2023 - Navigating the Small Molecule CMC Pathway: Strategies for Avoiding Regulatory Hurdles and Early Drug Development Pitfalls

Navigating the small molecule CMC pathway from discovery to the clinic comes with its own set of challenges and regulatory hurdles. Once the lead candidate has been selected to move into development, what’s next? Bridging discovery and clinical development can present many questions and unknown challenges for drug developers:
What are some of the drug substance, drug product and clinical supply considerations in advancing a drug candidate towards 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?
With the stakes high, having trusted and experienced guidance at this stage can help streamline the pathway from discovery towards IND, reduce risk and improve the likelihood of clinical success.
Consulting group NGT BioPharm Consultants and Quotient Sciences have helped hundreds of customers achieve their IND milestones and beyond. By offering strategic guidance and integrated services spanning the entire development pathway, both 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.
Join the featured speakers as they share their expertise around the challenges and considerations that drug developers may face in early development. Mapping out key early development milestones, they will share strategies on how they’ve helped customers remove obstacles off the critical path, reduce development risks and shorten the small molecule CMC pathway to the clinic.