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Program Area: “Biotechnology and Biomolecular Studies”.

Program Leader: John Langone, PhD

Scope: These laboratory studies aim to ensure that there is consistency of testing requirements and that the center is aware of and understands cutting edge biological technologies in the development of new devices or device materials.

Background: The emergence of technological advances in the field of biology provides opportunities for the use of new scientific tools for diagnostic analysis of adverse health effects that could result from exposure of materials from which devices are made. Laboratory studies in this area are conducted to determine if the development of new technology in the generation of devices or in diagnostic processes are safe and effective.

Program Description: Studies are proposed to address safety concerns about current and impending submissions of combination products, including the importance of possible immunotoxic reactions to incorporated biomaterials. The goal of these studies is to develop critical issues in the emerging field of combination product (ie. Biological matrices used in wound healing); issues in cardiovascular surgery; and issues addressing cell encapsulation. These studies will also address the potential of combination products to cause chronic inflammation.

Laboratory investigations will address intravascular cathers which are coated or impregnated with antimicrobial or anriseptic agents. It is important to assess microbial contamination of catheters and other medical devices and to compare and evaluate the efficacy of antimicrobial treatments. These studies use biosensors which are tools for effective real-time biological analysis. Bioluminescence is explored as the technology for such analyses.
Other studies explore the detailed mechanism of action of taxol or sirolimus in drug elutes stents. Mechanisms of action of platelets and an delayed endothelial healing leading to thrombosis will be investigated. Laboratory in vivo and in vitro exploration of neointimal hyperplasia leading to in-stent re-stenosis as well as elucidation of the factors that contribute to fatalities are planned in these studies Techniques using differential display will be develop for these analyses.

Center Relevance: Using new technology in the development of medical devices for pre-market approval is anticipated as the trend of products generated by creative research and biotechnological progress. Much of the laboratory work at CDRH evaluates production of leachables released from devices. Questions about whether a finished device, or a device material, or extract of the device produce adverse biological effects can be addressed using new technology. Output from this work would appear in guidances, in review consults and via scientific exchange. Reviewers can use these resources for rapid access to cutting edge information.

Five –year Plans

1. Scientific interactions through professional societies and meetings will be maintained to serve as knowledge managers of emerging technologies anticipated for new devices.
2. Participation with review groups in relevant divisions of ODE to keep pace with scientific quiries of special interest to reviewers so that needed technology information will be readily available through DLS scientists
3. Planned workshops and access to NIH and other government and academic centers will be maintained and developed for awareness of current cutting edge emerging technology.
4. Review annually of status of the research targets and accomplishments

Updated January 27, 2005

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