Pharmaceutical nonclinical safety programs provide important data for the clinical study of new drugs. Gradient supports pharmaceutical clients in each step of nonclinical safety, including design of initial proof-of-concept studies and conventional nonclinical safety programs, study contracting and oversight, preparation of drug regulatory applications and interactions, and responding to regulatory questions. Expert risk assessment and risk communication are the cornerstone of our comprehensive approach. Through our professional relationships with contract research organizations (CROs), analytical testing labs, and regulatory consulting firms, Gradient toxicologists are part of collaborative and productive teams and provide our clients with exceptional service.
Nonclinical Safety Testing Support for Pharmaceutical Excipient
Gradient assisted a company with developing a nonclinical toxicity testing plan and coordinating laboratory testing of a new drug excipient. We determined the appropriate set of toxicity studies, prepared bidding documents for testing laboratories, and coordinated toxicity testing. Gradient provided study oversight and contributed to the interpretation and development of the reports that were submitted to an Investigational New Drug (IND) Phase 1 clinical study.
Drug Regulatory Agency Applications and Supporting Documents
Gradient supported the submission of an Investigational New Drug (IND) application for a successful Phase 1 clinical study to the US FDA. Additionally, Gradient guided the preparation of briefing documents for the Medicines and Healthcare products Regulatory Agency (MHRA) and German Federal Institute for Drugs and Medical Devices (BfArM) scientific advisory meetings. We worked closely with regulatory consulting firms on the nonclinical sections of the submissions, as well as the proposed clinical development program.
Antisense Oligonucleotide Safety Analysis
Gradient conducted a comprehensive review of approved antisense oligonucleotide drugs. We analyzed data to identify potential chemistry or dosing determinants of dose-limiting toxicity, common mechanisms of toxicity, and a nonclinical toxicology study program design. Our expert analyses helped our client to develop a nonclinical testing strategy.
Weight of Evidence for Nonclinical Carcinogenicity Study
Gradient conducted a weight-of-evidence (WoE) evaluation of carcinogenicity hazard to support a waiver from conducting traditional carcinogenicity assessments in two species, as described in ICH S1B. Our evaluation was submitted to the US FDA Carcinogenicity Assessment Committee (CAC) via a Special Protocol Assessment (SPA).
Immunology of Novel Skin Cancer Treatments
For a small biopharmaceutical company, Gradient evaluated flow cytometry data to gauge human immune responses to skin cancer treatments. We aided in the development of new assays to better understand dermal tumor immunology. Our comprehensive advice advanced our client’s research and development of skin cancer treatment.