InSymbiosis is well versed in the process of moving a lead compound towards a clinical candidate. The integration of physicochemical profiling, polymorph screening, ADME and PK studies, in vitro toxicology and hERG assessment, bioanalysis and animal efficacy studies with medicinal chemistry are all key to the lead optimization process for small molecule drugs. For large molecules such as monoclonal antibodies, we possess the skills to guide your program through the lead optimization process, including humanization, affinity maturation, Fc engineering, improvement of biochemical and biophysical properties leading to exploratory PK/PD studies.
InSymbiosis’ toxicologists possess a vast amount of experience performing non-clinical GLP compliant toxicology and safety pharmacology programs to enable IND/IMPD as well as NDA submissions. Having worked both in CRO and biopharma environments, our toxicologists are well equipped to help ensure our clients’ non-clinical programs are properly designed to meet regulatory requirements and that the CROs are professionally managed. This includes study strategy and planning, protocol development/review and finalization, study monitoring during all critical study stages and report review and finalization. In addition, our toxicologists can, when required, help our clients in the authoring of non-clinical sections of regulatory submissions as well as their scientific interactions with regulatory authorities.
InSymbiosis’ chemistry, manufacture and control (CMC) scientists possess a thorough understanding of the pharmaceutical development process for both small and large molecules. By working with a global network of contract manufacturing organizations (CMOs) our CMC scientists help our clients oversee their CMC projects from project design, through CMO selection and final delivery of product. With expertise in the manufacturing of active pharmaceutical ingredients (API) and of clinical trial material (CTM) across all stages of development, including the integration of analytical sciences, InSymbiosis is always available to help our clients with their CMC programs.
Our clinical scientists specialize in clinical operations and CRO management. With experience ranging from Phase I to Phase III studies, we support our clients every step of the way, from finding a suitable clinical CRO through to vendor oversight and management.
At the start of any new clinical program, our clinical experts carry out the vitally important work of identifying the right CROs, performing an in-depth comparative analysis of the proposals received, negotiating CRO and study budgets in conjunction with the client, and performing QA audits of new CROs added to our network.
Once a clinical program is ongoing, the oversight of CRO activities, collaboration with the client on study management discussions and activities, provision of a primary liaison and point of escalation for clinical vendors and investigator sites are all key activities that can be provided by our clinical experts.
As an added benefit of our General Contractor Model, our approach allows the integration of all clinical vendors and collaborators that are required for a study through a single arrangement with InSymbiosis, thereby simplifying the entire process.
Our scientists are experienced in designing drug development programs to ensure the outputs meet regulatory requirements. This experience extends to the authoring of the CMC, non-clinical and clinical sections for regulatory submissions, as well as supporting clients in meetings with regulatory authorities. In terms of overall regulatory strategy, InSymbiosis has external regulatory experts specialized in the various regulatory disciplines.
A range of specialized regulatory consultants and consulting groups
