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Bioceramics 2014 Plenary Speakers

Register for Bioceramics 2014


Dr. Hyun Bae, surgeon, The Spine Institute, USA


Title: Surgical Trends


Abstract: Coming soon.


Biography: Bae is a board-certified orthopedic surgeon at the Cedars-Sinai Spine Center, specializing in minimally invasive microsurgery and the treatment of cervical and lumbar spinal disease. Dr. Bae is a national leader in minimally invasive surgery, motion preservation technology, artificial disc replacement and non-fusion technologies. He is co-director of the Spine Fellowship Program. Dr. Bae earned a bachelor’s degree in biomechanics from the Columbia University School of Engineering and Applied Sciences. He earned his medical degree, cum laude, from the Yale University School of Medicine. He completed his surgical internship at North Shore University Hospital and his orthopedic surgical residency at the Hospital for Special Surgery in New York. He completed a spine fellowship at Case Western Reserve Hospital in Cleveland.


Larry Hench

Larry L. Hench, University Professor of Engineering, Florida Institute of Technology


Title: Affordable healthcare? Role of bioceramic technology


Abstract: Affordable healthcare for an aging society will not be achieved by legislation and taxation. Ever increasing desires cannot be met by ever decreasing resources. The only viable solution to the rising costs of healthcare is to achieve revolutions in healthcare technology, distribution, expectations and priorities. Previous revolutions in healthcare, prevention of death and replacement of tissues, need to be augmented with two new, innovative revolutions: tissue regeneration and prevention of tissue deterioration. This lecture addresses the past, present and future revolutions in healthcare and outlines the potential for bioceramics in various forms to be able to provide the scientific and industrial foundation for these revolutionary technological changes. The magnitude of run-away costs of healthcare in the US and world is presented to illustrate the need for alternative technologies for maintenance of high quality of life without increasing cost of care. The technology emphasis is on the following topics: 1) bioactive glasses and ceramics for regeneration of tissues, 2) innovative bio-photonics technology for rapid, inexpensive human cell based screening of biomaterial-cell and tissue interactions and patient specific diagnosis and treatment, 3) control of angiogenesis, soft tissue engineering and repair of chronic wounds.


Biography: Hench is currently University Professor, Biomedical Engineering Program, Florida Institute of Technology, Melbourne, Florida, Professor and Director of Special Projects at the University of Central Florida, Visiting Professor at Kings College/ Guy’s Hospital University of London, Guest Faculty at the Department of Bioengineering at Florida Gulf Coast University, and Emeritus Professor at the University of Florida and Imperial College London. For 10 years he served as Co-Director of the Imperial College Tissue Engineering and Regenerative Medicine Centre. He assumed the Chair of Ceramic Materials at Imperial College in 1995 following 32 years at the University of Florida where he served as Graduate Research Professor , Director of the Bioglass Research Center and Co-Director of the Advanced Materials Research Center. Larry completed his Bachelor of Ceramic Engineering degree at The Ohio State University in 1961 and his PhD in 1964. Dr. Hench has received almost all the awards in ceramics, materials science and biomaterials that are possible, including membership in the National Academy of Engineering and A CerS’ W.D. Kingery Award. He is also a Fellow and Distinguished Life Member of ACerS.


Safdar Khan 

Dr. Safdar Khan, MD, chief, division of spine, The Ohio State University, USA


Title: Clinical Testing


Abstract: Coming soon.


Biography: Khan joined the Department of Orthopaedic Surgery at The Ohio State University Medical Center in August 2011. He has served on the American Academy of Orthopaedic Surgeons Biological Implants Committee and has received awards for his research from the Orthopaedic Research and Education Foundation, Scoliosis Research Society, Orthopaedic Trauma Association and Western Orthopaedic Association. He is the author of more than 60 peer-reviewed publications and 10 book chapters and has guest edited several major publications. He earned his MD from The Aga Khan University Medical College, Pakistan in 1998 and performed his residency at Orthopaedic Surgery, Department of Orthopaedic Surgery, University of California at Davis.


Glenn Stiegman 

Glenn Stiegman, vice president, clinical and regulatory affairs, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), USA


Title: The Current Regulatory Environment


Abstract: As the material science of ceramics and their utility in the body continues to advance, the FDA often times is several years behind industry in how these materials are being used, especially in Orthopedics. As these new materials and uses are being developed and studied, companies want to understand how their device will be regulated and how to approach the FDA with their new material or indication. In addition, companies want to comprehend the various regulatory hurdles that they must overcome including mechanical testing, animal testing, and clinical data. In order to understand how best to gain market clearance or approval of your device, an understanding of how ceramics and bioceramics are regulated for various orthopedic applications. This presentation will not only outline the various regulations for ceramic devices, but also an overview of testing needed to achieve future clearance or approval will be described. Furthermore, this presentation will review a description of some of the hurdles and questions from the FDA as well as consideration when approaching the FDA with your new ceramic or bioceramic. Lastly, the presentation will review how and when to approach the FDA with a new technology to gain the most success with developing your overall regulatory strategy.


Biography: Stiegman is vice president of clinical and regulatory affairs at Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) in New York, New York. He leads the submission, regulatory strategy, analysis, and development of products at MCRA. As former chief of the Orthopedic Devices Branch for the US FDA, Stiegman is an expert on the orthopedic industry and guidance and policy for marketed orthopedic devices.

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