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Suggested Citation:"Appendix C: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page 103
Suggested Citation:"Appendix C: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page 104

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Appendix C Statement of Task The emerging and multidisciplinary field of regenerative engineering aims to repair, regenerate, or replace damaged tissues in the body using a combination of principles and technologies from advanced materials sci- ence, developmental/stem cell biology, and immunology. The term “regen- erative engineering,” used here to encompass regenerative medicine and tissue engineering, reflects the growing number of research and product development efforts that incorporate elements from both fields. Because regenerative engineered therapies rely on live cells and/or scaffolds, there are inherent challenges in quality control associated with variability in source and final products. Each patient recipient, tissue donor, and product application is unique and therefore the field faces complexities in the devel- opment of safe and effective new products and therapies that are not faced by developers of more conventional therapies. To further explore the vari- ous factors that contribute to successful regenerative engineering products, an ad hoc committee will plan a 1-day public workshop in Washington, DC. Invited speakers and participants may discuss factors and sources of variability in the development and clinical application of regenerative engi- neering products, characteristics of high-quality products, and how differ- ent clinical needs, models, and contexts can inform the development of a product. Speakers may also discuss ways to reduce variability and ensure consistent, high-quality products and improve patient outcomes, share lessons learned, and highlight opportunities for collaboration. A broad ­ array of stakeholders may take part in the workshop, including academic and industry experts, regulators, clinicians, patients, and patient advocates. 103 PREPUBLICATION COPY­ Uncorrected Proofs —

104 EXPLORING VARIABILITY IN REGENERATIVE ENGINEERING PRODUCTS The ad hoc committee will develop the workshop agenda, select and invite speakers and discussants, and may moderate the discussions. Proceedings of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures. PREPUBLICATION COPY­ Uncorrected Proofs —

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The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results.

The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

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