The Power of Outsourcing in Early through Preclinical Drug Development
September, 9th 2010
Hyatt Regency in La Jolla
Mark your calendar and plan to join us for a one day Symposium featuring 9 senior level pharmaceutical and biotechnology industry speakers in a keynote address, case study presentations and discussions covering hot topics and end-to-end solutions across the drug-development spectrum. The presentations will explore a number of issues related to “Early through Preclinical Drug Development” and features internationally recognized experts in drug discovery and development discussing topics including:
Keynote Topic: The objective of this presentation is to provide the biotech companies the most effective ways of outsourcing pre-clinical testing. These will include identifying the criteria for choosing the appropriate contract lab based on its history, capabilities, expertise, and finally making a choice between science and quality of the product versus cost.
Panel Topics:
Medicinal Chemistry: IP generation, hit validation, lead optimization and solving tough synthetic problems
In Vitro Approaches for Organ Specific Toxicity Screening: A new in vitro approach designed to determine if a drug will cause adverse effects in liver, heart, or kidney. By incorporating a two cell model, organ specific toxicity endpoints, and markers of general cell health that it is possible to identify a drugs potential to cause liver, heart, or kidney toxicity
Challenges Associated with “Metabolomics”: The comprehensive, integrated analytical and data handling platform that provide a chemo-centric global metabolism analyses of biological systems. Presenting a specific case study describing the impact of this platform in a Drug Mechanism of Action Study
“Biologics,” or Large Molecules: Showcasing many significant ways in which the development process of a large molecule differs from that of traditional small molecules, including immune response, dose solution preparatory considerations, species-specific pharmacologic factors, and delivery methods
Chemistry, Manufacturing and Control (CMC): Formulation and analytical development topics along with early phase cGMP clinical supply manufacturing.The presentation will provide participants with the fundamentals needed to successfully implement an early stage CMC development process
Phase I Clinical Pharmacology and Early Clinical Research Studies: Cardiac safety, PK/PD, drug interaction and methodology studies. Incorporating pharmacogenetics and biomarkers into exploratory and proof of concept studies
Date: Thursday, September 9th
Agenda: 4:00 p.m. - 5:00 p.m.Registration, Networking & Visiting Exhibit Hall: Complimentary cocktails and horsd'oeuvres will be served
5:00 p.m. - 8:30 p.m.: Panel Presentation
Keynote Speaker & Moderator:
Ali Faqi, Ph.D., DVM, DABT, MPI
Panel of Speakers:
Grace M. Furman, Ph.D., DABT CEO/President, Paracelsus, Inc.
Sylvie K. Sakata, PhD Senior Director Pfizer Inc. La Jolla and St Louis Lead External Research Solutions RCoE
David C. Zimmermann, CEO - Kalexsyn Inc.
James McKim, Ph.D., DABT - CSO, CeeTox Inc
John Ryals, Ph.D. - CEO, Metabolon
Dean Knuth - CEO, Jasper Clinic
David McGee, Ph.D., DABT – MPI Research
David Barnes, PhD - CSO, Velesco Pharmaceutical
8:30 p.m. -9:00 p.m. Q&A
9:00 p.m. Adjourn
Place: Hyatt Regency in La Jolla
Sponsorship levels: Diamond ($1,000.00); Platinum ($400.00), Gold ($200.00), and Silver ($100.00) To become a sponsor please email us at info@ialsn.org
