Conflict of Interest Disclosure

Disclosure of Conflict of Interest: Timothy Charlebois
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.

Timothy Charlebois has a conflict of interest in relation to his service on the Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing because he is the Vice President of Technology and Innovation Strategy for BioTherapeutics Pharmaceutical Sciences at Pfizer.
The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, it must include a committee member who has current experience in the pharmaceutical industry involved with commercializing and licensing biologics and biotherapeutic products. As his biographical summary makes clear, Dr. Charlebois has extensive current experience in the licensing of biologics for Pfizer. In addition, Dr. Charlebois has current knowledge of developing, integrating, and maintaining strategy for process, product, and analytical technologies in support of biotherapeutics and can provide practical knowledge about the difficulties of commercializing biotherapeutics.

The National Academies has determined that the experience and expertise of Dr. Charlebois is needed for the committee to accomplish the task 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. Timothy Charlebois 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.

Disclosure of Conflict of Interest: Matthew DeLisa
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.

Matthew DeLisa has a conflict of interest in relation to his service on the Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing because of his financial interest in four spinoff companies from his university laboratory (Glycobia, Versatope, Ajuta Therapeutics, and SwiftScale Biologics) and holds patents relevant to the manufacturing of protein drugs.

The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, it must include a committee member who has direct current experience in protein biosynthesis and the development of therapeutically and industrially relevant molecules. As his biographical summary makes clear, Dr. DeLisa has broad experience in these areas and brings unique expertise given his successful commercialization of technologies facilitating discovery, design, and manufacturing of human drugs.

The National Academies has determined that the experience and expertise of Dr. DeLisa is needed for the committee to accomplish the task 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. Matthew DeLisa 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.

Disclosure of Conflict of Interest: Todd Przybycien
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.

Todd Przybycien has a conflict of interest in relation to his service on the Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing because he currently consults for Pfizer.
The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, it must include a committee member who has direct current experience in downstream processing and drug delivery. As his biographical summary makes clear, Dr. Przybycien has broad experience in industrial downstream bioprocessing and on drug delivery and medical device development as well as expertise in multiple other disciplinary areas that are needed for the committee to address its task.

The National Academies has determined that the experience and expertise of Dr. Przybycien is needed for the committee to accomplish the task 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. Todd Przybycien 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.

Disclosure of Conflict of Interest: Saly Romero-Torres
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.

Saly Romero-Torres has a conflict of interest in relation to her service on the Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing because she is a Senior Director of Digital Quality Systems at Thermo Fisher Scientific.

The National Academies has concluded that in order for the committee to accomplish the tasks for which it was established, it must include a committee member who has direct current experience in application of data science, machine learning, and advanced process control in the pharmaceutical industry. As her biographical summary makes clear, Dr. Romero-Torres has direct experience in each of those areas and is an industry leader in this field.

The National Academies has determined that the experience and expertise of Dr. Romero-Torres is needed for the committee to accomplish the task 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. Saly Romero-Torres 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.

Committee Membership Roster Comments

Added Arlene Joyner as a committee member.