Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations (2021)
Chapter: Appendix B: Disclosure of Unavoidable Conflicts of Interest
B
Disclosure of Unavoidable Conflicts of Interest
The conflict-of-interest policy of the National Academies of Sciences, Engineering, and Medicine (https://www.nationalacademies.org/about/institutional-policies-and-procedures/conflict-of-interest-policies-and-procedures) prohibits the appointment of an individual to a committee like the one that authored this 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 only if the National Academies determine that the conflict is unavoidable and the conflict is promptly and publicly disclosed.
When the committee that authored this report was established a determination of whether there was a conflict of interest was made for each committee member given the individual’s circumstances and the task being undertaken by the committee. A determination that an individual has a conflict of interest is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest.
Dr. Timothy Charlebois was determined to have a conflict of interest because he is the Vice President of Technology and Innovation Strategy for BioTherapeutics Pharmaceutical Sciences at Pfizer.
Dr. Todd Przybycien was determined to have a conflict of interest because he currently consults for Pfizer.
Dr. Matthew DeLisa was determined to have a conflict of interest because of his financial interest in four spinoff companies from his university laboratory (Glycobia, Versatope, Ajuta Therapeutics, and SwiftScale Biologics) and his patents relevant to the manufacturing of protein drugs.
Saly Romero-Torres was determined to have a conflict of interest because she initially was the Senior Manager of Advanced Data Analytics at Biogen and is now a Senior Director of Digital Quality Systems at Thermo Fisher Scientific.
In each case, the National Academies determined that the experience and expertise of the individuals were needed for the committee to accomplish the task for which it was established. The National Academies could not find other available individuals who had the equivalent experience and expertise and did not have a conflict of interest. Therefore, the National Academies concluded that the conflicts were unavoidable and publicly disclosed them on its website (www.nationalacademies.org).
