USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics

The U.S. Pharmacopeia (USP) views expanded early engagement with key stakeholders through workshops, roundtable meetings/studies, and Pharmacopeial Forum (PF) Stimuli articles as an essential component in advancing performance-based standards for biologic products.

USP is making clear that a collaborative approach is needed to determine where its contribution will be most valuable and to develop the biological standards that are prioritized.

At a Pharmacopeial Interest Group (PIG) meeting held at the 2019 PDA/FDA conference in mid-September in Washington, D.C., USP Global Biologics VP Fouad Atouf shed considerable light on the evolution of USP’s traditional standard-setting process to better support the manufacturing, evaluation, and control needs of the new generation of biologics.

With more than a decade of experience at USP, Atouf now leads the scientific activities of the pharmacopeia related to the development of documentary and reference standards for biologics and antibiotics – overseeing the laboratory engagement at both the US and India sites. Prior to joining USP, he worked at NIH researching cell-based therapies for diabetes. He holds a PhD in cell biology from the Pierre and Marie Curie University in Paris.

Moderating the session was Biogen Regulatory Intelligence & Pharmacopoeial Affairs Head Janeen Skutnik-Wilkinson, who co-chairs the PDA PIG. During her pharmaceutical career, she has been actively involved in excipient compendial affairs, in particular, and has played a leadership role in the International Pharmaceutical Excipients Council (IPEC).

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