Tuesday, September 30, 2008

Oct 29th NevBio Meeting at Nevada Cancer Institute

"How to Manage Early Stage Drug Development" Dr. Peter Sausen of Covance Labs at the Nevada Cancer Institute
One Breakthrough Way, Las Vegas, NV 89135
Wednesday Oct 29th 11:30 AM Check-in, Speaker & Lunch 12 PM Cost: $35
Please RSVP-Judy at 839-7222 or jrebholz@cvbt.com

Sausen on "Managing Early Drug Development"

Dr. Peter Sausen of Covance Laboratories is focused on early stage drug development. He leads a team of scientists and project managers to help drug companies with their drug development needs from preclinical safety assessment through clinical proof of concept (Phase II) clinical trials. Dr. Sausen received his Doctorate in Toxicology from the University of Wisconsin-Madison in 1992. He completed a Postdoctoral Fellowship at the Chemical Industry Institute of Toxicology and has worked at G.D. Searle and Eli Lilly, before moving to Covance in 2005. In his article, "Effective Project Management for Multi-Sourced Early Drug Development," he noted the components associated with Investigational New Drugs (IND) and Clinical Trial Application (CTA):

· Genetic and molecular toxicology · Mammalian toxicology
· Safety pharmacology · Bioanalytical
· Drug metabolism · Dose formulations
· Program management · Regulatory strategy
· Pre-IND meetings · Investigator's brochure
· IND/CTA preparation · GMP analytical support
· Pharmacokinetics

He also noted the some of the causes for delays in development nonclinical stages such as:
· Interruption of drug supplies
· Unavailable validated analytical methods
· Lack of process for timely problem resolution
· Lack of process to assess data and interpret for inclusion in summary documents
· Failure to match nonclinical program with clinical goals

In Phases I & II, some of the causes for delays were as follows:
· Failure to prepare suitable formulation for clinical use
· Insufficient stability data to support clinical trials
· Lack of compliance with cGMPs
· Failure to prepare acceptable container label
· Inadequate information for ethics committee
· Inadequate insurance for trial participants
· Inadequate informed consent forms
· Lack of clearly focused clinical endpoints

Sausen summarized the article saying, "A well-designed development strategy is crucial to the success of a drug candidate which also requires developing a team with scientific and regulatory expertise to ensure that a streamlined and comprehensive development pathway is attained. The ability to funnel all phases of a study through a common pathway of data management, analysis, and reporting generates more efficient, consistent, and accurate results. Throughout the process the cumulative applied technical and scientific expertise of the study team is required to meet project requirements. In some cases, no amount of preplanning can predict all of the situations that may arise. The team must respond rapidly to scientific issues and regulatory requirements thereby ensuring the continued progress of the project towards critical milestones."

Sausen will be talking at the October 29, 2008 NevBio luncheon to be held at the Nevada Cancer Institute. The program will be two hours; although those who need to leave early, will be able.

Covance is a drug development services company that provides early-stage and late-stage product development services primarily to the pharmaceutical, biotechnology, and medical device industries worldwide. The company has over 8,000 employees and revenues over a billion. Covance believes in supporting growing biotech organizations and has graciously flown Dr. Peter Sausen to Las Vegas for this meeting. NevBio appreciates their support. COVANCE-HELPING TO BRING MIRACLES TO MARKET SOONER.

We also want to thank Nevada Cancer Institute for hosting this meeting.

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