• 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.
  • Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies - A Workshop Date: June 26, 2017 (8:30 AM Eastern)

    On June 26, 2017, the Forum on Regenerative Medicine will host a public workshop to examine and discuss challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop will be to learn from existing examples of manufacturing of early generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes as well as designing and adhering to standards to help in the navigation of the scale-up process from a research laboratory to the manufacturing environment. Stakeholders, which may include research scientists, clinicians, patients, regulators, and representatives from pharmaceutical and biotech companies, will be invited to present their perspectives and participate in discussions throughout the day.
  • Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies - A Workshop Date: October 13, 2016 (8:30 AM Eastern)

    Regenerative medicine holds the potential to create living, functional cells and tissues which can be used to repair or replace those that have suffered irreparable damage due to disease, age, traumatic injury, or congenital defects. The field of regenerative medicine is broad and includes research and development of gene and cell therapies, tissue engineering, and non-biologic constructs. Although regenerative medicine has the potential to result in health and economic benefits, this relatively new field has struggled to enact policies and procedures that will assure patients that novel therapies are both safe and effective. On October 13, 2016, the Forum on Regenerative Medicine hosted a public workshop with the goals of exploring current research and novel applications of new technologies to repair, regenerate, or renew tissues and organ functions throughout the body; examining the obstacles that hinder progress in research; and highlighting scientific successes, lessons learned, and opportunities to move the field forward and bring new therapies to patients. Stakeholder groups including research scientists, clinicians, patients, payers, regulators, and representatives from pharmaceutical and biotech companies, presented their perspectives and participated in discussions during the workshop.