Welcome! If you are looking for expertise in Musculoskeletal Research to support your nonclinical drug development program, then please take a few moments to learn more about me. I offer to provide guidance for the conduct of pharmacology, efficacy or safety studies, or help with data interpretation to unravel the mysteries of skeletal evaluations.

Core Expertise:

→        Animal models

→        Study design and monitoring for proof-of-concept, efficacy, pharmacology, mechanistic and bone safety studies, including regulatory requirements. Protocol and report preparation and review

→        Integration and interpretation of study data:

• Biomarkers: bone, cartilage turnover, hormones
• Imaging: Bone densitometry: DXA, pQCT, Micro-CT, radiography
• Histomorphometry
• Bone strength
• Bone quality
• Bone toxicology: Safety assessments, all standard species and routes of administration, young adult, juvenile and aged populations: acute, sub-chronic, chronic toxicity studies, and carcinogenicity testing

Experience in numerous therapeutic areas and drug classes, with large and small molecules, including:

• Bone: anabolics and anti-resorptives
• Arthritis
• Muscle
• Metabolic diseases (diabetes, obesity, kidney)
• Medical device testing
• Cancer

For a comprehensive overview of this field please check out our recently released book:

Bone Toxicology. 2017 Eds: SY Smith, A Varela, R Samadfam, Springer: Molecular and Integrative Toxicology series.

Contact: For more information or to schedule a call please contact me at: sysmithconsulting@gmail.com