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Insights on Regulatory Due Diligence
September 17, 2020 @ 10:00 am
Emerging biopharma startups are continuing their stronghold on the drug development pipeline. These potential therapies address a range of diseases, offering hope for innovative new treatments for patients. These companies face increased pressure to validate drug candidates earlier in the discovery and development lifecycle to ensure their viability. To prioritize and select the most viable drug candidates, startups must apply de-risking measures to determine the most probable regulatory pathway. This results in an increased ability to optimize pre-clinical and clinical spending.
Join experts from Cardinal Health Regulatory Sciences (CHRS) and the venture capital community in this discussion on regulatory due diligence. They will share the process of developing a “de-risking” framework, and provide insights throughout the regulatory lifecycle from discovery to early development and from clinical to post approval. Explore the processes that aid in decision-making related to product and portfolio development.
- De-risking model for drug discovery & development
- Assessing your technology readiness level (TRL)
- Keys to conducting regulatory due diligence
- Regulatory considerations for cell and gene therapy development