Mike Luksic, B.Sc.
Mike is a professional consultant in the biotechnology, pharmaceutical, and healthcare industry, with over 14 years of relevant experience specializing in human health toxicology and quality assurance focussed on Good Laboratory Practices (GLP). His primary responsibility is helping both established and emerging pharmaceutical companies navigate the hurdles of drug development. He has worked to help them understand 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 molecule. Mike has represented clients at the Food and Drug Administration (FDA), Health Canada, 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 also has been commissioned to participate on behalf of global laboratories being audited by various regulatory agencies for GLP compliance. As a founding Principal of Intrinsik Health Sciences, he has also dealt with the challenges of establishing a business which now has a growing nonclinical and regulatory group. Mike understands that emerging firms need innovative thought and strategies to be successful.
- Founding Principal of Intrinsik Health Sciences 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 Good Laboratory Practices.
- 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. (Hons), Biomedical Toxicology, University of Guelph