You might wondering why? Well, everything starts with a product. You have a new technology, but is it a product yet? How is it better than the competition or standard of care? Is it more efficacious, safer, easier to administer, or less expensive to manufacture? Will the regulators approve it? Will someone buy it? Will doctors prescribe it? Will patients use it? Will investors invest in it?
All this info is neatly defined in a Target Product Profile (TPP) document. That’s your map, your keystone, your anchor to a successful product.
If there is no clarity in your target product profile, you’ll have a hard time fundraising, face challenges in communicating with the regulators, and a very hard time convincing pharma companies to acquire it. As a new start-up, you’ll be struggling to communicate your value proposition to potential investors, partners or governmental bodies without a well written TPP
So read on to better understand how to define,evaluate and utilize a TPP to increase your chances of success.
Drug discovery and development is increasingly risky, time-consuming, and not to mention, expensive – and that’s all just to get to the IND stage. Any new therapy needs to “start with the end in mind” by crafting a guiding document for its pre-clinical and clinical development strategy to maximize the commercial prospects of the new product.
That document is the holy grail of pharmaceutical product development: The Target Product Profile (TPP). But does it even exist? And if you can lay your hands on it, will you know what you’ve got? Can you summon the vague memory of a slide from a distant presentation? You’d better. At this watershed moment for pharmaceutical / biotech start-ups, it’s an imperative time to revisit the vital role of the TPP in the drug development process.
Too often, questions about the commercial viability of new molecular entities (NME) are asked too late in the process to impact or change the development path. Thus, a TPP must serve not only as the developmental guide but also to support the position of the NME in the future therapeutic paradigm, it’s valuation and investment and capital commitment decisions.
Consequently, the TPP facilitates your communications with investors, granting bodies and regulators. Yes, even regulators! The Center for Drug Evaluation and Research (CDER) has publicly acknowledged in released guidance that “The purpose of a TPP is to provide a format for discussions between a sponsor and the FDA.”
Collectively, the TPP has portability by performing a vital role in those discussions with external key stakeholders and in the ensuing tactical decisions for pre-clinical assessment and clinical trial design.
The TPP facilitates better communication because it summarizes the drug development program in terms of intended labeling content and claims. Additionally, it embodies the market insights necessary to determine the commercial viability of the asset. For example, achieving a statistical primary endpoint in pivotal clinical trials may be sufficient for regulatory approval, but that may not provide a compelling addition to the therapeutic armamentarium: the result might yield an approvable marketed product that does not deliver a good return on investment. Because strategic decisions are based upon marketplace needs, not just regulatory needs, the framework for decision-making contained within the TPP must include the targeted value provided to each customer. If a company loses sight of the original desired target (as driven by unmet market needs), assessment of the product can be colored by emergent preclinical or clinical data ultimately resulting in a product that has no place in the market.
In summary, the TPP guides the strategic decisions for the pre-clinical and clinical development path but also incorporates the foundation for commercial success. A scaffold that recognizes the need to develop a solution to a problem, and the need to focus on the marketplace and individual customer value rather than on product attributes alone, thereby facilitating discussion and decisions relative to achieving the commercial success.
And, if you’re wondering where to even begin drafting one, just drop us a note at firstname.lastname@example.org. We’d love to build a TPP with you!