{"id":32587,"date":"2020-07-28T14:22:35","date_gmt":"2020-07-28T13:22:35","guid":{"rendered":"https:\/\/www.biotechpharmasummit.com\/?page_id=32587"},"modified":"2023-04-29T13:41:59","modified_gmt":"2023-04-29T12:41:59","slug":"morteza-minaee","status":"publish","type":"page","link":"https:\/\/www.biotechpharmasummit.com\/index.php\/companion-diagnostics-biomarkers-2017-speakers\/morteza-minaee\/","title":{"rendered":"Morteza Minaee"},"content":{"rendered":"<div class=\"vgblk-rw-wrapper limit-wrapper\">\n\n\t<h2>Dr. Morteza Minaee<\/h2>\n<h4>Vice President of Regulatory Affairs at Guardant Health<\/h4>\n\t<p>Dr. Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations.<\/p>\n<p>He is currently Vice President of Regulatory Affairs at Guardant Health in Red Wood City California. Prior to Guardant Health he served as Senior Director, Regulatory Affairs at Roche leading many FDA clearances in digital pathology applications including breast cancer biomarkers.<\/p>\n<p>He also held senior positions in Regulatory, Clinical Affairs, and Quality for companies such as Abbott Molecular and Siemens Healthcare. He holds a doctorate in law and policy from Northeastern University, and MS in administration from Boston University.<\/p>\n\t\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2.jpg\" alt=\"Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2\" itemprop=\"image\" height=\"1224\" width=\"820\" title=\"Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2\" onerror=\"this.style.display='none'\"  sizes=\"auto, (max-width: 768px) 100vw, 100vw\" srcset=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2.jpg 820w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-201x300.jpg 201w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-686x1024.jpg 686w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-768x1146.jpg 768w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-630x940.jpg 630w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-420x627.jpg 420w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile_2-315x470.jpg 315w\" \/>\t\t\t\t\t\t\t\n<h3>\n\tTitle: Regulatory considerations for Next Generation Sequencing (NGS)-based circulating tumor DNA (ctDNA) as biomarker candidates into companion diagnostics\n\t<\/h3>\n<ul>\n<li>Evolving Regulatory environment for NGS and Cancer Comprehensive Genomic Profiling<\/li>\n<li>ctDNA assays- Challenges and opportunities<\/li>\n<li>ctDNA intended uses and indications- A changing model<\/li>\n<li>Analytical Performance Studies Consideration<\/li>\n<li>Clinical Validation Considerations\n<ul>\n<li>Three Alternative Pathways\n<ul>\n<li>Method Comparison Approach<\/li>\n<li>Retrospective Clinical Bridging Approach<\/li>\n<li>Prospective patient enrollment Approach<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\t<a href=\"https:\/\/sociopharma.com\/\" target=\"_blank\" role=\"button\" rel=\"noopener\">\n\t\t\t\t\tPresentation available only at SocioPharma.com\n\t<\/a>\n<h4>\n\t\t\t<a href=\"#\" title=\"On the Web\" target=\"_self\" rel=\"noopener\">\n\tOn the Web\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/guardanthealth.com\/\" target=\"_blank\" rel=\"noopener\">https:\/\/guardanthealth.com\/<\/a><\/p>\n<h4>\n\t\t\t<a href=\"#\" title=\"On LinkedIn\" target=\"_self\" rel=\"noopener\">\n\tOn LinkedIn\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/www.linkedin.com\/in\/morteza-minaee-772229167\/\" target=\"_blank\" rel=\"noopener\">Visit Profile<\/a><\/p>\n\n<\/div><!-- .vgblk-rw-wrapper -->","protected":false},"excerpt":{"rendered":"<p>Dr. Morteza Minaee Vice President of Regulatory Affairs at Guardant Health Dr. Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations. He is currently Vice President of Regulatory Affairs at Guardant Health in Red Wood City California. Prior to Guardant&#8230;<\/p>\n","protected":false},"author":1,"featured_media":32588,"parent":32539,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-32587","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Morteza Minaee &#8226; BioTech Pharma Summit<\/title>\n<meta name=\"description\" content=\"Dr. Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotechpharmasummit.com\/index.php\/companion-diagnostics-biomarkers-2017-speakers\/morteza-minaee\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Morteza Minaee &#8226; BioTech Pharma Summit\" \/>\n<meta property=\"og:description\" content=\"Dr. Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.biotechpharmasummit.com\/index.php\/companion-diagnostics-biomarkers-2017-speakers\/morteza-minaee\/\" \/>\n<meta property=\"og:site_name\" content=\"BioTech Pharma Summit\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/biotechpharmasummit\/\" \/>\n<meta property=\"article:modified_time\" content=\"2023-04-29T12:41:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/07\/Morteza_Minaee_Guardant_Health_BioTech_Pharma_Summit_Profile.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"900\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@biotechsummit\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.biotechpharmasummit.com\/index.php\/companion-diagnostics-biomarkers-2017-speakers\/morteza-minaee\/\",\"url\":\"https:\/\/www.biotechpharmasummit.com\/index.php\/companion-diagnostics-biomarkers-2017-speakers\/morteza-minaee\/\",\"name\":\"Morteza Minaee &#8226; 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