IND-Enabling Program Management and Support

A small biologics research company possessing valuable intellectual property for proprietary applications of two biological molecules engaged Pharma Technology Resources. Early-stage discovery efforts had yielded preliminary data regarding the pharmacologic activity of the molecules. A commercial application was targeted, but the company lacked the expertise and infrastructure needed to define, provide and manage resources to execute an IND-enabling program culminating in the submission of an IND.

Pharma Technology Resources met with corporate leaders to determine client resource availability. At the Client’s request, Pharma Technology Resources detailed a project plan, provided and managed all personnel, and qualified, recommended and managed all laboratory resources.

The project team developed the project plan, identified laboratory resource requirements, and established priorities and timelines for resource availability and task execution. Contract laboratories were pre-qualified and engaged. The Pharma Technology Resources project team included sub-teams to address the complex project’s many specific technology areas such as process development, process engineering, formulation development, efficacy testing, toxicology and pharmacology, analytical development, and clinical development. Skilled teams located across the country leveraged information technology tools for efficient, seamless project flow and communications. PTR prepared a successful IND for submission to the FDA. FDA’s approval of the filing demonstrated the appropriateness of the project plan leading to the preparation and submission of the IND filing and entry into Clinical Trials.