10 steps to successful target product profile (TPP) testing TPP testing is a crucial activity in the development and procurement of new products. Time spent developing and executing a robust process and ensuring attention to detail is important. In this article we look at how incorporating some key features can ensure that an accurate and unbiased assessment can be performed in the most effective way. 1. Thoroughly research the disease and compile a comprehensive disease dossier This preparation should encompass an extensive disease strategy review taking into account epidemiology, market drivers and dynamics and the factors affecting each patient segment. This will require an understanding of factors influencing diagnosis and treatment in the target markets. It will also include the development of and adherence to, therapeutic guidelines, impact of reimbursement strategies, generics etc. It can usually be prepared using secondary research sources however it is wise to supplement this with expert interviews to ensure the information is up to date. 2. Research patient segmentation Pharma companies and prescribers often have different perspectives on segmentation. However it is the prescriber’s view that must be used. They will have their own view of segmentation and the unique patient challenges. These may be based on disease state and diagnosis, age, treatment received, treatment response, presenting co morbidities etc. An accurate assessment of agreed patient segments is paramount as these will be used to test the crafted target product profiles. Interviews with prescribers ahead of the TPP validation meeting are valuable in this respect 3. Prepare robust informative TPPs A range of target product profiles should be prepared starting with a base case – often the anticipated profile arising from the least ambitious clinical trials result. From this further enhancements can be crafted to create incremental versions of the base TPP. These need to be realistic and also incorporate appropriate negative aspects that might arise – such as increased efficacy but with an adverse tolerability profile. It is also important to consider and include every aspect that a prescriber may want to consider as if queries arise or requests for further information it will slow down the validation meeting. 4. Select KOLs who are real prescribers for the validation process A team of experts needs to be selected to perform the TPP validation. It is important that this team collectively represents the markets into which the drug is to be launched and also has current experience of the key patient segments – for example use of a leukaemia treatment in elderly patients. These real life prescribers will bring valuable experience of the pressures in their institution to use certain therapies or local prescribing policies (eg use of generics) that will also affect the candidate drug under observation. 5. Select KOLs with no allegiance Once a list of suitable experts has been constructed (using a robust quantitative selection process) it should be cross referenced with the pharma company’s own engagement records to eliminate any experts that have already provided advice or input on the candidate drug. These will include all those invited to advisory boards and investigators etc. It is paramount that the views expressed by the validation team are totally unbiased so that the results closely simulate the likely response that different TPPs will receive in the real world rather than aspirational situation 6. Use a blinded interactive validation process The most powerful TPP processes are blinded so that the identity of both pharma company and experts are not disclosed to either party . However the meeting can be viewed live and remotely by the commissioning pharma company and if state of the art technology is used, they can impart comments and instruct further ‘drill down’ directly to the moderator thus increasing the depth of advice received. 7. Understand expert views of unmet needs This is the starting point for the TPP validation meeting. The experts are taken through a quantitative interactive process which leads them to disclose both the importance of defined prescribing aspects and current satisfaction in being able to meet these with available therapies. A plot of these two dimensions enables a matrix to be constructed and agreed unmet needs of the expert group established. It is these unmet needs that serve as a foil for the TPPs to be assessed against. 8. Uncover incremental TPPs from base case upwards The experts should be exposed to each TPP in turn starting with the base case and using an interactive live or virtual process, input their views. This sequence is important as through this carefully moderated process the ‘tipping point’ can be established – the point at which the TPP becomes therapeutically interesting to the experts. It denotes the level of differentiation required to make an impact over current therapy for each patient segment 9. Construct a TPP versus patient segment matrix From this process the best TPP/patient segment opportunities (versus currently available therapies) will emerge and can be used for the basis of further testing through market research 10. Review TPPs versus the future market entrants Whilst we now have a view of the potential impact of the TPPs versus current therapy, we need to consider the new market entrants and market dynamics during the launch period (ie in 3 years time). The dossier constructed at the beginning of the process can be used so that any relevant competitors can be investigated. Is a candidate with the same mode of action and more convenient formulation going to launch 1 year before our drug? Once again the expert views can be sought against the known public domain information available for these competitors. Abstracts from the last international conference should be checked in preparation. Conclusion Using these elements a robust TPP testing process can be undertaken and provide accurate direction for future development.
Posted on: Mon, 27 Jan 2014 03:34:26 +0000
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