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Roundtable on Biomedical Engineering Materials and Applications (BEMA) The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is focused on identifying issues of significance related to biomaterials and the medical devices constructed from them. Using the BEMA approach, members are empowered through a unique dialogue with the people and the processes driving biomaterials product research, development, and commercialization. Read our Mission Statement below. BEMA Membership With a select and balanced membership of experts from government, industry, and academia, BEMA functions as a forum focused on the successful navigation of the technical, regulatory, and manufacturing elements that impact product development. BEMA History The history of BEMA dates back to the late 1990’s. It was developed as a joint activity of the NRC, the IOM, and the NAE. With commitments to participate from several federal agencies, a preliminary planning workshop was held in February 2000 to determine BEMA’s focus and function. Since that time, meetings and workshops have addressed a wide variety of topics and included many participants. In addition, BEMA activities have resulted in two publications - Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies and Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. BEMA operates under the National Materials and Manufacturing Board (NMMB). BEMA Leadership The BEMA staff and leadership committee are responsible for making executive decisions, developing meeting agendas, maintaining the web site, and ensuring BEMA continues to achieve its mission and meet the needs of its members. BEMA Programs 2012 June 27-28 - "Endovasuclar Therapy: Techniques, Successes, Challenges" Woods Hole, Massachussetts January 9 - "Addressing Obesity: Medical Device Therapies, Gender Issues" Washington, DC 2011 July 25-26 - "Preclinical Models for Development of Medical Devices and Combination Products" Woods Hole, Massachusetts May 4-5 - "Medical Device and Biomaterials Advances for Wounded Warriors, with Applications to Civilians" Washington, DC 2010 November 29-30 - "Regulatory Issues in the Design and Execution of Clincal Trials" Washington, DC July 8-9 - "Tissue Engineering Materials" Woods Hole, Massachusetts April 9 - "Management of Conflict of Interest within the Regulatry Framework" Washington, DC 2009 December 17 - "Navigating Speed Bumps in Medical Product Develoopment from Bench to Bedside" Washington, DC July 16 - "Novel Drug Delivery Applications" Woods Hole, Massachusetts
2008 March 18-19 – “Navigating the Valley of Death-Overcoming Barriers to Innovation” Washington, DC July 17-18 – “Novel Tissue Attachment Methods” Woods Hole, MA 2007 May 16-17 – “Workshop on Device-Centered Infection” Washington, DC July 12-13– “Polymer Therapeutics” Woods Hole, MA October 3 – “Novel Imaging Technologies” Washington, DC The BEMA Approach
The function of BEMA is to develop a network that empowers members through a unique dialogue with the people and processes driving biomaterial product research, development, and commercialization. This is achieved through: - Roundtable meetings: promote candid discussion on issues and solutions relevant to biomedical applications of materials
- Specialized problem-solving workshops: provide a more in-depth evaluation of a particular issue that involves the broader biomaterials community
- By-products: BEMA leadership has a strong interest in the development of spin-off studies and publications of workshop proceedings for its members
Mission Statement The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is focused on identifying issues of significance related to biomaterials and the medical devices constructed from them. With a select and balanced membership of experts from government, industry, and academia, BEMA functions as a forum focused on the successful navigation of the technical, regulatory, and manufacturing elements that impact product development. Formal meetings promote candid discussion on issues relevant to biomedical applications of materials. Our members gain insights and information from specialized problem-solving workshops and technical symposia. The end result is a network that empowers BEMA members through a unique dialogue with the people and processes driving biomaterial product research, development, and commercialization. Current BEMA Members
Rebecca Bergman (Co-chair) Vice President Cardiac Rhythm Disease Management Medtronic Corporation Arthur J. Coury (Co-chair) Consultant Coury Consulting Government
U.S. Food and Drug Administration Terry O. Woods Laboratory Leader, Solid Mechanics Library Center for Devices & Radiological Health Office of Science and Engineering Laboratories & Technology National Institutes of Health Pushpa Tandon Program Director National Cancer Institute Private Industry
Actamax Surgical Materials, LLC Robert DiLuccio Project and Process Development Leader
Lehmann Consulting John W. Lehmann Consultant
Boston Scientific Corporation Mark W. Boden Senior Fellow
Independent Consultant Michael N. Helmus
Genzyme Corporation, A Sanhofi Company Thomas H. Jozefiak Biomaterials Science & Engineering Academic/Non-profit Institutions University of Arizona Marvin Slepian Director, Interventional Cardiology
Alfred E. Mann Foundation for Biomedical Engineering A. Stephen Dahms President & CEO
Georgia Institute of Technology Robert E. Guldberg Director of the Institute for Bioengineering and Bioscience Rutgers University Joachim Kohn Director of the New Jersey Center for Biomaterials, and Board of Governors Professor of Chemistry Virginia Commonwealth University Barbara D. Boyan Dean, School of Engineering Georgia Institute of Technology Robert M. Nerem Parker H. Petit Professor and Director Institute for Bioengineering & Bioscience
University of Minnesota Richard W. Bianco Adjunct Associate Professor of Beterinary Population Medicine BEMA Contact Information National Materials and Manufacturing Board Attn: BEMA The National Academies 500 Fifth Street NW Washington, DC 20001 Phone: 202.334.3505 Fax: 202. 334.3718 E-mail: nmmb@nas.edu
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