Exploratory IND
ABOUT THE EXPLORATORY IND EVENT
An FDA Critical Path guidance was issued in January 2006 entitled "Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies". These guidelines are intended to clarify what manufacturing controls, preclinical testing, and clinical approaches can be considered when planning limited, early exploratory IND studies in humans.
Come join Judith Atkins of Parexel and Kevin Fehr from GSK for an overview and open discussion on exploratory IND in the context of FDA's Critical Path guidelines. Hear what the FDA wants and share with colleagues the strategies to meet their requirements.
Presenter: Judith Atkins, Parexel
Senior Consultant, PAREXEL Consulting
Moderator: Kevin O’Brien Fehr, Ph.D.
Director, R&D Alliances; GlaxoSmithKline Inc.
BACKGROUND MATERIALS FOR REGISTERED PARTICIPANTS
Guidance for Industry, Investigators, and Reviewers Exploratory IND StudiesDATE | TIME | LOCATION
June 29, 200611:30AM - 1:00PM
MaRS CENTRE
101 College St, Toronto
ABOUT THE DRUG DEVELOPMENT DISCUSSION GROUP
The Drug Development Discussion Group (DDD Group) is an informal moderated forum bringing together research professionals and clinicians interested in drug development.
Think of DDD Group as a Journal Club focused on global drug development issues; a place to hear candid comments from the practitioners in the field, a chance to debate and develop a rapport with industry and academic professionals you do not necessarily deal with on a daily basis.
If you are interested in moderating future sessions please contact Veronika Litinski (vlitinski@marsdd.com).
Click here for more information about the Drug Development Discussion Group (DDD Group).
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
