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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-andprocedures) prohibits the appointment of an individual to a committee such as 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. Scott Howell was determined to have a conflict of interest in relation to service on the Committee on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs based on his current role with Blue Line Advisors, LLC, through which he provides ad hoc consulting to companies such as Jazz Pharmaceuticals. He is cofounder of Synapse Sciences, an emerging global drug research network. Dr. Howell owns stock in Novartis and United Health Group.

The National Academies has concluded that for the committee to accomplish the tasks for which it was established, its membership must

include at least one person with current expertise and experience in how strategic investments are made by large pharmaceutical companies. As described in his biographical summary, owing to Dr. Howell’s experience in market access in the pharmaceutical industry, he understands the strategic investment landscape for commercializing innovative therapeutics to address unmet patient needs and making therapeutics deliverable to patients.

The National Academies has determined that the expertise and experience of Dr. Howell 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 expertise and experience 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. Howell can serve effectively as a member of the committee and that 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. Edith Perez was determined to have a conflict of interest in relation to service on the Committee on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs based on her role as chief medical officer at Bolt Biotherapeutics, which develops therapeutics to treat numerous cancers. She is on the board of directors of Artiva Biotherapeutics, an early-stage immunotherapy company, and is a member of the Genentech External Council for Advancing Inclusive Research. Her spouse has stock in Genentech.

The National Academies has concluded that for the committee to accomplish the tasks for which it was established, its membership must include at least one person who has relevant current expertise and experience in all phases of therapeutic development and the biopharmaceutical industry. As described in her biographical summary, owing to her current role as chief medical officer and her past roles as a physician, principal investigator, and vice president and head of bio-oncology at Genentech, Dr. Perez has extensive expertise and experience in basic science research and clinical trials and the biopharmaceutical industry launching novel therapies.

The National Academies has determined that the expertise and experience of Dr. Perez 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 expertise and experience 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. Perez can serve effectively as a member of the committee and that 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 July 2024, Dr. Perez’s role with Bolt Therapeutics changed from chief medical officer to advisor.

Mr. David Scheer was determined to have a conflict of interest in relation to service on the Committee on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs based on his current role as advisor for Nektar Therapeutics and Twist Biosciences. He is a board member of companies advancing novel therapeutics for unmet needs, including OrphAI Therapeutics and BiologicsMD. He is also cochair of BioCT, a nonprofit focused on promoting the growth of the life sciences in Connecticut. The National Academies has concluded that for the committee to accomplish the tasks for which it was established, the committee requires expertise in financial investment, including knowledge about the intricacies of commercialization, investment, and sale of novel therapies. Inherent in this expertise is knowledge about the incentives and regulatory policies that influence innovation and the perceived risks and returns on investment of innovative products. As described in his biographical summary, Mr. Scheer has expertise and experience in financial investment and has deep understanding of the many factors that influence the investment, growth, and sale of companies that translate basic science into novel therapeutics.

The National Academies has determined that the expertise and experience of Mr. Scheer 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 expertise and experience who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Mr. Scheer can serve effectively as a member of the committee and that 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 another available individual with the equivalent experience and expertise who did not have a conflict of interest. Therefore, the National Academies concluded that the conflict was unavoidable and publicly disclosed it on its website (www.nationalacademies.org).

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