A Scientific Journey of a Niche API Achieving Breakthrough Status

by the FDA for a Lifesaving Drug for Infants

DATE

February 17, 2021

TIME

8:00 a.m. PST / 11:00 a.m. EST / 16:00 GMT / 17:00 CET - Duration: 60 Minutes

Overview

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.

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

Brought to you by:

Speakers

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

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

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

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

Ann Thayer
Contributing Editor,
C&EN Media Group

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