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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. Suma Babu has a financial conflict of interest because of her work as a physician investigator in industry-sponsored clinical trials of disease-modifying therapeutics for amyotrophic lateral sclerosis (ALS) supported by Biogen, Novartis, Ionis, OrphAI Therapeutics, and Denali. As of March 2024, she also serves as a compensated consultant for uniQure, a gene therapy company.

The National Academies have concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one individual with current leadership experience and expertise in clinical trials and expanded access programs involving industry

sponsors. As described in her biographical summary, Dr. Babu bridges the interface between patient care and therapeutic development through her work at Massachusetts General Hospital leading a number of clinical trials and expanded access programs to benefit individuals living with ALS, with a particular focus on gene therapy, neuroimaging, and developing disease-modifying treatments and clinical trial biomarker readouts for patients with motor neuron diseases.

The National Academies have determined that the experience and expertise of Dr. Babu are 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 have concluded that the conflict is unavoidable.

The National Academies believe that Dr. Babu 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.

Dr. Chelsey R. Carter has a financial conflict of interest because of her work as a consultant on issues of race, equity, and inclusion for Amylyx, a pharmaceutical company developing new therapies for ALS.

The National Academies have concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one individual with current experience and expertise in race, equity, and inclusion and the experiences of people living with ALS. As described in her biographical summary, Dr. Carter brings significant experience and understanding of how systemic marginalization impacts historically underrepresented communities affected by neurodegenerative diseases, like ALS, and deep expertise in medicine, public health, and race. Dr. Carter is also undertaking a book project that includes an ethnographic study of the diverse experiences of living with ALS drawing on more than 15 years of experience with Black communities affected by ALS. Dr. Carter has previously been compensated for a presentation to Cytokinetics on issues of race, equity, and inclusion and currently presents on race, equity, and inclusion to Amylyx.

The National Academies have determined that the experience and expertise of Dr. Carter are 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 have concluded that the conflict is unavoidable.

The National Academies believe that Dr. Carter 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.

Dr. John Dunlop has a conflict of interest in relation to service on the Committee on Amyotrophic Lateral Sclerosis: Accelerating Treatments and Improving Quality of Life because of his relationships with Aliada Therapeutics, which develops therapeutics for central nervous system conditions including ALS.

The National Academies have concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one individual with current experience and expertise in private-sector ALS therapeutic research and development. As described in his biographical summary, Dr. Dunlop held scientific and leadership roles at firms such as Neumora Therapeutics, Amgen, AstraZeneca, Wyeth, and Pfizer, in addition to his current role as Chief Scientific Officer at Aliada. Dr. Dunlop also has ongoing roles for several entities and projects including the National Institutes of Health’s HEAL Partnership Committee, Target-ALS, MassBio, Vigil Neuroscience, and the Packard Center for ALS Research at Johns Hopkins.

The National Academies have determined that the experience and expertise of Dr. Dunlop are 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 have concluded that the conflict is unavoidable.

The National Academies believe that Dr. Dunlop 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. In each case, the National Academies determined that the experience and expertise of the individual was 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).

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