Designing Clinical Trials for Commercial Success

Coordinate team efforts to focus on your product’s competitive advantage.

By Maryanne Kelleher and Jaye Thompson, PhD

In the current environment of spiraling drug development costs and shrinking product lifecycles, pharmaceutical companies are increasingly challenged to develop innovative products that deliver clear and distinguishable benefits over existing therapies. The most critical success factor for any new compound is its potential to be clearly differentiated
from its competitors through clinical data.

Not only is such data a requirement for FDA approval, it is also key to commercial success. Given the intense pressure that the industry is under, a growing number of pharmaceutical companies are abandoning products that fail to distinguish themselves within the first 6 to 12 months following approval.

While clinical data serves as the foundation for the promotion and sales strategy of any product, commercial teams historically have had limited or no involvement in the clinical development process. However, as market demand for product differentiation intensifies, that is beginning to change. Many companies are beginning to recognize that the commercial perspective can bring valuable insight to the clinical process and help the Clinical teams focus on those therapeutic areas and compounds that have the greatest market potential. When Commercial, Clinical, and Regulatory teams collaborate early in the process and develop shared objectives, it enables the multi-functional teams to focus their efforts and resources on the compounds that offer the greatest opportunity for commercial success.

While the benefits of an early Commercial-Clinical-Regulatory partnership seem clear for many pharmaceutical companies, putting such efforts into practice can be challenging because the objectives for Clinical and Commercial are not always naturally aligned. Nor are Clinical and Regulatory teams always naturally aligned. Clinical and Regulatory teams are typically focused on getting the product approved, not on how the product will be promoted after approval. It is not uncommon for Clinical and Regulatory to rely on tried-and-true trial designs (e.g., the same patient population, same indications and endpoints), which may seem less risky than more novel designs. Commercial will generally be much more focused on a strong, uniquely promotable label that will clearly differentiate the product from competitors. Yet Commercial teams typically have limited knowledge of trial design and how to produce the data they need to support their desired claims. To achieve the desired goals, the Clinical and Commercial teams must work interdependently.

A Tool for Collaboration
Clinical and Commercial teams can successfully collaborate in a variety of ways. Committing to early, ongoing, and consistent communication is one way; another is by developing shared tools and processes. One instrument that can be used by the team to facilitate information sharing and cooperation is the Target Product Profile (TPP).

The TPP is a strategic tool that specifies ideal attributes as well as “must have” features for a commercially viable product. Defining the TPP ensures that Clinical, Regulatory, and Commercial team members understand the desired product claims and the plans to differentiate the product. Clinical studies will then be designed and powered with the intent to produce data to support the ideal attributes in the TPP. The TPP is updated as knowledge and experience of the product increase.

In order to develop a useful TPP, the team must have a deep and thorough knowledge of the therapeutic category and current and future competitive products. Through extensive primary and secondary research, the entire multi-functional team should be well grounded in the specific disease state, the market, patient populations, the pricing and reimbursement environment, and ultimately the unmet needs (clinical and/or economic) that the respective compound is trying to fulfill.

The role of the Commercial lead in developing the TPP should be to provide information, based on unbiased research, that will facilitate discussion and agreement on differentiation possibilities. Critical deliverables may include creating a comparison chart of each section of (current and future) competitors’ package inserts (PIs) to identify unmet needs and developing a preliminary TPP for the potential product.

Creating a Comparison Chart
The first step to creating the PI Comparison Chart is to review competitor PIs, section by section, keeping in mind that the team is scouring them for potential attributes by which the new compound can be clearly differentiated from competitors’ products. Table 1 (above) is a condensed example of a template (with hypothetical products) that can be used to facilitate discussion.

As the team reviews each section of the competitors’ PIs, team members should analyze the products’ weaknesses and strengths as well as home in on opportunities for clinical trials to be designed to answer an unmet need or make a claim of superiority and to provide clinical evidence to support the economics/ outcomes story for other stakeholders in the treatment decision pathway. The team should prioritize the desired attributes. Commercial team members should forecast the projected financial revenue for each degree of successful outcome of the attributes. This review of competitors’ labeling will help the team to develop the preliminary draft labeling for the new product.

Developing a Preliminary Profile
In creating the Target Product Profile, the Commercial, Clinical, and Regulatory teams should work collaboratively to ensure that all parties not only have input but also a sense of joint ownership of the TPP.

With information gained from the review of competitors’ PIs, the desired attributes are specified for the new drug for each of the various elements for the TPP. The attributes chosen are those that will offer the greatest degree of differentiation from competitors’ products and, therefore, the greatest profit potential. The team will qualify each attribute as “must have” and “nice to have.” Table 2 (see page 40) is an example of a hypothetical product’s TPP.

Testing and Refining
Once the team has a draft TPP on paper, it will become the basis for sharing information, ideas, discussion, and, ultimately—agreement. Table 3 (page 41) illustrates some questions that may help drive information sharing and lead the team toward consensus. A key goal is agreement on which TPP elements are “must-haves” for commercial success and which are “nice-to-haves” but not truly essential.

Conclusion
The PI Comparison Chart and the Target Product Profile may be useful instruments in facilitating critical thinking in a multi-disciplinary team and guiding the exploration of differentiating attributes early in the drug development process. Yet, ultimately, successful collaboration among Commercial, Clinical, and Regulatory team members requires more than just tools—it requires a commitment to changing roles and working differently. This commitment must come from the highest levels of the organization, with clear expectations set by the leadership of the clinical and commercial divisions of the company. It also requires Clinical and Commercial teams to approach these initiatives with mutual respect for the expertise and unique perspectives their colleagues bring to the process, as well as consistent, ongoing communication between teams.

Successful companies will be those that knock down the traditional barriers that exist between these organizations, work together early and throughout the development process, and have a clear understanding that the teams are truly better together than apart.

Jaye Thompson, PhD (jthompson@inVentivClinical.com), is Senior Vice President of Clinical Operations at inVentiv Clinical Solutions, and Maryanne Kelleher (mkelleher@consultchs.com) is Marketing Professional at inVentiv Advance Insights. These are two divisions of inVentiv Health, a provider of clinical and commercialization solutions for the healthcare industry.

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