1. Introduction Howard Lee, MD, PhD Associate Adjunct Professor Director, Center for Drug Development Science Department of Biopharmaceutical Sciences School of Pharmacy University of California San Francisco DTRCS Regulatory Education Seminar, October, 2007

2. Copyright © Howard Lee, All Rights Reserved Program Introduction1:00 - 1:05 PMHoward Lee Preclinical Data Package for IND Submission 1:05 - 1:45 PMCarl Peck CMC 101 for New Drug Candidates1:45 - 2:45 PMDavid Savello Break2:45 - 3:15 PM How Much Animal Data are Required to Move into Clinical Testing? 3:15 - 4:15 PMHilary Sheevers How to Choose the MRSD for FTIH Clinical Trials 4:15 - 4:50 PMHoward Lee Summary and Conclusion4:50 - 5:00 PMHoward Lee

3. Copyright © Howard Lee, All Rights Reserved Housekeeping Evaluation form Slides available at CTSI web site (http://ctsi.ucsf.edu/rks/index.php)http://ctsi.ucsf.edu/rks/index.php Presentation videotaped One-on-one consultation Regular consultation requests (http://ctsi.ucsf.edu/rks/dtrcs_ix.php)http://ctsi.ucsf.edu/rks/dtrcs_ix.php Next seminar (Microdosing in drug development, early 2008)

4. Copyright © Howard Lee, All Rights Reserved Acknowledgement David Kessler, MD Mary Anne Koda-Kimble, PharmD Joel Palefsky, MD, CM, FRCP(C) Deborah Grady, MD, MPH Jeanine Wiener-Kronish, MD Marlene Berro, MS Julie Nelson, MBA All speakers