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Drug Development Short Course - From the Bench Through the Clinic: Phase I to NDA |
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December 07, 2009, 9am to 5pm
University Technology Park at IIT
3440 South Dearborn Street
Chicago, IL 60616
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Cost |
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Members $35
Non-members $35
Online registration closed.
To register for this event, please e-mail or call AJ Pace at 312-422-1111 ext. 1.
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| Details |
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Note: this is part 2 of a two-part course.
Part 1: Preclinical Aspects of Product Translation, November 20
Part 2: First in Human Trials to the NDA, December 7
Part 2: First in Human Trials to the NDA, December 7
8:30 am - 9:00am Registration and Breakfast
9:00 am - 9:10 am Welcome Introduction, Ron Kirschner, MD, Catalyzing Collaborations, Michael Chansler, IIT Research Institute
9:10 am - 9:30 am Industry / Academic Collaboration, John Anderson, PhD; President IIT
9:30 am - 10:30 am Regulatory Expectations, Hurdles and Evaluations of Phase I-III Trials, John Leighton, Ph.D. ; Division of Drug Oncology Products, US FDA
10:30 am - 10:45 am Mid Morning Break
10:45 am - 12:00pm Panel Discussion: Commercialization Strategy: How to do it and what is expected, Caralynn Nowinski-Chenoweth, M.D., Sanogene Therapeutics, Midwest Venture Partners and ARCH Development Partners; Alice Martin. Esq. Barnes and Thornburg; Mike Flavin, Ph.D. CEO and Chairman, Advanced Life Sciences
12:00 pm - 1:00 pm Lunch
1:00 pm - 2:00 pm Partnering and Companion Diagnostics Tracey Colpitts, Ph.D. - Abbott Laboratories
2:00 pm - 3:30pm Clinical Trial Design and Implementation, Lewis Smith, M.D. Professor, Department of Medicine, Pulmonary Division, Feinberg School of Medicine, Northwestern University; Lhanoo Gunawardhana, PhD.
Associate Medical Director, Clinical Sciences in Pain & Inflammation, Takeda Global Research and Development
3:30 pm - 3:45 pm Mid Afternoon Break
3:45 pm - 4:30 pm Doing Business with Local CTSAs (Clinical and Translational Science Award institutions), David Johnson, PhD. Associate Director, Center for Translational Innovation Northwestern University
4:30 pm - 6:00 pm Wrap up and Networking
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| For more information |
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Call 312 567 4487
Visit https://payment.iit.edu/item.php?item=440
E-mail Info@iitri.org |
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