Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - A Workshop
“Regenerative engineering” – here defined as an emerging field at the intersection of traditional tissue engineering, advanced materials science, developmental/stem cell biology, and immunology – faces many of the same challenges inherent to the fields of regenerative medicine, tissue engineering, and the development of biologics and other medical products, including variability in source cells and tissues, patient variability, immunogenicity, the need for more effective standards for manufacturing and regulation, and complex manufacturing processes that are difficult to scale up to a commercial level. In many cases, the intended clinical application of a product can inform the specifications that the final product must meet to be considered safe and effective and can also highlight important qualities of source materials and reagents.
Each patient, donor, and product application is unique; therefore, the field faces complexities in the development of new products and therapies that are safe and effective that are not faced by developers of more conventional therapies. Because clinical needs are diverse, many different treatment approaches and models may be used, and that will necessitate a variety of manufacturing pathways and standards to ensure safety and efficacy. The patient’s condition, the physiological context of the treatment, and the delivery of the therapy are all variables that factor into the clinical application of a regenerative engineering therapy. By considering these elements along with the critical quality attributes of a product in the early stages of development and manufacturing, it may be possible to improve patient outcomes by increasing product consistency. Collecting more data could lead to a better understanding of these variables and how to plan and account for them in the early stages of product research and development.
To further explore the various factors that contribute to successful regenerative engineering products, the Forum on Regenerative Medicine hosted a one-day workshop in Washington, DC on October 18, 2018. The workshop explored 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. A broad array of stakeholders participated in the workshop, including academic and industry experts, regulators, clinicians, patients, and patient advocates.