CACO-San Diego Fall Workshop:

Major Sponsor: IIT Research Institute

Speakers: Dr. Cuiping "Tracy" Chen (Depomed), Dr. Jeff Etter (Celegen), Dr. Linval Depass (Duret) and Dr. Jim Wei (Medpace)

Date/Time: September 23, 2009; 8:45 AM - 5:00 PM 
Venue: Embassy Suites San Diego - La Jolla (4550 La Jolla Village Drive, San Diego, CA 92122)

Online Registration is now Open for this event.

Workshop Outline:

An investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Often, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed, and this can lead to significant delays in clinical development.  Additionally, the regulatory environment is changing as rapidly as the industry. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount.  In this workshop, our speakers, highly experienced with IND filings, will discuss systematically the preclinical studies required for small molecule IND filings. This will include "the nuts, bolts, and best practices" for putting together a high-quality IND package, as well as how to interact with various regulatory agencies. Below are the topics to be covered:

About the Speakers:

Dr. Cuiping “Tracy” Chen, Ph.D. is currently a director of Pharmacokinetics and Metabolism at Depomed, Menlo Park, CA. Tracy started as a Research Investigator in Metabolism & Pharmacokinetics in Bristol Myers Squibb (1997-1998), moved to the Pharmacokinetics, Dynamics, and Metabolism department at Pfizer (1998-2005) initially as a Research Scientist and promoted up to Senior Principal Scientist before she joined JNJ (2005-2007) as the DMPK head at Scios and later as an Associate Director of DMPK at Alza. Prior to Depomed, she was an Associate Director of DMPK/Translational Sciences in Celgene (2007-2008). Tracy received her Ph.D. from the school of pharmacy, university of North Carolina at Chapel Hill in the area of PK-PD and drug transporters, followed by a post-doctorial training in P450 metabolism. She is a frequent invited speaker at AAPS and. She has been a regular reviewer for multiple journals including Drug Metabolism & Disposition and has more than 30 publications in peer reviewed journals.

Dr. Linval DePass received his Ph.D. (Interdisciplinary Toxicology) from the University of Arkansas for Medical Sciences.  He is currently the Executive Director of Nonclinical Safety at Durect Corporation in Cupertino, CA.  Prior to joining Durect, he was the Department Head, Toxicology for Roche Palo Alto.  Before the acquisition of Syntex by Roche in 1994, he was a Department Head in the Department of Toxicology at Syntex where he started working in June 1984.  From February 1978 until joining Syntex, Dr. DePass worked at Union Carbide Bushy Run Research Center where he was Manager of Oral and Dermal Toxicology.  Dr. DePass has been a member of SOT since 1983 and served on the Animals in Research Committee from 1997 to 2000.  He was a Councilor and Secretary/Treasurer in the Regulatory and Safety Evaluation Specialty Section of SOT from 2001-2004.  He is a past President of the Northern California Chapter of SOT and he was a founding member of the Chapter.  He is also a member of the American College of Toxicology and AAAS.  Dr. DePass was a member of the editorial board of Fundamental and Applied Toxicology from 1989 to 1995 and is a Diplomate of the American Board of Toxicology.

Dr. Jeff Etter is currently the Director, Formulations at Celgene.  He received his Ph.D. in Organic Chemistry from the University of Colorado in 1987, and performed postdoctoral studies with Barry Trost at Stanford University as an NIH fellow.  He has more than 20 years of pharmaceutical/biotechnology industry experience in the areas of process development, manufacturing, quality control, analytical development, and formulation development.  Jeff has been involved in multiple start-up companies with broad responsibilities in the technical CMC area utilizing both in-house and contract facility resources to satisfy the requirements for regulatory submissions including INDs, IMPDs, NDAs, and MAAs. 

Dr. Xiaoxiong “Jim” Wei currently serves as Director of Clinical Pharmacology at Medpace located in Cincinnati, Ohio. He was a past senior reviewer in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research of FDA for about 10 years until November, 2007.  He was an active member for both Drug Metabolism/Drug Interaction Working Group and Pharmacogenetics Working Group at FDA. He received his Ph.D. in Pharmaceutical Sciences from the Idaho State University, Pocatello, Idaho (1991-1995). Prior to joining FDA in 1998, he was a post-doctoral fellow in the Laboratory of Metabolism, National Cancer Institute, National Institutes of Health, Bethesda, MD (1995-1998) and a Clinical Pharmacology Fellow in the Veterans Affairs Medical Center, Boise, Idaho (1989-1991).  Dr. Wei received his medical degree from Zhejiang University Medical School in 1983.  He is board certified in Clinical Pharmacology (the American Board of Clinical Pharmacology).   His regulatory expertise is involved in all clinical phases, especially in early clinical developments.  He was heavily involved in reviewing IND/NDA submissions in anti-diabetic drugs, lipid lowering drugs, insulin products, hormonal drug products, anti-osteoporosis, anti-obesity drugs, biological and botanical drug products, etc. He is member of ASCPT and ISSX.