Results-focused, Quality-driven Global Pharmaceutical Development and Regulatory Affairs Professional
Dr. Elizabeth Gordon is a recognized expert in regulatory affairs and pharmaceutical development with over 30 years of experience in the industry, including at the FDA. Dr. Gordon has an in-depth understanding of the requirements for successful new drug development and registration along with a first-hand appreciation for facilitating interactions with the FDA and other global regulatory authorities. She is a results-focused, quality-driven development and regulatory professional with extensive global experience in regulatory and product development strategy, management, and operations. Dr. Gordon demonstrates consistent delivery of milestones with geographically separate project teams within and across companies. She is a successful team member who can strategically lead and influence colleagues, regulators, and vendors. Her excellent written and oral communication skills have been instrumental in the success of her projects and programs. Her expertise in executing multiple projects and programs simultaneously while maintaining high performance standards is well recognized and respected.
Dr. Gordon is President of EG Consulting, Inc., where she provides expert advice on requirements for pharmaceutical and biological product development and regulation. She is a key member of the management team for client companies and her responsibilities routinely include project and strategic planning from candidate selection through successful completion of clinical studies; oversight of US and global regulatory strategy, operations, and activities; preparation of all types of regulatory submissions; implementation, maintenance and training of users on product development information management systems; and management of potential partners to support funding or other business transactions.
As Senior Vice President of Regulatory Affairs at Amplyx Pharmaceuticals, Inc., from 2015-2021, the leadership of Dr. Gordon supported the development of a novel broad-spectrum antifungal agent for the treatment of invasive fungal infections in immunocompromised patients caused by pathogens such as Candida, Aspergillus, and rare molds. In addition, she also had regulatory responsibility for the early-stage development of a potent neutralizing monoclonal antibody against BK virus, which can lead to devastating and costly consequences, such as nephropathy and rejection that primarily affects kidney transplant recipients, and hemorrhagic cystitis that affects hematopoietic cell transplant recipients. Amplyx Pharmaceuticals, Inc., was acquired by Pfizer Inc. in April 2021 and Dr. Gordon was instrumental in business development and transition efforts to support this transaction.
During a consultancy from 2011-2014 with Lumena Pharmaceuticals, Inc., she acted as Head of Regulatory Affairs. This position transitioned into full-time employment as Vice President of Regulatory Affairs in early 2014. Under her leadership and in close collaboration with the clinical team, 10 clinical trials were initiated in 9 different countries. These studies were authorized under 4 INDs and 24 CTAs, for which she had full responsibility. In addition, the drug candidate was granted orphan product designation in the United States and in the European Union for the treatment of four rare cholestatic liver diseases. In June 2014, Shire PLC acquired Lumena Pharmaceuticals, Inc. Dr. Gordon continued to lead these programs through the completion of the transition to Shire in June 2015, as Vice President of Regulatory Affairs and program Global Regulatory Lead. This early development effort set the groundwork for the continued development and NDA filing for the drug candidate under Mirum Pharmaceuticals, Inc.
Dr. Gordon also served as Senior Director, Regulatory Affairs, in the Medical and Regulatory Services Division of Quintiles Transnational, where she assisted clients in the development of efficient worldwide product development programs and provided strategic regulatory advice on all aspects of therapeutic development from discovery through post-marketing.
Prior to Quintiles, Dr. Gordon spent 6 years at the Food and Drug Administration serving in numerous positions in both the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. At CBER, she was an integral part of the team responsible for developing policy for the regulation of biological products.
Dr. Gordon has a Ph.D. in Microbiology from the University of Rhode Island and received a B.A. in Microbiology from the University of New Hampshire. She also completed an Executive M.S. in Technology Management at the University of Maryland.