Mike Luksic

Vice President, Senior Toxicologist

Mississauga, Ontario

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Phone: +1 905-364-7800
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Mike Luksic is a Vice President and Senior Toxicologist at Intrinsik Corp.  He has worked as a professional drug development consultant and regulatory toxicologist since 1998.  His primary focus has been nonclinical IND and NDA-enabling programs, quality assurance, and business development.  Having collaborated with both established and emerging pharmaceutical companies, he recognizes both the scientific and business challenges associated with success in this competitive area.  As a regulatory toxicologist, his focus is on nonclinical program development and understanding the implications of toxicology findings to the development of a product.

Mike has represented clients at the US Food and Drug Administration (FDA), Health Canada, and European Medicine Agency (EMA).  As a quality assurance professional, he has focussed on monitoring and auditing toxicology studies globally, having taken the lead on monitoring studies in North America, Asia, Europe, and Russia.  Mike has acted as the sponsor’s representative for over 200 studies and has been commissioned to participate on behalf of global laboratories being audited by various regulatory agencies for Good Laboratory Practices (GLP) compliance.  As a founding Principal of Intrinsik Corp., he has dealt with the challenges of establishing a business, which now has a growing nonclinical and regulatory group, and understands that emerging firms need innovative thought and strategies to be successful.

Experience Highlights

• Founding Principal of Intrinsik Corp., in January 2007.
• Represented Asian laboratory at the first FDA GLP audit of their facility.
• Published author in the area of nonclinical drug development.
• Represented sponsors successfully at meetings with the FDA, Health Canada, and EMA.
• Monitors nonclinical studies for scientific integrity and compliance with GLP.
• Analyzes and interprets toxicological data in order to integrate complex scientific concepts into client-ready documents.
• Toxicology expert for regulatory submissions.

Education and Professional Qualifications

• B.Sc. (Honours), Toxicology, University of Guelph
• Certified Good Clinical Practice (GCP)
• Certified GLP
• ERT, European Registered Toxicologist

Professional Affiliations

• Society of Quality Assurance
• Society of Toxicology