Accelerated pathways from global agencies like the FDA, MHRA, and EMA help meet unmet medical needs and improve treatments. Yet, compressed timelines and resource constraints pose unique challenges, ranging from limited API supply to clinical trial logistics.

In Quotient Sciences' presentation, we explore several different approaches for accelerated development which can be strategically used to meet requirements for expedited review pathways while mitigating CMC risks.

Our speaker will explore the critical role of expedited review pathways in accelerating the development and approval of new therapies. Attendees will learn about the various regulatory designations and how differing strategies for flexibility in early phases and clinical supply delivery through to commercialization may be leveraged to bring innovative treatments to market swiftly, while continuing to meet product quality needs and requirements for patient safety.

We 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.

  • Understand the different expedited review pathways, their requirements, and strategic considerations for leveraging these 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

Details About the Webinar

Tuesday, December 9, 2025 · 1:00 p.m. Eastern Time (US & Canada) (GMT -5:00)
Cost: Free
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About the Speaker

1761652033-490f38a45ae98955 Robert Cornog
Senior Director, Product Development, Quotient Sciences

Robert Cornog has over 26 years of experience in product development and process design. Across a broad range of dosage forms and technologies, Robert has focused on advancing pharmaceutical manufacturing through science and technical innovations. Through application of a deep understanding of manufacturing sciences and risk-based methodologies, he has successfully driven the adoption of new technologies and expanding manufacturing capabilities. Within the Integrated Development services team at Quotient Sciences, Robert provides technical and scientific support to operational and business development teams

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