Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - A Workshop
Date: October 18, 2018 (8:30 AM Eastern)
Regenerative engineered therapies rely on live cells and/or biologically active scaffolds, thereby creating inherent challenges associated with variability and consistency in source and final products. Each patient, donor, and product application is unique, and 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. To further explore the various factors that contribute to successful regenerative engineering products, the Forum on Regenerative Medicine held 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 took part in the workshop, including academic and industry experts, regulators, clinicians, patients, and patient advocates.