budget template for a drug development plan

The manufacturing approach will need to consider the involvement of potential contract manufacturing organizations (CMOs) for the entire product or parts of it that are not manufactured inhouse. The quality part of an IDP outlines the proposed manufacturing approach as well as the control strategy for the drug substance and the drug product. The platform specific TPP can be leveraged for all product candidates derived thereof. įor cell and gene therapies which are based on a particular platform a platform specific TPP can be a useful starting point for an IDP. Furthermore, target countries or regions and pricing should be considered. desired efficacy and safety profile, route of administration as well as dosing strategy.

The TPP comprises, often in a tabular format, the value proposition under consideration of the competitive environment, target indication(s) and population(s) for development incl. This goal can be visualized in the form of a target product profile (TPP). the product intended to be developed for commercialization in defined countries /regions. Therefore, starting as early as possible is more important than striving for the most perfect and complete document from the beginning.įigure 1: Key elements of an integrated drug development planĪ useful way to start creating an IDP is by having the goal in mind, i.e. The IDP is a living document that will need to be updated as the development progresses. Even for early-stage programs commercial aspects such as target countries for commercialization, the competitive environment as well as pricing / reimbursement aspects should be considered. This is true for the development of all drugs but is even more important for cell and gene therapies, where conventional development paradigms often don’t apply, and where more tailored approaches are needed.įor the creation of an IDP all development disciplines such as manufacturing, nonclinical and clinical development as well as regulatory affairs should be involved (see Figure 1). On this path, an integrated drug development plan (IDP) is an extremely useful tool to increase the overall success rate. While R&D focuses on identifying promising product candidates, drug development requires a diligent approach across various disciplines in a highly regulated environment to bring promising drug candidates to the commercial stage.

The transition from R&D stage to clinical stage is an important phase in drug development.

Budget template for a drug development plan