5th Annual Biosimilars USA Conference

5th Annual Biosimilars USA Conference is organized by SMi Group Ltd and will be held from Nov 14 - 15, 2018 at Renaissance Woodbridge Hotel, Iselin, New Jersey, United States of America.

WHO SHOULD ATTEND:
Medical Directors, Scientific Directors, VP's, Directors, Managers, Team Leaders, Partners, Consultants and Attorneys of:
Biosimilars, Biobetters, Biopharmaceuticals, Biostatistics, Business Alliances, Business Development, Clinical Operations, Commercial, Decision Analytics, Global Intelligence, Global Operations, Managed Markets and Trade Relations, Market assess, Marketing, Patient And Physician Services, R And D Policy, Regulatory Affairs, Scientific Affairs, and anyone else who works within the biosimilars industry!

BENEFITS OF ATTENDING:
• Assess challenges to gaining the FDA’s Interchangeability status and debate, is it worth it?
• Consider different device design options
• Explore routes to take if your biosimilar has a better formulation and/or administration than the originator
• Discuss the FDA’s CMC finger print comparability that requires a minimum of 10 batches for statistical considerations
• Examine whether more batches lead to better clinical trial outcomes
• Learn how to meet high GMP compliance when manufacturing outside of the US
• Analyze whether the biosimilar industry can provide co-payments and other healthcare benefits to patients to successfully complete with originators
• Discover how to get onto patient formularies, and the important role pharmacy benefit manages have in achieving this

Time: 8:30 am to 4:30 pm