2008 AAPS Workshop on Demonstrating Disease Modifying Effects for the Treatment of Parkinson’s Disease: Drug Development and Regulatory Issues
(co-sponsored by The Michael J. Fox Foundation, FDA, the PSG) 

Without an approved disease-modifying Parkinson's disease therapeutic or consensus on the pathway for assessing such a benefit, clinical trials have mainly focused on measuring symptomatic effects. Discussions in this workshop will focus on appropriate endpoints for discerning symptomatic and disease-modifying effects in Parkinson's disease clinical trials in order to combat this hurdle.  Experts in Parkinson's disease, drug development, quantitative clinical pharmacology, and statistics will address the following topics:

- Pathology of Parkinson's disease and pharmacological basis for a drug to alter disease progression 
- Quantitative analyses to describe the rate of progression, reasons for missing data, and patient baseline characteristics using data across registration trials in Parkinson’s disease 
- Appropriate endpoints and analyses to discern symptomatic and disease-modifying effects for registration and early trials 
- Regulatory expectations on the evidence of disease-modifying effects

The Michael J. Fox Foundation is eager to assist the field in tackling these critical issues and is pleased to be a co-sponsor of this meeting. We encourage investigators from Industry and Academia with an interest in clinical trials issues related to development of disease-modifying therapies to attend this meeting.

When: April 28-29, 2008

Where: Hyatt Regency Crystal City – Arlington, Virginia

Please visit www.aapspharmaceutica.com/parkinsons to register for this meeting and download the program agenda.

Please feel free to email research@michaeljfox.org for further information.