Patterson Shafer is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance.
Mr. Shafer has worked around the world to assist clients in the development and execution of strategies that promote innovation and growth, speed to market, operational efficiency, process excellence, and sustained regulatory compliance. He has worked extensively with global, top 5 companies to optimize performance as well as pre-revenue and emerging life sciences companies to build core capabilities and achieve launch readiness. He works regularly with Private Equity and M&A teams to support pre-deal regulatory, quality and compliance due diligence as well as post-merger integration.
Mr. Shafer's domestic and international regulatory experience includes developing new product regulatory strategies, health authority interactions, submissions/approvals, labeling compliance, 483/Warning Letter/Consent Decree response and remediation program development and execution. He is internationally recognized for his subject matter knowledge and experience concerning regulatory, quality and safety capabilities. He works frequently at the intersection of business and technology, designing and implementing regulatory and quality systems, including eQMS, Regulatory Information Management (RIM), Regulatory Intelligence and AI/machine learning.
Mr. Shafer is a strategic advisor to the FDA, having assisted them in various areas, including product quality, patient safety, and digital health. For several years, he has been co-leading collaboration efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality, including defining quality metrics, identifying leading practices for quality management review, and developing a playbook of leading practices for quality and corporate leadership. He is also the RIM Whitepaper team and Reference model co-lead as part of the Drug Information Association’s (DIA) RIM Reference Model initiative. He is frequently published and quoted in industry forums.
Prior to joining FTI Consulting, Mr. Shafer served in leadership roles at Grant Thornton and Deloitte Consulting. He started his career in communications and interactive learning, supporting professional development in the areas of finance, ethics and compliance, contract management and quality, and partnered with Juran Institute to create GM’s Quality College.