  {"id":3923,"date":"2015-06-08T07:13:22","date_gmt":"2015-06-08T12:13:22","guid":{"rendered":"https:\/\/www.vanderbilt.edu\/vise\/?p=3923"},"modified":"2017-06-27T15:37:08","modified_gmt":"2017-06-27T20:37:08","slug":"vise-seminar-incorporating-fda-regulatory-thinking-into-plans-for-medical-devices-thursday-june-11th-1210-sc-5326-refreshments-provided-at-noon","status":"publish","type":"post","link":"https:\/\/www.vanderbilt.edu\/vise\/vise-seminar-incorporating-fda-regulatory-thinking-into-plans-for-medical-devices-thursday-june-11th-1210-sc-5326-refreshments-provided-at-noon\/","title":{"rendered":"VISE Seminar: Incorporating FDA Regulatory Thinking Into Plans for Medical Devices. Thursday June 11th, 12:10. SC 5326, Refreshments provided at noon."},"content":{"rendered":"<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Title:<\/b>\u00a0 Incorporating FDA Regulatory Thinking Into Plans for Medical Devices<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Speaker:<\/b> Kenneth J. Holroyd, MD, MBA, Medical Director, Center for Technology Transfer and Commercialization<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\">Medical Device Regulatory Affairs Program, Assistant Vice Chancellor for Research<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Date:<\/b> Thursday, June 11<sup>th<\/sup> <\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Time:<\/b> 12:10pm start, noon snacks<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Place:<\/b> Stevenson Center 5326<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\">\u00a0<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b><img loading=\"lazy\" class=\"alignleft size-full wp-image-3924\" src=\"https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/holroyd-pic.png\" alt=\"holroyd pic\" width=\"113\" height=\"137\" srcset=\"https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/holroyd-pic.png 113w, https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/holroyd-pic-82x100.png 82w\" sizes=\"(max-width: 113px) 100vw, 113px\" \/>Abstract:<\/b> Discussion of the utility of thinking about Food and Drug Administration regulations\u00a0 to promote greater success in medical device grant applications, research, development, clinical investigation, and technology commercialization. Sharing information about Vanderbilt\u2019s Medical Device Regulatory Affairs Program, begun last year, which was created to support the faculty in these areas.<\/span><\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>Note:<\/b>\u00a0 I have also attached the flyer associated with Medical Device Regulatory Affairs Program (MDRAP), that Dr. Holroyd will speak to us about.<\/span><\/div>\n<div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><b>S<\/b><b>hort Bio:<\/b>\u00a0 Ken Holroyd is a physician with board certification in anesthesiology, pulmonary medicine, and internal medicine, with training at Johns Hopkins University and the National Institutes of Health. Joining ÌìÃÀ´«Ã½¹ÙÍø in 2005, Ken is Medical Director of the Center for Technology Transfer and Commercialization, and leads the recently created Medical Device Regulatory Affairs Program.\u00a0 Other activities include: participation in the Clinical and Translational Science Award (CTSA) program and the Coordinating Center for the CTSA National Consortium, in the area of public-private partnerships; serving as a Vanderbilt representative on the Board of Directors for Informatics Corporation of America, DigiChart, Cumberland Emerging Technologies, Friends in Global Health, and previously served with LaunchTN, and Acuitec.; clinical care in the operating room as part of the Multi-Specialty Anesthesiology division; teaching the Owen MBA class on the pharmaceutical, biotech, and medical device industries.\u00a0\u00a0 Before joining Vanderbilt, Ken was Chief Operating Officer of NASDAQ drug development company Genaera Corporation, with publications related to drug development in oncology, ophthalmology, cystic fibrosis, bacterial infections of diabetic foot ulcers, and asthma. <\/span><\/div>\n<div><\/div>\n<div>MDRAP information sheet:<\/div>\n<div><span style=\"font-family: Calibri,sans-serif;font-size: small\"><span style=\"color: #1f497d\">\u00a0<img loading=\"lazy\" class=\"alignleft size-thumbnail wp-image-3935\" src=\"https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/MDRAP-flyer-150x150.jpg\" alt=\"MDRAP flyer\" width=\"150\" height=\"150\" srcset=\"https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/MDRAP-flyer-150x150.jpg 150w, https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/MDRAP-flyer-80x80.jpg 80w, https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/MDRAP-flyer-190x190.jpg 190w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/span><\/span><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Title:\u00a0 Incorporating FDA Regulatory Thinking Into Plans for Medical Devices Speaker: Kenneth J. Holroyd, MD, MBA, Medical Director, Center for Technology Transfer and Commercialization Medical Device Regulatory Affairs Program, Assistant Vice Chancellor for Research Date: Thursday, June 11th Time: 12:10pm start, noon snacks Place: Stevenson Center 5326 \u00a0 Abstract: Discussion of the utility of thinking&#8230;<\/p>\n","protected":false},"author":4,"featured_media":3926,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spay_email":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false,"jetpack_publicize_feature_enabled":true,"_links_to":"","_links_to_target":""},"categories":[12],"tags":[231],"acf":[],"jetpack_featured_media_url":"https:\/\/cdn.vanderbilt.edu\/vu-URL\/wp-content\/uploads\/sites\/193\/2019\/03\/19171017\/ViSE_06-11-2015.jpg","jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p98pzF-11h","_links":{"self":[{"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/posts\/3923"}],"collection":[{"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/comments?post=3923"}],"version-history":[{"count":7,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/posts\/3923\/revisions"}],"predecessor-version":[{"id":5803,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/posts\/3923\/revisions\/5803"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/media\/3926"}],"wp:attachment":[{"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/media?parent=3923"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/categories?post=3923"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vanderbilt.edu\/vise\/wp-json\/wp\/v2\/tags?post=3923"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}