Thu, Oct 17, 2019 · 8:00

Sponsors often take for granted the fact that early phase trial design and operations can make or break future studies. When hard data is severely limited and is used to predict well beyond its boundaries, the quality of that data is absolutely paramount. The data obtained from phase 1 first-in-human studies through phase 2 proof-of-concept and dose range finding studies are vital to effectively designing future registration studies. Early phase clinical trials should be safe experiments on humans, not small-scale phase 3 trials. Therefore, it is beneficial to intelligently optimize early phase clinical activity to ensure successful trial execution and regulatory approval.
*Implement adaptive study designs and predictive models to successfully accelerate early phase trials
*Improve vendor identification and communication from negotiation to study execution
*Overcome the evolving challenges of patient recruitment and retention for different diseases
*Leverage techniques to help identify genetic predisposition and risk factors for adverse events and drug reactions
*Discuss innovative strategies to optimize early phase clinical trial operations




Standard: USD 2095.00
Early Bird: USD 1895.00
Onsite Pricing: USD 2295.00

Speakers: Michel Azoulay, Global Oncology Leader, SANOFI CLINICAL OPERATIONS STRATEGY, Wesley Day, Lead Global Clinical Development, MTDA, Martin Gutierrez, M.D., Director of the Drug Discovery , JOHN THEURER CANCER CENTER, Chelsea McCabe, Project Manager, JOHN THEURER CANCER CENTER, Jim Nissel,Director, Clinical Trial Management, Translational Development – Clinical Pharmacology, CELGENE, Rosemarie Pincus, Principal Medical Writing Scientist, Oncology Division, JOHNSON & JOHNSON, Laura Vessey, Director, Early Clinical Development, MERCK, Tami Crumley, Principal Scientist, Translational Pharmacology, MERCK, Bruce Morimoto, Vice President, Drug Development Operations, ALKAHEST, Paul Rothenberg, Executive Director, Strategic Product Development, COVANCE, Pranab Mitra, Associate Principal Scientist, MERCK, William B. Smith, President, NEW ORLEANS CENTER FOR CLINICAL RESEARCH