Sohini Chowdhury, 2011
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The document discusses the Parkinson's Progression Markers Initiative (PPMI), a public-private partnership aiming to accelerate Parkinson's disease drug development. PPMI is conducting a large clinical study to identify biomarkers that can complement current clinical measures and help overcome challenges in PD therapy testing. It has recruited over 600 subjects across sites in the US, Europe, and soon Australia. Industry partners provide input while data is standardized, shared in real-time, and made widely available to support more efficient drug development.
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The document summarizes a research roundtable held by the Michael J. Fox Foundation (MJFF) to discuss their strategy for accelerating Parkinson's disease research. MJFF has funded over $240 million in Parkinson's research since 2000. They discussed key focus areas like developing disease-modifying therapies, biomarkers like the Parkinson's Progression Markers Initiative to help drug development, and improving treatments for motor/non-motor symptoms like dyskinesia. Experts from academic institutions also provided insights on challenges and opportunities in these areas.
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- 1. Public-Private Partnership Model: The Parkinson’s Progression Markers Initiative •Sohini Chowdhury, Vice President, Research Partnerships Sept 16, 2011
- 2. Parkinson’s is a global disease and prevalence is growing Parkinson’s disease (PD) is a progressive neurodegenerative disease that affects nearly six million worldwide. PD prevalence is expected to grow sizably over the next 25 years as the proportion of older citizens continues to increase globally. Current therapies address mild/moderate motor symptoms There is currently no therapy proven to modify – slow or halt – the progression of the disease. 2
- 3. Drug development is a lengthy and costly process Takes ~15 years for drug therapy to go through R&D and get to market ~8 of those years are spent in clinical testing 3
- 4. Clinical testing of PD therapies is challenging Obstacles include: • Current trial paradigm requires large number of subjects • Efficacy testing is a long process, diminishing patent value • Reliance on clinical measures alone confound trial interpretation • There are no biological indications of underlying disease that complement clinical changes Increases risk for pharma, the main sponsors of therapeutic trials
- 5. The Parkinson’s Progression Markers Initiative (PPMI) PPMI is a ground-breaking clinical study that aims to accelerate PD drug development by identifying biomarkers of Parkinson’s Disease
- 6. Critical to PPMI’s success is recruiting a cohort of 600 21 sites in Europe and US are recruiting subjects; soon to be expanded to Australia 6
- 7. Various groups provide input/management of study facets 7
- 8. Industry is a valuable partner
- 9. A strong emphasis on standardization and sharing SOPs 9
- 10. A strong emphasis on recruitment PPMI Enrollment Status As of Sept 2011 10
- 11. Data made available and shared in real-time via study website 11