Outsourced Pharma Capacity Update (OPCU) - July 2025 Online Event

Quotient Sciences will be presenting as part of the Outsourced Pharma Capacity Update Small Molecule Drug Product / Finished Dosage Form presentation series starting at 2pm Eastern time. 

Outsourced Pharma Capacity Update is sponsored by Outsourced Pharma and Life Sciences Leader. Join us for a series of short, digestible, digital presentations with live interaction give you an inside look at the capabilities and capacities of industry CDMO partners.

Join Quotient Sciences’ speaker Brad Rowe for an informative review of our capabilities in drug product formulation development and manufacturing.  

Register for this event with Outsourced Pharma

Quotient Sciences: How to Fast-Track Innovation While Addressing CMC Challenges in Expedited Approval Pathways

Presented by: Brad Rowe, Senior Director, Integrated Development at Quotient Sciences

Regulatory agencies around the world—including the US FDA, UK MHRA, EU EMA, and Japan PMDA—offer expedited processes to ensure that patients receive timely access to potentially life-saving treatments. These accelerated pathways are essential for both fulfilling unmet medical needs and providing significant improvements to existing treatments. However, challenges associated with compressed timelines are often encountered—ranging from limited API availability, support from experienced professionals, and maintaining flexibility in clinical trial material supply chains.

In our upcoming presentation, our speaker, Brad Rowe, Senior Director, Integrated Development at Quotient Sciences, will address 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 these can be leveraged to bring innovative treatments to market swiftly, while mitigating CMC risks. 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. 

Quotient Sciences is a global, integrated Contract Research, Development and Manufacturing Organizations (CRDMO). Our services range across drug development, inclusive of preformulation and formulation development, drug product clinical manufacturing and commercial manufacturing, and a full range of clinical pharmacology services (including DDI, SAD/MAD, human ADME programs and more). In addition, we integrate development services as a CRDMO partner as part of our flagship platform, Translational Pharmaceutics®. Translational Pharmaceutics® has been trusted for nearly two decades and more than 500 drug programs by emerging biotechs and large pharmaceutical clients alike to significantly reduce time and cost in development. This comprehensive approach to formulation development, on-demand GMP drug product manufacturing, and clinical testing leverages actionable data for more successful outcomes—manufacturing and releasing drug products in less than seven days and reducing overall development timelines by 9-12 months on average. 

Key learning objectives:

• 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