Stephanie Anderson
Stephanie Anderson is an Associate Director of Regulatory Affairs at Intrinsik Corp. She has been a regulatory affairs professional within the pharmaceutical/biotechnology industry since 2010. Stephanie has been involved in a broad range of regulatory activities from clinical development to post-registration license maintenance. Her experience includes authoring, review, and submission of CTAs, INDs, NDSs, NDAs, …
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Julia Chan
Associate Director, Regulatory Affairs Julia Chan is an Associate Director of Regulatory Affairs at Intrinsik Corp. She has been a regulatory affairs professional within the biotechnology industry for over 20 years, in both industry and consulting. Julia’s regulatory strategy, authoring support and submission management experience has been primarily for products in Canada and US, in …
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Robert Tavcar
Robert Tavcar is a Diplomate of the American Board of Toxicology (DABT), and brings more than 30 years of preclinical and clinical CRO experience to the team. He served most recently as a Senior Director, Toxicology where he was responsible for scientific, technical, and compliance aspects of general, infusion and reproductive toxicology as well as …
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Brante P. Sampey
Dr. Brante Sampey is a board-certified toxicologist based in the Research Triangle Park, North Carolina, USA, and has been in the biotech and pharmaceutical healthcare industry for over ten years. His primary focus as a regulatory toxicologist is to support the preparation and review of nonclinical drug development strategies, carrying out gap analyses for drug …
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Heather Wilson
Heather Wilson is the Business Development Manager at Intrinsik Corp., with over 23 years of experience in scientific and regulatory consulting. Heather helps small to midsize pharmaceutical and biotechnology companies achieve their goals. She has successfully overseen daily consulting operations while cultivating and nurturing relationships with both new and existing clients. Her focus is on …
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Faiza Waheed
Dr. Faiza Waheed is an Environmental Health Scientist, Health Impact Assessment (HIA) Lead at Intrinsik Corp. She specializes in the use of the HIA framework to assess the potential positive and negative impacts of major infrastructure and resource development projects on health. Dr. Waheed completed a Postdoctoral Fellowship at the Dalla Lana School of Public …
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Rebecca Countway
Rebecca Countway is a Senior Scientist with Intrinsik Ltd. She has over twenty years of experience as an environmental chemist and risk assessor. Since 2000, Rebecca has been providing technical scientific support and advice to private and government sector clients throughout the United States in the areas of human health and ecological risk assessment. She has …
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Claire McAuley
Claire McAuley is a Senior Scientist with Intrinsik Corp. She has over 30 years of experience spanning project management, risk assessment and environmental engineering. Claire has completed numerous traditional food studies with First Nations, specific to contaminants and food, water and vegetation quality and has provided technical reviews on a variety of environmental and human …
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Karen Phillipps
Karen Phillipps is a Senior Scientist with Intrinsik Corp., and has over 16 years of experience in toxicology and risk assessment consulting in Ontario and Western Canada. Her work has included the evaluation of potential health effects associated with air toxics, metals, accidental releases of crude oil, bitumen and produced water, hydrogen sulphide, hydrocarbons and …
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Christine McFarland
Christine McFarland is a human health risk assessment specialist with Intrinsik Corp. She has 14 years of experience in all aspects of human health risk assessment (HHRA): problem formulation, exposure and toxicity assessments, uncertainty analysis, and risk characterization. She has been responsible for multi-media exposure modelling, toxicological literature reviews and assessments, preparation of scientific reports …
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Jana Berghouwer
Jana Berghouwer is a Senior Manager, Regulatory Affairs at Intrinsik Corp., and has been in the biotechnology and pharmaceutical industry since 2006. She has been involved in a broad range of regulatory activities from the clinical development stage to post-registration maintenance of licenses. Her experience includes authorship, review and submission of CTAs, INDs, MAAs and …
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Kathryn Farmer
Kathryn Farmer is an Associate Director of Regulatory Affairs at Intrinsik Corp. She has been a regulatory consultant for the pharmaceutical industry since 2011 and a regulatory professional since 2006. She has experience managing regulatory submissions throughout the drug development process and post-approval for Canada and the US. With an educational background in biologics and …
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Robert Berger
Robert Berger has over 6 years of experience as a Regulatory Toxicologist at Intrinsik Corp., specializing in reproductive health. As a Senior Clinical/Nonclinical Writer, Robert’s primary responsibility is authoring and reviewing clinical and nonclinical sections of regulatory submissions, including pre-IND/pre-CTA, IND/CTA, NDAs/NDSs, and Investigator’s Brochures for a broad range of therapeutics. Robert also has experience …
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Mike Luksic
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 …
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