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Clinical Trial Management System
<!DOCTYPE html> <html> <head> <meta charset='utf-8'> <meta content='IE=9; IE=8; IE=7; IE=edge; chrome=1' http-equiv='X-UA-Compatible'> <meta content='width=device-width, initial-scale=1.0' name='viewport'> <title>Clinical Trial Management System</title> <meta content='Clinical Trial Management System' name='description'> <script src='https://cdnjs.cloudflare.com/ajax/libs/d3/3.5.17/d3.min.js'></script> <link rel="stylesheet" media="all" href="/assets/application-2b88168023166027c3927451ba5fe5884d3dd17f8a1146f1a59a6f2f3bdf402c.css" data-turbolinks-track="true" /> <script src="/assets/application-867a943759c53b40098556f2079629e8a4cf80a6e8bdb9d566fcd25c5011e8ca.js"></script> <meta name="csrf-param" content="authenticity_token" /> <meta name="csrf-token" content="zMLfKTKk1dy+BjISq6J47VFWURoFtn9kWP4QADY+AX/tLWwQeqTXGW1Pvt3JOipuJe1xIQN76x1BZ82E91XDog==" /> <script> //<![CDATA[ (function(i,s,o,g,r,a,m){ i['GoogleAnalyticsObject']=r;i[r]=i[r]||function(){ (i[r].q=i[r].q||[]).push(arguments)},i[r].l=1*new Date();a=s.createElement(o), m=s.getElementsByTagName(o)[0];a.async=1;a.src=g;m.parentNode.insertBefore(a,m) })(window,document,'script','//www.google-analytics.com/analytics.js','ga'); ga('create', 'UA-34837111-8', 'harvard.edu'); ga('send', 'pageview'); //]]> </script> </head> <body> <div class='container'> <header> <a href="/"><img id="logo" alt="Translational Medicine Group - Bringing New Therapeutics Into Focus" src="/assets/logos/tmg-7d0212e8dabbd693879daaa51b7052818e92dc9451fd7b3ef21888e6ab61e00c.png" /></a> </header> </div> <nav> <nav class='navbar navbar-default' role='navigation'> <div class='container'> <div class='navbar-inner'> <div class='navbar-header'> <button class='navbar-toggle collapsed' data-target='#i3-nav-collapse' data-toggle='collapse' type='button'> <span class='sr-only'>Toggle navigation</span> <span class='icon-bar'></span> <span class='icon-bar'></span> <span class='icon-bar'></span> </button> </div> <div class='collapse navbar-collapse' id='i3-nav-collapse'> <ul class='nav navbar-nav'> <li class='dropdown'> <a class='dropdown-toggle' data-toggle='dropdown'> Services <span class='caret'></span> </a> <ul class='dropdown-menu' role='menu'> <li> <a href="/services">Services</a> </li> <li> <a href="/services/nonclinical-development">Non-Clinical Development</a> </li> <li> <a href="/services/chemistry-manufacturing-controls">Chemistry Manufacturing & Controls</a> </li> <li> <a href="/services/regulatory-affairs">Regulatory Affairs</a> </li> <li> <a href="/services/clinical-development">Clinical Development</a> </li> <li> <a href="/services/clinical-database-platform">Clinical Database Platform</a> </li> <li> <a href="/services/clinical-trial-management-system">Clinical Trial Management System</a> </li> <li> <a href="/services/contracts-regulations">Contracts & Regulations</a> </li> </ul> </li> <li> <a href="/experience">Experience</a> </li> <li> <a href="/research">Research</a> </li> <li class='dropdown'> <a class='dropdown-toggle' data-toggle='dropdown'> About <span class='caret'></span> </a> <ul class='dropdown-menu' role='menu'> <li> <a href="/about">About</a> </li> <li> <a href="/about/who-we-are">Who we are</a> </li> </ul> </li> <li> <a href="http://www.massgeneral.org/news/">News</a> </li> <li> <a href="/contact">Contact</a> </li> </ul> <ul class='nav navbar-nav navbar-right'> <li> <form class="button_to" method="get" action="/login"><input class="btn btn-default" type="submit" value="Login" /></form> </li> </ul> </div> </div> </div> </nav> </nav> <main class='container fixed-width' role='main'> <div class='static-layout'> <div class='content' id='content'> <ul class="wiki_page_actions"> </ul> <div class="wiki_content fr-view"> <h1>Who We Are</h1><h3>Executive Leadership</h3><p>The Translational Medicine Group serves to connect academia and industry to identify synergies, provide strategic advice, and support the development of novel therapeutics. We leverage the assets of the Boston biomedical community and create cross-functional teams under the guidance of an executive leadership team with a thorough understanding of the drug development process and the best practices of both academia and industry.