Appendix C

Disclosure of
Unavoidable Conflicts of Interest

The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest.

Kent Kester has a conflict of interest in relation to his service on the Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) because he is employed by Sanofi Pasteur. The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has relevant and recent industry experience in medical countermeasures (MCMs) research and development (R&D) and medical supply chains. Dr. Kester has current experience in MCM R&D as the Vice President and the Head of Translational Sciences and Biomarkers at Sanofi Pasteur. Dr. Kester’s industry experience is combined with his extensive experience in the organizational and operational aspects of PHEMCE in the interagency environment at the U.S. Department of Defense, including developing policies relating to clinical and research aspects of infectious diseases and clinical vaccine development at the Walter Reed Army Institute of Research. The National Academies has determined that the experience and expertise of Dr. Kester is needed for the committee

to accomplish the tasks for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable. The National Academies believes that Dr. Kester can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Robin Robinson has a conflict of interest in relation to his service on the Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) because he is employed by RenovaCare, Inc. The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has substantial relevant experience in the operational aspects of PHEMCE from the standpoint of the Biomedical Advanced Research and Development Authority (BARDA), as well as relevant expertise and recent experience in MCM R&D and chemical, biological, radiological and nuclear (CBRN) defense. Dr. Robinson served as the Director of BARDA (2008–2016), leading the agency in the development and acquisition of MCMs, and as BARDA’s Influenza and Emerging Disease Program Director (2004–2008), where he gained valuable expertise and perspective on the development of vaccines, therapeutics, diagnostics, and medical devices to address CBRN threats. While serving as the Director of BARDA, Dr. Robinson was also the Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response. Dr. Robinson has extensive current experience in R&D as the Chief Scientific Officer for RenovaCare, Inc. In addition, from 1995–2004, Dr. Robinson served as the Director of Vaccines at Novavax, Inc., leading vaccine development, clinical trials, manufacturing, and licensing. The National Academies has determined that the experience and expertise of Dr. Robinson is needed for the committee to accomplish the tasks for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable. The National Academies believes that Dr. Robinson can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.