Outsourcing Preclinical Development
STRATEGIES FOR OPTIMIZING TOXICOLOGY, PHARMACOLOGY AND PHARMACOKINETIC STUDIES TOWARDS COMMERCIALIZATION
Speaker: Dr. Pliura, Executive Vice President, AeroLEFThe increasing trend in outsourcing preclinical studies is growing considerably in the biopharmaceutical industry. The majority of the safety-related attrition occurs preclinically, suggesting that approaches to better understanding preclinical safety liabilities earlier in the drug development process could lead to the design and/or selection of better drug candidates. Dr. Pliura will shed light into the types of information that is required by various organizations (FDA, venture capitalists, etc…), comment on the minimum standards and what is needed to convince various authorities, and provide guidance into selecting an outsourcing partner.
Dr. Pliura will be commenting in detail on the following points:
- Comment on concerns from research that "preliminary data" is almost always repeated by other investors at the "correct standard."
- Shed some light into outsourcing into Asia - is it given equal weight?
- Comment on what is the "minimum standard" as opposed to what is needed to convince poeple. Guidance into what records to keep and the number of people that get involved in the process.
- Discuss the necessity of bringing in a third party to manage the Project.
Cost: Free
Registration is now closed.
DATE | TIME | LOCATION
December 18, 200711:30AM - 1:00PM
MaRS Centre, CR3
101 College St., Toronto
Please bring your lunch
ABOUT THE SPEAKER
Dr. Pliura has over 25 years of experience in the pharmaceutical, biopharmaceutical and venture capital sectors. She was the founding President and CEO of DELEX Therapeutics Inc., which was acquired by YM BioSciences Inc. in May 2005. From 1998 through 2001, she served as Company Creator for the Eastern Technology Seed Investment Fund, responsible for assessment of biotechnology investment opportunities and serving in executive management roles for selected investments. In 1997, she founded a consulting firm focused on providing scientific and management expertise to biotechnology companies and their investors. Previously Dr. Pliura was a Scientific Advisor to MDS Health Ventures from 1996 to 1997 and Vice-President Research at Hemosol Inc. from 1992 through 1995. Prior to that, she held various positions at Syntex (Canada) Inc. from 1981 to 1991 including serving as Head of the Division of General Biochemistry in the drug discovery unit from 1989-1991. Dr. Pliura is a co-inventor or co-author on numerous patents and peer-reviewed articles. She received her doctoral degree in Chemistry from the University of Toronto and completed post-doctoral training at Harvard University.UPCOMING EVENTS
PAST EVENTS
- March 27, 2008
MaRS Drug Development Discussion Group - Structure-Guided Discovery Without Structures: Computer-aided design of GPCR ligands - February 27, 2008
MaRS Drug Development Discussion Group - Formulation: Giving new life to naturally occurring un-patentable compounds - January 25, 2008
Drug Development Discussion Group - Novel therapeutic targets for preventing bone loss in osteolytic disease - December 18, 2007
MaRS Drug Development Discussion Group - Outsourcing Preclinical Development - October 23, 2006
MaRS Drug Development Discussion Group - Chance and Necessity in Drug Discovery: The case history of calcimimetic drugs - August 31, 2006
Drug Development Discussion Group - Structure-based Lead Generation and Optimization - June 29, 2006
Drug Development Discussion Group - Exploratory IND - April 27, 2006
Drug Discussion Group - BioMarkers in Clinical Trials
