Navigating the Small Molecule CMC Pathway19 January 2023
Learn about drug substance and formulation considerations that can help improve downstream clinical outcomes.
Navigating the small molecule CMC pathway from discovery to the clinic comes with challenges and regulatory hurdles. Once the lead candidate has been selected to move into development, what’s next?
With the stakes high, having trusted and experienced guidance at this stage can help streamline the pathway from discovery to IND, reduce risk, and improve the likelihood of clinical success. Consulting group NGT BioPharm Consultants and Quotient Sciences has helped hundreds of customers achieve their IND milestones and beyond.
Bridging from discovery and clinical development can present many questions and unknown challenges for drug developers, such as:
- What are some of the drug substance, drug product, and clinical supply considerations in advancing a drug candidate toward a First-in-Human study?
- Would an integrated drug substance and drug development approach be best for a clinical program?
- How long does each critical step take before reaching the clinic?
- What regulatory considerations does one need to be aware of?
By offering strategic guidance and integrated services spanning the entire development pathway, both companies have supported programs with lead candidate selection, drug substance, drug development, biopharmaceutics, clinical and regulatory services, all focused on accelerating development and expediting strategies to address regulatory expectations toward clinical development.
Our featured speakers share their expertise around the challenges and considerations that drug developers may face in early development, and present case studies that demonstrate the benefits of an integrated drug substance and drug product approach.
- Get insight into the timeline for each stage of the development process
- Hear the benefits of an integrated approach to accelerate from candidate selection and onward into the clinic
- Learn about regulatory challenges to be aware of when bridging from candidate selection to IND and beyond
- Eleanor Row, Executive Director, Quotient Sciences
- Mark A. Krook, Head, Early Development, NGT BioPharma Consultants
- Roger Nosal, Head of Regulatory Strategy, NGT BioPharma Consultants