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.
At the FDA, Rob's practice was 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 was the head of 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.
In addition to these areas, Rob and his team at Hogan Lovells 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.
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.
Areas of Focus
Conducted an investigation of a drug company's compliance with FDA safety reporting regulations for clinical trials.
Helped a company obtain approval of its first drug by responding to significant data integrity and GCP compliance concerns raised by FDA.
Successfully assisted a biotechnology company appeal FDA's initial decision to deny the company's Fast Track designation request.
Assisted many companies draft and negotiate Safety Data Exchange Agreements, Manufacturing Quality Agreements, and all forms of clinical agreements.
Conducted numerous due diligence reviews of pharmaceutical and biotechnology assets being assessed for potential acquisition.