Preclinical Development and IND Filing: the
Nuts, Bolts, and Best Practices for Small Molecules
Major Sponsor: IIT Research
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
San Diego -
La Jolla (4550
La Jolla Village Drive, San Diego, CA 92122)
Online Registration is
now Open for this event.
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:
Overview of preclinical
studies required (Safety, DMPK & CMC)
regulatory agencies including FDA
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
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
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
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
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
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 (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
(1989-1991). Dr. Wei received his medical degree from
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.
Drug Metabolism and Metabolite ID
ACD Labs, Inc
Bioanalytical Method Validation
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C.A.C.O.-San Diego is
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(C.A.C.O.), which is a
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metabolism and pharmacokinetics, and related fields, working in diverse
organizations such as biotechnology and the pharmaceutical industry,
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The mission of C.A.C.O.
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provide educational and growth opportunities in the fields of analytical
chemistry, drug metabolism, pharmacokinetics, and related disciplines.
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Scientific Programs Chair: Sam Sperry, Ph.D. (Vertex
Treasurers: Jennifer Yang, Ph.D. (Ardea
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