Advancing Disease Modeling in Animal-Based Research in Support of Precision Medicine Proceedings of a Workshop (2018) / Chapter Skim
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1 Introduction to Precision Medicine and Animal Models
1 Introduction to Precision Medicine and Animal Models
Pages 1-15
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T o familiarize the audience with the concept of precision medicine, the workshop began with the historical context and roots of precision medicine, followed by an overview of the regulatory framework as it relates to precision medicine. In both the opening and penultimate sessions, ethical discourse regarding the use and welfare of laboratory animals, public opinion, and involvement of communities as precision medicine unfolds anchored the sessions.
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In particular, the workshop looked at the extent to which next-generation animal models, designed using patient data and phenotyping platforms targeted to reveal and inform disease mechanisms, will be essential to the successful implementation of precision medicine. The full Statement of Task for the workshop is in Box 1-1.
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• reproducibility concepts to improve the clinical relevance of animal-based validation experiments and pre- and co-clinical trials in the context of precision medicine. • welfare and regulatory considerations of current and especially next generation animal models that would inform the design of targeted, per sonalized therapies.
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Chapter 5 looks at in vitro alternatives to animal models, including induced pluripotent stem cells (iPSCs) and microphysiological systems.
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. Hook-Barnard pointed out that the statement of task and the background for that report did not mention precision medicine by name, but that the committee thought about the issues very broadly and determined that a new taxonomy of disease would require these large datasets and linkages to patient data.
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Finally, Valle said that, while change is difficult, the field of medicine can do better and should vigorously pursue precision medicine and what it has to offer patients. REGULATION OF PRECISION MEDICINE Robert Califf, Donald F
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There is no reason to believe that the process of developing precision medicine approaches would be any shorter; if anything, it is likely to be longer and more complex. Second, Califf said that there is a dearth of high-quality evidence to support current clinical practice guidelines, even for the average patient (Tricoci et al., 2009)
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Califf told workshop participants about the Project Baseline Study, a collaboration among Verily, the Duke University School of Medicine, Stanford University, Google, and the American Heart Association. Project Baseline is aimed at developing gold standard data, tools and technologies to provide a holistic view of human health and more efficiently and effectively conduct clinical research.
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However, if these discussions are held too late, the technology may already be so diffused into clinical care that it is too late for ethical considerations to have any impact through professional norms and standards, formal policy and regulation, or public opinion. Heitman noted that workshops held by the National Academies are often designed to explore emerging technologies with an eye to anticipatory governance.
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Ethicists must rely on others' reports about new scientific developments to identify their potential ethical impact and make recommendations about their ethical use, Heitman said, thus discussion of animal models in precision medicine is still too new to have generated a related ethical discourse. Heitman pointed out that, in fact, the first outline about animal models in precision medicine was published in 2016, in the article quoted by Kent Lloyd in his introductory remarks (see p.
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Heitman noted that this type of research has the potential to conflict with existing standards for safe animal housing, particularly when the research focuses on studying complex environmental exposures such as multiple pollutants or sick building syndrome (situations in which people who live or work in buildings experience adverse health effects that seem to be linked to spending time in the building, but there is no specific illness or cause identified)
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Collecting data about prolonged, chronic, and terminal illnesses may conflict with the goal of using refined, early end points in animal studies; research animals would normally be humanely euthanized before they were subjected to diseases such as advanced cancer. In addition, using animal models for studies on diseases linked to long-term environmental exposures will require exposing animals to harmful and potentially stressful settings for long periods of time, which conflicts with the ethical standards of housing and care currently employed.
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As precision medicine research advances, it is likely that animal models will play a significant role, and this increase in the need for animals in research may draw opposition. While these general areas of concern about animals are not novel, the rise of precision medicine may put increased focus on animal research.
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The Mayo Clinic, said Sharp, has three CABs that meet a handful of times throughout the year and provide input to researchers with regard to governance structures, procedures, and donor engagement. In addition to providing ongoing feedback, a CAB can also work with researchers to engage the community on specific topics or areas of concern.
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This process requires recognizing marginalized voices and recognizing divergent moral views. Ultimately, "by engaging opposing views we may not be able to reach consensus but we may be able to find some type of compromise position for which no one is happy but everyone is at least satisfied," said Sharp.
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