Moving Drug Substance Off The Critical Path - Streamlined Strategies To First-In-Human & Beyond

The need for accelerated drug development has become even greater, with added pressure on CDMOs to deliver customer’s programs in a timely, efficient and agile manner. Drug substance plays a major part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. As every molecule and development program is different, there is no single manufacturing solution. Understanding what strategy to move forward with, what processes and technologies are available and who to partner with, is key. But how do drug developers know which strategy and approach is right for their molecule?

In this webinar, Dr. Stephen McQuaker, Director of Drug Development Consulting at Quotient Sciences, explores case studies to demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substance off the critical path. He will discuss the different routes that drug developers can take to synthesize and manufacture their drug substance, along with the pros and cons of each approach. He will share how integrated drug substance and drug product capabilities in the candidate selection stage can aid in selecting the best molecules to move forward with into drug substance and beyond. He will also touch on the key technologies that can be employed to establish a robust, and commercially scalable synthetic process. Learn more about Quotient Sciences' services for integrating drug substance and drug product here.