Intrinsik Health Sciences Staff

Leadership

Jon Daniels, Ph.D, DABT, ERT
Executive Vice President and Senior Toxicologist
Dr. Daniels is a consulting toxicologist whose principal focus is the assessment of safety of regulated products and regulatory toxicology. Dr. Daniels interacts frequently on behalf of domestic and international clients with regulatory agencies such as FDA, EMA, MHRA, and Health Canada on product development and nonclinical safety matters.

For nearly 20 years, Jon has been extensively involved in the development of safety programs for drugs, biopharmaceuticals, food products, supplements, medical devices, and consumer products, and in the evaluation and presentation of nonclinical and clinical safety data in support of regulatory filings. In the last seven years, Dr. Daniels and his team have been responsible for successfully driving over 70 nonclinical development programs for new human therapeutics.

Dr. Daniels holds a Ph.D. degree in Pharmacology & Toxicology, is board certified as a Diplomate of the American Board of Toxicology (DABT), and is a Registered Toxicologist in Europe.

Jan Sedgeworth, Ph.D.
Vice President - Regulatory Affairs
Dr. Sedgeworth has over 20 years of experience in the pharmaceutical and biotechnology industry, mostly related to the drug registration process. She is recognized for her ability to establish strategies and execute plans within target timeframes and budgets.

Dr. Sedgeworth established her own consulting firm in 2003., offering consulting services to established pharmaceutical companies, emerging biotechnology companies and contract research organizations. Dr. Sedgeworth offers specialized knowledge of the regulatory environment and broad-based knowledge of global regulatory processes, including direct experience with Health Canada, FDA and the UK MCA (now MHRA). Her experience covers a number of therapeutic areas including CNS, respiratory, oncology, diabetes, anti-infectives etc., and different product types such as blood products, vaccines and small molecules.

Before establishing her firm., Dr. Sedgeworth held the position of Vice President of Global Regulatory Affairs at Hemosol Inc., where she was responsible for ensuring on time filing of the UK marketing application for the company's lead product, and resolution of outstanding issues in order to lift an FDA clinical hold for the same product. Prior to this appointment, Dr. Sedgeworth was responsible for Regulatory Affairs and Quality Operations at SmithKline Beecham Canada (subsequently GlaxoSmithKline) for more than eight years. During this time, she built an effective and highly motivated team of professionals (25 FTEs) and was responsible for the Canadian approval of more than 18 pharmaceutical and biological New Chemical Entities. Over the years, she gained additional experience in New Product Planning, Health Economics, and Patent Defence processes.

Dr. Sedgeworth began her career in the pharmaceutical industry as a research and development chemist, initially with Organon UK, then ICI UK, prior to emigrating to Canada in 1989.

During the 1990s, Dr. Sedgeworth was an active participant in shaping the Canadian regulatory environment, holding a number of roles in industry associations including Chair of the Regulatory Issues Advisory Committee of Rx&D. She was also a member of Rx&D's Drugs Programme Issues Committee and BIOTECanada's Human Healthcare Sub-Committee, as well as Health Canada's Cost Recovery Initiative (CRI-2) Reference Committee.

Dr. Sedgeworth holds B.Sc. (Honours) and Ph.D. degrees in chemistry from the University of Strathclyde, United Kingdom.

Mike Luksic, B.Sc.
Vice President and Senior Regulatory Toxicologist
Mr. Luksic is a toxicologist who has focused on generating high quality toxicology data by designing, placing, monitoring, and auditing studies. His work has included auditing over 400 studies on over 5 continents. Mr. Luksic's mandate is to ensure sponsor studies are carried out to the highest level of scientific, regulatory and quality standards. Mr. Luksic has also worked with laboratories to support them during audits by FDA and other regulatory authorities. Upon completion of protocol development, Mr. Luksic works in the placement, execution and monitoring of studies with CROs.

Mr. Luksic has over 10 years in the pharmaceutical industry and has been involved in project management and drug development regulatory strategies for preclinical programs for over 50 companies. Mr. Luksic has worked with companies to develop protocols which have been used in support of regulatory filings in the United States, Canada and Europe. He has also successfully advised clients through a number of difficult and complex scientific and regulatory issues in dealing with CROs and regulators.

