How To Fast-Track Innovation While Addressing CMC Challenges In Expedited Approval Pathways

Robert Cornog, Senior Director of Product Development, shares an in-depth exploration of regulatory designations and expedited review pathways. This session delves into strategic flexibility in clinical supply, demonstrating how to accelerate innovative treatments to market without compromising product quality or patient safety.

Key Takeaways:

• Strategic Development: Identify the ideal candidates and technologies to enhance solubility and long-term stability.
• Early-Stage Investment: Learn to refine pre-clinical screening via a modular approach tailored to your specific goals.
• Overcoming Solubility Hurdles: Compare the efficacy of amorphous solid dispersions, lipidics, and size reduction.