Abstract: Challenges in achieving comparability, reproducibility and accuracy in biological measurements has driven a demand for improved confidence in measurements that support development of regenerative medicine therapies.  There have been extensive discussions about the inability to reproduce biological research findings [1-3] and a survey of pharmaceutical companies found that “product consistency and lack of standards is possibly the single greatest challenge facing the field” of regenerative medicine [4].  The U.S. Food and Drug Administration held a workshop to begin discourse between regenerative medicine standards organizations [5] and there is a bill before the U.S. Senate that calls for a national strategy for developing standards for regenerative medicine [6].  There are many strategies for achieving measurement assurance, such as reference materials, inter-lab testing and standard test methods.  However, there are challenges in applying these strategies to complex biological measurements which will require critical thinking to unravel.  The hardest parts are determining exactly how the measurements will be used and the decision-making that the data are intended to support.  Examples of how measurement assurance strategies may help advance regenerative medicine therapies to the clinic will be presented and discussed.

1. Ioannidis JP. PLoS Med 2005;2:696-701.
2. Prinz F et al. Nat Rev Drug Discov 2011;10:712-713.
3. Begley CG, Ellis LM. Nature 2012;483;531-3.
4. Alliance for Regenerative Medicine. Pharma and Biotech Survey.  Washington, DC: ARM. 2014.
5. U.S. Food & Drug Administration. Workshop: Synergizing Efforts in Standards Development for Cellular Therapies & Regenerative Medicine, White Oak, MD, 2014.
6. U.S. Senate. S2126 Regenerative Medicine Promotion Act of 2014.

Bio: Dr. Simon leads a Project entitled “3D Tissue Scaffolds” in the Biosystems & Biomaterials Division at the National Institute of Standards and Technology in Gaithersburg, MD.  The goal is to develop advanced methods for measuring cell-material interactions in 3D tissue scaffolds to determine how scaffold physical properties influence stem cell differentiation.  Dr. Simon also develops measurement assurance strategies, such as standards and reference materials, to improve confidence in measurements critical to the advancement of successful regenerative medicine products.  Dr. Simon earned a B.S. in Biology from Bucknell University in 1992 and a Ph.D. in Biochemistry from University of Virginia in 1998. He joined NIST as a post-doctoral fellow in 1999 and became a staff scientist in 2003. Dr. Simon holds leadership positions in the “Society for Biomaterials” and “ASTM International” and is on the Editorial Boards for “Biomaterials” and “Journal of Biomedical Materials Research –Applied Biomaterials”.

~BME Faculty Host: Sherry Voytik-Harbin~

***Coffee and juice will be provided at West Lafayette***