Developing a successful drug requires more than a great idea - it requires a clear and effective strategy that addresses the needs of investors, regulatory agencies, and your development team. Without a well-defined target product profile, you risk losing precious time and resources on ineffective or misaligned strategies.
📣 A TPP is a strategic document and a tool for communicating with drug developers, regulatory bodies, investors, and other stakeholders.
📅 The TPP can make scientific advice meetings more efficient as it often bypasses a discussion about the history of the drug development program.
📍 It provides clear milestones. Milestones help the development team and other stakeholders assess the progress of the development process.
🏹 The TPP provides a clear picture of the outcome of the drug development process (i.e. where you are going with the product, its characteristics, target indications, and so on)
Including quality attributes in your Target Product Profile (QTPP) can help pharmaceutical companies ensure their product's safety, efficacy, and quality while maximizing efficiency and minimizing delays. Take advantage of the opportunity to tap into the benefits of QTPPs and take your product development to the next level!
The client was entering phase II, requiring a solid target product profile (TPP) to guide their development plan and coming interactions with authorities. They had completed phase I studies and conducted market research but needed to figure out the specific indication to focus on and the studies required for nonclinical and clinical aspects. Additionally, they sought to identify indications acceptable to regulatory authorities, considering potential differences between the EU and the US.
In collaboration with the client, a TPP was developed focusing on validating the optimal indication, which endpoints and effect levels were most relevant to support both their clinical and medical strategy and regulatory, payor, and commercial needs. This resulted in a strategically aligned TPP document outlining the project's milestones, the necessary studies, and optimized clinical and non-clinical study designs.
The client received a strategic document that was a pillar throughout the project, enhancing their understanding of phase 3 trials and thereby enabling a proactive approach. They achieved an optimized label on par with competitors while maintaining focus and consistency across all disciplines. This streamlined approach facilitated their interactions with authorities, eliminating significant changes during the project and saving time and money. The client benefited from a more structured, efficient, and optimized process, ultimately working towards a common goal.
The TPP Starter-Kit
The first step is a lecture on definition, use, and content of a TPP.
During this phase, we will present and guide you through the TPP template.
We analyse your TPP to identify potential gaps and opportunities.
During these two weeks, we identify topics for the upcoming workshop.
We conduct a tailored workshop with you. By using your initial TPP, we will involve relevant subject matter experts. After the workshop, we will summarize and identify tasks for you to follow up.
During the last stage, you will work through the remaining tasks.
After that, we will give you some conclusion by giving you feedback on the finished work.
You have created a first draft of your TPP! But just a friendly reminder; things change quickly in our industry. Don't put it in a drawer. Instead, keep developing the TPP over time and use it in your day-to-day work.
And we've got your back - even after week six.
In today's rapidly changing market, uncertainty makes it easy to feel overwhelmed. But there's a way to stay ahead of the curve: planning ahead with a target product profile. By investing time and effort in mapping out your targets, you'll be better equipped to face unexpected challenges and capitalize on emerging opportunities.
Contact Susanna Dahlgren
