The journey to market for a cellular or gene therapy is challenging given the unique and highly specialized nature of each individual program. Traditional approaches to the discovery and development process may not be valid, requiring innovative program strategies and study designs to address the distinct factors that affect the development of these emerging therapies. Choosing a partner with specialized expertise and proven experience developing these types of treatments and navigating the regulatory hurdles often associated with them can help you reach your goal of a commercially viable therapy.
In this podcast, Drs. Shawna Jackman and Lauren Black from Charles River discuss the special considerations and critical elements of a preclinical program strategy in the cell and gene therapy space. Key points include strategies to mitigate risk through thoughtful study design and execution, engaging regulators early, and understanding development timelines all which will help get your product to the patients as fast as possible.