Medpace Director of Clinical Pharmacology, Jim Wei, MD, PhD, Embarks on a Regulatory Policy
Speaking Tour in China in May
CINCINNATI, May 6 /PRNewswire-AsiaNet/ --
Medpace, a leading global full-service contract research organization, announced that Jim Wei, MD, PhD,
Medpace Director of Clinical Pharmacology, will address three international conferences in China in May.
He will speak at the Impact China IV Conference in Beijing, at the International Workshop on Mass
Spectrometry and New Drug Development in Hangzhou, and at the International Society for the Study of
Xenobiotics in Shanghai.
At the Impact China IV Conference in Beijing, China on 4-6 May, Dr. Wei will speak on "The Role of
Foreign Data and FDA Requirements." In his
presentation he will discuss how both pre-clinical and clinical data from foreign countries has increased in
Investigational New Drug Application (IND),
New Drug Application (NDA), and Biologic License Application (BLA) submissions
in the US.
Dr. Wei will talk about "Current FDA Policy and Opportunities for the Chinese Pharmaceutical Industry" at
the International Workshop on Mass
Spectrometry and New Drug Development in Hangzhou, China on 8-10 May. In his
presentation Dr. Wei will discuss regulatory policies that would help Chinese
generic suppliers and the opportunities for botanical drug products in the US
market.
At the Second Asian Pacific Regional Meeting of the International Society
for The Study of Xenobiotics, held in Shanghai, China on 11-13 May, Dr. Wei will speak on the "Current US
FDA Recommendations on Drug Interaction Studies
and Challenges to the Pharmaceutical Industry." In this presentation he will
reveal the challenges to the pharmaceutical industry -- the requirement of the
knowledge level of drug metabolism and drug interactions, optimal design of in
vitro and in vivo studies, and integrated analyses to assess the risk/benefit
ratio of new drugs for potential harmful drug interactions.
Dr. Wei joined Medpace in November 2007 with extensive experience in the
clinical trial regulatory aspects of early phase studies. He came to Medpace
from the FDA where he served as a Senior Reviewer in the Office of Clinical Pharmacology and was also
heavily involved in reviewing INDs and NDAs for the
Division of Metabolism and Endocrinology Products.
ABOUT MEDPACE
Medpace is a leading global full-service contract research organization led by top therapeutic and
regulatory experts who are driven to further the
advancement of pharmaceutical agents for use in cardiology, metabolism, and oncology. Medpace has
assembled the industry's most experienced and
therapeutically focused team to execute at every level of the company's
operations, providing complete and seamless drug development services.
Through specialized regulatory expertise and therapeutically focused
clinical operations, Medpace creates strategic partnerships with
pharmaceutical and biotechnology companies to provide the most efficient and
cost-effective path to drug development -- from program planning and execution
to product approval.
With more than 700 employees and clinical trial experience in over 40 countries, Medpace has the global
reach and capability to conduct studies and
navigate regulatory requirements worldwide within the core therapeutic areas
of cardiology, metabolism, and oncology.
Medpace provides centralized image management and reading from Imagepace,
centralized laboratory and therapeutically specialized testing from Medpace Reference Laboratories, and
Phase I / IIa research services from Medpace Clinical Pharmacology.
Contact: John Wynne, 513-579-9911, x2407
j.wynne@medpace.com
SOURCE Medpace, Inc.
CONTACT: John Wynne of Medpace, Inc.,
+1-513-579-9911, x2407,
j.wynne@medpace.com
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