Robert F. Church

Rob Church brings a wealth of knowledge and experience to his pharmaceutical and biotechnology regulatory law practice, having previously served as an Associate Chief Counsel at the Food and Drug Administration (FDA), and in senior positions at Amgen Inc. He currently serves as the global lead of the clinical trials working group at Hogan Lovells.

At the FDA, Rob focused on the regulation of all aspects of the pharmaceutical industry, with particular emphasis on clinical trials, drug development, and new product approvals. At Amgen, Rob served as associate general counsel and the company's lead FDA lawyer. During his last three years at the company, Rob led Amgen's Global Research and Development Compliance Department where he had oversight responsibility for all quality assurance, audit, and compliance activities within Amgen's R&D operations.

Through these experiences, Rob developed an in-depth understanding of the regulatory requirements and operational details of clinical trials, new drug approvals, and the commercialization of pharmaceutical products. In his practice, Rob also frequently helps clients on pharmaceutical and biotechnology product life cycle management strategies, exclusivity questions, and bioequivalence standards.

Additionally, Rob and his team help clients draft and negotiate a wide range of regulatory agreements, including Safety Data Exchange Agreements, Manufacturing Quality Agreements, and all forms of agreements used in clinical trials. He also assists clients with corporate transactional matters, including the assessment of opportunities in the life sciences markets. His knowledge and understanding of the requirements and standards that impact his clients has helped him earn recognition as a Regulatory Star in LMG Life Sciences.

Immediately following law school, Rob clerked in the U.S. District Court for the Eastern District of Virginia. He also served as a Peace Corps volunteer in Honduras following his undergraduate studies.