The value of New Product Planning (NPP) is often overlooked, but it plays a crucial role in the success of drug development projects. By incorporating NPP early in the process, you can increase the likelihood of commercial success and minimize risks.

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“It’s too early to bring in commercialization resources.”

“We don’t have the resources to hire New Product Planning (NPP).”

“There isn’t buy-in from senior leadership on the need for NPP.”

These statements, and many more like them, are the kinds of things we often hear from both current and prospective clients. My response is always the same: New Product Planning is an absolute necessity. Further, there is a great deal of value in infusing early commercial insights throughout all stages of the drug development process, even when an asset is in the preclinical stage. It is never too early to get started. Wouldn’t you want to know prior to the Phase I protocol development that an indication that is clinically attractive doesn’t have any commercial viability and won’t address the needs of patients?

What Is New Product Planning?

While it goes by many names — “Early Commercialization Planning,” “New Product Strategy,” “Commercial Planning” — at its core, NPP ensures that deep market insights and a thorough understanding of healthcare professional (HCP) and patient needs guide program development and corporate strategy.

The fact is that NPP plays a pivotal role in getting the necessary answers. By leveraging professional experience together with secondary and primary research, NPP helps define the market landscape and opportunity, develop a target product profile that considers past product successes/failures and, ultimately, drive prioritization of indications.

Without NPP, biopharma companies may invest resources in pursuing an opportunity that is crowded and where limited differentiation may exist for their product. Furthermore, NPP ensures that the patient journey is understood within the company so that the patient perspective is infused into the development plans.

NPP is the key to increasing the likelihood of meeting patient needs and commercial success through product adoption by both patients and HCPs.

Internal Stakeholders and Key Questions

Many stakeholders are involved in the cross-functional effort of new product planning, including Finance, Tech Ops, Regulatory, and others. However, the primary stakeholders are Corporate Strategy, Research, Clinical Development, Investor Relations, and Business Development. Each functional area has its own unique set of questions and concerns, and all of them have a perspective on the answers that will guide the product to the market.

Corporate Strategy:

One of Corporate Strategy’s responsibilities is prioritizing resources that align with the long-term vision of the company and will maximize ROI. NPP can be an important partner by supporting portfolio prioritization and long-range planning. Vital questions include:

  • How does this asset fit with the overall corporate strategy?
  • How does the company vision impact therapeutic areas or diseases of interest?
  • How do we communicate the value and vision of the company and product?

Research and Clinical Development:

Research and Clinical Development are primarily concerned with optimizing program development and addressing unmet needs in the marketplace.Answers to the following questions can help the R&D organization with trial design, understanding the competitive landscape, and prioritization of assets within the pipeline.

  • What is the current treatment paradigm, and how might this evolve based on the competitive landscape?
  • What are the benchmark standard of care (SOC) parameters?
  • What should be the lead indication?

Investor Relations and Business Development:

These two functions help communicate the commercial story to external stakeholders, including investors and potential partners. New Product Planning develops the early positioning/messaging for the asset, as well as the revenue forecast model. Vital questions include:

  • What is the market size for the diseases of interest?
  • What is the value proposition within the disease?
  • What is the high-level revenue potential of the asset across indications and geographies?

New Product Planning in Practice… A Client Example

Over the years, The NemetzGroup has supported many small, emerging biopharma companies at the preclinical or Phase 1 stage. Although executive leaders may recognize the value of New Product Planning, getting buy-in at the functional head level has often been challenging, likely due to the pressures these leaders are under to deliver their function’s goals.

Recently, while interviewing key stakeholders in an emerging biopharma company (our typical engagement starting point), we helped identify upcoming milestones and places where commercial insights would be most valuable — an area where several interviewees were struggling.

By mapping key decision points and outlining which deliverables would be most informative, we developed a robust target product profile (TPP) and clinical trial landscape assessment. Together, these formed the basis for the clinical advisory board to align on the inclusion/exclusion criteria for the Phase 1 trial and enabled the company to have an informed discussion with key advisors. Without the TPP or benchmarks from competitor trials, the company may have designed a protocol that didn’t consider the evolving landscape and the latest thinking around endpoints and sub-populations that will increase the likelihood of meeting patient needs and the probability of success.

Since that experience, NPP has now been embraced by the initially hesitant cross-functional leaders!

Next Steps

If you are a leader in an emerging biopharma company, this example provides a strong rationale for establishing your New Product Planning function, particularly at the earliest stages of drug development.

As you think about recruiting for this role, rest assured that there may be people on your own team who have the necessary skillset. These include those who have the following personal characteristics that are most valuable among people in this role: Individuals in R&D who are commercially savvy, those in Marketing with strong scientific acumen, or former consultants who have developed market assessments for pipeline assets. All of these profiles tend to do well. Success in NPP requires the ability to collaborate, work cross-functionally, and think analytically.

Keep in mind that if you are not yet ready to hire a full-time headcount, there are options to outsource this resource. You may benefit from bringing a consulting firm such as The NemetzGroup on board to execute New Product Planning activities during the time frame between preclinical and Phase 2. Optimally, the external resource would be experienced and able to routinely sit on the Program team and be part of the conversations rather than just producing deliverables.

However, you get the job done, as you move from go/no-go to the registrational trial, including the capability of NPP is a must!