Target Product Profiles

Alacrita frequently develops Target Product Profiles for biotech companies and investors. A target product profile (TPP) is a realistic description of the launch product containing an achievable and competitive set of product performance parameters. It serves as a strategic roadmap, guiding the entire development process from early research to regulatory approval and commercialization. A TPP is also necessary for new product planning, opportunity mapping exercises and valuations. 

Why is a Target Product Profile so crucial for early-stage biotechs?


Focus and Alignment: A well-defined TPP provides a clear vision of the final product, aligning all stakeholders - scientists, clinicians, regulators, investors, and marketers—around a common goal. This ensures that everyone is working towards the same objectives, minimizing miscommunication and maximizing efficiency.

Risk Mitigation: By identifying potential risks and challenges early on, a TPP allows companies to proactively address them, potentially saving significant time and resources. It also helps in making informed decisions about which drug candidates to pursue, reducing the risk of costly failures.

Regulatory Guidance: A TPP helps biotech companies understand and meet regulatory expectations. By defining the desired characteristics of the drug, including its safety and efficacy profile, it can facilitate a smoother and more efficient regulatory approval process.

Investor Confidence: A well-articulated TPP can attract investors by demonstrating a clear development path and a compelling value proposition. It can also help secure funding by providing a realistic assessment of the drug's potential market and commercial viability.

Competitive Advantage: A TPP can help a biotech company differentiate its product from competitors by highlighting its unique features and benefits. This can be particularly important in crowded therapeutic areas where multiple drugs are vying for market share.

Decision-Making Framework: Throughout the development process, a TPP serves as a reference point for making critical decisions. Whether it's about clinical trial design, manufacturing processes, or marketing strategies, the TPP provides a framework for evaluating options and choosing the best course of action.

The below list of recent projects and case studies can help illustrate the type of target product profile guidance we typically provide.

 

Recent Target Product Profile Projects:

  • Evaluating the attractiveness and potential positioning of a new kinase inhibitor: An in-silico drug discovery company requested an expert review of the robustness and potential positioning of a new kinase inhibitor in oncology and inflammatory disease. Alacrita was commissioned to identify the most attractive indication space based on scientific and commercial understandings, and to develop a draft Target Product Profile (TPP) to aid further internal development of the asset.

  • Characterizing the European commercial opportunity for a microbiome company: A clinical stage microbiome company was developing a microbiome therapeutic for the treatment of recurrent C. Difficile infection (rCDI). The company was progressing through clinical development and wanted assistance with characterizing the European market opportunity for the product, including developing a target product profile (TPP), detailing the drug's performance, proposed positioning and assumed clinical usage.

  • Developing a target product profile for a gene therapy: A privately-held biotechnology company developing and exploiting a proprietary technology platform for optimizing and controlling gene therapy expression was looking to evolve its business model, including examining the potential for the company to build its own internal cell and gene therapy pipeline.  The Board and investor had decided to prioritize review of an idea of exploitation of the company’s existing technology in developing a novel gene therapy for a rare cardiovascular condition. Alacrita was asked to develop an outline Target Product Profile (TPP) for a gene therapy for this particular condition.
  • Market access plan for novel kidney disorder treatment: A biopharma start-up developing a small molecule to treat a rare kidney disorder sought Alacrita’s advice on its Target Product Profile (TPP) and market attractiveness. Specifically, they wanted feedback from payers on a realistic pricing window and to understand the market access challenges and opportunities for its drug.

  • Market Assessment and Physician Research for Microbiome Products: A privately held biotech company with a focus on the human microbiome had demonstrated that a prebiotic+probiotic approach could generate a healthy microbiome and improve gut health. The company had developed a bespoke drug delivery technology which was IND-ready, for the prevention of Clostridioides difficile infection (CDI) recurrence, and ulcerative colitis (UC). While two FDA approved competitors were already on the market, no other company had attempted to combine a probiotic with prebiotics and administer treatment using a drug delivery technology similar to our client’s.

    To guide further development and set a foundation for partnering discussions, the company asked Alacrita for help in characterizing the market opportunity in CDI recurrence and UC, and in developing and testing a Target Product Profile (TPP) for each indication with key opinion leaders.

  • Comprehensive review of the glioblastoma (GBM) landscape: A stem cell research company had developed a target product profile (TPP) for a novel therapy for glioblastoma (GBM).  The company asked Alacrita to conduct a comprehensive review of the GBM landscape including insights on market growth, epidemiology, competitor profiles, standard of care, patient journey and pricing. The study was to form part of a Board paper that would ultimately support a Business Case justification.


Target Product Profile Case Studies

Challenge: A privately-held biotechnology company developing and exploiting a proprietary technology platform for optimising and controlling gene therapy expression was looking to evolve its business model, including examining the potential for the company to build its own internal cell and gene therapy pipeline.  The Board and investor had decided to prioritise review of an idea of exploitation of the company’s existing technology in developing a novel gene therapy for a rare cardiovascular condition. Alacrita was asked to develop an outline Target Product Profile (TPP) for a gene therapy for this particular condition.

Our lead consultant had significant experience in neurology, psychiatry and molecular neurobiology, as well as 20-years experience in drug development from first-in-human studies through multiple Phase III clinical trials, across a range of CNS indications. Prior to joining the Alacrita network, he had been Chief Medical Officer and SVP in Drug Development at a neuroscience company.

Solution:

Alacrita first created a hypothetical TPP based on the technology’s capabilities, which guided commercial, technical and clinical analysis. The TPP addressed factors such as target patient population(s); dosing, format and delivery method; standard of care displaced and unmet needs (disease modification and symptom control); clinical differentiation; prospective pricing; and market access considerations and requirements. Where relevant, we defined criteria for a base case for a minimally viable product and an upside case. This draft TPP was created initially from focussed secondary research, covering published academic literature, competitor disclosures and clinical trial protocols and Alacrita’s internal databases. We then tested, refined and amplified the draft TPP through interviews with KOLs and payers in EU and US. The deliverable was presented to the Board.

Challenge: Our client had an investment in a company developing a re-formulated small molecule for CNS disorders and was considering listing the company via an IPO or a SPAC. In support of this it required a valuation of the lead asset in two key indications and commissioned Alacrita to use its proprietary MonteCarlo risk-adjusted Net Present Value (rNPV) model.

Solution:

We initially developed a target product profile (TPP) and estimated the target patient population in each indication together with the likely market penetration and market share based on the competitive landscape and current treatment practices. Using benchmarked pricing assumptions we then developed revenue projections and using tailored probability of success calculations we accounted for risk in the program. Finally, we mapped the remaining investment required to gain approval and launch in the US and Europe e.g., clinical trial, manufacturing, launch and marketing costs. These assumptions were input into the MonteCarlo model and the global rNPV in each indication was calculated. The results and all supporting assumptions and analysis were delivered to the client in a PowerPoint report.