A guide for use throughout the drug development journey
The target product profile (TPP) is essentially a blueprint for an asset's development strategy. It outlines the aspirational as well as the more realistic attributes that an asset may demonstrate. In many cases the TPP claims may map directly to the regulatory labelling claims that may be achieved should the asset gain approval. However, at ICON we don’t just focus on the submission. We look beyond to the market and payer positioning and work with clients to establish a reimbursable TPP (rTPP).
The TPP guides decisions throughout the drug development journey, such as:
- Indications: Which disease or diseases?
- Patient population: Who are the patients and where do we find them?
- Efficacy: Is it clinically effective?
- Safety and tolerability: Is it safe? What types and numbers of adverse events are expected?
- Stability: How is stored and for how long?
- Administration: What route of administration is best; oral, injectable, transdermal, other?
- Dosing: How frequently is it given to patients and for how long?
- Cost: Will it be affordable to the target population, will it be reimbursable?
- Time: How long will it take to develop?
To answer these questions, our clinical, commercial and regulatory experts review and assess the competitive landscape, unmet medical need, attributes of existing, approved products, regulatory guidelines and other relevant details.
We will help you develop a rTPP which will serve as a strategic map for your asset. We can assist in rTPP generation for assets at all stages of development, be it an innovative product, early in development, a re-purposed asset or an asset in life-cycle management.
Contact us to learn more about how we can assist you in generating a custom TPP to meet your specific requirements.Contact