Susan Y Smith, MSc

My career in preclinical safety assessments began more than 30 years ago at Charles River Laboratories in Montreal, known then as Bio-Research, where initially I learnt the regulatory aspects of drug development in QA, followed by several years as a toxicologist working as a study director.

Bone Research has been at the heart of my career for more than 20 years starting in 1994 when the FDA issued guidelines for Osteoporosis drug testing. To meet the needs for the preclinical “Bone Quality” studies a unique department was created which today is recognized as the #1 laboratory world-wide for preclinical musculoskeletal research. The platform grew over the years to encompass various animal models, including bone healing, arthritis and muscle, in addition to screening models and short and long-term osteoporosis pharmacology and safety studies. As the Scientific Director for this endeavour, I acquired an in-depth knowledge of the core areas, including biochemical markers, bone densitometry, histomorphometry and biomechanical strength testing. I also gained extensive experience with most therapeutic classes of bone drugs, including PTH, bisphosphonates, vitamin D agonists, SERM’s, RANKL inhibitors, sclerostin antibodies, and cathepsin K inhibitors.

In recent years my focus has shifted to include skeletal evaluations to assess adversity in order to establish the potential for any liability as part of drug safety assessments. This opportunity presented new challenges requiring the merging of my skill-sets and knowledge acquired for musculoskeletal drug testing with those of the toxicologist. This highly successful area of bone toxicology presented me with an opportunity to lead the group to work with compounds in other therapeutic areas including metabolic diseases (diabetes in particular), cardiovascular disease, muscle dystrophies, kidney disease and cancer. It also triggered the revision of processes to address the added complexity of applying bone end-points to neonatal and juvenile toxicology studies. Recognizing the skeleton as an endocrine organ opened new areas for me to gain an understanding of the cross-talk between the skeleton and other organ systems, particularly relevant when interpreting effects of new drug classes affecting energy metabolism such as FGF21 mimetics, and agents such as myokines, FGF23 agonists, SGLT inhibitors, proton pump inhibitors and retinoids. The successful integration of other scientific disciplines was facilitated by an ever-expanding network of world-renown scientific contacts who continue to provide their expert advice. Being recognized as a key opinion leader in the preclinical musculoskeletal drug testing arena continues to provide me with opportunities to gain experience in other endeavors including speaking engagements, chairing sessions at scientific meetings, editing a bone toxicology book, and now consulting.

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