Research and Development Pathology Support
EPL has extensive and diverse expertise and work experience in support of the pharmaceutical and biotechnology industries. This includes supporting research from exploratory stages through submission of information to regulatory agencies and participating in follow-up actions to resolve questions arising from animal toxicity or efficacy studies. In addition to a deep understanding of international pharmaceutical regulations and expectations of health authorities, our experts have broad knowledge of pathophysiology and target organ toxicity related to the administration of biopharmaceuticals to animals.
EPL West Coast assists clients in the design and conduct of nonclinical efficacy, biomarker and toxicity studies; in understanding and communicating the toxicological significance of morphological effects internally and to regulatory agencies; in responding to regulatory concerns regarding test article-related effects; and in exploring mechanisms of action or toxicity.
EPL West Coast Services:
- Evaluation of tissues from research and development studies
- Pathology peer review and scientific review of study reports
- Model identification and development
- Preparation of expert reports, specialized overviews, and integrated summaries of data for internal perspective or for inclusion in briefing packages and other regulatory documents
- Strategies for nonclinical development programs and assistance with study design and protocol generation
- Interactions with global health regulatory authorities and responses to regulatory queries
- Due diligence review and critical advice for compounds for in-licensing
Dr. Ted Birkebak is EPL’s West Coast Manager with over 14 years of experience in drug development in the areas of oncology, inflammatory and infectious disease, and ophthalmology. EPL’s West Coast office also provides on-site research and development support to San Francisco Bay Area clients.