A target product profile is the business plan for your product. The holy grail of product development pharmaceutical. The target product profile tpp is the profile of the drug you expect to launch. Below are example worksheets that define the minimalideal profile of the final marketed product and shows the ultimate goals of the.
In 2007, the center for drug evaluation and research cder, part of the u. A target brand product must pass all testing before. Aug 07, 2017 establishing the target product profile in previous columns, weve explored the importance of an early consideration of the target product profile, or the key areas of the ultimate labelpackage insert, such as the indication, dosage and administration, and safety. The twin challenges faced can be summarized by multidrug resistant malaria from the. The tpp is essentially an organized wishlist of characteristics, features, and attributes that one would like to see in a newly developed medical product once it reaches the market. Capsules have evolved from the orally administered gelatin capsule to a portfolio of capsules with. Target product profile tpp for the advance market commitment amc for pneumococcal conjugate vaccines master table the product specifications tabled below are called the target product profile tpp. What are drug labels and how to they relate to target product profiles. Aug 12, 2012 drug product cqas derived from the quality target product profile andor prior knowledge the cqas are used to guide the product and process development. The cber office of cellular, tissue and gene therapies octgt web page for industry education also has a webinar on tpp. The tpp document format correlates each development goal to planned or completed clinical testing andor development activities.
Cirm target product profile tpp template target product profile for product therapy here indication. Target product profile tpp has been defined as a prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure that the desired quality, and thus the safety and efficacy, of a drug product are realized. Next step is to determine the type of clinical studies required in each phase to meet the criteria stated in the target product profile. A target product profile tpp is a planning tool for therapeutic candidates based on fda guidelines the cber office of cellular, tissue and gene therapies octgt web page for industry education also has a webinar on tpp. At first, this profile will be the same as the stp.
The list of potential cqas can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase. Target product profile guiding crossfunctional strategies. Here, we argue that combining realworld data rwd with primary market research pmr delivers more granular and robust insights for development of next generation tpps. A target product profile tpp describes how a product will be utilized by the end user. The clinical development plan follows a hypothetical drug labeltarget product profile. The clinical development plan follows a hypothetical drug label target product profile. Before production starts, we audit the factory and meet with the vendor and manufacturer. These are all vital questions that can be clearly answered using a robust target product profile tpp process that drives important regulatory, clinical, preclinical, marketing, health economic. The document type quality target provides the following properties. Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics e. Yn preind ind submission eop1 eop2a eop2prephase 3 prendabla. Food and drug administration fda issued a draft guidance that defined the content and format of the target product profile tpp. Quality target product profile qtpp defines the desired product characteristics and sets development goals.
Jul 03, 2014 these are all vital questions that can be clearly answered using a robust target product profile tpp process that drives important regulatory, clinical, preclinical, marketing, health economic. The target product profi le tpp is supposed to be the cornerstone of pharmaceutical product development. What are the top 45 features that are needed in a tb diagnostic test for developing countries. We require vendors to test targetbrand products at thirdparty laboratories throughout production. Experience with tppfocused meetings with sponsors at the fda has indicated that such documents can be useful see appendix a.
Target product profile indication protection from morbidity and mortality caused by all subtypes of circulating and emerging drifted and shifted influenza a subtype viruses and influenza b lineage viruses target population from six weeks with no upper age limit. A systematically developed tpp can ensure alignment of. Beginning with the end in mind using a target product profile. A target product profile tpp is a strategic development tool which summarizes a drug products development goals, ideally as expressed in terms of its labeling and promotional concepts. A systematically developed tpp can ensure alignment of objectives across company departments, accelerate. Cmc considerations for a successful regulatory submission. Key risk decisions examples early decisions on whether to proceed with a drug development program go decisions or to discontinue the program nogo decisions may be based on phase i single agent or combination study data. A more robustly developed target product profile tpp could reduce this risk and result in a stronger business case, forecast and basis for clinical trial design decisions. Yn preind ind submission eop1 eop2a eop2prephase 3 prendabla other specify preide.
The target product profile tpp is the critical component of the development plan dp, and its existence is necessary to achieve a desired commercial outcome for the particular product. Quality by design qbd overview parenteral drug association. The target product profile tpp is the starting point for the drug product development, defining the required and desired drug product attributes for the final marketed product 1. The path malaria vaccine initiatives target product profile template was a table that identified a range of target characteristics, from desired to minimally acceptable, for each class of malaria vaccines, as well as the attributes of a specific product as it. The target product profile tpp is the critical component of the development plan dp, and its existence is necessary to achieve a desired commercial outcome for the. Using a target product profile tpp during a development programme is wellestablished best practice to provide focus, enable alignment of both clinical and commercial stakeholders around a common vision, and to facilitate dialogue with regulatory authorities.
