Professional Profile
Dr. Kristina Ulrich is a toxicologist practicing in the United Kingdom, with 20 years of expertise in pharmaceutical discovery, development, and regulatory science. She has nonclinical safety experience with biologic, small-molecule, and cell and gene therapy products in a wide variety of therapeutic indications, including rare diseases, pain/neurology, oncology, respiratory, ocular, dermatology, and renal/urinary diseases, as well as multiple routes of administration (oral, ocular, intravenous, subcutaneous, inhalation, and dermal).
Dr. Ulrich is a former 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. This included first-in-human and first-in-UK trials and involved all types of therapeutic indications and medicinal products. 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 nonclinical 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, from early discovery to late-stage development and post-approval. She has been responsible for the toxicology sections of regulatory documents, including nonclinical overviews, INDs, CTAs, PSP/PIPs, NDAs, briefing documents for health authorities, and risk management plans, and has provided toxicology input for pharmaceutical in-licensing opportunities.
As a consultant, Dr Ulrich specializes in the design and implementation of nonclinical safety strategies, nonclinical data review, problem solving and recommendations for future investigations, health authority interactions and regulatory document preparation. She provides support to clients working on a broad range of therapeutic modalities (small molecules, biologics, and cell and gene therapies).