John Kapeghian an independent consultant (President, Preclinical Safety Associates in Reno, NV) specializing in preclinical drug development and issues impacting drug safety. He was formerly head of Charles River’s Navigator Scientific and Regulatory Consulting group,and prior to that, John held several senior management positions at Sierra Biomedical, Inc, an independent contract research organization subsequently acquired by Charles River Laboratories, Inc. John previously worked for Ciba Pharmaceuticals (now Novartis), heading up regulatory toxicology units, representing preclinical safety on international project teams, and directing their U.S. Experimental Toxicology program.He received his Ph.D. in pharmacology/toxicology from the University of Mississippi (Oxford campus) and has been board-certified in general toxicology by the American Board of Toxicology since 1985. John is a member of the AmericanCollege of Toxicology (ACT), Society of Toxicology (SOT), and International Society for the Study of Xenobiotics (ISSX). John formerly chaired the Pharmaceuticals Manufacturing Association’s DRUSAFE committee on In Vitro Toxicology. He previously served as a Section Editor for the International Journal of Toxicology. John has extensive experience in both small molecule and biologics drug development, biochemical and genetic toxicology, ophthalmics preclinical development, and mechanisms of drug-induced hepatotoxicity. He has worked on both U.S., Canadian, and European drug regulatory applications, has over 20 years of experience in preclinical safety, and has numerous publications and scientific presentations in the field. In 2007, he formed the Preclinical Training Institute (now Global Preclinical Training) for advancing the science and art-form of preclinical development through sponsored workshops and symposia around the world.
Gayla Ouellette is an independent consultant specializing in marketing, new business strategies, and corporate events. Gayla has worked in the aerospace, cosmetic, technology-development, and biotech industries. She spent 12 years with Charles River as a corporate marketing manager for Preclinical Services and was the marketing director for Sierra Biomedical (SBi) prior to its acquisition in 1999 by Charles River. During her career with Charles River and Sierra Biomedical, Gayla served as part of a dynamic team integral to the crafting of the Annual Biotech Symposium which is recognized in the industry as a viable platform for open discussion and active debate on biopharmaceuticals of various subclasses, immunomodulatory agents and other cutting-edge technologies. Gayla has extensive experience in developing and implementing marketing strategies and development plans, as well as in developing short- and long-range operating objectives.Highly skilled as an Asian interface, she has traveled extensively throughout the Pacific Rim, representing U.S. companies in product development, manufacturing, quality control, and import/export activities. She partnered with John in mid-2008 to collaborate on multiple projects, including developing Global Preclinical Training, and PreCliNet a revolutionary web-based, comprehensive platform scheduled to debut soon.