In the previous blog, we looked at the concept of the Target Product Profile (TPP). At one level, the TPP can be thought of as a document that sets out the aspirations for the product. Indeed, it usually provides the foundation of the product label or package insert.
A further level of sophistication in the design of a TPP is the concept of scaling. In this model, the TPP includes more than one description of the attributes or characteristics for the product—ranging from minimally acceptable to ideal—and thus aids in decision making. Whichever approach is taken to the production of a TPP, simply identifying goals for the product is not sufficient.
If product development is thought of as a journey, then the TPP describes the destination and points of interest along the way. However, we also need to know how to reach that destination and what’s needed to make the journey. That is the role of the Integrated Development Plan (IDP).
The graphic below illustrates the large number of activities required to progress a drug or biological product from Discovery through to Licensing and beyond. This graphic was included in the previous blog; however, here it’s overlaid with an indication of how resources (money and people) are linked over time to these activities.
Expenditure is relatively low at the early stages of development, but it continues to rise as a product progresses towards clinical development and through clinical trial stages. Even after, product launch costs related to development may continue to rise, for example, when post marketing surveillance is required as a condition of licensing. While the number of people also increases through to clinical trials, this drops off rapidly once submissions for product authorization are made.
The IDP is a document that details:
- The development activities
- How and when the activities should be undertaken
- The interdependencies of the activities
- The resources required
- An assessment of risks and mitigations that ideally including alternative strategies for consideration
Not all IDPs will be the same or need to include the same amount of detail. The structure and content will depend upon the type of product that is the subject of the IDP. For example, the IDP for a wholly novel drug or biological would, on one hand, be more complex and involve consideration of a full range of issues. On the other hand, it would be subject to a great deal of uncertainty and therefore be light on detail in some areas. Development of a “me too” type product might require minimal consideration of some topics but include more detail on necessary steps and resources. This is due to more certainty about the development pathway.
Typical contents and considerations of an IDP would include the following*:
It should be clear that the TPP and the IDP are interdependent. Both are living documents. As new data become available, such as results of pre-clinical studies, stability studies on the active ingredient, or reports about a competitor’s product, the impact on future work and timings would need to be considered. That means adjustments would need to be made to the IDP and possibly the TPP.
To continue the journey analogy, it’s like having to rethink what roads to take in a traffic jam or hearing about a highway closure on your route. To paraphrase Moltke the Elder, “No plan survives contact with the enemy.” In the same way, no initial IDP survives contact with reality!
Customized Solutions for Biotech
PRA understands the pressures emerging biotech companies face. We resource client studies with team leads that remain for the duration of the study…
Regulatory Considerations for Biotech
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
5 Questions Small Biotech Should Ask Their Rare Disease Development Partner
Rare disease is a complicated but rewarding space for drug developers of all sizes. Most rare diseases have no approved treatment options, making…