Pharmacology/toxicology consultants design and implement comprehensive nonclinical plans to enable successful product development from early discovery through post-approval lifecycle management. PPD’s nonclinical team has experience with a variety of compound types (small molecules and biologics, including biosimilars), targets, routes of administration and therapeutic areas.
PPD’s nonclinical development experts work with clients to:
- Design streamlined, efficient pharmacology/toxicology programs to support the intended dose, route and duration of treatment in the clinic and enable successful regulatory filings
- Identify and address key pharmacology and toxicology issues unique to the compound, the indication or the patient population, in accordance with relevant regulatory guidances
- Provide advice on budgets, timelines and global regulatory requirements
- Design nonclinical studies, prepare protocols, monitor studies, and review data and reports
- Provide literature-based toxicological assessments of extractable/leachable studies and devise strategies to support manufacturing changes and to identify/qualify impurities and degradation products
- Prepare and review nonclinical summaries for global regulatory submissions, including but not limited to IND/CTA and NDA/BLA/MAA and meeting packages
- Provide expert toxicology representation before regulatory authorities
- Develop gap analysis of nonclinical packages with assessments of strengths, weaknesses, opportunities and threats
- Support business development activities by leading nonclinical tasks for due diligence activities, preparing and reviewing nonclinical packages for partnering/out-licensing efforts, and representing companies sharing global programs and strategies to potential partners/outside investors
Our nonclinical development scientists include American Board of Toxicology-certified and European Registered Toxicologists with advanced degrees and backgrounds in small, mid-size and large pharmaceutical and biotechnology companies, nonclinical contract research organizations and academia.