Small pharma companies are driving pipeline innovation and are increasingly taking more complex small molecules further down the development pipeline, if not all the way to market. The growth in expedited regulatory programs has added a need for greater speed onto the already significant list of challenges they face.
Yet, the molecules are also more likely to be complex in nature, whether because they are difficult to make or difficult to formulate. A significant proportion of the small molecules in development may as well be classified as “highly potent.” This adds the requirement for specialized handling capabilities.
Small biotechs are unlikely to have in-house capabilities, and selecting the right integrated CDMO has never been more important. Experienced CMC partners are critical in helping to avoid costly regulatory missteps. The right partner can be the difference between success and failure, and this webinar will explain what to look for.
Key Learning Objectives:
- Current pharma development pipeline trends
- The importance of CMC in regulatory review
- What to look for in a CDMO CMC partner