</p><h4>Mason W. Freeman, M.D., Center Director & Founder</h4><address> <strong>Phone:</strong> 617-724-7704<br><strong>Email:聽</strong><a href="mailto:freeman@molbio.mgh.harvard.edu">freeman@molbio.mgh.harvard.edu</a> </address><p><img class="pull-left fr-dii fr-fin fr-draggable" src="/data/wiki_pages/15/mason.png"></p><p>Dr. Freeman graduated from Harvard College and received his M.D. at the University of California, San Francisco. He served as an intern, resident, endocrinology fellow, and Chief Resident in Medicine in the Department of Medicine at the Massachusetts General Hospital. He trained as a post-doctoral research fellow in the Biology Department of the Massachusetts Institute of Technology, where he played a central role in cloning the first macrophage scavenger receptor to be molecularly identified. He became Chief of the Lipid Metabolism Unit at the MGH in 1992 and continues to direct that Unit as well as the Translational Medicine programs of both the MGH Center for Computational and Integrative Biology and the MGH Clinical Research Division. From 2005-2007, while on a leave of absence from Harvard, he served as a head of the Novartis Translational Medicine program for Cardiovascular &amp; Metabolic Diseases as well as the company鈥檚 Global Head of Biomarker Development. Dr. Freeman has served as a consultant to multiple life science startup companies either independently or through his role as a venture partner at 5AM Ventures, an early-stage life science venture firm. At 5AM, he has contributed to the creation of over 30 companies, serving on the boards of Crinetics and Envoy Therapeutics, a neuroscience company acquired by Takeda in 2012. 聽 Dr. Freeman also played a key medical advisor role at Relypsa, which developed the first chronic oral therapy for hyperkalemia approved by the FDA in over 50 years. 聽Dr. Freeman is a Professor of Medicine at Harvard Medical School and editor of the Adult Primary Care lipid section of UpToDate, one of the world鈥檚 most widely read and cited on-line medical textbooks.</p><h4>Brian Seed, Ph.D., Founder</h4><address> <strong>Phone:</strong> 617-726-5975<br><strong>Email:聽</strong><a href="mailto:bseed@ccib.mgh.harvard.edu">bseed@ccib.mgh.harvard.edu</a> </address><p><img class="pull-left fr-dii fr-fin fr-draggable" src="/data/wiki_pages/15/brian.png"></p><p>Dr. Seed is a Professor of Genetics at Harvard and Director of the Center for Computational and Integrative Biology at the Massachusetts General Hospital (MGH). He obtained his B.S. and Ph.D. degrees from the California Institute of Technology. Prof. Seed has published widely in the field of genetics and molecular biology with an emphasis on the development of methods and technology. His early efforts to develop genetic selections for transiently expressed genes led to the identification of cDNAs encoding the majority of the then-recognized lineage antigens of the immune system. In addition he has made several contributions to the understanding of the mechanisms of T cell activation. His work on immunoglobulin fusion proteins led to the identification of several co-receptors and ligands and laid the basis for the development of several therapeutic fusion proteins that conceptually underlies much of the current biologics effort in the pharmaceutical industry. 聽 It was this work that led to the creation of etanercept (Enbrel庐), one of the most successful biologic therapeutics of the past two decades. 聽Dr. Seed has co-founded several biotech companies, including Connetics, Edge Biosystems, Phylos, and Egret Pharma (Shanghai) Ltd. and has served on advisory boards for Hoechst/Aventis, Medigene A.G., St. Jude Children鈥檚 Research Hospital, Phylos and New Leaf Ventures. Dr. Seed holds approximately 50 patents or pending patent applications.聽</p><h4>Yuan-Di Halvorsen, Ph.D., Chief Operating Officer</h4><address> <strong>Phone:</strong> 617-726-4236<br><strong>Email:聽</strong><a href="mailto:yhalverson@ccib.mgh.harvard.edu">yhalvorsen@ccib.mgh.harvard.edu</a> </address><p><img class="pull-left fr-image-dropped fr-fin fr-dii fr-draggable" src="/data/wiki_pages/15/Halvorsen.jpg" width="93" style="width:110px;"></p><p>Dr. Halvorsen joined the Translational Medicine program of the Center for Computational and Integrative Biology at MGH in 2007. She has established the group鈥檚 core competencies in program management, regulatory and clinical operations, and implemented Quality Assurance systems within this academic enterprise. By applying these management tools and leveraging the research and clinical knowledge of MGH faculty members, the Translational Medicine program has advanced multiple therapeutic development projects in an effective, efficient and economical manner. Through her leadership, TMG has successfully advanced both small molecules and biologics from basic research discovery labs to the clinic. These programs have ranged widely, including new therapies for diabetes, depression, respiratory papillomatosis, and anemia. Earlier stage programs in cholera vaccine development and stroke therapy are also ongoing. Dr. Halvorsen also advises academic investigators and biotechnology companies on new drug development, including regulatory and clinical strategy. Prior to her work at the MGH, Dr. Halvorsen co-founded two biotechnology companies with platform technologies in cell-based therapy and led the clinical development of protein and antibody drugs for cancer and supportive care for cancer patients. She served as Associate Director of Clinical Development at CuraGen Corporation, Vice President of Research at Artecel Sciences, and Vice President of Research &amp; Development and President of Zen-Bio, Inc. In addition, Dr. Halvorsen was an Adjunct Associate Professor at the University of North Carolina at Greensboro. She obtained her Ph.D. in Biochemistry at the University of Kentucky and received postdoctoral training at the Dana Farber Cancer Institute and Harvard Medical School.