ToxStrategies’ professionals in our Biopharmaceutical/Pharmaceutical Practice have extensive expertise in assisting clients with a wide array of issues related to the nonclinical safety assessment of small-molecule and biological products (biologics), including biosimilars, synthetic peptides, and oligonucleotides. Our scientists have worked at the FDA, as well as in the biotechnology and pharmaceutical industries, accruing unique expertise for assisting clients with complicated scientific, regulatory, and strategic challenges that arise during the nonclinical development of drug candidates. We believe that knowledge of current regulatory expectations is critical for success in gaining regulatory approval of drug candidates. Additionally, our in-house team of PhD-level toxicologists takes on urgent, multifaceted projects. Our services range from providing comprehensive toxicology support for companies without toxicology expertise to assisting in-house technical staff in addressing specific toxicology needs (e.g., preparing expert reports, conducting risk assessments). Examples of areas where our staff has extensive experience include:
- Supporting toxicology needs for the entire drug development process, from the assessment of theoretical risks that is needed at target identification, to the comprehensive nonclinical toxicology evaluations that are key components of marketing submissions (BLA, NDA, MAA)—and every step in between
- Serving as the toxicology representative on project teams
- Conducting study design, data interpretation, and monitoring of toxicology studies in rodent and non-rodent animal species, including incorporation of TK/PK/ADME data and/or anti-drug antibody responses into overall assessments
- Preparing or overseeing preparation of the pharmacology/toxicology sections of pre-IND, IND, CTA, NDA, BLA, and MAA submissions, as well as investigator brochures, annual reports, and safety information in product labels
- Participating in meetings with regulatory authorities (global)
- Participating in expert nonclinical development advisory boards
- Preparing toxicology monographs and conducting and reporting risk assessments and safety assessments for pharmaceutical excipients, impurities, extractables, and leachables
- Designing and overseeing nonclinical comparability studies (i.e., pharmacology, pharmacokinetics, toxicology) to support pre- and post-approval manufacturing process changes
- Addressing scientific, regulatory, and business challenges associated with the development of biosimilar products, including pharmacology/toxicology studies, immunogenicity assessments, and use of foreign reference product, among other aspects
- Lending toxicology expertise in due diligence meetings for in- and out-licensing of biopharmaceutical/pharmaceutical products
- Developing company comments and positions on draft guidance issued by regulatory authorities worldwide.
For more information about our services, please contact us.