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.
The mission of the
6th Clinical Trials Phase I & Phase IIA Summit is to provide attendees with the strategies and insight necessary to ensure their early stage clinical trials are executed on time and within budget while exploring how to leverage innovative approaches to managing clinical trials for all therapeutic areas.
Top Five Reasons to Attend
- 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
Who Should Attend
This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:
- Clinical Research/Operations/Outsourcing/Affairs
- Early Phase Research/Development
- Pharmacology/Pharmacokinetics/Pharmacodynamics
- Pharmacovigilance
- Translational/Experimental Medicine
- Biostatistics/Biometrics
- Pharmacometrics
- Clinical Data Management/Statistics
- Clinical Innovation
- Regulatory Affairs/Compliance
- Medical Research/Affairs
- Patient Recruitment/Engagement
- Drug Safety
This conference is also of interest to:
- Clinical Research Organizations
- Clinical/Quality Risk Consultants
- Medical Informatics Companies
- Functional Service Providers
- Patient Engagement and Retention Services
- Clinical Technology and Data Management Solution Providers
Speakers
- Wesley Day, Lead Global Clinical Development, MTDA
- Martin Gutierrez, M.D., Director of the Drug Discovery , JOHN THEURER CANCER CENTER
- Susan Lubin, Director- CP & Oncology Operations, BRISTOL MYERS SQUIBB
- Chelsea McCabe, Project Manager, JOHN THEURER CANCER CENTER
- Bruce Morimoto, Vice President, Drug Development Operations, ALKAHEST\
- Laurie Myers, Global Health Literacy Director, MERCK & CO., INC.
- Jim Nissel, Director, Clinical Trial Management, Translational Development - Clinical Pharmacology, CELGENE
- Rosemarie Pincus, Principal Medical Writing Scientist, Oncology Division, JOHNSON & JOHNSON
- William B. Smith, President, NEW ORLEANS CENTER FOR CLINICAL RESEARCH
- Laura Vessey, Director, Early Clinical Development, MERCK
Please fill in your name and email to receive the Conference Agenda of this event.
Venue
Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA
To make reservations, guests can call 1-800-SONESTA (766-3782) and request the group rate for ExL's October Meetings.
The group rate is available until September 25, 2019. Please book your room early, as rooms available at this rate are limited.
