Conflict of Interest Disclosure

Disclosure of Unavoidable Conflicts of Interest Statement: Guo-li Ming
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.

Guo-li Ming has a conflict of interest in relation to her service on the Committee on the State of the Science and Future Needs for Nonhuman Primate Model Systems because of her financial interests in 3Dnamics, a biotechnology company that generates disease-specific and organoid models for pre-clinical drug screening and efficacy/toxicity testing.

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 current experience in the development and use of organoid model systems for biomedical research. As described in her biographical summary, Dr. Ming has direct experience in the development of brain organoids and their use to investigate brain development and disease processes, and to evaluate potential treatments. As Perelman Professor of Neuroscience at the University of Pennsylvania School of Medicine and in her role as co-founder and scientific advisor for 3Dnamics, Dr. Ming has been a leader in the development of patient-derived induced pluripotent stem cell model systems, such as brain organoids, and their use to understand molecular mechanisms underlying neurodevelopment and how its dysregulation may contribute to developmental neurological disorders. Her experience with these in vitro systems in the industry setting provides important insights into their development status as related to commercialization (e.g., issues of scalability).

The National Academies has determined that the experience and expertise of Dr. Ming 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. Ming 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 Unavoidable Conflicts of Interest Statement: Szczepan Baran
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.

Szczepan Baran has a conflict of interest in relation to his service on the Committee on the State of the Science and Future Needs for Nonhuman Primate Model Systems because of his employment as Chief Scientific Officer at VeriSIM Life, a company that is commercializing an artificial intelligence (AI)-enabled platform for biosimulations to predict clinical outcomes and improve drug-related research and development.

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 current experience in computational and in vitro models intended to reduce reliance on or replace research with nonhuman primates. As described in his biographical summary, Dr. Baran has direct experience in the development and evaluation of computational and in vitro models, such as microphysiological systems (“organs-on-a-chip”). Through his current role as Chief Scientific Officer of VeriSIM Life and his previous role as Head of Emerging Technologies at Novartis, Dr. Baran has been at the forefront of efforts to develop and integrate AI platforms and microphysiological systems into the drug development pathway. His experience with these new approach methodologies in the industry setting provides important insights into their development status as related to commercialization and wide-scale adoption (e.g., issues of scalability, regulatory pathways).

The National Academies has determined that the experience and expertise of Dr. Baran 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. Baran 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 Unavoidable Conflicts of Interest Statement: Ashutosh Agarwal

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.
Ashutosh Agarwal has a conflict of interest in relation to his service on the Committee on the State of the Science and Future Needs for Nonhuman Primate Model Systems because of his patents related to microphysiological systems and his financial interests in Bio-Vitro LLC, a company that is commercializing organ-on-chip microfluidic devices that are amenable to large scale manufacturing with the goal of accelerating the development of disease models and novel therapeutics.
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 current experience in the commercial development of microphysiological systems and other in vitro models with the potential to reduce reliance on or replace research with nonhuman primates. As described in his biographical summary, Dr. Agarwal is currently engaged in the commercial development of organ mimic platforms, such as microphysiological systems, intended to replace or significantly reduce animal testing for discovery of therapies and drugs and for modeling of human diseases. Dr. Agarwal has been pioneering “organ-on-a-chip” technology and developing such microengineered models of human physiological systems for a wide variety of biomedical applications through his role as co-founder at Bio-Vitro LLC, as well as in his academic research. He is the inventor/co-inventor on several patents relating to these technologies, including muscle chips, among others. His experience with these in vitro systems in the industry setting provides important insights into their development status as related to commercialization (e.g., issues of scalability).

The National Academies has determined that the experience and expertise of Dr. Agarwal 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. Agarwal 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

-Christian Larsen added as a member on 3/29/2022.
-There were minor editorial changes made to Christian Abee's biography.
-Minor edits made to the bios of Kenneth Ramos and Eliza Bliss Moreau on 4/18/2022.
-There has been a change in the committee membership with the resignation of Dr. Christian Larsen, effective 04/08/2022.
-Minor edits made to the bio of Melanie Graham on 4/25/22
-Minor edits made to the bio of Eliza Bliss-Moreau on 6/27/22
-There has been a change in the committee membership with the appointment of Dr. Ashutosh Agarwal and Dr. Steven Piantadosi, effective 7/28/2022.
-Minor edit made to the bio of Steven Piantadosi on 8/1/22.
-Edits made to the bios of Ashutosh Agarwal, Asgerally Fazleabas, and Steven Piantadosi on 9/14/2022.
-Edits made to the bios of Szczepan Baran, Myrtle Davis, Melanie Graham, and Kelly Metcalf Pate on 2/3/2023.