Join us for our seminar in Boston: CMC Strategies to Manage the Risks Associated with Accelerated Submission Pathways 

About

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. They will also 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 

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.

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Join us at the Quotient Sciences Capability Expo at our Reading facility, a leading centre for early development and clinical manufacturing. 

This exclusive event provides a unique opportunity to explore our facility, engage with industry experts, and gain insights into how we accelerate molecules from early development to clinical supply.  Through presentations, discussions, and networking we will showcase innovations in drug development on key topics, including:

• CMC strategies to support early-phase development
• Optimising clinical manufacturing for accelerated drug development pathways
• Amorphous solid dispersion technology screening, from bench to clinic

The event will also be followed by a networking reception where you can connect with industry experts and peers.

Take the opportunity to engage with our leadership and scientific team, including:

• Martin Wing-King, VP and General Manager, Reading facility
• Asma Patel, VP Integrated Development Services
• Valeria Ciarnelli, Senior Director, Product Development
• Andrew Parker, Senior Drug Development Consultant

Why attend?

• Gain insights into innovative early development and clinical manufacturing strategies
• Engage with industry leaders and Quotient Sciences experts
• Explore our state-of-the-art facility and see our capabilities firsthand
• Expand your network within the drug development community

We look forward to welcoming you to our Reading facility for this exciting event!

Register now