Julie Warneck

Julie Warneck is a toxicologist and pharmaceutical development consultant with over 30 years’ experience working in/with mid pharma and virtual biotech companies.  Julie has an established background in developing small molecules (including psychotics), peptides, ATMPs and drug re-profiling programmes in a variety of therapeutic areas (including inflammation, pain, endocrinology, ophthalmology, diabetes/weight loss, dermatology, CNS disease, women’s reproductive health, anti-infectives, emesis, NASH and GI disease) and routes of administration (oral, IV infusion, ocular (topical and IVT), SC, dermal,).  Julie established her consultancy company in 2019 to provide strategic expertise including design and monitoring of non-clinical development programmes and regulatory interactions to take products through First in Human to MAA/NDA.

Julie Warneck holds a BSc (Hons) in Biochemistry with a focus on Toxicology from the University of Surrey, completed in 1989. She has undergone extensive training in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), with certifications regularly updated from 2000 to 2024, reflecting her commitment to professional development in regulatory compliance and clinical research.

Julie’s career began at Enzymatix Ltd, where she worked in process development for fermentation protein products. She later advanced to senior roles at Celltech R&D, managing pharmacology and ADME studies and leading an inflammation research program that advanced novel chemical entities (NCE) to Phase 1 trials.

At Takeda Cambridge, Julie led strategic pre-clinical and clinical development plans, managing two oral product development programs in oncology and reproductive health. Her leadership focused on progressing these programs through 505(b)(2) pathways and first-in-man (FIM) studies. From 2007 to 2009, she was Head of Pre-clinical Operations at Serentis Ltd, where she successfully managed non-clinical safety programs and led a topical anti-pruritic project through early clinical phases.

Since 2009, Julie has been the Director of Protogenia Consulting Ltd, providing consultancy services in non-clinical and early clinical development to the pharmaceutical industry. Her expertise spans regulatory dossier preparation, project management, and support across therapeutic areas such as oncology, inflammation, and pediatric medicine. Julie has worked with regulatory bodies, including the FDA, MHRA, and PMDA, and has taken on interim corporate project management roles.

Julie has been a member of the Society of Toxicology since 2007 and the British Association of Research Quality Assurance (BARQA) since 2009, maintaining her commitment to upholding industry standards.