This unique and in-depth symposium will provide an overview of the interplay between preclinical development, clinical, regulatory and Chemistry Manufacturing and Controls (CMC) in supporting the progression of novel therapeutics from clinical candidate nomination through market authorization. The discussion will focus on the design of an IND enabling and clinical development program to achieve the desired target product profile and product label.

Key themes that will be highlighted in the discussion:

• Capstone overview of project stage gates from discovery through launch
• Using the target product profile and product label to guide drug development strategy
• Designing an IND enabling program that integrates clinical goals, safety assessment and CMC
• Overview of clinical phases and clinical study design(s)
• Clinical supply chain considerations
• High-level overview of the interplay between clinical and regulatory including special designations (e.g. fast track, orphan designation)

Designed for executives and academics interested in understanding the intricacies of drug development.

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