Target Product Profiles (TPPs) are descriptions of key features needed in a new treatment for a disease and are used to guide and drive drug research and development. They can save time and aid communication with regulatory agencies, they can provide direction for drug development programmes, they can help to stop inappropriate drug development and save resources, they can point the way to the critical experiments, and they can summarize drug profiles to varying stakeholders. As we shall see, TPPs have different meaning and structure dependent on usage. Here we intend to explore and clarify.
TPPs can be broadly divided into 3 related forms:
Aspirational (ATPP). A fixed description of the essential attributes of a treatment for a disease, derived from a wide ranging understanding of the disease in question, the medical and commercial opportunity, the regulatory hurdles, any real or potential competitors, the access and re-imbursement environment, and the goals of the developing organization.
Emerging (ETPP). As the drug undergoes trials its properties are revealed. This will describe the likely attributes in terms of indication, patient population, efficacy, safety, adverse events, dosage and administration as data becomes available through experimentation and trials and the performance of the treatment becomes clearer. This will inevitably have a shorter term focus and will change as the drug moves through development.
Regulatory (RTPP). The desired labelling concept and goals for the treatment in development, targeted during the development and regulatory process for the drug. This facilitates regulatory interactions during the drug development process by outlining the desired labelling and driving the discussion on the trials and data needed to support those claims.
It is possible to use only one TPP to cover most of the aspects of the 3, but this can lead to confusion, delay and inefficient use of resources.
Each of these are useful to different groups of stakeholders, they can be used as an internal document to define and guide drug development within commercial organizations, they can serve to advertise the necessary profile for a treatment for a disease that a public funding group is seeking, they can be used to define data needs and hence clinical trial design for regulatory groups, or they can be used to showcase the performance of a drug in order to attract development funding from commercial backers.
It is not essential that any of the TPPs described are developed for a new drug, but they serve to streamline the development process, clarify communication and make best use of resources. Also TPPs do not deny a science led development strategy, rather they are there to provide a broad working construct with essential key attributes. As such they should be not seen as a process barrier – rather they should support serendipity, optionality and adaptation. Indeed, with an unexpected discovery in an existing project, ATPPs can be developed which reflect the new disease area or patient population which could be treated
We describe the three kinds of TPP in more detail, in related articles in this section.
Our associates have many years’ experience in the use of TPPs. Get in touch with us – we’d be pleased to talk to you about TPP development and use.
Written by Graham Finch, Nick Brindley, Mike Florence and Pauline Stewart-Long