A small biotech company was developing its first oral compound — a novel small molecule. The company needed support in taking the compound to first-in-man studies and Phase II clinical trials.
Our CMC consultant joined the virtual team responsible for the development, applying a wealth of expertise in several key areas:
- drug substance characterization, including polymorphism and salt selection studies, development of analytical methods and stability testing
- pre-formulation studies as part of dosage form selection
- designing and developing a formulation for Phase I studies, which could be readily modified for Phase II trials
- selecting and managing chief research officers and chief marketing officers responsible for CMC activities
- providing input into the specifications for drug substance and product
- compiling CMC data for the IMPD (Investigational Medicinal Product Dossier)