Keith Wonnacott, Ph.D.
Chief, Cellular Therapies Branch
Office of Cellular, Tissue, and Gene Therapies
CBER, Rockville, MD
- 13 years at FDA
- Ph.D. from The Pennsylvania State University
- B.S. from Brigham Young University
I am interested in the regulation of cellular, xenotransplantation, and regenerative medicine products. I am also interested in enabling technologies that will support the development of these products.
Proposed Research Project for an FDA Commissioner's Fellow:
This fellowship project involves the application of 3D printing to medical devices and biologics. 3D printing, a form of additive manufacturing, builds a part layer-by-layer without a mold or other scaffolding. Complex parts can be manufactured as a single piece and allows for rapid changes in part design (e.g. no need for retooling). 3D printers are driven by digital design files created by engineers or from 3D imaging such as a computed tomography (CT) or magnetic resonance (MR). This allows 3D printers to create truly personalized devices by utilizing a patient’s own medical imaging.
3D Printing and other additive manufacturing techniques are already used to make some patient-specific surgical cutting guides and general surgical, orthopedic, and dental devices. Recent research and popular news articles show a high and sustained commercial interest in opportunities afforded by 3D printing and bioprinting, indicating that applications of 3D printing will continue to grow. New, innovative devices can incorporate features and geometries that were not possible with traditional technologies and can also include living cells. When incorporating stem cells or other cells, this technology can be used to print tissue engineered scaffolds or potentially even organs. Technology to create blood vessel formation that allows cells to survive and function in these three-dimensional structures is also being developed.
While 3D printing shows a great deal of promise moving forward, this technology presents interesting questions. For example, mechanical properties of devices produced using 3D printing can vary significantly from those of conventional wrought or cast devices and biological properties of living cells embedded in three-dimensional structures can be very difficult to assess and control. In addition, application of 3D printing technology spans a number of product review divisions within the FDA due to the wide range of potential applications of the technology.
This project will be a cross-center evaluation of the opportunities related to 3D printing within the FDA. This project will involve the following aims: 1) determine what devices made through additive manufacturing have been cleared, including the technology, material, and supporting information provided by the sponsor regarding the additive manufacturing process, 2) search reviews and databases (such as MDR reports) to identify and evaluate deficiencies and concerns for 3D printed products and cell-scaffold combination products, 3) evaluate current scientific trends to determine the challenges and opportunities that FDA is likely to encounter in the future with 3D printing technology. In addition to these aims, the fellow will also spend time working in both CBER and CDRH and will have the opportunity to participate in regulatory review and/or laboratory activities within the agency.
The FDA Regulatory Science Priority Area for the project is Ensure FDA Readiness to Evaluate Innovative Emerging Technologies.
Ph.D. in Biomedical engineering or related field. Applicant should have training and experience that involves both engineering and biology. Experience with 3D printing, artificial organs, and/or 3D culture systems is preferred.
Selected Recent Publications:
- MSC-Based Product Characterization for Clinical Trials: An FDA Perspective. Mendicino M,Bailey AM, Wonnacott K, Puri RK, Bauer SR. Cell Stem Cell, 2014;14(2): 141-145,.
- Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States. Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill CA, Wonnacott KM, Wells MA, Oh SS. Tissue Eng Part B Rev. 2010 Feb;16(1):41-54.
- Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy. Wonnacott K, Lavoie D, Fiorentino R, McIntyre M, Huang Y, Hirschfeld S. Cytotherapy. 2008;10(3):312-6.