A Scientific Journey of a Niche API Achieving Breakthrough Status by the FDA for a Lifesaving Drug for Infants

We will take a deep dive into the program, with a focus on:

• Optimization of the synthetic process
• Physicochemical characterization of the API molecule
• Analytical controls and specifications development
• Technology transfer to manufacture
• Process performance qualification (i.e. process validation)
• Establishing a phase and product-appropriate regulatory concept and dossier

Presenter: Bahareh Khalili, Ph.D. (Sr. Group Leader, Solid State & Process Analytical R&D, Eurofins CDMO Alphora Inc.)

Presenter: Petar Duspara, Ph.D. (Senior Group Leader, Research and Development, Eurofins CDMO Alphora Inc.)

Presenter: Yan Rodriguez-Evora, Ph.D. (Senior Team Leader, Analytical Services, Eurofins CDMO Alphora Inc.)

Presenter: Graham McGowan, Ph.D. (CMC and Regulatory Sciences Group Leader, Eurofins CDMO Alphora Inc.)

Presenter: Jeff Huber (Contributing Editor, C&EN Media Group)