CMC Strategies to Manage the Risks Associated with Accelerated Submission Pathways

Join us for our seminar, "CMC Strategies to Manage the Risks Associated with Accelerated Submission Pathways".

There has been a growing need for the development of new treatments to address rare diseases, which often have limited or even 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, providing “Fast Track status,” awarding research grants, and providing other incentives when certain criteria are met. These offer advantages to streamline the development of new therapies to treat rare diseases, and similar standards also exist in the United Kingdom and the European Union. The acceleration of the clinical program reduces overall drug development timelines, which can bring CMC challenges along the way.

In this seminar, Brad Rowe & Bob Cornog  will delve into how global agencies have implemented accelerated regulatory pathways to develop novel therapies to treat serious diseases. They will discuss navigating the pathways for accelerated submission and exploring the regulatory framework as it relates to orphan drugs for rare diseases. She/he will discuss CMC strategies to manage the risks associated with accelerated submission pathways, up to and including the scale-up and commercial manufacturing of drug products.

Key Takeaways 

• Navigating accelerated approval pathways – regulatory framework
• Challenges and solutions at different stages of drug development to manage CMC risks
• First-in-Human to Proof-of-Concept – acceleration to patient data (Parallel tracking CMC strategies i.e., fit for phase and patient-centric dosage forms. Progressing rapidly into human volunteer trials. Customizing manufacture and supply of drug products into patient studies)
• Proof-of-Concept to commercial launch – requirements and needs
• Use of innovative solutions to overcome the challenges – in silico i.e. M&S and ASAP, also covering TP and GCTS and niche commercial manufacturing strategies

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*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.