Watch on Demand! Regulatory Considerations, Use of Ancillary Materials in Biologics Nov 14th, 2023

by Natika Calhoun | October 17, 2023


We invite you to the 4th Annual Biotech Start-up Symposium, a free, two-day event to help Biotech Start-ups navigate their path to commercialization. This Symposium features industry experts who present and discuss various aspects of emerging technologies and the latest trends in their fields.

On November 14th, Day 1, you won’t want to miss the presentation from Natika Calhoun on Regulatory Considerations: Use of Ancillary Materials in Biologics. 

Here is an overview of what is discussed:

What are the expectations for using qualified raw materials in developmental phases? There are many definitions, especially for novel modalities like Cell and Gene Therapies. Key definitions are evolving across agencies, and it’s necessary to understand regulations, guidelines, and international standards.

Watch on Demand!

Senior Regulatory Consultant

Natika Calhoun is a regulatory Subject Matter Expert for cellular and viral gene therapy products, biological APIs, and antibody-drug conjugates, based in California. In her current role, she works directly with manufacturing sites and customers as a regulatory liaison to support expansions, technical writings, filings, and submission success for clinical and commercial biological products.

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