austrian Agency for Health and Food Safety, MedImmune, Bristows LLP, Schwegman Lundbe4rg Woessner, Selecta Biosciences, STC Biologics, BioInsights Inc, amp BIosimilars AG (Germany)…

BENEFITS OF ATTENDING BIOSIMILARS & BIOBETTERS USA 2015:
 •  Evaluating the regulatory landscape and pharmacovigilance of biosimilars
 •  Assessing and challenging the BPCIA's dispute resolution process
 •  Understanding and recognising the technical challenges in biosimilars
 •  Discussing how to strategically plan and revolutionise biologics manufacturing
 •  Reviewing the status on biosimilars - Clinical development and continued progress
 •  Recognising commercialisation strategies & improving market development
 •  Developing further awareness on biobetters; are they the future?
 •  Examining unexpected in results in Immunogenicity testing

Featured presentations for 2015 include:
 - The first biosimilar approved by the FDA. Speaker: John Pakulski, Head US Biopharmaceutical Regulatory Affairs, Sandoz Inc.
 - Update: Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars. Speaker: Rakesh Dixit, VP, R&D, Global Head, Biologics Safety Assessment, MedImmune
 - Case Study: Creating biobetters with improved efficacy and safety by addressing product immunogenicity with tolerogenic nanoparticles, Kei Kishimoto, Selecta Biosciences. Speaker: Kei Kishimoto, CSO, Selecta BioSciences
 - The litigation landscape in Europe- Where are we now? Speaker: Dominic Adair, Partner, Patent Litigation, Bristows LLP
-What are the opportunities in America- Where will we be in 2018? Speaker: Cliff Mintz, President & CEO, BioInsights Inc.

The complete 2-day event programme including all speakers and their topics can be downloaded at www.biosimilars-usa.com/bioequip

Biosimilars & Biobetters 2015 event attendees include, but are not limited to CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders from the following roles: Legal and regulatory affairs, Intellectual property, Regulatory compliance, Pharmacovigilance, New Product Development, and Analytical Characterisation

Plus, the event programme also includes two interactive half-day post-conference workshops:
Workshop A: A Regulatory Perspective on Biosimilars
Workshop leader: Ravi S. Harapanhalli, Vice President, ParExel and former Senior Executive, FDA

Workshop B: Development, Regulatory & Commercial Needs for Global Biosimilars
Workshop leaders: Gerry McGettigan, CEO & Regulatory Expert, and Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

Biosimilars & Biobetters 2015 is proudly sponsored by Schwegman Lundberg & Woessner.

Platinum Media Partner – Biosimilar News. Supported by Drug Target Review, Biocompare, Bio-Equip, GenericsWeb, GBi…

For sponsorship inquiries, contact Alia Malick at +44 (0) 7827 6168 or email amalick@smi-online.co.uk  
For media inquiries, contact Julia Rotar at +44 (0) 20 7827 6088 or email jrotar@smi-online.co.uk  
To register, contact Fateja Begum at +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk  
Biosimilars & Biobetters USA
Iselin, New Jersey, USA
16th-17th November 2015
http://www.biosimilars-usa.com/bioequip