Brett Howard

Company: U.S. Pharmacopeia

Job title: Senior Director, Regulatory Policy

Bio:

Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP’s regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Before joining USP, he spent the previous decade working for chemical and pharmaceutical trade associations, developing and implementing advocacy strategies related to chemical exposure, sustainability, nitrosamines, and microplastics, among others. Brett also spent several years as a patent litigator at a boutique IP firm in the DC area. He has a PhD in organic chemistry from UC Irvine (2009) and a JD from the University of Maryland (2012).

Seminars:

Orthogonal Methods for Empty/Full AAV Characterization: Enabling Regulatory Confidence and Lifecycle Management 11:30 am

Discuss the need for “regulatory confidence” in complex modality analytics. FDA (and other agencies) want reliable, orthogonal data for product quality attributes Discuss lessons learned from validating orthogonal methods (AUC, SEC-MALS, mass photometry, CD-MS, UV-Vis), and how the scientific community (including USP) approaches method selection, orthogonality, and dispute resolution Discuss harmonization efforts through CDMO working…Read more

day: Conference Day Two

Panel Discussion: Navigating Global Regulatory Expectations for Cell & Gene Therapy Development 9:00 am

As cell and gene therapy programs become increasingly global, developers must align with diverse regulatory frameworks across regions. This session explores what’s required to successfully advance programs through non-clinical, CMC, and clinical milestones in markets such as Europe, Asia-Pacific, and Latin America. Understanding regional differences in CTA requirements for advanced therapies Preparing CMC and comparability…Read more

day: Conference Day Two