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

RECORD | Already taken place We, 17.2.2021

A case study illustrating how to overcome technical challenges of an orphan drug that received FDA breakthrough status, while ensuring fast-track development milestones and stringent timelines.

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C&EN: 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)

C&EN

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:

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