Our preclinical, regulatory and clinical experts leverage their extensive experience to transition novel compounds into the clinic. They evaluate the maturity of a compound's development and anticipate risks. Based on our careful assessment, our team drafts a comprehensive plan outlining the most efficient path toward first-in-man Phase I clinical trials. This includes:
- Safety package/plan, including toxicology, pharmacokinetics and pharmacology.
- Chemistry, Manufacturing and Controls, including bioanalytical method, drug formulation, manufacturing and stability.
- Completeness of regulatory package.
- Phase I trial design, including patient safety, feasibility of proposed dose, route of administration, inclusion/exclusion criteria, incorporation of appropriate biomarkers, and any other special program requirements.
With this plan in place, our drug-development project managers efficiently execute and manage the entire program from the pre-investigational new drug (IND) stage through clinical development. By having one project team responsible for guiding our clients from preclinical into clinical development, we create a seamless transition that is key to the success of our clients' oncology programs.