CMC and CDMO: The Importance of Choosing the Right Partner

With small molecule drugs becoming ever more complex and timelines increasingly aggressive, getting a new medicine onto the market has never been more challenging. Find out how choosing the right CDMO can be key to meeting CMC challenges and achieving regulatory success.

Register Free: https://www.pharmtech.com/pt_w/cmc-and-cdmo

Event Overview:

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 mis-steps. 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 reviewWhat to look for in a CDMO CMC partner
• What to look for in a CDMO CMC partner

Speakers:

David Hall
Senior Director, Commercial
Development, Small Molecules
Lonza

David Hall joined Lonza in 2021 and serves as Senior Director, Commercial Development for the EMEA and APAC regions within Lonza’s Small Molecule Division. David has more than 20 years’ experience in Senior Commercial and Operations roles, leading global CDMOs supporting both drug substance and drug product services.

Register Free: https://www.pharmtech.com/pt_w/cmc-and-cdmo