Recent Milestones

CAMD, in collaboration with the Clinical Data Interchange Standards Consortium (CDISC), formally developed the first therapeutic area data standard to be used in regulated clinical research and clinical trials for Alzheimer's disease and Mild Cognitive Impairment. CDISC is the only data standard format recommended by the U.S. Food and Drug Administration (FDA).

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use issued a positive opinion on the use of volumetric MRI to help enrich recruitment into regulated clinical trials in the pre-dementia stage of AD. This was a result of the CAMD Biomarkers team's innovative research and resulting request for qualification decision, and is the first imaging-based biomarker for AD to be granted a positive opinion by a regulatory agency.

The CAMD Modeling and Simulation team filed a qualification package to the FDA for a groundbreaking mild and moderate AD modeling and simulation tool. If qualified, sponsors across industry will be able to use it to inform the design of clinical trials and evaluate new medicines.

The Data team brought the PD Clinical Trial Database online, establishing a foundation upon which CAMD's initiatives in biomarkers and disease modeling simulation for this disease will be built.

 

Patient Advocacy

CAMD collaborates with the Alzheimer's Association to acquire more clinical trial data for CAMD's AD database, supports its CSF Quality Control program for biomarker assay standardization and harmonization, and participates in the Global Biomarker Standardization Consortium.

CAMD supports the Alliance for Aging Research and ACT AD in calling for inclusion of a fourth focus on drug discovery for AD in the National Action Plan for Alzheimer's (NAPA).

CAMD submitted to NAPA the following topics for consideration focused on accelerating advancement of effective therapies in AD patients:

  • Include early MCI in the drug development paradigm
  • Explore combinatorial biomarkers for AD
  • Speed development of methods/processes on standards and harmonization for biomarker assays
  • Increase resources for FDA to develop a review process for qualification of drug development tools

CAMD participates in Leaders Engaged in Alzheimer's Disease (LEAD).

CAMD attended the Alliance for Aging Research 25th Anniversary celebration and the Alzheimer's Association Gala to promote awareness and financial support of AD.