Khandan Baradaran

Company: Ultragenyx Pharmaceutical Inc

Job title: VP Regulatory CMC

Bio:

Khandan Baradaran, Ph.D., is Vice President and Global Head of Regulatory CMC at Ultragenyx Pharmaceutical. In this role she is responsible for multiple AAV gene therapy products as well as several other small molecule and biologics modalities across all stages of product development and commercial operations. She has 25 years of experience in the pharmaceutical industry, including early- and late-stage clinical development and commercial products.

Prior to Ultragenyx she has held positions of increasing responsibility in regulatory affairs, CMC, quality control and quality assurance at Dimension Therapeutics, Shire, Biogen, Dyax, and Novartis Vaccines. Dr. Baradaran received her B.A. degree in molecular biology from Wellesley College and her Ph.D. in virology from Harvard University

Seminars:

Panel Discussion: Establishing a Commercial-Ready CMC Checklist for Expedited Pathways 2:15 pm

Defining key sticking points to ensuring CMC and clinical development are aligned when a programme is under an expedited pathway Considerations for CMC-focused meetings with the regulators when moving through the clinic Laying out a commercial manufacturing plan upon receiving an expedited pathway designationRead more

day: Day 2 MANUFACTURING PM

TACKLING THE MOST PRESSING REGULATORY CMC CHALLENGES 9:00 am

Navigating regulatory expectations after process changes, including technical regulatory strategies for successful comparability assessments Taking advantage of all channels available for drug sponsors to interact with the regulators Identifying the commonly observed CMC-related issues that have potential to lead to a clinical hold Identifying common pitfalls related to product characterization and manufacturing process controls Leveraging…Read more

day: Workshop Day - track c