Start-ups in the life sciences and biotech sectors, with an urgency to see their products come to market, continue to react to today’s ever-changing business and regulatory landscape. With an abundance of life sciences companies in the spotlight, regulatory strategic planning is more urgent than ever. The stakes are high as companies are faced with the task of navigating regulatory requirements and coordinating regulatory activity with business and patent strategies.

Among the topics to be explored:

• FDA Exclusivities—Requirements and Strategy
• Requirements for Bioequivalence and Biosimilarity
• Coordinating IP Strategy with Clinical Trials
• Patent Term Extension