2014-02-20 11:11:33 - SMi’s Regulatory Challenges and Opportunities in Antibiotic Drug Development and Registration masterclass - hosted by TranScrip Partners will take place on the 8th April in London
Regulators in the U.S. and Europe recently have moved to clear roadblocks that have impeded antibiotic development, with the U.S. granting priority review for innovative new drugs. Research funding is beginning to flow as well. The European Union funds antibiotic research projects with industry and universities. U.S. government funding is available to companies developing promising new molecules. Alternative commercial models are being discussed that get around the problem of low sales volumes: selling new drugs in bulk to health-care providers for use when needed, or charging a fixed license fee for access to them.
(Source: The Wall Street Journal, Drug Makers Tiptoe Back Into Antibiotic R&D, 2014)
Against this backdrop, SMi's masterclass hosted by TranScrip Partners will deal with issues related to
the opposing forces of investment, research and development when constructing a commercial forecast for a novel agent.
Key benefits to this masterclass are:
• Understand the global situation and the medical need
• Identify value added activities and regulatory needs
• Consider some of the push/pull incentives available for the right antibiotic
• Learn how to create early phase product development that achieve early regulatory approval
• Become aware of the importance of valuing the asset early and how to achieve higher pricing for limited
For more information and full programme details please visit: www.smi-online.co.uk/2014gcp4.asp