Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a bottle, tablet, capsule, or syringe being sold to patients and Doctors as medicine. One of the best ways to focus a development team is to use a Target Product Profile (TPP). The use of the TPP varies among companies, and ranges from not using it at all, using the document exclusively as a Regulatory Affairs tool, to using it with the entire core development team. ProPharma Group recommends using this format as a Program Management tool with the Core Development Team.
The benefits to using a TPP to manage the Core Development Team are many and all point most directly at COMMUNICATION! How many readers of this blog have spent hours searching for one key fact about the dosage form(s) for or pre-clinical studies that have been performed with early stage products? This is common where there are a number of drugs in the pipeline being developed by different core teams. Yes, this may be pretty specific information that is most interesting to the Pre-Clinical, Clinical or Regulatory Affairs groups. However, with so few new chemical entities (NCE) in development, more companies are developing products using an approved active for new indications or new dosage strengths, and this kind of information is needed on a much more frequent basis. This is the type of information that needs to be communicated accurately. The TPP can serve as a roadmap, not unlike the Design History File (DHF) used in the development of a Medical Device.
The TPP becomes the one stop shop for information on the formulation and drug product characteristics, pre-clinical, and clinical studies. Another great benefit of using the TPP with a development team is that it provides the team with a vision and focus. Just as having a physical target helps an archer be able to hit the bullseye, the TPP gives the core development team a glimpse of what could be a real product. It brings a perspective to the years of science and development ahead and can make the goal of improving the quality of life for a patient that much more real.
The FDA has a formal Guidance document on how to develop the TPP and, FDA representatives in presentations have advocated , its use in advisory meetings with BioPharma companies. It provides the FDA with the technical details of the proposed product to better frame the questions being asked during the meeting.
More information on the Target Product Profile can be found on the FDA website at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati…