Research@UIC > Life Sciences Initiative > Current Agenda

Current Agenda

Drug development Short Course - From the Bench Through the Clinic

November 20, 2009 - Discovery to IND
December 7, 2009 - Phase I to NDA

University Technology Park at IIT
3440 South Dearborn Street
Chicago, IL 60616

Agenda:

Part 1 - Preclinical Aspects of Product Translation

Date:
November 20, 2009—8:30 a.m. to 6:00 p.m.

Cost: $35

TIME	TOPIC	SPEAKERS
8:30 a.m.–9:00 a.m.	Arrival: Coffee and Pastries
9:00 a.m.–9:10 a.m.	Welcome and Introduction	Ron Kirschner, M.D. Catalyzing Collaborations Michael Chansler Business Dev. Director IIT Research Institute (IITRI)
9:10 a.m.–9:30 a.m.	Industry and Academia: Success in Collaboration	John Anderson, Ph.D. President, IIT
9:30 a.m.–10:30 a.m.	Introduction to Preclinical Trial Design, Animal Modeling, and Toxicology	David McCormick, Ph.D., D.A.B.T. IITRI SVP and Director and IIT Professor
10:30 a.m.–10:45 a.m.	Mid- Morning Break
10:45 a.m.–11:45 a.m.	Regulatory Expectations, Hurdles, and Evaluations of Toxicology Programs	Robert Ings, Ph.D. President, RMI Pharmacokinetics (formerly VP, DMPK Roche Pharmaceuticals)
11:45 a.m.–12:30 p.m.	CMC Considerations: cGMP Exemptions for Phase I Clinical Trials (21CFR 210/211)	Ann V. LeFever, Ph.D. LeFever Consulting
12:30 p.m.–1:30 p.m.	Lunch in Technology Park Atrium
1:30 p.m.–2:15 p.m.	From Discovery to IND: Points to consider in lead selection and early development	Mitchell B. Friedman, Ph.D., D.A.B.T. Director of Toxicology, Takeda Global Research and Development
2:15 p.m.–3:15 p.m.	An Alternative Drug Development Engine—Lilly's Chorus	David Monteith Ph.D. Clinical Advisor Lilly/Chorus Group
3:15 p.m.–3:30 p.m.	Afternoon Break
3:30 p.m.–4:30 p.m.	Commercialization Strategy: Planning and Funding	Ali Andalibi, Ph.D. Program. Director, NCI SBIR Dev. Center
4:30 p.m.–6:00 p.m.	Wrap-up and Networking

Part 2 - First in Human Trials to the NDA

Date:
December 7, 2009—8:30 a.m. to 6:00 p.m.

Cost: $35

TIME	TOPIC	SPEAKERS
8:30 a.m.–9:00 a.m.	Arrival: Coffee and Pastries
9:00 a.m.–9:10 a.m.	Welcome and Introduction	Ron Kirschner, M.D., Catalyzing Collaborations Michael Chansler, Business Dev. Director IIT Research Institute (IITRI)
9:10 a.m.–9:30 a.m.	Industry and Academia: Success in Collaboration	Alan Cramb, Ph.D. Provost and SVP for Academic Affairs, IIT
9:30 a.m.–10:30 a.m.	Pharmacology Toxicology and the Investigator's Brochure: Translating nonclinical study findings to support clinical clinical development	John Leighton, Ph.D. Division of Drug Oncology Products, US FDA
10:30 a.m.–10:45 a.m.	Break
10:45 a.m.–12:00 p.m.	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 p.m.–1:00 p.m.	Lunch in Technology Park Atrium
1:00 p.m.–2:00 p.m.	Partnering and Companion Diagnostics	Tracey Colpitts, Ph.D. Abbott Laboratories
2:00 p.m.–3:30 p.m.	Clinical Trial Design and Implementation	Lewis Smith, M.D. Professor, Department of Medicine, Pulmonary Division, Feinberg School of Medicine, Northwestern University Lhanoo Gunawardhana, Ph.D. Associate Medical Director, Clinical Sciences in Pain and Inflammation, Takeda Global Research and Development
3:30 p.m.–3:45 p.m.	Break
3:45 p.m.–4:30 p.m.	Doing Business with Local CTSAs (Clinical and Translational Science Award institutions)	David Johnson, Ph.D. Associate Director, Center for Translational Innovation, Northwestern University
4:30 p.m.–6:00 p.m.	Wrap-up and Networking