Diane Stephenson Email and Phone Number

Critical Path for Parkinson's (CPP) is one of twelve consortia of the Critical Path Institute, a non-profit organization founded to deliver on the vision of FDA's Critical Path Initiative. CPP brings together a diverse group of key stakeholder from around the world including academia, industry, the advocacy community, and federal and regulatory agencies to accelerate therapies for PD. We encourage partners to share and pool data and collectively develop data standards and quantitative disease models to improve the efficiency of clinical trials. The mission of CPP is to serve as the main international vehicle to develop new, regulatory endorsed drug development tools based on the most current scientific insights into early Parkinson's. CPP focuses on early stages of the disease, a time that has the best chance for delaying disease progression. Early intervention is a priority need as expressed from patients. By combining resources, organizations can advance science more effectively and efficiently than by working alone.

The overall goal of the new HD Regulatory Science Consortium (HD-RSC) initiative is to create a global forum for collectively advancing new HD therapies by all stakeholders. Thanks to the generous support of CHDI Foundation, HD-RSC is bringing together participants in the HD community to advance drug development tools for regulatory endorsement, and to facilitate clinical data standardization and collaboration. These tools will be made publicly available to help expedite and de-risk the drug-development pathway, speed the time of drug approval, and offer further incentive to drug developers to advance therapies for HD.A kickoff meeting was held on November 6-7 with approximately 100 participants. Information can be found on the Critical Path Institute website. Please take a few moments to view the inspiring video presentation by Charles Sabine, a spokesperson and advocate for Huntington's disease.

The Coalition Against Major Diseases (CAMD) is, one of five consortia of the Critical Path Institute, a non-profit, public-private partnership with the Food and Drug Administration (FDA) focused on accelerating drug development for neurodegenerative diseases. CAMD brings together a diverse group of key stakeholder from academia, industry, the advocacy community, and federal and regulatory agencies to advance qualification by encouraging partners to share and pool data and collectively develop data standards and quantitative disease models in alignment with the FDA’s Critical Path Initiative. The mission of CAMD is to accelerate the development of therapies for Alzheimer’s and Parkinson’s diseases by generating the best methods and tools for evaluating drug efficacy, expediting clinical trials, and streamlining review by regulatory agencies. Objectives: The members of CAMD work to develop tools that can identify patients with neurodegenerative diseases at an early, asymptomatic or mildly symptomatic stage, thereby offering a greater chance for therapies to prevent or slow these diseases so the patients can maintain independence and quality of life.

• Initiated the genesis of the first dedicated research unit in the pharmaceutical industry focused on development of therapies to treat Autism Spectrum Disorders (ASD). Presently directing a lab to advance novel therapies for the treatment of neurodevelopmental disorders.• Contributed to the formation of the first academic/industry-wide precompetitive consortium for ASD, AUTISMMEDS. The Innovative Medicines Initiative (IMI) in Europe will fund a five-year topic focused on translational biomarkers and animal models for ASD.• Served as Research Project Leader for cross-discipline Alzheimer’s Disease Neuroinflammation team focused on drug repurposing. • Identified key opinion leaders and developed collaborative relationships to optimize strategies and to conduct research projects. Champion for resource investments in research conducted externally.• Contributed to development of more than six CNS therapeutic candidates that have advanced from target identification into patients.

• Led research effort to investigate the effects of a novel D2 dopamine receptor agonist on pathology and behavioural outcomes in thirty six MPTP treated primates resulting in three published manuscripts.• Investigated mechanisms of neurodegeneration/neuroprotection in Alzheimer’s disease, Parkinson’s disease and stroke. • Studied neuroinflammatory mechanisms in ischemia and in adult onset neurodegenerative diseases. • Investigated molecular correlates of cognitive function and dysfunction.• Investigate role of COX2 in the CNS under normal and pathologic conditions, with particular focus on focal ischemia.• Led and coordinated COX2 external consultants meeting involving 10 key opinion leaders in the field of stroke.

Studied mechanisms of neurodegeneration and evaluated of novel neuroprotective agents for the treatment of stroke and Alzheimer's disease.

Investigated the pathophysiology and neuropathology of ALS. Neuroanatomic and biochemical description of novel nervous system specific antigens, in vitro models, animal models, human postmortem studies all aimed to identify underlying mechanisms of motor neuron degeneration.

Investigated mammalian sperm DNA content using flow cytometric techniques.