Regulatory challenges & opportunities in antibiotic drug development & registration

Antibiotic resistance in bacteria poses a major problem to modern public health. Infections that were once routinely treated with antibiotics have become extremely problematic to effectively kill, making even simple surgical operations dangerous from the perspective of contracting a resistant infection . Resistant strains of bacteria, such as methicillin-resistant Staphylococcus aureus, have sprung up in hospitals where they must be carefully contained lest the infection spread further.

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 populations