Ms. Cicero is Deputy Director and Chief Operating Officer of the Center for Biosecurity of UPMC. With nearly 2 decades of experience as a practicing attorney in both the U.S. federal government and the private sector, Ms. Cicero brings to the Center her unique expertise in forming and managing successful collaborations and public/private partnerships in the healthcare, pharmaceutical, and biotech sectors. Before joining the Center, Ms. Cicero was the Managing Partner in charge of the Washington, DC, office of Drinker, Biddle & Reath, LLP, where she was responsible for more than 100 lawyers and approximately 200 staff members. Ms. Cicero is the first woman to have served in this role. With extensive experience managing biopharmaceutical consortia focused on technical, scientific, regulatory, and policy issues, Ms. Cicero has worked with a group that focused on reformulating inhaled therapies to meet international treaty mandates and with global privacy officers in developing good practices for compliance with international data protection and security laws. She also worked with clinical research sponsors and institutional review boards (IRBs) that were addressing overarching issues in clinical research, such as adverse event reporting. Additionally, Ms. Cicero provided counsel to a number of individual clients on privacy policies related to clinical research and pharmacovigilance activities, and she advised IRBs and academic medical centers on protections for human research subjects. In the realm of biosecurity, Ms. Cicero managed a consortium of companies that focused on advancing public policy to foster research and development of medical countermeasures. Among its accomplishments, the consortium provided invited analysis to the U.S. government on strategy and organizational capacity and developed recommendations for advancing the science of efficacy studies for countermeasures in the absence of human subject data. The group also made recommendations regarding the value of expanding the Tropical Disease Priority Review Voucher program for countermeasure development and proposed a central government-industry database of animal model data that would reduce the number of animal studies and improve the speed with which new candidate products could be developed. Ms. Cicero has had considerable experience in structuring and forming consensus approaches to complex regulatory and scientific challenges and in collaborating with U.S. government officials to solve problems. In this capacity, she has worked with officials from the FDA, HHS, DOD, EPA, the State Department, the U.S. Congress, the European Commission, and other bodies in the U.S. and Europe. Ms. Cicero also has extensive experience in international environmental treaty negotiations within the United Nations framework. Before joining Drinker, Biddle & Reath, Ms. Cicero focused on environmental litigation and counseling. As an attorney in the Honors Program at the U.S. Department of Justice, Environmental Enforcement Section, Ms. Cicero represented the EPA in civil litigation under the Clean Air Act, the Clean Water Act, and the Comprehensive Environmental Response, Compensation and Liability Act. Ms. Cicero is a graduate of the Yale Law School. She received her undergraduate degree with high honors from Oberlin College, was a member of Phi Beta Kappa, and was awarded the 4-year Harry S. Truman Scholarship for academic excellence. |
