Jon Daniels, Ph.D., DABT, ERT
Dr. Daniels is a founding Principal of Intrinsik Health Sciences whose primary focus is the safety assessment of regulated products and regulatory toxicology. Jon interacts frequently on behalf of domestic and international clients with regulatory agencies such as the FDA, EMA, MHRA, and Health Canada on product development and nonclinical safety matters. For more than 20 years Jon has been extensively involved in the strategic 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. Jon leads an experienced team of professionals that have been responsible for the preparation of numerous INDs (senior staff have been actively involved in over 100 successful INDs) and contributed to more than 20 NDAs during their careers. Jon holds a Ph.D. degree in Pharmacology & Toxicology, is board certified as a Diplomate of the American Board of Toxicology, and is a Registered Toxicologist in Europe.
- Planned and executed over 100 nonclinical testing programs for new human pharmaceuticals and biologics covering a broad range of therapeutic areas.
- Frequent invited speaker on nonclinical drug development and regulatory toxicology.
- Successfully represents of sponsors at meetings with health authorities including FDA, Health Canada, BfArM, MRHA, and EMA.
- Analyzes and interprets toxicological data in order to integrate complex scientific concepts into client-ready documents.
- Functions as toxicology expert for regulatory submissions.
- Manages clients, CROs, and subcontractors to oversee quality, science, timelines, and budgets for nonclinical studies.
Education and Professional Qualifications
Ph.D., Pharmacology and Toxicology, Queen’s University
DABT, Diplomate of the American Board of Toxicology (accredited 1997; recertified 2002, 2007, 2012)
ERT, European Registered Toxicologist (accredited 1998; recertified 2003, 2008, 2013)