Over 20 years of experience working in a GLP setting with clients in the pharmaceutical, biotechnology and medical device industries, to design customized studies to meet specific mechanistic and regulatory requirements to establish:

• Proof-of-concept
• Mechanism of action
• Lead optimization
• Efficacy
• Pharmacokinetics
• Pharmacodynamic profiling
• Pharmacology
• Bone safety, toxicology

With a strong background based on many years experience as a scientific director and study director I can monitor studies and facilitate protocol and report preparation and review. My expertise will assure data are appropriately integrated, and that reports are concise and well-written.

Selected publications:

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

Studies on articular and general toxicity of orally administered ozenoxacin in juvenile rats and dogs. Borroto JIG, Awori MS, Santillan D, Chouinard L, Smith SY, Asamara CT, Blazquez T, Gargallo-Viola D, Zsolt I. Future Microbiology, Chapter 3. Chondrotoxicity of Ozenoxacin. Accepted March 2018.

Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34). Jolette J, Attalla B, Varela A, Long GG, Mellal N, Trimm S, Smith SY, Ominsky MS, Hattersley G. Regul Toxicol Pharmacol. 2017 Jun;86:356-365.

Carcinogenicity risk assessment of romosozumab: a review of scientific weight-of-evidence and findings in a rat lifetime pharmacology study.  Boyce RW, Chouinard L, Felx M, Mellal N, Varela A, Mann P, Jolette J, Samadfam R, Smith SY, Locher K, Buntich S, Ominsky MS, Pyrah I.  Regul Toxicol Pharmacol. 2016 Nov 81:212-222.

Does activin receptor blockade by bimagrumab (BYM338) pose detrimental effects on bone healing in a rat fibula osteotomy model?  Tankó LB, Goldhahn J, Varela A, Lesage E, Smith SY, Pilling A, Chivers S.  Calcif Tissue Int. 2016 May 11. [Epub ahead of print]

Effects of denosumab, alendronate, or denosumab following alendronate on bone turnover, calcium homeostasis, bone mass and bone strength in ovariectomized cynomolgus monkeys.  Kostenuik PJ, Smith SY, Samadfam R, Jolette J, Zhou L, Ominsky MS. J Bone Miner Res. 2015 Apr;30(4):657-69.

Effects of pioglitazone and fenofibrate co-administration on bone biomechanics and histomorphometry in ovariectomized rats.  Smith SY, Samadfam R, Chouinard L, Awori M, Bénardeau A, Bauss F, Guldberg RE, Sebokova E, Wright MB. J Bone Miner Metab. 2015 Nov;33(6):625-41.

The effect of rosiglitazone on bone mass and fragility is reversible and can be attenuated with alendronate.  Kumar S, Hoffman SJ, Samadfam R, Mansell P, Jolette J, Smith SY, Guldberg RE, Fitzpatrick LA. J Bone Miner Res. 2013 Jul;28(7):1653–65.

Assessment of a nonsteroidal aromatase inhibitor, letrozole, in juvenile rats.  Pouliot L, Schneider M, DeCristofaro M, Samadfam R, Smith SY, Beckman DA.  Birth Defects Research B Dev Reprod Toxicol. 2013 Oct 98(5):374–90.

Combination treatment with pioglitazone and fenofibrate attenuates pioglitazone-mediated acceleration of bone loss in ovaroectimized rats.  Samadfam R, Awori M, Benardeau A, Bauss F, Sebokova E, Wright M, Smith SY, J Endocrinol. 2012 Feb;212(2):179-86.

Two Doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength.  Ominsky MS, Vlasseros F, Jolette J, Smith SY, Stouch B, Doellgast G, Gong J, Gao Y, Cao J, Graham K, Tipton B, Cai J, Deshpande R, Zhou L, Hale MD, Lightwood DJ, Henry AJ, Popplewell AG, Moore AR, Robinson MK, Lacey DL, Simonet WS, Paszty C.  J Bone Miner Res. 2010 May;25(5):948-59.

A toxicity profile of osteoprotegerin in the cynomolgus monkey.  Smith BB, Cosenza ME, Mancini A, Dunstan C, Gregson R, Martin SW, Smith SY, Davis H. Int.  J. Toxicol. 2003 Sept-Oct: 22(5) 403-12.

The RANKL inhibitor OPG-Fc increases cortical and trabecular bone mass in young gonad-intact cynomolgus monkeys.  Ominsky MS, Kostenuik PJ, Cranmer P, Smith SY, Atkinson JE. Osteoporos Int. 2007 Aug;18(8):1073-82.

Home