Drug Commercialization Process vs. Launching

By Dora Bibila

Of all the misunderstandings that can result in a failed drug launch, one of the most common – and maybe the most tragically avoidable – is caused by a company thinking they embraced commercialization planning when really, they waited until it was time to plan for launch.

Equating a commercialization strategy as being strictly connected to the launch sets off a chain reaction of missed opportunities that end up robbing a product of its best chance at meeting the needs of patients and maximizing its potential value over its lifecycle.

Both commercialization planning and launch planning are key to your product’s market success and its ability to help patients. Let’s explore each of these terms.

The Difference Between Commercialization and Launch Planning

Commercialization is a mindset or ethos that pervades all aspects of development and preparing to bring a product to market, ultimately optimizing value for patients and the company.

• The overall set of steps that prepare the market and company to successfully deliver their product to the patients they serve.
• A complex multidimensional multiyear process that should start early in the clinical development program through preparation for launch and beyond – planning for maximum value and impact throughout the product lifecycle.
• Not just the responsibility of the commercial/marketing team. Unfortunately, this is often the assumption.

Launch planning is a later tactical process that introduces a product to the market. The launch plan applies the data gathered during earlier stages of commercialization planning to create a successful go-to-market strategy.

Objectives and Scope

Commercialization planning includes everything you do to transform an innovative idea into a viable, profitable reality. In the biopharma industry, its goal is to ensure the earliest decisions consider how to benefit patients while optimizing ROI.

To do that, commercialization considers multiple stakeholders; focuses on the needs of patients, prescribers, and payers; and considers factors like competition, evolving healthcare landscapes, and market dynamics.

The goal of launch planning, on the other hand, is to get a fully realized product into the hands of doctors and patients.

It lays out specific tactics to build awareness through marketing, grow demand through sales, and establish distribution channels to connect customers with the product.

Timing

Because commercialization has a much wider scope than launch planning, it also has a substantially longer time horizon.

Launch planning typically begins twelve to eighteen months before the product is commercially available in a given market. Commercialization planning begins far, far earlier – before the drug is even developed in the clinic. And it lasts as long as the product is on the market.

Why Commercialization Planning Needs to Start Early

Emerging biotech companies, especially, are typically focused on clinical development— potentially underestimating the critical importance of early commercialization planning in long-term success.

Early commercialization planning is important for maximizing both the value of your company and your asset. It maximizes the value of your company by:

• Demonstrating to investors, licensors, or acquirers that you are doing what is needed to achieve the maximum value of the asset.
• Showing investors what financial commitment is needed to get the asset to market—“eyes wide open.”
• Informing financing and provides a detailed overview regarding the “use of proceeds” to tell a story to potential investors or prospective BD partners.
• It provides better negotiating leverage with prospective license and acquisition partners and allows strategic evaluation of such options vs. going it alone.

And… it maximizes the value of your asset by:

• Ensuring expensive clinical development plans are informed early on with real-time market and competitive insight, ensuring a strong, differentiated product profile to meet patient needs.
• Identifying what it will take to successfully bring the product to market and maximize not just its launch but its long-term value to patients and the company over its life cycle.
• Identifying what needs to be done, when and what resources it will take, and it thereby helps support important discussions on strategic choices before getting into the details of a tactical launch plan (typically developed 12-18 months before product approval and launch).

Ideally, clinical development of a drug needs to be informed by commercialization insights starting in its early stages to secure maximum patient benefit and market success. According to Deloitte, more than one-third of new pharmaceutical launches in the U.S. fail to meet expectations – and nearly half of those failures can be chalked up to a poor understanding of market and customer needs.

Market insights are critical to start early and to continue throughout the commercialization planning period to help inform all strategy development.

Key considerations:

• Who are the patients who could benefit from this treatment? What aspects (data, features, formulation) would make our drug more attractive to them than another option?
• Who are the providers who will prescribe the treatment? What kind of data will convince them it can help their patients?
• What will convince the payers who reimburse the drug that it is worth covering?
• What competitors are already in this market? Are other treatments in development, and will they launch before us?
• What are the dynamics in the healthcare landscape? How is that landscape likely to change by the time we are ready to launch?

Market and competitive analysis in the development phase provides guidance on how to develop a strong target product profile (TPP), how to position the drug as a valuable solution for patients and providers, highly differentiated from competitive offerings. Then, the clinical trials can be specifically designed to collect data supporting that positioning.

Building early relationships with patients and their advocates before the product makes it too far down the development path provides valuable insights to guide product development.

Finally, when it comes to payers, in addition to data showing the drug is safe and effective, payers need to know how many patients might take this drug, how it will be used vs. alternative options, how it will impact patient health outcomes, how it will impact their budget, and whether it will be cost-effective to cover it.

When clinical trial design is guided by commercialization insights and market access considerations are taken into account early, plans can be put in place to ensure that data is generated to support a strong value proposition to payers.

Development of a Successful Commercialization Plan

Cross-functional integration and collaboration (meaning R&D, clinical, regulatory, market access, medical, marketing, operations planning, and communications), including the incorporation of market, customer, and patient insights throughout the journey are critical for the successful commercialization of the product.

Prioritization of critical activities and stage-gating investments during the commercialization planning period is also important to mitigate risk and ensure that investments are undertaken wisely in line with the clinical development milestones.

Launch Planning and Post-Launch Commercialization Considerations

About twelve to eighteen months before it is estimated the product may receive regulatory clearance, it’s time to translate your strategy into a tactical launch plan.

Launch plans are unique to the drug and the market and focus on all tactical aspects of bringing the drug to market including go-to-market strategy, promotional messaging and tactics, field force strategy, distribution strategy, medical education, and patient education and support programs.

After the actual product launch, commercialization planning continues. Your product must continually evolve and improve to maintain a share in a competitive market.

Years after a successful launch, the commercialization and research teams continue their collaboration to expand the label with additional indications, provide additional clinical and real-world data to help increase patient benefits, patient adherence, and doctors’ willingness to prescribe – in short, to increase product adoption, which leads to increased market success.

Biopharma companies without internal commercialization expertise can get started with commercialization and launch planning using Corval, a cloud-based strategic planning platform that enables teams to quickly build and manage tailored multi-year commercialization roadmaps, detailed budgets, and full resource plans.

Corval’s dynamic, configurable platform provides teams with a custom roadmap showing what needs to happen, when, and what resources it will take to get things done.

The cost to develop and commercialize pharmaceuticals is incredibly high and takes many years. Understanding the difference between commercialization and launch – and planning appropriately for both – is the best chance biopharma companies have of seeing a return on that investment and serving patient needs.

Dora Bibila is Corval’s in-house commercialization consultant. She is an innovative senior pharmaceutical/biotech executive with deep experience and demonstrated success in leading strategy, product development, and global commercialization.

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