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<p class="MsoNormal"><b><span style="font-size:12.0pt;color:black">From: </span></b><span style="font-size:12.0pt;color:black">Chelsea Catania <cataniac@mit.edu><br>
<b>Subject: </b>MIT Microbiome Club Industry Seminar: Dr. Julie Schwedock from Takeda, 4/23 12pm<o:p></o:p></span></p>
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<a name="_MailOriginalBody"><span style="font-size:18.0pt;font-family:"Avenir Book";color:#77984C">MIT Microbiome Club </span><o:p></o:p></a></p>
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<span style="mso-bookmark:_MailOriginalBody"><span style="font-size:18.0pt;font-family:"Avenir Book";color:#77984C">Industry Seminar Series</span><o:p></o:p></span></p>
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<span style="mso-bookmark:_MailOriginalBody"><img width="150" height="146" style="width:1.5625in;height:1.5208in" id="FE5B8A76-1536-4F16-AE81-9EC0993D5817" src="cid:image001.jpg@01D3D7F0.CF50FAB0" alt="cid:DE188664-4E8D-43E8-AA08-7505B7991C01@broadinstitute.org"><o:p></o:p></span></p>
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<span style="mso-bookmark:_MailOriginalBody"><b><span style="font-size:36.0pt;font-family:"Avenir Book";color:#28916B">Dr. Julie Schwedock </span></b><o:p></o:p></span></p>
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<span style="mso-bookmark:_MailOriginalBody"><i><span style="font-size:36.0pt;font-family:"Avenir Book";color:#28916B">Manufacturing Live Bacterial Therapeautics: What does it take to turn organisms into drugs?</span></i><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-size:24.0pt;font-family:"Avenir Book";color:#3A3E44">Monday, April 23<sup>rd</sup> at 12 pm in MIT 56-614</span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-family:"Avenir Book";color:#453CCC"> </span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-size:10.5pt;font-family:"Avenir Book"">You’ve done your discovery research, and you have a great set of candidate
organisms for your ground-breaking, life-saving live bacterial therapeutic. How do you turn that set of organisms into an FDA-approved (or EMA-, or JP-approved) drug? This talk will take you through the basics of what occurs after drug discovery. We will
go over the basics of drug development and pharmaceutical sciences for therapeutics that contain live organisms. This will include the basics of process and analytical development, “Good Manufacturing Practices” (GMP), FDA-regulated clinical phase trials,
and the special concerns of dealing with a live product.</span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><img width="134" height="142" style="width:1.3958in;height:1.4791in" id="_x0039_D53E6D8-17BE-4A33-8299-3DA8F451895C" src="cid:image002.jpg@01D3D7F0.CF50FAB0" alt="cid:FAA23D4FD92F794D97B78BF656B72135@exchange.mit.edu"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-size:10.5pt;font-family:"Avenir Book"">Dr. Julie Schwedock is an Associate Scientific Fellow of the New Modalities
Development group from Takeda Pharmaceuticals. She got her B.S. in Life Science from MIT, her Ph.D from Stanford advised by Dr. Sharon R. Long, and held two postdoc positions at Harvard in Dr. Richard Losick and Dr. Colleen Cavanaugh’s groups.</span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-family:"Avenir Book";color:#453CCC"> </span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><span style="font-family:"Avenir Book";color:#453CCC"> </span><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span style="mso-bookmark:_MailOriginalBody"><i><span style="font-family:"Avenir Book";color:#16191F">The MIT Microbiome Club, part of the Center for Microbiome Informatics and
Therapeutics, brings together inquisitive MIT undergrads, grad researchers, postdocs, faculty, and clinicians in the emerging field of microbiome studies and microbiome-based medicine.
</span></i></span><span style="mso-bookmark:_MailOriginalBody"><u><span style="font-family:"Avenir Book";color:#386EFF">Learn more on our Facebook page.
</span></u></span><span style="mso-bookmark:_MailOriginalBody"><i><span style="font-family:"Avenir Book";color:#16191F">Or follow us on
</span></i></span><a href="https://twitter.com/MITubiomeclub"><span style="mso-bookmark:_MailOriginalBody"><i><span style="font-family:"Avenir Book"">Twitter</span></i></span><span style="mso-bookmark:_MailOriginalBody"></span></a><span style="mso-bookmark:_MailOriginalBody"><i><span style="font-family:"Avenir Book";color:#16191F">. </span></i><o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody"><b>Chelsea Catania, Ph.D.</b></span><span style="mso-bookmark:_MailOriginalBody"><o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody">MIT Microbiome Club Communications Chair<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody">Postdoctoral Associate<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody">Laboratory for Energy and Microsystems Innovation<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody">Department of Mechanical Engineering<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="mso-bookmark:_MailOriginalBody">@</span><a href="https://twitter.com/MITubiomeclub"><span style="mso-bookmark:_MailOriginalBody">MITubiomeclub</span><span style="mso-bookmark:_MailOriginalBody"></span></a><span style="mso-bookmark:_MailOriginalBody"> <o:p></o:p></span></p>
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