Diane Hustead

Merck & Co., Inc.
Executive Director, Regulatory Affairs
Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has extensive expertise within Regulatory Affairs (CMC, various therapeutic areas, labeling, regulatory operations) and Quality Auditing (manufacturing). Diane currently leads regulatory affairs at Merck for US product shortages, discontinuations, import/export activities and regulatory innovation, and has developed business continuity plans for large-scale disruptive events. Additionally, she is the chair of the ISPE Drug Shortage Initiative Team.

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iSpeak Blog
Streamlining the Path to Drug Supply Resilience in the US
Everyone can agree patients need reliable access to their medicines. When a cancer patient can't get their chemotherapy, when a parent can't find their child's seizure medication, when a hospital runs low on a critical anesthetic, these aren't abstract policy problems. They're human crises. As a result, preventing shortages has been a shared priority for many stakeholders, including the US...
The ISPE Drug Shortages Prevention Model
iSpeak Blog
A Holistic Mindset is Key to Supply Resiliency

Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global stakeholders (Figure 1), resulting in widespread attention and many perspectives on how to improve drug shortages and associated vulnerabilities in the drug supply chain. At its core, supply resiliency is the ability for a manufacturer to have the agility, capacity, quality maturity, and risk...

Risk Management for Avoidance of Drug Shortages
Features
Risk Management for Avoidance of Drug Shortages

Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages.Acosta, A., E. P. Vanegas, J. Ronvira, B. Godman, and T. Bochenek. “Medicine Shortages: Gaps Between Countries and...