[bioundgrd] FW: MIT Microbiome Club Industry Seminar: Dr. Julie Schwedock from Takeda, 4/23 12pm

[Joshua Stone]

From: Chelsea Catania <cataniac at mit.edu>
Subject: MIT Microbiome Club Industry Seminar: Dr. Julie Schwedock from Takeda, 4/23 12pm

MIT Microbiome Club
Industry Seminar Series
[cid:DE188664-4E8D-43E8-AA08-7505B7991C01 at broadinstitute.org]
Dr. Julie Schwedock
Manufacturing Live Bacterial Therapeautics: What does it take to turn organisms into drugs?
Monday, April 23rd at 12 pm in MIT 56-614

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.
[cid:FAA23D4FD92F794D97B78BF656B72135 at exchange.mit.edu]
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.


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. Learn more on our Facebook page. Or follow us on Twitter<https://twitter.com/MITubiomeclub>.

Chelsea Catania, Ph.D.
MIT Microbiome Club Communications Chair
Postdoctoral Associate
Laboratory for Energy and Microsystems Innovation
Department of Mechanical Engineering
@MITubiomeclub<https://twitter.com/MITubiomeclub>


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