Jason Brown
Founder
Brown Pharma Consulting
Jason Brown is an experienced end to end nitrosamine expert, E&L strategist, and analytical CMC leader. Successful analytical support for development projects, clinical batches, and regulatory submissions including NDA, ANDA, and tech transfers. Leadership of Extractables & Leachables studies from initial risk assessment to study design. Navigating the scientific challenges and frequent regulatory updates to ensure compliance.
Proven knowledge in nitrosamine risk assessments, structural identification, analytical techniques, root cause analysis, reformulation, and control strategies. Author of July 2025 AAPS Newsmagazine Cover Article, “Nitrosamine Control Strategies: From Risk Identification to Implementation.” Recognized innovator with a patent application for reformulation techniques and research articles concerning inhibition techniques and gastric nitrosamine formation in addition to numerous panel discussions, speakerships, posters, articles, and co-host of the USP Nitrosamine Conversations.
DAY 2: December 3rd, 2026
SESSION: Nitrosamine Risks and Controls for Large Molecules and Synthetic Biologics
◆ What is in scope? From a regulatory standpoint and understanding the science, which product types and possible nitrosamines are of concern?
◆ What are the unique differences in risks with these product types?
◆ Why are active nitrosamine controls more important for large molecules and synthetic biologics? What are the key components to keep your product safe?
DAY 1: December 4th, 2025
SESSION: Effective Strategies for Nitrosamine Control and Inhibition
◆ Processes from initial risk identification through control strategy implementation.
◆ Product control vs. testing requirements.
◆ Mitigation techniques, when active change is needed.
