Early-stage decisions in drug development are essential for laying the groundwork of a strong development pathway. A well-defined target product profile (TPP) guides product development and plays a critical role in securing investor confidence, influencing the trajectory of a therapy from concept to clinical success.
In an increasingly competitive pharmaceutical landscape, a TPP must clearly differentiate a product with a compelling value proposition to attract investors. Without a strong and convincing strategy, even promising therapies can be overlooked.
The role of target product profiles in drug development
The pharmaceutical landscape is increasingly competitive, with mounting pressure to develop groundbreaking drugs quickly and efficiently. With substantial investments required for research, development, and clinical trials, the stakes are high for companies striving to bring new therapies to market.
A target product profile (TPP) serves as a strategic guide, aligning scientific innovation with regulatory expectations and market demand. It defines a product’s key characteristics for a specific indication, including formulation attributes, target populations, competitive advantage and differentiation, and critical attributes such as safety and efficacy.
Dr Brett Wagner, Search and Evaluation Manager at Douglas CDMO, emphasizes how a well-crafted TPP can minimize risks and optimize resources throughout the development process. One key element that a successful TPP captures is critical feedback from end users, such as clinicians and patients. “Ultimately, these are the people who will be using your product,” says Brett. “Having a TPP that reflects the preferences of your target population helps build a strong development pathway and ensures market success, so their input should never be overlooked.”
“It’s important to remember that a TPP is not a static document but an iterative one. As you gather critical feedback from stakeholders and the market evolves, the TPP should be updated to reflect new insights. The last thing you want is your guiding document to become disconnected from the current landscape or to fail to capture vital information that could influence your development strategy.”
Dr Brett Wagner, Search and Evaluation Manager at Douglas CDMO
Aligning stakeholders through the TPP
A clinical advisory board plays a vital role in this process, offering expert guidance and integrating diverse perspectives. Dr Peter Surman, Chief Scientific Officer at Douglas CDMO, highlights the importance of incorporating these insights into a TPP through the development of their oral extended-release ketamine tablet for treatment-resistant depression. Given the drug’s classification as a substance with abuse potential, it was important to gather a broad range of expert opinions to determine where this product would be positioned in the treatment paradigm. “The U.S. is a significant market with specific regulatory, clinical and commercial expectations,” Peter adds. “It was important for us to incorporate perspectives in our TPP that truly met the needs of that market, otherwise you risk misaligning your product and impacting your overall success.”
A well-defined TPP not only guides product development but also plays a critical role in securing investor confidence. Beyond formulation attributes, it should also address key commercial factors such as pricing, insurance coverage —particularly in the U.S. market— and market potential. A strong intellectual property strategy further protects the asset and enhances its value. “Investors are focused on the return for their investment,” says Brett. “This is where thorough market research pays off. In a competitive landscape, differentiation is essential, and you need to communicate that clearly and convincingly.”
A robust TPP also ensures alignment among stakeholders, preventing misaligned expectations that can derail development. Peter highlights this in Douglas’ ketamine tablet development, where defining the product’s indication was a key step. “We took a conservative approach, targeting treatment-resistant depression rather than major depressive disorder, positioning it as a third- or fourth-line treatment,” he explains. “In that case we knew it would be prescribed by psychiatrists with a well-controlled supply chain, and we created a formulation to minimize abuse and addictive potential. These factors help to reassure investors and provide a clear pathway for development.”
Phase I clinical plans: The bridge to product success
Clinical safety and efficacy are top priorities for biopharma investors. Early trials, such as Phase I, generate important safety data and early efficacy signals. A strong Phase I plan ensures meaningful first-in-human insights, guiding development and investment decisions.
“Generating that first efficacy signal in humans is so important,” says Brett. “Preclinical data are valuable, but it’s not human data. A clear pathway to obtaining that data builds investor and regulatory confidence.”
Importantly, data from early-phase clinical trials help to inform and refine TPPs. This iterative process helps adjust target populations, dose levels, and administration routes to ensure alignment with clinical realities. A well-structured clinical plan also minimizes risk in later development. “Identifying safety concerns early, optimizing patient selection, and refining dosing strategies can prevent costly setbacks,” says Brett.
Douglas’ development of a ketamine tablet for treatment-resistant depression underscores this importance. Phase 1 safety and efficacy signal studies suggested a therapeutic dose that would need to be supported by chronic non-clinical safety studies to open an application for an Investigational New Drug (IND) with the United States Food and Drug Administration. Douglas was able to conduct Phase 2 trials outside the US while the IND opening studies were on-going in parallel.
“By continuously integrating findings from non-clinical and clinical studies in our TPP and clinical plans, we strengthened our regulatory submissions and maintained development momentum —ultimately putting us two to three years ahead of competitors,” says Peter.
Experience counts
Partnering with an experienced contract development and manufacturing organization, such as Douglas CDMO can enhance the likelihood of a product advancing from concept to commercialization. Douglas provides end-to-end support, ensuring TPPs and clinical development plans are strategically aligned with regulatory requirements and evolving market needs, as well as being attractive to external stakeholders and investors.
With expertise in high-potency, small-molecule development, regulatory strategy, and Good Manufacturing Practice (GMP), Douglas CDMO helps streamline your development pathway from preclinical development to commercial success.
Brett Wagner, Search and Evaluation Manager at Douglas CDMO
About Dr Brett Wagner
Brett Wagner specializes in identifying innovative opportunities for in-licensing at Douglas CDMO with a keen focus on drug repurposing, connections with universities and advancements in animal health.
Peter Surman, Chief Scientific Officer at Douglas CDMO
About Dr Peter Surman
Peter Surman is Chief Scientific Officer at Douglas CDMO, and has been with Douglas Pharmaceuticals for over 28 years. He has led the process for more than 20 products from concept to market in the USA, Europe and Australasia.
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