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Optimizing the Predictive Value of Preclinical Research Lessons Learned Sharon Hesterlee Ph.D.

Optimizing the Predictive Value of Preclinical Research Lessons Learned Sharon Hesterlee Ph.D. Research Director for Parent Project Muscular Dystrophy and the Association for Frontotemporal Degeneration. What We Need (Stanley Lazic, F. Hoffman-LaRoche):.

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Optimizing the Predictive Value of Preclinical Research Lessons Learned Sharon Hesterlee Ph.D.

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  1. Optimizing the Predictive Value of Preclinical Research Lessons Learned Sharon Hesterlee Ph.D. Research Director for Parent Project Muscular Dystrophy and the Association for Frontotemporal Degeneration What We Need (Stanley Lazic, F. Hoffman-LaRoche): • Unbiased and reproducible estimates of effect size • Appropriate and reasonable precision of these estimates

  2. Consistent Theme: Treat preclinical study design the way you would clinical study design • Develop Standard Operating Procedures: • Pre-specify measurements • Pre-determine inclusion/exclusion criteria • Use randomization methods, allocation concealment and blinding procedures • Validate preclinical model, endpoints and statistical methodology • Make sure scope of preclinical investigation is adequate • Include PK/PD data in investigations

  3. Alzheimer’s Drug Discovery Foundation • -Solution: Used expert advisory panel to generate and disseminate standards and invest in resources • CAMARADES Collaboration • -Solution: Collaborative group to set standards and disseminate those standards • ALS Therapy Development Institute • -Solution: Building collaborative group to properly validate preclinical animal models Is it enough? And how do you know if it’s working?

  4. Top Down Approaches (Funders, Journals, Reviewers): -Consensus statements -Funding Requirements -Publication Requirements -Review Requirements -Educational/Training Efforts Bottom Up Approaches (Investigators): -Education/Training -Consensus statements -Transparency -Cultural Shifts -Incentive Shifts

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