CMC Strategies to Manage the Risks Associated with Accelerated Submission Pathways: Houston, TX

Join us for our seminar in Houston, addressing drug product CMC and scale up challenges that come as a result of accelerated approval pathways.

There has been a growing need for the development of new treatments to address rare diseases, which often have limited or no viable treatment options available. Since the signing of the Orphan Drug Act into law in the United States in 1983, the US Food and Drug Administration (FDA) has given special consideration to companies by providing "Fast Track" or similar status, awarding research grants and other incentives when certain criteria are met. Similar criteria exist in the UK, Europe, and other parts of the world to incentivize innovation in drug development for areas of unmet need.

Greatly accelerated regulatory pathways offer advantages in the development of new therapies, however they bring CMC challenges along the way. In this seminar, Robert Cornog, Senior Director of Product Development, shares how accelerated regulatory designations can be leveraged to bring innovative treatments to market swiftly, while mitigating CMC risks. He will address real case studies and the relationships that Quotient Sciences has built with our clients as a trusted CRDMO outsourcing partner to navigate accelerated pathways effectively to meet urgent healthcare needs. 

Key Takeaways  

• Understand the different expedited review pathways, their requirements, and strategic considerations for leveraging them in drug development
• Identify CMC challenges and solutions in managing compressed development timelines
• Gain insights into real-world applications and success stories of expedited pathways
• Hear how we have helped with customized manufacture and supply of drug products into patient studies, scale-up to commercial launch, and use of innovative solutions to overcome development challenges (e.g., modeling & simulation, ASAPPrime Software)

Space is limited, so please register early.  

*We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.

Register now