The commercial team tpp is tested with prescribers for the potential patient share and this information helps in estimating the net present value npv of the product. Disease or condition for which your producttherapy will be indicated optimal indication and decision criteria minimally acceptable indication and criteria. A systematically developed tpp can ensure alignment of objectives across company departments, accelerate development timelines, minimize development risks, and eventually lead to an optimal product. Developing a multidisciplinary framework to address these challenges and inform the decisionmaking process can provide medical device and diagnostic organizations with a significant advantage in early product development, resulting in a higher probability of approval and successful product launch. Jan 19, 2020 a target product profile tpp is a planning tool for therapeutic candidates based on fda guidelines. In previous columns, weve explored the importance of an early consideration of the target product profile, or the key areas of the ultimate labelpackage insert, such as the indication, dosage and administration, and safety. The specifications relate to the public health impact and suitability of the product, covering measures of vaccine efficacy, safety, dose. Common document property used by all document types are documented by document properties. The target counties of interest are then identified. A target product profile is the business plan for your. Biotechnological and pharmaceutical companies have long used target product profiles tpps to plan their research and development processes. Drug development is a very expensive and time consuming process.
Target product profile tpp for chagas disease pointof. The path malaria vaccine initiatives target product profile template was a table that identified a range of target characteristics, from desired to minimally acceptable, for each class of malaria vaccines, as well as the attributes of a specific product as it moved into late development figure 1. Target product profile and technical requirements for. Drug product cqas derived from the quality target product profile andor prior knowledge the cqas are used to guide the product and process development. Cirm target product profile tpp template target product profile for indication. At what pricecost can a new tb diagnostics be sold depending on volume. Target is nothing but a result that we try to achieve.
However, per the fdas guidance, it will be updated as clinical data reflect the latest estimates of the drug you want the fda to approve. Target product profile tpp for chagas disease pointofcare. We require vendors to test target brand products at thirdparty laboratories throughout production. Target product profile tpp under this title target is important word. What are the unmet diagnostic needs and target product profiles tpps of greatest relevance. High risk populations including pregnant women, children with underlying medical. How to identify critical quality attributes and critical. A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy. The first priority is to develop a safe, effective, and practical stage 2 hat drug to replace current firstline treatments, and to improve and simplify the current case management. Target product profile for amc support the specifications relate to the public health impact and suitability of the product, covering measures of vaccine efficacy, safety, dose scheduling, presentation and packaging, and represent the minimally acceptable standard a vaccine needs to meet in order to be eligible for amc support.
The list of acronyms and abbreviations related to qtpp quality target product profile. Target product profile and clinical development plan. Considerations in developing a target product profile for. Pdf link critical requirements for any sputumbased naat that is intended for pointofcare tb testing use at the level of peripheral microscopy centers in highburden countries pdf link target product profiles tpps for tb diagnostics. Sep 15, 2010 a target product profile tpp describes how a product will be utilized by the end user. Drug name may be modified for use with devices milestone meetingsubmission date tpp submitted. Quality target product profile qtpp linkedin slideshare.
A targetbrand product must pass all testing before. Target product profile how is target product profile. Please note that only information about specific properties is provided here. A target product profile tpp is a summary of the drug development program described in terms of labeling concepts it is prepared by the all departments of the company involved in the development of the therapeutic or diagnostic agent its submission to the fda is voluntary but has specific benefits. Target product profile sleeping sickness based on discussion with various hat players and experts, a dual strategy is proposed. We have tools and processes in place to ensure product safety and quality at every stage of production. Drug product quality drug release, stability, etc 9.
The working group proposed tpps for three different scenarios. Target product profile consensus the working group proposed tpps for three different scenarios. The quality target product profile qtpp describes the design criteria for the product, and should therefore form the basis for development of the cqas, cpps, and control strategy. Beginning with the end in mind using a target product. Ppq reports formal verification that the process control strategy has been.
Which attributes within the tpp are the most important to focus on. The name given to this template was the target product profile. Industries develop a tool known as target product profile tpp, which is simply a planning tool for the development of a drug candidate from discovery to clinical development. Target product profile, critical path and preclinical. Rationalizing capsule selection based on desired performance. The target product profile provides a structure for the scientific, technical, clinical, and market information, which is the basis for the product development strategy. Pqs target product profiles a target product profile tpp is a strategic document that lists the principal desired features of a product category for future performance, quality, and safety pqs prequalification. Using parallels to product target profiling in manufacturingoriented qbd, reagents, excipients and apis can be coordinated with robust analytical methods to refine overall efficiency. Sep 30, 2016 therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics e. Pointofcare sputum based test as a replacement for microscopy 4.