Infrastructure

Dr. Goodenowe’s Dietary Therapeutics was created with a straightforward objective: to move plasmalogen-based approaches from theory to formal, regulated clinical development for Alzheimer’s disease and related dementias.

The company’s infrastructure is designed to support that process effectively. It brings together three core areas: chemistry and manufacturing, clinical trial facilities, and biochemical research laboratories.

Chemistry & Manufacturing – Moose Jaw, Saskatchewan

The Moose Jaw site is a purpose-built, FDA-compliant drug manufacturing facility designed specifically for plasmalogen precursor therapeutics, including ProdromeNeuro. It provides:

  • Controlled synthesis of structurally defined plasmalogen precursors.
  • GMP-aligned manufacturing workflows for investigational drug product.
  • Integrated quality control, batch verification, and documentation.
  • Scalable production capacity sufficient to support multi-year clinical programs.

 

Clinical Trial Facilities – Temecula & Moose Jaw

Clinical infrastructure in Temecula, California, and Moose Jaw, Saskatchewan, is being built to run plasmalogen-focused trials under full regulatory oversight. These sites are configured to support:

  • Phase I and Phase II studies of plasmalogen precursor therapies.
  • Standardized cognitive, functional, and neurologic assessments in aging and dementia.
  • Systematic collection of imaging and biochemical biomarkers.
  • Protocol-driven execution consistent with FDA expectations for Phase IIb Alzheimer’s studies.

 

Biochemical Research Laboratories – Temecula, California

The Temecula laboratories form the analytical and mechanistic core of the program. They house ultra‑high‑resolution FT‑ICR mass spectrometry and complementary platforms capable of:

  • High‑resolution, non‑targeted metabolomic profiling of human samples.
  • Detailed lipidomics, including quantification of structurally specific plasmalogens.
  • Mechanistic studies of membrane biology, cholesterol handling, and amyloid processing.
  • Development and validation of biomarker panels that feed directly into trial design and regulatory dossiers.