Navigating Policy, Funding, CMC and Regulatory Dynamics for Successful Orphan Drug Development
Summary: Developing orphan drugs is a complex process that involves several challenges, such as navigating government policies, limited funding, small patient population, and high costs. Manufacturing orphan drugs with complex properties requires meticulous attention to detail. It involves navigating expedited regulatory pathways and managing the heightened risks associated with accelerated program timelines. To accomplish this, a strategic approach to formulation development is necessary, along with the implementation of robust risk mitigation strategies. Additionally, manufacturing scale flexibility is crucial for success. Join our panel of thought leaders in the orphan drug industry as they guide you through the policy and regulatory maze, offer practical CMC solutions, and discuss investment trends and strategies for securing funding. By attending this webinar, attendees will gain valuable insights, strategies, and practical knowledge to overcome the challenges and pave a successful path to orphan drug development and commercialization.