</p><h3><br></h3><h3>Management Team</h3><h4>Ryan DeAngelis, MS, Clinical Trial Manager I, TMG</h4><p><br></p><h4>Divyalakshmi Hariharan, MS, Sr. Regulatory Operations Specialist & Quality Assurance</h4><p><img class="pull-left fr-dib fr-draggable fr-fil" src="/data/wiki_pages/15/divya.png" style="width:110px;"></p><p>Ms. Hariharan joined the Translational Medicine Group (TMG) at Massachusetts General Hospital in 2019. She is responsible for managing Regulatory Operations and Quality Assurance activities. Prior to joining TMG, she worked for 6 years leading consulting assignments at various pharmaceutical companies based out of Cambridge MA. She led computer systems validation for Cell Traceability, Regulatory Submissions, Quality Management and Document Management systems. Ms. Hariharan holds a Master鈥檚 Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University, Boston MA.</p><hr><h4><br></h4><hr><h4>Tara K. Thurber, BS, Director, Clinical Operations</h4><p><img class="pull-left fr-fin fr-dii fr-draggable" src="/data/wiki_pages/15/Tara.jpg" width="100" style="width:110px;"></p><p>Ms. Thurber has been at Massachusetts General Hospital since 2000 and brings years of project and financial management to the TMG. She is responsible for the overall management of global clinical trials and associated resources. She leads global phase 2-3 trials with sites in the US, Europe and Asia Pacific. In addition she has led the design of <em>HIVE,聽</em>the TMG Clinical Trial Management System web portal.</p><hr><h4>Tong (Tony) Wu, M.D., Medical Monitor, Clinical Operations</h4><p><img class="pull-left fr-dib fr-draggable fr-fil" src="/data/wiki_pages/15/tony.png" style="width:110px;"></p><p>Dr. Wu joined the Translational Medicine Group at MGH in 2019. He graduated from University of British Columbia with BSc. in Biochemistry and received his M.D. at Ross University School of Medicine. He served as an intern and resident in the Department of Medicine at the North Shore Medical Center, a member of Mass General Brigham. He joined TMG as a medical monitor, where he is responsible for reviewing and analyzing results from clinical studies, assisting development of protocol and medical monitoring plan, and reviewing clinical study report and medical/pharmacological coding.聽</p><hr><h3>Support Team</h3><h4>Lisa Bernardo, Administrative Coordinator</h4><p><img class="pull-left fr-dib fr-draggable fr-fil" src="/data/wiki_pages/15/lisa.png" style="width:110px;"></p><p>With almost 25 years of administrative experience, Lisa Bernardo provides executive administrative support to the Director and management team of the Translational Medicine Group. 聽She is responsible for calendaring, making travel and meeting arrangements, creating and tracking invoices and payments, preparing expense reports and reimbursements, preparing materials for meetings and conferences, and carrying out special projects.</p><hr> </div> </div> </div> </main> <footer> <div class='fixed-width'> </div> <div class='footer-bg-cta'> <h3>Get started Today!</h3> <a class='btn btn-lg btn-primary' href='/contact'> Contact Us <i class='fa fa-chevron-right'></i> </a> </div> <div class='footer' role='contentinfo'> <div class='footer-logo'> <a href="http://hms.harvard.edu"><img src="/assets/static_site/footer-logo-harvard-fb01b726d0d5ad1115df89a310bcfcb5c5b47003a7e871e352fcdf8d2e3a7367.jpg" alt="Footer logo harvard" /></a> <a href="http://www.partners.org"><img src="/assets/static_site/footer-logo-partners-40e790a7392280b0a8cfedb9b155ae8177ea11856ad911e33c32780d73d5b7ab.jpg" alt="Footer logo partners" /></a> <a href="http://massgeneral.org"><img src="/assets/static_site/footer-logo-mgh-340c2259e4bab858c85028aafdd600de00242274bb0211f32905b7f150a0b721.jpg" alt="Footer logo mgh" /></a> </div> <div class='footer-links'> <ul> <li> <a href='/'>Home</a> </li> <li> <a href='/services'>Services</a> </li> <li> <a href='/experience'>Experience</a> </li> <li> <a href='/research'>Research</a> </li> <li> <a href='/about'>About</a> </li> <li> <a href='/news'>News</a> </li> <li> <a href='/contact'>Contact</a> </li> </ul> </div> <address> <strong>Massachusetts General Hospital</strong> <br> Richard B. 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