Mr. Luksic graduated from the University of Guelph, with a B.Sc in Toxicology. He has presented work at conferences and has been an invited speaker on topics related to the nonclinical development of novel pharmaceuticals and biotechnology.

Kathryn Bibeau, B.Sc., RAC, DABT, Senior Regulatory Toxicologist

Ms. Bibeau has been a consultant to the biotechnology industry in pharmaceutical & healthcare and pest control product areas since 2000. She has experience in a broad range of development and regulatory activities leading to product registration. Ms. Bibeau's focus is on nonclinical program development and she has been involved in the design, implementation, and monitoring of hundreds of nonclinical studies (toxicology, safety pharmacology, genotoxicity, reproductive and developmental toxicity, carcinogenicity) in support of regulatory applications. Ms. Bibeau has also been responsible for literature-based human health safety assessments of excipients, contaminants, degradants, and impurities, often eliminating the need to conduct toxicology studies.

Having obtained her U.S. Regulatory Affairs Certification and with experience in the current regulatory field in the U.S. and Canada, Ms. Bibeau manages the regulatory aspects of product development programs.  She also monitors nonclinical studies at CROs for quality and compliance with GLPs, and has been an invited speaker on GLP regulations and implementation.

Ms. Bibeau graduated in 1999 with her B.Sc. (Hons) from the University of Guelph in Biomedical Toxicology. She is a current member of the Regulatory Affairs Professionals Society, the Society of Toxicology, and the Safety Pharmacology Society. In addition, she is board certified as a Diplomate of the American Board of Toxicology.

Geoff Goodfellow, Ph.D, DABT, Associate Director - Toxicology Research and Compliance
Dr. Goodfellow is a toxicologist and has been a consultant to the pharmaceutical industry since 2001. Dr. Goodfellow's primary focus is the development of safety programs for drugs and biopharmaceuticals and he has been involved in the design and development of protocols for hundreds of studies including general toxicology, safety pharmacology, PK/ADME, genotoxicity, reproductive and developmental toxicity, and carcinogenicity studies. Dr. Goodfellow also assists companies by preparing/reviewing preclinical drug development strategies, carrying out gap analyses for drug or pharmaceutical products, drug delivery systems, and natural health products, and conducting due diligence reviews to evaluate preclinical data and/or technology platforms. Dr. Goodfellow monitors preclinical studies at CROs and has been involved in the management and development of programs for over 35 companies.

Dr. Goodfellow has authored or co-authored over 150 publications, expert reports, or regulatory submissions, including peer-reviewed articles of scientific, research-based papers and regulatory topics. As a regulatory toxicologist, he evaluates preclinical and clinical data for preparation of regulatory submissions (e.g., INDs, CTAs, IMPDs). Dr. Goodfellow has also been invited to participate in several drug development/regulatory toxicology workshops and has given presentations at national and international meetings.

Dr. Goodfellow graduated with a B.Sc. (Honours) in Life Sciences from Queen's University and holds a M.Sc. and Ph.D. in Pharmacology from the University of Toronto. In addition, he is board certified as a Diplomate of the American Board of Toxicology.

Katharine Manson, Hon. B.Sc., RAC, Senior Manager of Regulatory Affairs
Ms. Manson has been a consultant to the biotechnology industry in pharmaceutical & healthcare since 2003. She has experience in a broad range of development and regulatory activities leading to product registration. Ms. Manson's focus is on North American regulatory affairs and she has extensive experience with multiple pharmaceutical applications, including NDS, CTA, NDA, and IND. Ms. Manson has regulatory experience with both small molecule and biologic compound applications.

Having obtained her Canadian Regulatory Affairs Certification and with experience in the current regulatory field in the U.S. and Canada, Ms. Manson manages the regulatory aspects of product development programs.

Ms. Manson graduated in 2001 with her B.Sc. (Hons) from the University of Guelph in Biomedical Sciences, and received a post graduate certificate in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College. She is a current member of the Regulatory Affairs Professionals Society (RAPS) and she serves as Toronto Officer for the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA).