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Recorded Webinar
Biologics Battlefield: Opportunities and Obstacle
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The development and distribution of biologic therapeutic products will be a central focus of research and business, in both traditional and new economic ventures, for years to come. As "big pharma" faces a patent cliff, activity to produce new "blockbuster" therapies has increased. Given the high cost and potential profitability of these new live saving medicines, smaller companies, some well versed in Hatch-Waxman experience and others with innovative ideas and venture funding, have been strongly motivated to enter the field.
Regulation of biosimilars in the United States has been long delayed. Enactment of the "Biologics Price Competition and Innovation Act of 2009," as part of the 2010 US Heatlthcare Reform Legislation, has made such regulation both possible and necessary. After time spent assessing scientific aspects of comparability between original products and biosimilars, the FDA is currently considering standards to govern authorization for marketing of biosimilars, interchangeables and even "biobetters." The new legislation also creates new and different standards, as well as new barriers to entry, in its definitions of data exclusivity and patent litigation procedures.
“This presentation will provide an overview of current and future opportunities in the biologic therapeutics marketplace, potential costs of entry, the FDA's November 2010 hearing on a new US biosimilars pathway, data exclusivity and potential evergreening of biologic reference products, and patent litigation prospects, all focusing on the opportunities for and means to enable successful entry of biosimilars in the marketplace.”
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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