Dr. Kristina Ulrich is a toxicologist practicing in the United Kingdom with 15 years of experience in pharmaceutical discovery development, and regulatory compliance. She has nonclinical experience with biologic and small-molecule products in a wide variety of therapeutic indications, including neurology, oncology, respiratory, dermatology, and renal/urinary diseases, as well as multiple routes of administration (oral, intravenous, subcutaneous, inhalation, and dermal).
Dr. Ulrich has regulatory agency experience as a nonclinical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Dr Ulrich was responsible for reviewing nonclinical data packages submitted with applications for clinical trials to be conducted in the UK and Europe, including first-in-human and first-in-UK trials, and involved all types of medicinal products, including biologics and advanced therapy medicinal products and therapeutic indications. Dr Ulrich also acted as nonclinical rapporteur for centralized marketing authorization applications, where she reviewed nonclinical packages (pharmacology, pharmacokinetics, and toxicology, including ecotoxicology) for a variety of therapy areas. Dr Ulrich has provided scientific and regulatory advice to pharmaceutical companies regarding non-clinical development in support of clinical trials and marketing authorization and has presented to national expert advisory groups (e.g., Commission for Human Medicine).
During her career in the pharmaceutical industry, Dr. Ulrich has led the nonclinical safety strategy for products at various stages of development and has been responsible for toxicology sections of regulatory documents, including nonclinical overviews, INDs, CTAs, PIPs, core data sheets, briefing documents for health authorities, and risk management plans, and has provided toxicology input for pharmaceutical in-licensing opportunities.