Webinar: Supporting the Development of Biologics Through the IND-Enabling Studies and Clinical Phases by InsideScientific

Supporting the Development of Biologics Through the IND-Enabling Studies and Clinical Phases

About

In this webinar, Linda Randall, PhD, AVP of Biologics Development, Manufacturing and Control at Pharmaron, focuses on advancing the development of biological drugs from discovery through to commercial supply.

With expertise in both microbial and mammalian expression systems, the key steps from discovery to candidate selection are outlined. Learn how to move effectively from discovery to candidate selection, and explore the steps required to complete the IND-enabling phase of product development. The session also covers the preparation needed for BLA and MAA submissions, ensuring the requirements for successful regulatory approval are met.

Key Topics:

Navigating discovery to candidate selection efficiently

Completing the IND-enabling phase for product success

Preparing for BLA and MAA submissions to achieve regulatory approval

Presenter

Dr. Linda Randall

Associate Vice President of Biologics Development, Manufacturing and Control

Linda is Associate Vice President of Biologics Development, Manufacturing and Control at Pharmaron. Linda is passionate about driving the development of new medicines to address unmet medical needs of patients and in her role she and her team support the CMC development of customer’s biological drugs from candidate selection through the IND enabling work and onto registration submission.

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